Major DepressionMINDNCT07380451
Modular Intervention for Depression Study
A study testing Modular Intervention for Depression Therapy (MIND Therapy) and Psychotherapy as Usual (TAU) in people with Major Depression, run by Pontificia Universidad Catolica de Chile at 5 sites in Chile.
Trial summary
The goal of this psychotherapy clinical trial is to evaluate whether a algorithm-based personalized modular psychotherapy is more effective than usual individual psychotherapy in treating major depressive disorder complicated by personality dysfunction and/or complex trauma in adults aged 18 to 65 receiving care in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Modular Intervention for Depression Therapy (MIND Therapy) and Psychotherapy as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesChile
- Study dates
- 1 May 2026to 28 Feb 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current diagnosis of major depressive disorder, defined as:
- Positive diagnosis on the MINI diagnostic interview, and
- PHQ-9 score greater than 10
- Evidence of personality dysfunction, defined as a score above the cutoff on the Level of Personality Functioning Scale-Brief Form (LPFS-BF 2.0).
- History of moderate to severe early life adversity, defined as elevated scores on at least one scale of the Childhood Trauma Questionnaire (CTQ), and/or clinically significant alterations in self-organization.
- Presence of at least one elevated domain of alteration of self-organization, including emotion regulation difficulties, interpersonal sensitivity, and/or interpersonal functioning problems, as assessed by standardized self-report measures (DERS, A-RSQ, OQ-45-IR).
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- Receiving care at a participating public community mental health center in Chile.
- Ownership of a smartphone (Android or iOS) with internet access and an active data plan.
- Ability to provide written informed consent.
Who cannot join
- Acute suicide risk requiring immediate intensive intervention, as assessed by the MINI.
- Any severe psychiatric disorder other than major depressive disorder that is the primary clinical diagnosis, including:
- Schizophrenia or other psychotic disorders
- Bipolar I disorder
- Severe substance use disorder, active within the past 6 months.
- Diagnosis of post-traumatic stress disorder (PTSD) meeting full diagnostic criteria, as assessed by standardized instruments (ITEM and ITQ).
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- Meeting diagnostic criteria for:
- Antisocial personality disorder (two or more criteria), or
- Borderline personality disorder with more than three diagnostic criteria
- Severe medical, cognitive, or psychosocial condition that would interfere with participation in weekly psychotherapy.
- Concurrent participation in another active psychotherapy or initiation/change of psychotropic medication during the study period, except for:
- Stable antidepressant treatment
- Medications prescribed for sleep
- Benzodiazepines used only on an as-needed (PRN) basis.
- Inability to comply with study procedures or assessments.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Chile5 sites, 4 recruiting
- Recruiting
CDT CASR
Santiago
Director, +56925762330, matiascorrearamirez@gmail.com
- Active, not recruiting
COSAM La Bandera
Santiago
- Recruiting
COSAM La Granja
Santiago
Director, +5625761806, direccioncosam09@gmail.com
- Recruiting
COSAM La Pintana
Santiago
Director, +5625457697, cosampintana@gmail.com
- Recruiting
COSAM Rinconada
Santiago
Director, +56925412271, cosamrinconada.sanramon@gmail.com
About this study
Official title: Modular Optimization of Psychotherapy for Individuals With Depression Complicated by Personality Dysfunction and Complex Trauma: A Pilot Study in the Chilean Public Health System
The goal of this psychotherapy clinical trial is to evaluate whether a algorithm-based personalized modular psychotherapy is more effective than usual individual psychotherapy in treating major depressive disorder complicated by personality dysfunction and/or complex trauma in adults aged 18 to 65 receiving care in the Chilean public mental health system.
The main questions it aims to answer are:
Read more
- Does algorithm-based modular psychotherapy lead to greater clinically significant reduction and remission of depressive symptoms compared to usual psychotherapy?
- Does algorithm-based modular psychotherapy lead to greater improvement in emotional regulation, interpersonal functioning, and self-related functioning, including changes observed in daily life?
Researchers will compare algorithm-based modular psychotherapy to usual individual psychotherapy provided in public community mental health centers to see if the modular, personalized approach results in better clinical outcomes, stronger therapeutic alliance, and higher treatment satisfaction.
Participants will:
- Be randomly assigned to receive either algorithm-based modular psychotherapy or usual individual psychotherapy
- Attend weekly individual psychotherapy sessions
- Complete structured diagnostic interviews and self-report questionnaires before, during, and after treatment
- Provide brief daily reports on mood, emotions, and interpersonal experiences using a smartphone before and after treatment
Read the detailed description
This randomized controlled clinical trial evaluates an algorithm-based personalized modular psychotherapy designed for adults with major depressive disorder whose condition is complicated by long-standing emotional, interpersonal, and self-related difficulties associated with early life adversity or personality functioning problems. These individuals often have poorer outcomes with standard psychotherapeutic approaches offered in public mental health services.
The experimental intervention consists of a modular psychotherapy approach. All participants in this group receive a core, evidence-based depression treatment. Additional short therapy modules are added based on each participant's baseline clinical profile following a module-assignment algorithm, targeting specific difficulties such as problems with emotion regulation, sensitivity to rejection and interpersonal threat, difficulties in social functioning, or disturbances in self-concept and self-worth. The number and type of modules are personalized for each participant, allowing the treatment to be tailored while remaining feasible within routine public mental health care.
The comparison group receives usual individual psychotherapy, which reflects standard care provided in community mental health centers in Chile. These treatments are delivered weekly by trained clinicians and are not guided by the modular protocol.
150 adults aged 18 to 65 will be recruited from public mental health centers. Eligible participants have major depressive disorder along with evidence of personality-related dysfunction and/or moderate to severe early life trauma. Participants are randomly assigned in a 1:1 ratio to either modular psychotherapy or usual care.
The primary outcomes of the study are clinically meaningful reduction in depressive symptoms and remission from depression following treatment. Secondary outcomes include changes in emotional regulation, interpersonal functioning, daily emotional and interpersonal experiences assessed through brief smartphone-based daily reports, quality of the therapeutic alliance, and satisfaction with treatment from both patients and therapists.
The purpose of this pilot trial is to determine whether a personalized algorithm-based modular psychotherapy approach improves clinical and functional outcomes compared to usual psychotherapy for people with complex depression in the Chilean public health system, and to inform future implementation and scaling of personalized mental health interventions.
- Conditions
- Major Depression
- Being tested
- Modular Intervention for Depression Therapy (MIND Therapy), Psychotherapy as Usual (TAU)
- Keywords
- Complicated Depression, Early Life Adversity, Personality Dysfunction
- 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.
Modular Intervention for Depression Therapy (MIND Therapy)Behavioural
Also called Psychotherapy
The MIND intervention is an algorithm-based, personalized, modular psychotherapy for adults with depression complicated by personality dysfunction and/or complex trauma. All participants receive a core evidence-based depression treatment that includes behavioral activation, cognitive, and interpersonal psychotherapy strategies. Additional short therapy modules are selected based on each participant's baseline emotional, interpersonal, and self-related functioning profile, using a predefined clinical algorithm. These modules target specific difficulties such as emotion regulation problems (DBT Module), sensitivity to rejection and interpersonal threat (MBT and CBASP Modules), social functioning difficulties (Social Thinning Module). The type and number of modules are tailored to individual needs following an algorithm based on baseline measures (DERS, A-RSQ, OQ-45-IR). Treatment is delivered as weekly individual psychotherapy sessions.
Psychotherapy as Usual (TAU)Behavioural
Also called Psychotherapy
Psychotherapy as usual (TAU) consists of individual psychotherapy delivered in public community mental health centers according to routine clinical practice. Treatment is provided weekly by trained clinicians and may vary in therapeutic orientation, techniques, and structure depending on the therapist and center. TAU is not guided by the modular psychotherapy protocol or algorithm used in the experimental intervention and reflects standard care available in the Chilean public mental health system.
| Study group | Role | What they receive |
|---|---|---|
| Modular Psychotherapy (MIND) | Experimental | Participants assigned to the MIND arm receive a personalized modular psychotherapy designed for depression complicated by personality dysfunction and/or complex trauma. All participants receive a core evidence-based depression treatment, including behavioral activation, cognitive, and interpersonal psychotherapy strategies. Additional short therapy modules are selected and added based on each participant's baseline emotional and interpersonal functioning profile following a module assignment algorithm. These modules target specific areas: emotion regulation difficulties, sensitivity to rejection and interpersonal threat, social functioning problems. Treatment is delivered as weekly individual psychotherapy sessions, with the number and combination of modules tailored to individual clinical needs. Receives: Behavioral: Modular Intervention for Depression Therapy (MIND Therapy) |
| Treatment as Usual (TAU) | Active comparator | Participants assigned to the treatment as usual (TAU) arm receive individual psychotherapy as typically provided in public community mental health centers in Chile. This treatment reflects routine clinical practice and may vary in therapeutic approach according to the therapist's usual orientation. Sessions are delivered individually and on a weekly basis, without the use of the modular psychotherapy protocol. Receives: Behavioral: Psychotherapy as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression remission.
Primary depression outcomes will be assessed using the MINI International Neuropsychiatric Interview. The MINI is a structured interview. Remission is defined as a negative MINI assessment for major depressive disorder.
Measured: Baseline (pre-intervention), end of treatment (session 15; approximately 3 months), and 3-month post-treatment (approximately 6 months after baseline assessment).
Clinically significant symptom reduction
Clinically significant symptom reduction will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 has a range between 0 and 27. Higher scores indicate more symptom severity. Clinically significant symptom reduction is defined as a reduction of at least 5 points on the PHQ-9 from baseline and a post-treatment PHQ-9 score ≤9.
Measured: Baseline (pre-intervention), end of treatment (session 15; approximately 3 months), and 3-month post-treatment (approximately 6 months after baseline assessment).
Secondary outcomes (13)
Emotional regulation difficulties
Emotional regulation will be assessed using the Difficulties in Emotion Regulation Scale (DERS-E). The DERS has a range of 25 to 125. Higher scores indicate more emotion regulation difficulties.
Measured: Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).
Interpersonal sensitivity and rejection sensitivity
Interpersonal sensitivity will be assessed using the Adult Rejection Sensitivity Questionnaire (A-RSQ). Changes in sensitivity to interpersonal rejection will be evaluated from baseline to post-treatment. The A-RSQ has a range of 1 to 36. Higher scores indicate more rejection sensitivity.
Measured: Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).
Interpersonal functioning and social problems
Interpersonal functioning will be measured using the Interpersonal Relations subscale of the Outcome Questionnaire - Interpersonal Relations (OQ-45-IR). Changes in social and interpersonal problems will be assessed from baseline to post-treatment. The range of the OQ-45 is 0 to 44. Higher scores indicate more interpersonal problems.
Measured: Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).
Daily emotional and interpersonal functioning
Daily emotional and interpersonal functioning will be assessed using smartphone-based ecological momentary assessment (EMA). Participants will report momentary negative affect, interpersonal experiences, rejection sensitivity, and self-related experiences multiple times per day during one week before treatment and one week after treatment.
Measured: One week prior to treatment initiation and one week following treatment completion (after 15 sessions; approximately 3 months after baseline assessment).
Therapeutic alliance
Therapeutic alliance will be assessed using the Working Alliance Inventory (WAI), completed by participants after each therapy session. Change in alliance quality over the course of treatment will be examined.The range of the WAI is 12 to 84. Higher scores indicate a better working alliance perceived by the patient.
Measured: After each treatment session, from session 1 through session 15 (approximately 3 months)
Treatment satisfaction
Treatment satisfaction will be assessed in patients using the Client Satisfaction Questionnaire-8 (CSQ-8). The range of the CSQ-8 is 8 to 32. Higher scores indicate more satisfaction with the treatment.
Measured: End of treatment (after session 15; approximately 3 months after baseline)
Improvements in Quality of life
Quality of life will be assessed using the Recovering Quality of Life questionnaire (ReQoL). Changes in quality of life will be evaluated from baseline to post-treatment and follow-up. The range of the ReQoL is 0 to 40. Higher scores indicate better perceived quality of life.
Measured: Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).
Acceptability of the Intervention
Therapist perspectives on the intervention will be assessed using the Acceptability of Intervention Measure (AIM). The range of the AIM is 0 to 5. Higher scores indicate more acceptability of the intervention.
Measured: End of treatment (after session 15; approximately 3 months after baseline)
Feasibility of Intervention
Therapist perspectives on the feasibility of the intervention will be asses using the Feasibility of Intervention Measure (FIM). The range of the FIM is 0 to 5. Higher scores indicate that the intervention is considered more feasible by the therapists.
Measured: End of treatment (after session 15; approximately 3 months after baseline)
Intervention Appropriateness
Therapist perspectives on the appropriateness of the intervention will be measured using the Intervention Appropriateness Measure (IAM). The range of the IAM is 0 to 5. Higher scores indicate higher intervention appropriateness.
Measured: End of treatment (after session 15; approximately 3 months after baseline)
Disability/Functional Impairment
Patient's degree of disability and functional impairment will be assessed through the WHO Disability Assessment Schedule (WHODAS). The range of the WHODAS is 12 to 60. Higher scored indicates higher disability.
Measured: Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).
Personality Functioning
Patient's personality functioning will be assess using the Levels of Personality Functioning Scale (LPFS-BF). The range of the LPFS is 12 to 48. Higher socres indicate more personality dysfunction.
Measured: Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).
Psychological Distress
Patient's psychological distress will be assessed using the Clinical Outcomes in Routine Evaluation - Outcome Measure Short Version (CORE-10). The rage of the CORE-10 is 0,8 to 3,2. Higher scores indicate more psychological distress.
Measured: Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies 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
- This is a randomized, parallel-group clinical trial in which eligible participants are assigned in a 1:1 ratio to either an algorithm-based personalized modular psychotherapy or usual individual psychotherapy. Participants receive only the intervention to which they are assigned, and outcomes are compared between groups over the course of treatment and follow-up.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- MIDAP Millennium Institute for Research in Depression and Personality
- Responsible party
- Principal investigator, Alex Behn, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380451
- Sponsor's protocol ID
- 240531010
- Other IDs
- 1251070
- Acronym
- MIND
- Status last verified
- May 2026
- First submitted
- 29 Dec 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modular Optimization of Psychotherapy for Individuals With Depression Complicated by Personality Dysfunction and Complex Trauma: A Pilot Study in the Chilean Public Health System
- ClinicalTrials.gov ID
- NCT07380451
- Acronym / sponsor ID
- MIND / 240531010
- Conditions
- Major Depression
- Keywords
- Complicated Depression, Early Life Adversity, Personality Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- MIDAP Millennium Institute for Research in Depression and Personality
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 2 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.
The goal of this psychotherapy clinical trial is to evaluate whether a algorithm-based personalized modular psychotherapy is more effective than usual individual psychotherapy in treating major depressive disorder complicated by personality dysfunction and/or complex trauma in adults aged 18 to 65 receiving care in the Chilean public mental health system.
The main questions it aims to answer are:
- Does algorithm-based modular psychotherapy lead to greater clinically significant reduction and remission of depressive symptoms compared to usual psychotherapy?
- Does algorithm-based modular psychotherapy lead to greater improvement in emotional regulation, interpersonal functioning, and self-related functioning, including changes observed in daily life?
Researchers will compare algorithm-based modular psychotherapy to usual individual psychotherapy provided in public community mental health centers to see if the modular, personalized approach results in better clinical outcomes, stronger therapeutic alliance, and higher treatment satisfaction.
Participants will:
- Be randomly assigned to receive either algorithm-based modular psychotherapy or usual individual psychotherapy
- Attend weekly individual psychotherapy sessions
- Complete structured diagnostic interviews and self-report questionnaires before, during, and after treatment
- Provide brief daily reports on mood, emotions, and interpersonal experiences using a smartphone before and after treatment
Detailed description
This randomized controlled clinical trial evaluates an algorithm-based personalized modular psychotherapy designed for adults with major depressive disorder whose condition is complicated by long-standing emotional, interpersonal, and self-related difficulties associated with early life adversity or personality functioning problems. These individuals often have poorer outcomes with standard psychotherapeutic approaches offered in public mental health services.
The experimental intervention consists of a modular psychotherapy approach. All participants in this group receive a core, evidence-based depression treatment. Additional short therapy modules are added based on each participant's baseline clinical profile following a module-assignment algorithm, targeting specific difficulties such as problems with emotion regulation, sensitivity to rejection and interpersonal threat, difficulties in social functioning, or disturbances in self-concept and self-worth. The number and type of modules are personalized for each participant, allowing the treatment to be tailored while remaining feasible within routine public mental health care.
The comparison group receives usual individual psychotherapy, which reflects standard care provided in community mental health centers in Chile. These treatments are delivered weekly by trained clinicians and are not guided by the modular protocol.
150 adults aged 18 to 65 will be recruited from public mental health centers. Eligible participants have major depressive disorder along with evidence of personality-related dysfunction and/or moderate to severe early life trauma. Participants are randomly assigned in a 1:1 ratio to either modular psychotherapy or usual care.
The primary outcomes of the study are clinically meaningful reduction in depressive symptoms and remission from depression following treatment. Secondary outcomes include changes in emotional regulation, interpersonal functioning, daily emotional and interpersonal experiences assessed through brief smartphone-based daily reports, quality of the therapeutic alliance, and satisfaction with treatment from both patients and therapists.
The purpose of this pilot trial is to determine whether a personalized algorithm-based modular psychotherapy approach improves clinical and functional outcomes compared to usual psychotherapy for people with complex depression in the Chilean public health system, and to inform future implementation and scaling of personalized mental health interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, parallel-group clinical trial in which eligible participants are assigned in a 1:1 ratio to either an algorithm-based personalized modular psychotherapy or usual individual psychotherapy. Participants receive only the intervention to which they are assigned, and outcomes are compared between groups over the course of treatment and follow-up.
| Arm | Type | Receives |
|---|---|---|
| Modular Psychotherapy (MIND) | Experimental | Behavioral: Modular Intervention for Depression Therapy (MIND Therapy)Participants assigned to the MIND arm receive a personalized modular psychotherapy designed for depression complicated by personality dysfunction and/or complex trauma. All participants receive a core evidence-based depression treatment, including behavioral activation, cognitive, and interpersonal psychotherapy strategies. Additional short therapy modules are selected and added based on each participant's baseline emotional and interpersonal functioning profile following a module assignment algorithm. These modules target specific areas: emotion regulation difficulties, sensitivity to rejection and interpersonal threat, social functioning problems. Treatment is delivered as weekly individual psychotherapy sessions, with the number and combination of modules tailored to individual clinical needs. |
| Treatment as Usual (TAU) | Active comparator | Behavioral: Psychotherapy as Usual (TAU)Participants assigned to the treatment as usual (TAU) arm receive individual psychotherapy as typically provided in public community mental health centers in Chile. This treatment reflects routine clinical practice and may vary in therapeutic approach according to the therapist's usual orientation. Sessions are delivered individually and on a weekly basis, without the use of the modular psychotherapy protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Current diagnosis of major depressive disorder, defined as:
- Evidence of personality dysfunction, defined as a score above the cutoff on the Level of Personality Functioning Scale-Brief Form (LPFS-BF 2.0).
- History of moderate to severe early life adversity, defined as elevated scores on at least one scale of the Childhood Trauma Questionnaire (CTQ), and/or clinically significant alterations in self-organization.
- Presence of at least one elevated domain of alteration of self-organization, including emotion regulation difficulties, interpersonal sensitivity, and/or interpersonal functioning problems, as assessed by standardized self-report measures (DERS, A-RSQ, OQ-45-IR).
- Receiving care at a participating public community mental health center in Chile.
Key exclusion criteria (15 listed)
- Acute suicide risk requiring immediate intensive intervention, as assessed by the MINI.
- Any severe psychiatric disorder other than major depressive disorder that is the primary clinical diagnosis, including:
- Severe substance use disorder, active within the past 6 months.
- Diagnosis of post-traumatic stress disorder (PTSD) meeting full diagnostic criteria, as assessed by standardized instruments (ITEM and ITQ).
- Meeting diagnostic criteria for:
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 |
|---|---|---|
| Modular Intervention for Depression Therapy (MIND Therapy)Also: PsychotherapyThe MIND intervention is an algorithm-based, personalized, modular psychotherapy for adults with depression complicated by personality dysfunction and/or complex trauma. All participants receive a core evidence-based depression treatment that includes behavioral activation, cognitive, and interpersonal psychotherapy strategies. Additional short therapy modules are selected based on each participant's baseline emotional, interpersonal, and self-related functioning profile, using a predefined clinical algorithm. These modules target specific difficulties such as emotion regulation problems (DBT Module), sensitivity to rejection and interpersonal threat (MBT and CBASP Modules), social functioning difficulties (Social Thinning Module). The type and number of modules are tailored to individual needs following an algorithm based on baseline measures (DERS, A-RSQ, OQ-45-IR). Treatment is delivered as weekly individual psychotherapy sessions. | Behavioural | Modular Psychotherapy (MIND) |
| Psychotherapy as Usual (TAU)Also: PsychotherapyPsychotherapy as usual (TAU) consists of individual psychotherapy delivered in public community mental health centers according to routine clinical practice. Treatment is provided weekly by trained clinicians and may vary in therapeutic orientation, techniques, and structure depending on the therapist and center. TAU is not guided by the modular psychotherapy protocol or algorithm used in the experimental intervention and reflects standard care available in the Chilean public mental health system. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Depression remission.
Time frame: Baseline (pre-intervention), end of treatment (session 15; approximately 3 months), and 3-month post-treatment (approximately 6 months after baseline assessment).
Primary depression outcomes will be assessed using the MINI International Neuropsychiatric Interview. The MINI is a structured interview. Remission is defined as a negative MINI assessment for major depressive disorder.
Clinically significant symptom reduction
Time frame: Baseline (pre-intervention), end of treatment (session 15; approximately 3 months), and 3-month post-treatment (approximately 6 months after baseline assessment).
Clinically significant symptom reduction will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 has a range between 0 and 27. Higher scores indicate more symptom severity. Clinically significant symptom reduction is defined as a reduction of at least 5 points on the PHQ-9 from baseline and a post-treatment PHQ-9 score ≤9.
13 secondary outcomes
Emotional regulation difficulties
Time frame: Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).
Interpersonal sensitivity and rejection sensitivity
Time frame: Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).
Interpersonal functioning and social problems
Time frame: Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).
Daily emotional and interpersonal functioning
Time frame: One week prior to treatment initiation and one week following treatment completion (after 15 sessions; approximately 3 months after baseline assessment).
Therapeutic alliance
Time frame: After each treatment session, from session 1 through session 15 (approximately 3 months)
Treatment satisfaction
Time frame: End of treatment (after session 15; approximately 3 months after baseline)
Improvements in Quality of life
Time frame: Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).
Acceptability of the Intervention
Time frame: End of treatment (after session 15; approximately 3 months after baseline)
Feasibility of Intervention
Time frame: End of treatment (after session 15; approximately 3 months after baseline)
Intervention Appropriateness
Time frame: End of treatment (after session 15; approximately 3 months after baseline)
Disability/Functional Impairment
Time frame: Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).
Personality Functioning
Time frame: Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).
Psychological Distress
Time frame: Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).
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 12 May 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be shared.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modular Intervention for Depression Therapy (MIND Therapy) and Psychotherapy as Usual (TAU) in people with Major Depression, run by Pontificia Universidad Catolica de Chile at 5 sites in Chile.
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 9 inclusion and 15 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Chile. 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 Alex J Behn, PhD (+56942152484, albehn@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression remission. (time frame: Baseline (pre-intervention), end of treatment (session 15; approximately 3 months), and 3-month post-treatment (approximately 6 months after baseline assessment).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.