Major Depressive Disorder (MDD)PERSPECTNCT07388004
Group Therapy for Major Depression: Comparing Expectation-Focused and Reward-Focused Psychotherapy Approaches
A study testing Expectation-Focused Psychotherapeutic Intervention and Reward Enhancement and Activation Therapy in people with Major Depressive Disorder (MDD), run by Philipps University Marburg at 1 site in Germany.
Trial summary
Major depressive disorder (MDD) is one of the most common psychiatric conditions and often remains difficult to treat effectively. Many patients continue to experience residual symptoms or relapse even after receiving established forms of psychotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Expectation-Focused Psychotherapeutic Intervention and Reward Enhancement and Activation Therapy
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 13 Oct 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-80 years
- Current diagnosis of major depressive disorder (MDD) according to DSM-5, confirmed by structured clinical interview (e.g., DIPS)
- Hamilton Depression Rating Scale (HAMD-21) score ≥ 9
- Ability to attend group therapy sessions (2×/week for 5 weeks)
- Ability to undergo MRI scanning (for participants in the fMRI component) Written informed consent
Who cannot join
- Current or lifetime diagnosis of bipolar disorder, psychotic disorder, or primary substance use disorder
- High acute suicide risk requiring immediate intervention
- Severe neurological disorder, brain injury, or contraindications for MRI (e.g., metal implants, claustrophobia)
- Ongoing psychotherapy or initiation of a new antidepressant medication within the past 4 weeks
- Insufficient German language proficiency to participate in therapy and complete study assessments
- Cognitive impairment or other conditions interfering with informed consent or study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Philipps-University Marburg
Marburg, Hesse, 35032
Masia Fernanda Hoffmann, M.Sc., +4917656538480, fernanda.hoffmann@uni-marburg.de
Lukas Kirchner, Dr., lukas.kirchner@uni-giessen.de
About this study
Official title: Rewiring Expectations and Amplifying Rewards: A Study Protocol for a Randomized Controlled Trial of Mechanism-Based Group Psychotherapy for Major Depressive Disorder
Major depressive disorder (MDD) is one of the most common psychiatric conditions and often remains difficult to treat effectively. Many patients continue to experience residual symptoms or relapse even after receiving established forms of psychotherapy. This study tests whether targeting specific psychological mechanisms can improve outcomes for people with depression. We compare two novel group therapies: (1) Expectation-Focused Psychotherapeutic Intervention (EFPI), which aims to modify rigid, negative expectations that maintain depressive symptoms, and (2) Reward Enhancement and Activation Therapy (REACT), which focuses on increasing sensitivity to positive experiences and strengthening reward-related learning. Both are delivered in a group format to foster peer support and shared learning.
A total of 150 adults with a current MDD diagnosis will be randomly assigned to EFPI, REACT, or a waiting-list control. Participants in the intervention groups receive 10 group sessions over five weeks. Waiting-list participants complete baseline and 3-month follow-up assessments before being offered standard treatment options.
Read more
Clinical outcomes are assessed at baseline, immediately after treatment, and at 3- and 6-month follow-ups (for the intervention groups). Primary outcomes are reductions in depressive symptoms measured by clinician ratings and self-report questionnaires. Secondary outcomes include changes in expectation processes and reward sensitivity.
In addition, functional MRI (fMRI) tasks examine brain mechanisms related to expectation updating and reward processing pre- and post-intervention, to help identify neural changes that may underlie symptom improvement.
By directly addressing dysfunctional expectations and reduced reward sensitivity, this study seeks to provide evidence for more targeted psychotherapeutic approaches. If successful, the results may support more personalized treatments and better long-term outcomes in MDD.
Read the detailed description
Major depressive disorder (MDD) remains a leading cause of disability and often shows incomplete response or relapse after established treatments. A promising strategy is to move beyond broad, symptom-focused interventions toward therapies that directly target the psychological and neurobiological mechanisms maintaining depression. This trial evaluates two mechanism-based, group-delivered psychotherapies that each target a core process implicated in MDD: maladaptive expectation processing and reduced reward sensitivity.
Rationale and mechanistic framework. Expectation pathway. Predictive coding accounts propose that the brain continuously updates prior beliefs in light of new information. In depression, negative expectations about the self, others, and the future often become rigid and resistant to change. Cognitive immunization-discounting or reframing disconfirming evidence-prevents adaptive belief updating, maintains symptoms, and can weaken responses to conventional cognitive-behavioral interventions. Targeting dysfunctional expectations directly-via structured behavioral experiments that produce positive expectation violations and procedures that reduce cognitive immunization-may restore flexibility in belief revision and enhance treatment effects.
Reward pathway. Depressed patients frequently show reduced reward sensitivity, including blunted anticipation of reward and impaired reinforcement learning, processes linked to mesolimbic dopaminergic circuitry (e.g., ventral striatum/nucleus accumbens). These deficits can limit the benefit of nonspecific activity scheduling, which increases exposure to potentially rewarding situations but does not specifically remediate anticipatory and learning-related components of reward processing. Interventions that systematically enhance reward sensitivity and strengthen reinforcement contingencies may therefore improve motivational drive and positive affect.
Neurobiological component. Expectation updating has been associated with activity in the dorsolateral prefrontal cortex (DLPFC) and anterior insula, whereas reward processing consistently engages the ventral striatum and insular cortex. This trial includes a functional MRI (fMRI) module to probe these mechanisms pre- and post-intervention. Participants perform established paradigms tapping threat/expectation learning, future-directed thinking, and social reward/expectation. Linking neural responses to clinical change will clarify how mechanism-based therapies exert their effects and may inform biomarkers for treatment selection and monitoring.
Study design overview. This is a randomized, controlled, superiority trial with three parallel groups: (1) EFPI, (2) REACT, and (3) waiting-list control. The trial follows a 3 × 5 repeated-measures design with planned assessments at baseline (pre-treatment), post-treatment (after 5 weeks), and 3- and 6-month follow-ups. Intervention groups complete all follow-ups; after the 6-month assessment they may initiate further treatment if desired. Waiting-list participants complete baseline and the 3-month follow-up before being ethically permitted to access other treatments. They continue to receive follow-up questionnaires at later time points, including items on additional treatments, to enable sensitivity analyses.
Randomization is performed at the individual level with a 1:1:1 allocation ratio. Allocation is managed through secure electronic data capture to ensure concealment until assignment. Given the nature of group psychotherapy, participants and therapists are not blinded; however, outcome assessors remain blind to group allocation, and standardized procedures are applied for clinician-rated measures. Because treatment is delivered in groups, potential therapist- and group-related effects are monitored and considered analytically.
Interventions (concise). EFPI and REACT are manualized group interventions delivered in 10 sessions over five weeks (two 100-minute sessions per week) by trained CBT therapists under regular supervision.
- EFPI targets maladaptive expectations and cognitive immunization through psychoeducation; identification/documentation of negative expectations; structured real-life behavioral experiments (predict-test-experience-reflect); guided cognitive integration to promote flexible belief updating; and maintenance strategies.
- REACT targets reduced reward sensitivity through systematic reinforcement procedures: identifying reward deficits and attentional biases; enhancing and prolonging positive experiences (e.g., savoring, imagery); structured engagement in meaningful rewarding activities with explicit reinforcement plans; and relapse-prevention strategies to sustain reward engagement.
Therapist training, supervision, adherence checklists, and standardized materials support fidelity. The waiting-list control receives no active group intervention during the first three months but is offered standard treatment options thereafter.
Assessments and timeline (overview). Clinical and behavioral data are collected at baseline, post-treatment, 3- and 6-month follow-ups in the intervention arms; the waiting-list control is assessed at baseline and 3 months prior to accessing further care. Digital data capture (e.g., REDCap) includes automated range and plausibility checks; follow-ups are facilitated via secure online questionnaires and structured telephone contacts to minimize attrition. In addition to clinician- and self-rated depression severity, the battery includes validated measures of expectation processing, reward sensitivity (anticipatory and learning components), and related cognitive-emotional constructs. Eligibility criteria and outcome measures are specified elsewhere in this record.
Neuroimaging component (overview). An fMRI module is acquired at baseline and post-intervention (or the matched 3-month time point for the waiting-list group) to assay neural correlates of expectation updating and reward processing. Paradigms include: (i) conditioning-based tasks probing threat expectancy and expectation violation; (ii) future-directed thinking tasks eliciting positive/negative prospective/retrospective imagery; and (iii) a social reward/expectation paradigm using structured interactions with virtual partners. Region-of-interest analyses focus on DLPFC/anterior insula (expectation) and ventral striatum/insula (reward); whole-brain and connectivity analyses complement ROI findings. Standard preprocessing (e.g., motion correction, normalization, smoothing) and task-based GLMs with multiple-comparison control are used. Neuroimaging endpoints are related to clinical trajectories to test mechanistic hypotheses.
Adherence, concomitant care, and retention. Participants confirm availability for the 5-week schedule before enrollment; attendance is monitored and automated reminders are sent. During the 5-week intervention phase, participants are asked to maintain stable psychotropic medication and to refrain from initiating additional psychotherapy; deviations are documented. After the intervention, participants may seek external psychotherapy; additional treatments at follow-up are recorded for sensitivity/covariate analyses. Retention is supported through reminders, flexible scheduling, and brief telephone assessments if full questionnaires are declined.
Sample size and operating characteristics. Planned enrollment is N = 150 (~50 per arm), allowing for expected attrition while preserving power to detect group × time effects of practical relevance in linear mixed-effects models. Power considerations were based on moderate effects from prior mechanism-focused psychotherapy literature; primary analyses will use linear mixed models.
Statistical analysis (overview). Primary clinical analyses use linear mixed-effects models with fixed effects for Group, Time, and their interaction, and random intercepts (and where appropriate, random slopes) to account for within-subject dependency and between-subject heterogeneity. Models will consider therapist/group clustering where indicated. Prespecified mediation analyses test whether changes in expectation processing and reward sensitivity account for symptom change; moderation analyses examine whether baseline profiles predict differential benefit. Missing data are handled under missing-at-random assumptions using maximum likelihood, with multiple imputation in sensitivity analyses. Neuroimaging analyses relate pre-to-post changes in activation/connectivity to clinical improvements; ROI-based hypotheses are complemented by exploratory whole-brain analyses with appropriate error control.
Safety monitoring and harms. Given the non-invasive, low-risk nature of group psychotherapy, no independent Data Safety Monitoring Board is planned. Safety is monitored by the investigative team throughout treatment and follow-up. Adverse events (including clinically significant symptom worsening or emergent suicidality) are documented and managed according to predefined procedures, with referral to appropriate care as needed and ethics notification when required. Criteria for discontinuation include persistent non-attendance or need for higher-level care during the intervention phase.
Data management and confidentiality. All data are pseudonymized (unique study IDs); identifying information is stored separately on access-restricted institutional servers. Electronic data capture uses role-based access, audit trails, and automated checks. After completion, personally identifying data are deleted; anonymized datasets are retained per policy and may be shared under GDPR-compliant agreements to support transparency and reproducibility.
Ethical conduct and dissemination. The protocol adheres to SPIRIT recommendations and has received ethics approval from the responsible institutional review board. Written informed consent is obtained from all participants prior to any study procedures. Results will be disseminated via peer-reviewed publications and scientific meetings; de-identified data and analysis code may be shared under controlled access agreements to promote open science.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Expectation-Focused Psychotherapeutic Intervention, Reward Enhancement and Activation Therapy
- Keywords
- Major Depressive Disorder, Psychotherapy, Group Therapy, Expectation Violation, Reward Sensitivity, Mechanism-Based Intervention, Randomized Clinical Trial
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expectation-Focused Psychotherapeutic InterventionBehavioural
Also called EFPI
EFPI is a manualized group psychotherapy for major depressive disorder that directly targets maladaptive expectations. The treatment integrates psychoeducation, cognitive restructuring, and behavioral experiments to modify negative expectancies and reduce cognitive immunization, thereby enhancing adaptive expectation updating.
Delivery: Group format (5-10 participants), 10 sessions (twice weekly for 5 weeks).
Reward Enhancement and Activation TherapyBehavioural
Also called REACT
REACT is a manualized group psychotherapy for major depressive disorder that focuses on enhancing reward sensitivity and motivation. The intervention combines attentional retraining, savoring techniques, and reinforcement-based strategies to increase engagement with rewarding stimuli and experiences.
Delivery: Group format (5-10 participants), 10 sessions (twice weekly for 5 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Expectation-Focused Psychotherapeutic Intervention (EFPI) | Experimental | Participants receive 10 group therapy sessions (2 sessions per week over 5 weeks) of EFPI, a mechanism-based psychotherapy targeting maladaptive expectations.
The intervention combines psychoeducation, structured behavioral experiments, and cognitive restructuring to systematically challenge negative expectations.
A central focus is reducing cognitive immunization-the tendency to dismiss or reframe positive disconfirming evidence-to foster more flexible and adaptive belief updating.
Sessions are conducted in small groups (5-10 participants) to facilitate peer modeling, social reinforcement, and shared learning.
The first session includes baseline clinical assessments, and the final session includes immediate post-treatment assessments.
All participants are additionally followed up at 3 and 6 months after the intervention to evaluate the persistence of treatment effects. Receives: Behavioral: Expectation-Focused Psychotherapeutic Intervention |
| Reward Enhancement and Activation Therapy (REACT) | Experimental | Participants receive 10 group therapy sessions (2 sessions per week over 5 weeks) of REACT, a mechanism-based psychotherapy designed to enhance reward sensitivity.
Core intervention components include attentional retraining toward rewarding stimuli, savoring exercises to prolong positive affect, and structured reinforcement plans to strengthen motivation and engagement in rewarding activities.
Group discussions normalize difficulties in experiencing pleasure and provide strategies for sustaining rewarding behavior long-term.
Sessions are conducted in small groups (5-10 participants). The first session includes baseline assessments, and the final session includes immediate post-treatment assessments.
Long-term outcomes are assessed through follow-up evaluations at 3- and 6-months post-intervention. Receives: Behavioral: Reward Enhancement and Activation Therapy |
| Waiting-List Control | No intervention | Participants assigned to the waiting-list control condition do not receive active treatment during the initial 3-month period. They complete baseline assessments at study entry and a follow-up assessment after 3 months, corresponding to the time frame of the active intervention arms. After the 3-month assessment, participants are ethically permitted to pursue standard care outside the study. For comparability and long-term analyses, waiting-list participants continue to complete follow-up assessments at 6 months, including questions about any additional treatments received after the waiting-list phase. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depressive Symptoms (Beck Depression Inventory-II)
Change in depressive symptom severity assessed with the Beck Depression Inventory-II (BDI-II), a 21-item self-report questionnaire measuring cognitive, affective, and somatic symptoms of depression.
Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms.
The primary endpoint is the change from baseline to post-treatment (5 weeks). Symptom stability and maintenance will be examined at follow-up assessments.
Measured: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups
Secondary outcomes (9)
Change in Depressive Symptoms (Hamilton Depression Rating Scale, 21-item)
Change in clinician-rated depressive symptom severity assessed with the Hamilton Depression Rating Scale (HAMD-21), administered by trained, blinded assessors.
Total scores range from 0 to 64, with higher scores indicating more severe depressive symptoms.
Measured: Baseline and post-treatment (5 weeks)
Depressive Expectations (Depressive Expectations Scale)
Change in depressive expectations assessed with the Depressive Expectations Scale (DES), a self-report questionnaire measuring negative, situation-specific expectations related to mood regulation, social interactions, performance, and coping. Items are rated on a 5-point Likert scale; higher scores indicate more negative and dysfunctional expectations.
Measured: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups
Hopelessness (Beck Hopelessness Scale)
Change in hopelessness assessed with the Beck Hopelessness Scale (BHS), a 20-item self-report questionnaire measuring negative expectations about the future.
Total scores range from 0 to 20, with higher scores indicating greater hopelessness.
Measured: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups
Socially Negative Expectations (Social Anxiety-Negative Beliefs Scale, SANB-5)
Change in negative social expectations assessed with the Social Anxiety-Negative Beliefs Scale (SANB-5), a 5-item self-report measure capturing fears of negative evaluation and rejection in social contexts.
Items are rated on a 4-point Likert scale; higher scores indicate stronger negative social expectations.
Measured: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups
Behavioral Activation and Reward Responsiveness (Behavioral Activation System Scale)
Change in reward responsiveness assessed with the Behavioral Activation System (BAS) Scale, a self-report questionnaire measuring approach motivation, reward sensitivity, and positive affective reactivity.
Items are rated on a 4-point Likert scale; higher scores indicate greater behavioral activation and reward sensitivity.
Measured: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups
Resilience (Resilience Scale, RS-25)
Change in psychological resilience assessed with the Resilience Scale (RS-25), a 25-item self-report questionnaire measuring personal competence, acceptance of self and life, and adaptive functioning.
Items are rated on a 7-point Likert scale; higher scores indicate greater resilience.
Measured: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups
General Self-Efficacy (Allgemeine Selbstwirksamkeit Kurzskala, ASKU)
Change in perceived self-efficacy assessed with the General Self-Efficacy Short Scale (ASKU), a 3-item self-report measure of confidence in one's ability to cope with difficult situations.
Items are rated on a 5-point scale; higher scores indicate greater self-efficacy.
Measured: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups
Treatment Expectations and Experiences (Generic Expectation Evaluation Questionnaire)
Treatment-related expectations and experiences assessed with the Generic Expectation Evaluation Questionnaire (G-EEE), including expected symptom improvement, worsening, and side effects prior to treatment, as well as perceived changes during and after treatment.
Ratings are provided on numerical rating scales from 0 to 10, with higher scores indicating stronger expectations or perceived effects.
Measured: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups
Suicidal Ideation and Behavior (Suicide Behaviors Questionnaire-Revised)
Suicidal ideation and behavior assessed with the Suicide Behaviors Questionnaire-Revised (SBQ-R), a 4-item self-report screening instrument covering lifetime suicidal ideation and attempts, frequency of ideation, threat of attempt, and self-assessed likelihood of future suicide.
Item responses are recoded and summed to yield a total score ranging from 3 to 18; higher scores indicate greater suicide risk.
Measured: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start13 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in equal proportions to one of three parallel groups: EFPI, REACT, or waiting-list control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Sponsor
- Investigators
- Winfried Rief, Prof. Dr., Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388004
- Sponsor's protocol ID
- PERSPECT CRC393-C02
- Other IDs
- 521379614, 23-272BO
- Acronym
- PERSPECT
- Status last verified
- Feb 2026
- First submitted
- 8 Dec 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be made available upon reasonable request after publication of the main results, in accordance with DFG and CRC/TRR 393 data sharing policies. Data access will require a data use agreement and ethical approval.
Publications
Treadway MT, Zald DH. Reconsidering anhedonia in depression: lessons from translational neuroscience. Neurosci Biobehav Rev. 2011 Jan;35(3):537-55. doi: 10.1016/j.neubiorev.2010.06.006. Epub 2010 Jul 11.
PubMed 20603146Whitton AE, Treadway MT, Pizzagalli DA. Reward processing dysfunction in major depression, bipolar disorder and schizophrenia. Curr Opin Psychiatry. 2015 Jan;28(1):7-12. doi: 10.1097/YCO.0000000000000122.
PubMed 25415499Watkins E, Brown RG. Rumination and executive function in depression: an experimental study. J Neurol Neurosurg Psychiatry. 2002 Mar;72(3):400-2. doi: 10.1136/jnnp.72.3.400.
PubMed 11861707Kazdin AE. Mediators and mechanisms of change in psychotherapy research. Annu Rev Clin Psychol. 2007;3:1-27. doi: 10.1146/annurev.clinpsy.3.022806.091432.
PubMed 17716046Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.
PubMed 17074942Rief W, Shedden-Mora MC, Laferton JA, Auer C, Petrie KJ, Salzmann S, Schedlowski M, Moosdorf R. Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial. BMC Med. 2017 Jan 10;15(1):4. doi: 10.1186/s12916-016-0767-3.
PubMed 28069021Rief W, Anna Glombiewski J. The role of expectations in mental disorders and their treatment. World Psychiatry. 2017 Jun;16(2):210-211. doi: 10.1002/wps.20427. No abstract available.
PubMed 28498580Potsch L, Rief W. Transdiagnostic considerations of the relationship between reward sensitivity and psychopathological symptoms - a cross-lagged panel analysis. BMC Psychiatry. 2023 Sep 4;23(1):650. doi: 10.1186/s12888-023-05139-3.
PubMed 37667190Pizzagalli DA. Toward a Better Understanding of the Mechanisms and Pathophysiology of Anhedonia: Are We Ready for Translation? Am J Psychiatry. 2022 Jul;179(7):458-469. doi: 10.1176/appi.ajp.20220423.
PubMed 35775159Pizzagalli DA. Depression, stress, and anhedonia: toward a synthesis and integrated model. Annu Rev Clin Psychol. 2014;10:393-423. doi: 10.1146/annurev-clinpsy-050212-185606.
PubMed 24471371Pan PM, Sato JR, Paillere Martinot ML, Martinot JL, Artiges E, Penttila J, Grimmer Y, van Noort BM, Becker A, Banaschewski T, Bokde ALW, Desrivieres S, Flor H, Garavan H, Ittermann B, Nees F, Papadopoulos Orfanos D, Poustka L, Frohner JH, Whelan R, Schumann G, Westwater ML, Grillon C, Cogo-Moreira H, Stringaris A, Ernst M; IMAGEN Consortium. Longitudinal Trajectory of the Link Between Ventral Striatum and Depression in Adolescence. Am J Psychiatry. 2022 Jul;179(7):470-481. doi: 10.1176/appi.ajp.20081180. Epub 2022 May 18.
PubMed 35582783Kube T, Schwarting R, Rozenkrantz L, Glombiewski JA, Rief W. Distorted Cognitive Processes in Major Depression: A Predictive Processing Perspective. Biol Psychiatry. 2020 Mar 1;87(5):388-398. doi: 10.1016/j.biopsych.2019.07.017. Epub 2019 Jul 29.
PubMed 31515055Kube T, Rief W, Gollwitzer M, Gartner T, Glombiewski JA. Why dysfunctional expectations in depression persist - Results from two experimental studies investigating cognitive immunization. Psychol Med. 2019 Jul;49(9):1532-1544. doi: 10.1017/S0033291718002106. Epub 2018 Aug 22.
PubMed 30131084Kirchner L, Rief W, Muller L, Buchwald H, Fuhrmann K, Berg M. Depressive symptoms and the processing of unexpected social feedback: Differences in surprise levels, feedback acceptance, and "immunizing" cognition. PLoS One. 2024 Aug 26;19(8):e0307035. doi: 10.1371/journal.pone.0307035. eCollection 2024.
PubMed 39186743Insel TR, Cuthbert BN. Medicine. Brain disorders? Precisely. Science. 2015 May 1;348(6234):499-500. doi: 10.1126/science.aab2358. No abstract available.
PubMed 25931539
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rewiring Expectations and Amplifying Rewards: A Study Protocol for a Randomized Controlled Trial of Mechanism-Based Group Psychotherapy for Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07388004
- Acronym / sponsor ID
- PERSPECT / PERSPECT CRC393-C02
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Major Depressive Disorder, Psychotherapy, Group Therapy, Expectation Violation, Reward Sensitivity, Mechanism-Based Intervention, Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Major depressive disorder (MDD) is one of the most common psychiatric conditions and often remains difficult to treat effectively. Many patients continue to experience residual symptoms or relapse even after receiving established forms of psychotherapy. This study tests whether targeting specific psychological mechanisms can improve outcomes for people with depression. We compare two novel group therapies: (1) Expectation-Focused Psychotherapeutic Intervention (EFPI), which aims to modify rigid, negative expectations that maintain depressive symptoms, and (2) Reward Enhancement and Activation Therapy (REACT), which focuses on increasing sensitivity to positive experiences and strengthening reward-related learning. Both are delivered in a group format to foster peer support and shared learning.
A total of 150 adults with a current MDD diagnosis will be randomly assigned to EFPI, REACT, or a waiting-list control. Participants in the intervention groups receive 10 group sessions over five weeks. Waiting-list participants complete baseline and 3-month follow-up assessments before being offered standard treatment options.
Clinical outcomes are assessed at baseline, immediately after treatment, and at 3- and 6-month follow-ups (for the intervention groups). Primary outcomes are reductions in depressive symptoms measured by clinician ratings and self-report questionnaires. Secondary outcomes include changes in expectation processes and reward sensitivity.
In addition, functional MRI (fMRI) tasks examine brain mechanisms related to expectation updating and reward processing pre- and post-intervention, to help identify neural changes that may underlie symptom improvement.
By directly addressing dysfunctional expectations and reduced reward sensitivity, this study seeks to provide evidence for more targeted psychotherapeutic approaches. If successful, the results may support more personalized treatments and better long-term outcomes in MDD.
Detailed description
Major depressive disorder (MDD) remains a leading cause of disability and often shows incomplete response or relapse after established treatments. A promising strategy is to move beyond broad, symptom-focused interventions toward therapies that directly target the psychological and neurobiological mechanisms maintaining depression. This trial evaluates two mechanism-based, group-delivered psychotherapies that each target a core process implicated in MDD: maladaptive expectation processing and reduced reward sensitivity.
Rationale and mechanistic framework. Expectation pathway. Predictive coding accounts propose that the brain continuously updates prior beliefs in light of new information. In depression, negative expectations about the self, others, and the future often become rigid and resistant to change. Cognitive immunization-discounting or reframing disconfirming evidence-prevents adaptive belief updating, maintains symptoms, and can weaken responses to conventional cognitive-behavioral interventions. Targeting dysfunctional expectations directly-via structured behavioral experiments that produce positive expectation violations and procedures that reduce cognitive immunization-may restore flexibility in belief revision and enhance treatment effects.
Reward pathway. Depressed patients frequently show reduced reward sensitivity, including blunted anticipation of reward and impaired reinforcement learning, processes linked to mesolimbic dopaminergic circuitry (e.g., ventral striatum/nucleus accumbens). These deficits can limit the benefit of nonspecific activity scheduling, which increases exposure to potentially rewarding situations but does not specifically remediate anticipatory and learning-related components of reward processing. Interventions that systematically enhance reward sensitivity and strengthen reinforcement contingencies may therefore improve motivational drive and positive affect.
Neurobiological component. Expectation updating has been associated with activity in the dorsolateral prefrontal cortex (DLPFC) and anterior insula, whereas reward processing consistently engages the ventral striatum and insular cortex. This trial includes a functional MRI (fMRI) module to probe these mechanisms pre- and post-intervention. Participants perform established paradigms tapping threat/expectation learning, future-directed thinking, and social reward/expectation. Linking neural responses to clinical change will clarify how mechanism-based therapies exert their effects and may inform biomarkers for treatment selection and monitoring.
Study design overview. This is a randomized, controlled, superiority trial with three parallel groups: (1) EFPI, (2) REACT, and (3) waiting-list control. The trial follows a 3 × 5 repeated-measures design with planned assessments at baseline (pre-treatment), post-treatment (after 5 weeks), and 3- and 6-month follow-ups. Intervention groups complete all follow-ups; after the 6-month assessment they may initiate further treatment if desired. Waiting-list participants complete baseline and the 3-month follow-up before being ethically permitted to access other treatments. They continue to receive follow-up questionnaires at later time points, including items on additional treatments, to enable sensitivity analyses.
Randomization is performed at the individual level with a 1:1:1 allocation ratio. Allocation is managed through secure electronic data capture to ensure concealment until assignment. Given the nature of group psychotherapy, participants and therapists are not blinded; however, outcome assessors remain blind to group allocation, and standardized procedures are applied for clinician-rated measures. Because treatment is delivered in groups, potential therapist- and group-related effects are monitored and considered analytically.
Interventions (concise). EFPI and REACT are manualized group interventions delivered in 10 sessions over five weeks (two 100-minute sessions per week) by trained CBT therapists under regular supervision.
- EFPI targets maladaptive expectations and cognitive immunization through psychoeducation; identification/documentation of negative expectations; structured real-life behavioral experiments (predict-test-experience-reflect); guided cognitive integration to promote flexible belief updating; and maintenance strategies.
- REACT targets reduced reward sensitivity through systematic reinforcement procedures: identifying reward deficits and attentional biases; enhancing and prolonging positive experiences (e.g., savoring, imagery); structured engagement in meaningful rewarding activities with explicit reinforcement plans; and relapse-prevention strategies to sustain reward engagement.
Therapist training, supervision, adherence checklists, and standardized materials support fidelity. The waiting-list control receives no active group intervention during the first three months but is offered standard treatment options thereafter.
Assessments and timeline (overview). Clinical and behavioral data are collected at baseline, post-treatment, 3- and 6-month follow-ups in the intervention arms; the waiting-list control is assessed at baseline and 3 months prior to accessing further care. Digital data capture (e.g., REDCap) includes automated range and plausibility checks; follow-ups are facilitated via secure online questionnaires and structured telephone contacts to minimize attrition. In addition to clinician- and self-rated depression severity, the battery includes validated measures of expectation processing, reward sensitivity (anticipatory and learning components), and related cognitive-emotional constructs. Eligibility criteria and outcome measures are specified elsewhere in this record.
Neuroimaging component (overview). An fMRI module is acquired at baseline and post-intervention (or the matched 3-month time point for the waiting-list group) to assay neural correlates of expectation updating and reward processing. Paradigms include: (i) conditioning-based tasks probing threat expectancy and expectation violation; (ii) future-directed thinking tasks eliciting positive/negative prospective/retrospective imagery; and (iii) a social reward/expectation paradigm using structured interactions with virtual partners. Region-of-interest analyses focus on DLPFC/anterior insula (expectation) and ventral striatum/insula (reward); whole-brain and connectivity analyses complement ROI findings. Standard preprocessing (e.g., motion correction, normalization, smoothing) and task-based GLMs with multiple-comparison control are used. Neuroimaging endpoints are related to clinical trajectories to test mechanistic hypotheses.
Adherence, concomitant care, and retention. Participants confirm availability for the 5-week schedule before enrollment; attendance is monitored and automated reminders are sent. During the 5-week intervention phase, participants are asked to maintain stable psychotropic medication and to refrain from initiating additional psychotherapy; deviations are documented. After the intervention, participants may seek external psychotherapy; additional treatments at follow-up are recorded for sensitivity/covariate analyses. Retention is supported through reminders, flexible scheduling, and brief telephone assessments if full questionnaires are declined.
Sample size and operating characteristics. Planned enrollment is N = 150 (~50 per arm), allowing for expected attrition while preserving power to detect group × time effects of practical relevance in linear mixed-effects models. Power considerations were based on moderate effects from prior mechanism-focused psychotherapy literature; primary analyses will use linear mixed models.
Statistical analysis (overview). Primary clinical analyses use linear mixed-effects models with fixed effects for Group, Time, and their interaction, and random intercepts (and where appropriate, random slopes) to account for within-subject dependency and between-subject heterogeneity. Models will consider therapist/group clustering where indicated. Prespecified mediation analyses test whether changes in expectation processing and reward sensitivity account for symptom change; moderation analyses examine whether baseline profiles predict differential benefit. Missing data are handled under missing-at-random assumptions using maximum likelihood, with multiple imputation in sensitivity analyses. Neuroimaging analyses relate pre-to-post changes in activation/connectivity to clinical improvements; ROI-based hypotheses are complemented by exploratory whole-brain analyses with appropriate error control.
Safety monitoring and harms. Given the non-invasive, low-risk nature of group psychotherapy, no independent Data Safety Monitoring Board is planned. Safety is monitored by the investigative team throughout treatment and follow-up. Adverse events (including clinically significant symptom worsening or emergent suicidality) are documented and managed according to predefined procedures, with referral to appropriate care as needed and ethics notification when required. Criteria for discontinuation include persistent non-attendance or need for higher-level care during the intervention phase.
Data management and confidentiality. All data are pseudonymized (unique study IDs); identifying information is stored separately on access-restricted institutional servers. Electronic data capture uses role-based access, audit trails, and automated checks. After completion, personally identifying data are deleted; anonymized datasets are retained per policy and may be shared under GDPR-compliant agreements to support transparency and reproducibility.
Ethical conduct and dissemination. The protocol adheres to SPIRIT recommendations and has received ethics approval from the responsible institutional review board. Written informed consent is obtained from all participants prior to any study procedures. Results will be disseminated via peer-reviewed publications and scientific meetings; de-identified data and analysis code may be shared under controlled access agreements to promote open science.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in equal proportions to one of three parallel groups: EFPI, REACT, or waiting-list control.
| Arm | Type | Receives |
|---|---|---|
| Expectation-Focused Psychotherapeutic Intervention (EFPI) | Experimental | Behavioral: Expectation-Focused Psychotherapeutic InterventionParticipants receive 10 group therapy sessions (2 sessions per week over 5 weeks) of EFPI, a mechanism-based psychotherapy targeting maladaptive expectations. The intervention combines psychoeducation, structured behavioral experiments, and cognitive restructuring to systematically challenge negative expectations. A central focus is reducing cognitive immunization-the tendency to dismiss or reframe positive disconfirming evidence-to foster more flexible and adaptive belief updating. Sessions are conducted in small groups (5-10 participants) to facilitate peer modeling, social reinforcement, and shared learning. The first session includes baseline clinical assessments, and the final session includes immediate post-treatment assessments. All participants are additionally followed up at 3 and 6 months after the intervention to evaluate the persistence of treatment effects. |
| Reward Enhancement and Activation Therapy (REACT) | Experimental | Behavioral: Reward Enhancement and Activation TherapyParticipants receive 10 group therapy sessions (2 sessions per week over 5 weeks) of REACT, a mechanism-based psychotherapy designed to enhance reward sensitivity. Core intervention components include attentional retraining toward rewarding stimuli, savoring exercises to prolong positive affect, and structured reinforcement plans to strengthen motivation and engagement in rewarding activities. Group discussions normalize difficulties in experiencing pleasure and provide strategies for sustaining rewarding behavior long-term. Sessions are conducted in small groups (5-10 participants). The first session includes baseline assessments, and the final session includes immediate post-treatment assessments. Long-term outcomes are assessed through follow-up evaluations at 3- and 6-months post-intervention. |
| Waiting-List Control | No intervention | –Participants assigned to the waiting-list control condition do not receive active treatment during the initial 3-month period. They complete baseline assessments at study entry and a follow-up assessment after 3 months, corresponding to the time frame of the active intervention arms. After the 3-month assessment, participants are ethically permitted to pursue standard care outside the study. For comparability and long-term analyses, waiting-list participants continue to complete follow-up assessments at 6 months, including questions about any additional treatments received after the waiting-list phase. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-80 years
- Current diagnosis of major depressive disorder (MDD) according to DSM-5, confirmed by structured clinical interview (e.g., DIPS)
- Hamilton Depression Rating Scale (HAMD-21) score ≥ 9
- Ability to attend group therapy sessions (2×/week for 5 weeks)
- Ability to undergo MRI scanning (for participants in the fMRI component) Written informed consent
Key exclusion criteria (6 listed)
- Current or lifetime diagnosis of bipolar disorder, psychotic disorder, or primary substance use disorder
- High acute suicide risk requiring immediate intervention
- Severe neurological disorder, brain injury, or contraindications for MRI (e.g., metal implants, claustrophobia)
- Ongoing psychotherapy or initiation of a new antidepressant medication within the past 4 weeks
- Insufficient German language proficiency to participate in therapy and complete study assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expectation-Focused Psychotherapeutic InterventionAlso: EFPIEFPI is a manualized group psychotherapy for major depressive disorder that directly targets maladaptive expectations. The treatment integrates psychoeducation, cognitive restructuring, and behavioral experiments to modify negative expectancies and reduce cognitive immunization, thereby enhancing adaptive expectation updating. Delivery: Group format (5-10 participants), 10 sessions (twice weekly for 5 weeks). | Behavioural | Expectation-Focused Psychotherapeutic Intervention (EFPI) |
| Reward Enhancement and Activation TherapyAlso: REACTREACT is a manualized group psychotherapy for major depressive disorder that focuses on enhancing reward sensitivity and motivation. The intervention combines attentional retraining, savoring techniques, and reinforcement-based strategies to increase engagement with rewarding stimuli and experiences. Delivery: Group format (5-10 participants), 10 sessions (twice weekly for 5 weeks). | Behavioural | Reward Enhancement and Activation Therapy (REACT) |
Primary outcome
Change in Depressive Symptoms (Beck Depression Inventory-II)
Time frame: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups
Change in depressive symptom severity assessed with the Beck Depression Inventory-II (BDI-II), a 21-item self-report questionnaire measuring cognitive, affective, and somatic symptoms of depression. Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms. The primary endpoint is the change from baseline to post-treatment (5 weeks). Symptom stability and maintenance will be examined at follow-up assessments.
9 secondary outcomes
Change in Depressive Symptoms (Hamilton Depression Rating Scale, 21-item)
Time frame: Baseline and post-treatment (5 weeks)
Depressive Expectations (Depressive Expectations Scale)
Time frame: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups
Hopelessness (Beck Hopelessness Scale)
Time frame: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups
Socially Negative Expectations (Social Anxiety-Negative Beliefs Scale, SANB-5)
Time frame: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups
Behavioral Activation and Reward Responsiveness (Behavioral Activation System Scale)
Time frame: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups
Resilience (Resilience Scale, RS-25)
Time frame: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups
General Self-Efficacy (Allgemeine Selbstwirksamkeit Kurzskala, ASKU)
Time frame: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups
Treatment Expectations and Experiences (Generic Expectation Evaluation Questionnaire)
Time frame: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups
Suicidal Ideation and Behavior (Suicide Behaviors Questionnaire-Revised)
Time frame: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 20603146Treadway MT, Zald DH. Reconsidering anhedonia in depression: lessons from translational neuroscience. Neurosci Biobehav Rev. 2011 Jan;35(3):537-55. doi: 10.1016/j.neubiorev.2010.06.006. Epub 2010 Jul 11.
- Background: PubMed 25415499Whitton AE, Treadway MT, Pizzagalli DA. Reward processing dysfunction in major depression, bipolar disorder and schizophrenia. Curr Opin Psychiatry. 2015 Jan;28(1):7-12. doi: 10.1097/YCO.0000000000000122.
- Background: PubMed 11861707Watkins E, Brown RG. Rumination and executive function in depression: an experimental study. J Neurol Neurosurg Psychiatry. 2002 Mar;72(3):400-2. doi: 10.1136/jnnp.72.3.400.
- Background: PubMed 17716046Kazdin AE. Mediators and mechanisms of change in psychotherapy research. Annu Rev Clin Psychol. 2007;3:1-27. doi: 10.1146/annurev.clinpsy.3.022806.091432.
- Background: PubMed 17074942Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.
- Background: PubMed 28069021Rief W, Shedden-Mora MC, Laferton JA, Auer C, Petrie KJ, Salzmann S, Schedlowski M, Moosdorf R. Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial. BMC Med. 2017 Jan 10;15(1):4. doi: 10.1186/s12916-016-0767-3.
- Background: PubMed 28498580Rief W, Anna Glombiewski J. The role of expectations in mental disorders and their treatment. World Psychiatry. 2017 Jun;16(2):210-211. doi: 10.1002/wps.20427. No abstract available.
- Background: PubMed 37667190Potsch L, Rief W. Transdiagnostic considerations of the relationship between reward sensitivity and psychopathological symptoms - a cross-lagged panel analysis. BMC Psychiatry. 2023 Sep 4;23(1):650. doi: 10.1186/s12888-023-05139-3.
- Background: PubMed 35775159Pizzagalli DA. Toward a Better Understanding of the Mechanisms and Pathophysiology of Anhedonia: Are We Ready for Translation? Am J Psychiatry. 2022 Jul;179(7):458-469. doi: 10.1176/appi.ajp.20220423.
- Background: PubMed 24471371Pizzagalli DA. Depression, stress, and anhedonia: toward a synthesis and integrated model. Annu Rev Clin Psychol. 2014;10:393-423. doi: 10.1146/annurev-clinpsy-050212-185606.
- Background: PubMed 35582783Pan PM, Sato JR, Paillere Martinot ML, Martinot JL, Artiges E, Penttila J, Grimmer Y, van Noort BM, Becker A, Banaschewski T, Bokde ALW, Desrivieres S, Flor H, Garavan H, Ittermann B, Nees F, Papadopoulos Orfanos D, Poustka L, Frohner JH, Whelan R, Schumann G, Westwater ML, Grillon C, Cogo-Moreira H, Stringaris A, Ernst M; IMAGEN Consortium. Longitudinal Trajectory of the Link Between Ventral Striatum and Depression in Adolescence. Am J Psychiatry. 2022 Jul;179(7):470-481. doi: 10.1176/appi.ajp.20081180. Epub 2022 May 18.
- Background: PubMed 31515055Kube T, Schwarting R, Rozenkrantz L, Glombiewski JA, Rief W. Distorted Cognitive Processes in Major Depression: A Predictive Processing Perspective. Biol Psychiatry. 2020 Mar 1;87(5):388-398. doi: 10.1016/j.biopsych.2019.07.017. Epub 2019 Jul 29.
- World Health Organization. (2023). Mental health at work. WHO.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be made available upon reasonable request after publication of the main results, in accordance with DFG and CRC/TRR 393 data sharing policies. Data access will require a data use agreement and ethical approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Winfried Rief, Prof. Dr. principal investigator
Philipps University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expectation-Focused Psychotherapeutic Intervention and Reward Enhancement and Activation Therapy in people with Major Depressive Disorder (MDD), run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Masia Fernanda Hoffmann, M.Sc. (+4917656538480, fernanda.hoffmann@uni-marburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive Symptoms (Beck Depression Inventory-II) (time frame: Baseline, post-treatment (5 weeks), 3-month and 6-month follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07388004, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.