Depression MildNCT05402150
An Online Intervention Targeting Depression and Low Reward Sensitivity
A study testing Behavioral Activation, Mindulness and Gratitude and Combination of Behavioral Activation and Mindfulness and Gratitude in people with Depression Mild and Depression Moderate, run by Philipps University Marburg at 1 site in Germany.
Trial summary
This study aims to evaluate and compare the effectiveness of different online interventions targeting reward sensitivity and depressive symptoms. We hypothesize that behavioral activation, a mindfulness and gratitude intervention, as well as a combination of both, will significantly reduce depressive symptoms and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression Mild, Depression Moderate
- What is being tested?
- Behavioral Activation, Mindulness and Gratitude and Combination of Behavioral Activation and Mindfulness and Gratitude
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteGermany
- Study dates
- 30 May 2022to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or above
- Fluent in German
- Informed consent
- Depressive symptoms (PHQ-9 > 5)
Who cannot join
- suicidality, severe depression
- current or lifetime: substance use disorder, psychotic disorders, bipolar I or II
- current psychotherapy
- if antidepressant medication: has not been stable over the last 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Online Intervention Targeting Depression and Low Reward Sensitivity - A Randomized Controlled Trial
This study aims to evaluate and compare the effectiveness of different online interventions targeting reward sensitivity and depressive symptoms. We hypothesize that behavioral activation, a mindfulness and gratitude intervention, as well as a combination of both, will significantly reduce depressive symptoms and increase reward sensitivity, compared to the waitlist group. In addition, we assume that behavioral activation will have an increased effect on reward sensitivity compared to the mindfulness and gratitude intervention.
The investigators will further investigate factors influencing treatment success in another paper based on data of this study (see secondary and other pre-specified outcome measures).
Read the detailed description
Depression is characterized by low reward sensitivity, which is a potential maintaining factor of depressive symptoms. This is why treatment for depression should include evidence-based interventions that target reward insensitivity. Up until now, there is a lack of research that studies reward sensitivity as main outcome measure or focus of interventions, especially in the online format. However, it is crucial to identify psychological interventions that are most effective in treating low reward sensitivity. Previous studies showed that behavioral activation can be a powerful intervention to increase the availability of rewards in everyday life. In addition, mindfulness-based interventions offer effective interventions with regards to low reward sensitivity since mindfulness refocusses attention on the present moment.
This study aims to evaluate the effectiveness of different online interventions compared to a waitlist control condition in a randomized controlled trial. The sample will include participants with mild to moderate depressive symptoms, who have been preselected for their low trait reward responsiveness. Inclusion and exclusion criteria will be confirmed via a preliminary online survey and a telephone screening, which will be administered by a trained psychologist. Suicidal participants or participants who suffer from severe depression will be excluded. Those will be informed about possibilities to get intensive professional help. Further exclusion criteria will be an ongoing psychotherapy, an antidepressant medication which has been taken for a shorter time period than four weeks, persons with a lifetime diagnosis of bipolar disorder (I and II), psychotic disorders or a substance use disorder.
Participants will be randomly assigned into four groups. The randomization will be stratified according to their depression score (mild or moderate). The investigators aim to include 50 participants per group (N = 200 in total). The first group ("Behavioral Activation") will be instructed to include daily positive activities and fill out a mood protocol, which covers the time period shortly before, during and after the activity. The second group ("Mindfulness and Gratitude") will fill out a mindfulness diary and reflect upon daily pleasant situation via revisiting the impressions of their five senses during this situation. In addition, participants will specify how long they have dealt with the situation and will name something they are grateful for. The third group will do a combination of the two interventions. The fourth group will be the waitlist control condition and receive the intervention material of the third group after two weeks.
Participants will receive a pre-intervention online survey with questionnaires as a baseline measurement. This survey includes a psychoeducation video and an instruction video explaining the intervention rationale and the daily excercises. Participants will receive working sheets to protocol their daily exercises over a course of two weeks. In addition, participants are encouraged to report their results and possible problems with the implementation of the excercises in a short online survey. In addition, every day a different case study will be presented which deals with obstacles and shows strategies to solve problems. Furthermore, participants are able to contact the principal contact person of the study (Laura Potsch) via telephone to help with problems. After two weeks of daily interventions, participants will receive a post-questionnaire to measure treatment effects and will receive a follow up questionnaire after 4 months.
- Conditions
- Depression Mild, Depression Moderate
- Being tested
- Behavioral Activation, Mindulness and Gratitude, Combination of Behavioral Activation and Mindfulness and Gratitude
- Keywords
- reward sensitivity, reward processing, depression, randomized controlled trial, online intervention, behavioral activation, mindfulness, gratitude
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
- instruction to create a list of individual positive activities.
- instruction to include daily positive activities and fill out a mood protocol, which covers the time period shortly before, during and after the activity.
Mindulness and GratitudeBehavioural
- instruction to fill out a mindfulness diary: reflection of daily pleasant situation, instructing the participants to revisit the impressions of their 5 senses during this situation, in addition they should specify how long they have actually dealt with these pleasant impressions of the situation they reflected upon
- instruction to do a gratitude exercise and name one or more things they are generally grateful for each day.
Combination of Behavioral Activation and Mindfulness and GratitudeBehavioural
This group will do a combination of the two intervention types.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation | Experimental | 14 days of daily excercises Receives: Behavioral: Behavioral Activation |
| Mindfulness and Gratitude | Experimental | 14 days of daily excercises Receives: Behavioral: Mindulness and Gratitude |
| Combination: Behavioral Activation and Mindfulness and Gratitude | Experimental | 14 days of daily excercises Receives: Behavioral: Combination of Behavioral Activation and Mindfulness and Gratitude |
| Waitlist control group | No intervention | Will receive the intervention (combination) after two weeks of intervention time of the other groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms (Patient Health Questionnaire-9, PHQ-9)
- Items range from 0 to 3 (0 = not at all; 1 = several days; 2 = more than a week; 3 = nearly every day).
- PHQ-9 total score ranges from 0 to 27 (classification of scores: 5-9 mild depression; 10-14 as moderate depression; 15-19: moderately severe depression; 20 - 27 severe depression).
- Consequently, a higher score means worse depressive symptoms.
Measured: baseline, post intervention (after 2 weeks), 4 months follow up
Change in reward sensitivity (Positive Valence System Scale-21, PVSS-21)
- Items range from 1 to 9 (1 = extremely untrue of me, 2 = very untrue of me, 3 = moderately untrue of me, 4 = slightly untrue of me, 5 = neutral, 6 = slightly true of me, 7 = moderately true of me, 8 = very true of me, 9 = extremely true of me).
- PVSS-21 total score ranges from 21 to 189.
- Consequently, a higher score means a higher reward responding.
Measured: baseline, post intervention (after 2 weeks), 4 months follow up
Secondary outcomes (11)
Somatization psychopathology (Patient Health Questionnaire-15, PHQ-15)
- Items in the PHQ-15 range from 0 to 2 (0 = not bothered at all, 1 = bothered a little, 2 = bothered a lot), two items (which are included in the PHQ-9 (question 2c and d) originally range from 0 to 3 (0 = not at all; 1 = several days; 2 = more than a week; 3 = nearly every day), here 2 and 3 are counted as 2.
- PHQ-15 total score ranges from 0 to 30 (classification of scores: ≥5 mild level of somatization, ≥10 moderate level of somatization, ≥15 severe level of somatization).
- Consequently, a higher score means a worse somatization.
Measured: Baseline, post intervention (after 2 weeks), 4 months follow up
Generalized anxiety disorder psychopathology (Generalizied Anxiety Disorder Scale-7, GAD-7)
- Items range from 0 to 3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day).
- GAD-7 total score ranges from 0 to 21 (classification of scores: 0 - 4: no to low risk, 5 - 9: mild, 10 - 14: moderate, >= 15 severe).
- Consequently, a higher score means a worse generalized anxiety disorder psychopathology.
Measured: Baseline, post intervention (after 2 weeks), 4 months follow up
Eating disorder psychopathology (Eating Disorder Examination-Questionnaire-8, EDE-Q-8)
- Items range from 0 to 6 (0 = characteristic was not present to 6 = characteristic was present every day or in extreme form).
- Subscale scores (restraint, eating concern, weight concern, shape concern), as well as a total score can be calculated, the total score ranges from 0 to 48.
- Consequently, a higher score means a worse eating disorder psychopathology.
Measured: Baseline, post intervention (after 2 weeks), 4 months follow up
Social anxiety disorder psychopathology (Mini-Social Phobia Inventory, Mini-SPIN)
- Items range from 0 to 4 (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = very much, 4 = extremely).
- Mini-Spin total score ranges from 0 to 12.
- Consequently, a higher score means a worse social anxiety disorder psychopathology.
Measured: Baseline, post intervention (after 2 weeks), 4 months follow up
Treatment expectation (Generic Rating for Treatment Pre-Experiences, Treatment Expectations, and Treatment Effects, G-EEE)
- Items range from 0 to 10 (depending on the item from "no improvement" to "greatest improvement imaginable", from "no worsening" to "greatest worsening imaginable", from "no complaints" to "greatest complaints imaginable") and one item, where previous treatment experience is assessed via a choice of "I have never experienced this treatment." (continue with question 8), "I have experienced this treatment during the last 12 months (nearly) daily.", "I have experienced this treatment during the last 12 months on more than 10 days.", "I have experienced this treatment during the last 12 months on about 5 to 10 days.", I have experienced this treatment during the last 12 months on about 1 to 4 days." And "I have not experienced this treatment during the last 12 months, but I have experienced it before."
Measured: Baseline, post intervention (after 2 weeks)
Treatment credibility and expectancy (Credibility/Expectancy Questionnaire, CEQ)
- Items range from 1 to 9 (Item 1 of Set 1: 1= not at all logical, 5 = somewhat logical, 9 = very logical, Item 2 of Set 1: 1= not at all useful, 5 = somewhat useful, 9 = very useful, Item 3 of Set 1: 1 = not at all confident, 5 = somewhat confident, 9 = very confident, Item 1 of Set 2: 1 = not at all, 5 = somewhat, 9 = very much), Item 4 of Set 1 and Item 2 of Set 2 give a choice of 0% to 100% in steps of 10 %.
- CEQ composite score can be derived for each factor (expectancy and credibility)
Measured: Baseline
Trait reward responsiveness (Reward Responsiveness Scale, RRS)
- Items range from 1 to 4 (1= strong disagreement, 2 = mild disagreement, 3 = mild agreement, 4 = strong agreement)
- RRS total score ranges from 8 to 32.
- Consequently, a higher score means a higher reward responsiveness.
Measured: Baseline, post intervention (after 2 weeks), 4 months follow up
Stress level (Perceived-Stress-Scale 10, PSS-10)
- Items range from 1 to 5 (1= never, 2 = almost never, 3 = sometimes, 4 = fairly often, 5 = very often) Items 4, 5, 7 and 8 are reverse scored for the total score.
- PH=perceived helplessness subscale; PSE=perceived self-efficacy subscale
- PH subscale is computed by summing up Items 1, 2, 3, 6, 9 and 10; the PSE subscale is computed by summing up items 4, 5, 7 and 8
- PSS-10 total score is the sum of all PH and reversed PSE items
- Consequently, a higher score means a greater level of stress.
Measured: Baseline, post intervention (after 2 weeks), 4 months follow up
Anhedonia (Snaith-Hamilton-Pleasure-Scale, SHAPS-D)
- Items range from "Definitely Agree", "Agree", "Disagree", and "Strongly Disagree". Either of the "Disagree responses" receive a score of 1 and either of the "Agree responses" receive a score of 0.
- SHAPS-D total score ranges from 0 to 14.
- Consequently, a higher score means a greater state anhedonia.
Measured: Baseline, post intervention (after 2 weeks), 4 months follow up
Depressive expectations (Depressive Expectations Scale, DES)
- Items range from 1 to 5 (1 = I disagree , 2 = I partially disagree, 3 = neutral, 4 = I partially agree, 5 = I agree).
- DES total score ranges from 25 to 125
- Consequently, a higher score means more dysfunctional depressive expectations.
Measured: Baseline, post intervention (after 2 weeks), 4 months follow up
Personality traits (Big Five Inventory 10, BFI-10)
- Items range from 1 (disagree strongly) to 5 (agree strongly).
- Scales: openness to experience, conscientiousness, extraversion, agreeableness and neuroticism
Measured: Baseline, post intervention (after 2 weeks), up to four months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start30 May 2022
- Primary completion15 May 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Depression MildStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Winfried Rief, Prof. Dr., Principal investigator, Dept. of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402150
- Sponsor's protocol ID
- ReSet your Mind
- Status last verified
- Oct 2023
- First submitted
- 23 May 2022
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alloy LB, Olino T, Freed RD, Nusslock R. Role of Reward Sensitivity and Processing in Major Depressive and Bipolar Spectrum Disorders. Behav Ther. 2016 Sep;47(5):600-621. doi: 10.1016/j.beth.2016.02.014. Epub 2016 Mar 7.
PubMed 27816074Craske MG, Meuret AE, Ritz T, Treanor M, Dour HJ. Treatment for Anhedonia: A Neuroscience Driven Approach. Depress Anxiety. 2016 Oct;33(10):927-938. doi: 10.1002/da.22490.
PubMed 27699943Craske MG, Meuret AE, Ritz T, Treanor M, Dour H, Rosenfield D. Positive affect treatment for depression and anxiety: A randomized clinical trial for a core feature of anhedonia. J Consult Clin Psychol. 2019 May;87(5):457-471. doi: 10.1037/ccp0000396.
PubMed 30998048Eshel N, Roiser JP. Reward and punishment processing in depression. Biol Psychiatry. 2010 Jul 15;68(2):118-24. doi: 10.1016/j.biopsych.2010.01.027. Epub 2010 Mar 29.
PubMed 20303067Geschwind N, Peeters F, Drukker M, van Os J, Wichers M. Mindfulness training increases momentary positive emotions and reward experience in adults vulnerable to depression: a randomized controlled trial. J Consult Clin Psychol. 2011 Oct;79(5):618-28. doi: 10.1037/a0024595.
PubMed 21767001Kryza-Lacombe M, Pearson N, Lyubomirsky S, Stein MB, Wiggins JL, Taylor CT. Changes in neural reward processing following Amplification of Positivity treatment for depression and anxiety: Preliminary findings from a randomized waitlist controlled trial. Behav Res Ther. 2021 Jul;142:103860. doi: 10.1016/j.brat.2021.103860. Epub 2021 Apr 15.
PubMed 33894554Linke J, Wessa M. Mental Imagery Training Increases Wanting of Rewards and Reward Sensitivity and Reduces Depressive Symptoms. Behav Ther. 2017 Sep;48(5):695-706. doi: 10.1016/j.beth.2017.04.002. Epub 2017 Apr 18.
PubMed 28711118Renner F, Ji JL, Pictet A, Holmes EA, Blackwell SE. Effects of Engaging in Repeated Mental Imagery of Future Positive Events on Behavioural Activation in Individuals with Major Depressive Disorder. Cognit Ther Res. 2017;41(3):369-380. doi: 10.1007/s10608-016-9776-y. Epub 2016 Apr 9.
PubMed 28515538Potsch L, Rief W. Effectiveness of behavioral activation and mindfulness in increasing reward sensitivity and reducing depressive symptoms - A randomized controlled trial. Behav Res Ther. 2024 Feb;173:104455. doi: 10.1016/j.brat.2023.104455. Epub 2023 Dec 13.
PubMed 38128402
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Online Intervention Targeting Depression and Low Reward Sensitivity - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05402150
- Acronym / sponsor ID
- ReSet your Mind
- Conditions
- Depression Mild, Depression Moderate
- Keywords
- reward sensitivity, reward processing, depression, randomized controlled trial, online intervention, behavioral activation, mindfulness, gratitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 2 Jun 2022 (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.
This study aims to evaluate and compare the effectiveness of different online interventions targeting reward sensitivity and depressive symptoms. We hypothesize that behavioral activation, a mindfulness and gratitude intervention, as well as a combination of both, will significantly reduce depressive symptoms and increase reward sensitivity, compared to the waitlist group. In addition, we assume that behavioral activation will have an increased effect on reward sensitivity compared to the mindfulness and gratitude intervention.
The investigators will further investigate factors influencing treatment success in another paper based on data of this study (see secondary and other pre-specified outcome measures).
Detailed description
Depression is characterized by low reward sensitivity, which is a potential maintaining factor of depressive symptoms. This is why treatment for depression should include evidence-based interventions that target reward insensitivity. Up until now, there is a lack of research that studies reward sensitivity as main outcome measure or focus of interventions, especially in the online format. However, it is crucial to identify psychological interventions that are most effective in treating low reward sensitivity. Previous studies showed that behavioral activation can be a powerful intervention to increase the availability of rewards in everyday life. In addition, mindfulness-based interventions offer effective interventions with regards to low reward sensitivity since mindfulness refocusses attention on the present moment.
This study aims to evaluate the effectiveness of different online interventions compared to a waitlist control condition in a randomized controlled trial. The sample will include participants with mild to moderate depressive symptoms, who have been preselected for their low trait reward responsiveness. Inclusion and exclusion criteria will be confirmed via a preliminary online survey and a telephone screening, which will be administered by a trained psychologist. Suicidal participants or participants who suffer from severe depression will be excluded. Those will be informed about possibilities to get intensive professional help. Further exclusion criteria will be an ongoing psychotherapy, an antidepressant medication which has been taken for a shorter time period than four weeks, persons with a lifetime diagnosis of bipolar disorder (I and II), psychotic disorders or a substance use disorder.
Participants will be randomly assigned into four groups. The randomization will be stratified according to their depression score (mild or moderate). The investigators aim to include 50 participants per group (N = 200 in total). The first group ("Behavioral Activation") will be instructed to include daily positive activities and fill out a mood protocol, which covers the time period shortly before, during and after the activity. The second group ("Mindfulness and Gratitude") will fill out a mindfulness diary and reflect upon daily pleasant situation via revisiting the impressions of their five senses during this situation. In addition, participants will specify how long they have dealt with the situation and will name something they are grateful for. The third group will do a combination of the two interventions. The fourth group will be the waitlist control condition and receive the intervention material of the third group after two weeks.
Participants will receive a pre-intervention online survey with questionnaires as a baseline measurement. This survey includes a psychoeducation video and an instruction video explaining the intervention rationale and the daily excercises. Participants will receive working sheets to protocol their daily exercises over a course of two weeks. In addition, participants are encouraged to report their results and possible problems with the implementation of the excercises in a short online survey. In addition, every day a different case study will be presented which deals with obstacles and shows strategies to solve problems. Furthermore, participants are able to contact the principal contact person of the study (Laura Potsch) via telephone to help with problems. After two weeks of daily interventions, participants will receive a post-questionnaire to measure treatment effects and will receive a follow up questionnaire after 4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation | Experimental | Behavioral: Behavioral Activation14 days of daily excercises |
| Mindfulness and Gratitude | Experimental | Behavioral: Mindulness and Gratitude14 days of daily excercises |
| Combination: Behavioral Activation and Mindfulness and Gratitude | Experimental | Behavioral: Combination of Behavioral Activation and Mindfulness and Gratitude14 days of daily excercises |
| Waitlist control group | No intervention | –Will receive the intervention (combination) after two weeks of intervention time of the other groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or above
- Fluent in German
- Informed consent
- Depressive symptoms (PHQ-9 > 5)
Key exclusion criteria (4 listed)
- suicidality, severe depression
- current or lifetime: substance use disorder, psychotic disorders, bipolar I or II
- current psychotherapy
- if antidepressant medication: has not been stable over the last 4 weeks
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 |
|---|---|---|
| Behavioral Activation* instruction to create a list of individual positive activities. * instruction to include daily positive activities and fill out a mood protocol, which covers the time period shortly before, during and after the activity. | Behavioural | Behavioral Activation |
| Mindulness and Gratitude* instruction to fill out a mindfulness diary: reflection of daily pleasant situation, instructing the participants to revisit the impressions of their 5 senses during this situation, in addition they should specify how long they have actually dealt with these pleasant impressions of the situation they reflected upon * instruction to do a gratitude exercise and name one or more things they are generally grateful for each day. | Behavioural | Mindfulness and Gratitude |
| Combination of Behavioral Activation and Mindfulness and GratitudeThis group will do a combination of the two intervention types. | Behavioural | Combination: Behavioral Activation and Mindfulness and Gratitude |
Primary outcome
Change in depressive symptoms (Patient Health Questionnaire-9, PHQ-9)
Time frame: baseline, post intervention (after 2 weeks), 4 months follow up
* Items range from 0 to 3 (0 = not at all; 1 = several days; 2 = more than a week; 3 = nearly every day). * PHQ-9 total score ranges from 0 to 27 (classification of scores: 5-9 mild depression; 10-14 as moderate depression; 15-19: moderately severe depression; 20 - 27 severe depression). * Consequently, a higher score means worse depressive symptoms.
Change in reward sensitivity (Positive Valence System Scale-21, PVSS-21)
Time frame: baseline, post intervention (after 2 weeks), 4 months follow up
* Items range from 1 to 9 (1 = extremely untrue of me, 2 = very untrue of me, 3 = moderately untrue of me, 4 = slightly untrue of me, 5 = neutral, 6 = slightly true of me, 7 = moderately true of me, 8 = very true of me, 9 = extremely true of me). * PVSS-21 total score ranges from 21 to 189. * Consequently, a higher score means a higher reward responding.
11 secondary outcomes
Somatization psychopathology (Patient Health Questionnaire-15, PHQ-15)
Time frame: Baseline, post intervention (after 2 weeks), 4 months follow up
Generalized anxiety disorder psychopathology (Generalizied Anxiety Disorder Scale-7, GAD-7)
Time frame: Baseline, post intervention (after 2 weeks), 4 months follow up
Eating disorder psychopathology (Eating Disorder Examination-Questionnaire-8, EDE-Q-8)
Time frame: Baseline, post intervention (after 2 weeks), 4 months follow up
Social anxiety disorder psychopathology (Mini-Social Phobia Inventory, Mini-SPIN)
Time frame: Baseline, post intervention (after 2 weeks), 4 months follow up
Treatment expectation (Generic Rating for Treatment Pre-Experiences, Treatment Expectations, and Treatment Effects, G-EEE)
Time frame: Baseline, post intervention (after 2 weeks)
Treatment credibility and expectancy (Credibility/Expectancy Questionnaire, CEQ)
Time frame: Baseline
Trait reward responsiveness (Reward Responsiveness Scale, RRS)
Time frame: Baseline, post intervention (after 2 weeks), 4 months follow up
Stress level (Perceived-Stress-Scale 10, PSS-10)
Time frame: Baseline, post intervention (after 2 weeks), 4 months follow up
Anhedonia (Snaith-Hamilton-Pleasure-Scale, SHAPS-D)
Time frame: Baseline, post intervention (after 2 weeks), 4 months follow up
Depressive expectations (Depressive Expectations Scale, DES)
Time frame: Baseline, post intervention (after 2 weeks), 4 months follow up
Personality traits (Big Five Inventory 10, BFI-10)
Time frame: Baseline, post intervention (after 2 weeks), up to four months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Background: PubMed 27816074Alloy LB, Olino T, Freed RD, Nusslock R. Role of Reward Sensitivity and Processing in Major Depressive and Bipolar Spectrum Disorders. Behav Ther. 2016 Sep;47(5):600-621. doi: 10.1016/j.beth.2016.02.014. Epub 2016 Mar 7.
- Background: PubMed 27699943Craske MG, Meuret AE, Ritz T, Treanor M, Dour HJ. Treatment for Anhedonia: A Neuroscience Driven Approach. Depress Anxiety. 2016 Oct;33(10):927-938. doi: 10.1002/da.22490.
- Background: PubMed 30998048Craske MG, Meuret AE, Ritz T, Treanor M, Dour H, Rosenfield D. Positive affect treatment for depression and anxiety: A randomized clinical trial for a core feature of anhedonia. J Consult Clin Psychol. 2019 May;87(5):457-471. doi: 10.1037/ccp0000396.
- Background: PubMed 20303067Eshel N, Roiser JP. Reward and punishment processing in depression. Biol Psychiatry. 2010 Jul 15;68(2):118-24. doi: 10.1016/j.biopsych.2010.01.027. Epub 2010 Mar 29.
- Background: PubMed 21767001Geschwind N, Peeters F, Drukker M, van Os J, Wichers M. Mindfulness training increases momentary positive emotions and reward experience in adults vulnerable to depression: a randomized controlled trial. J Consult Clin Psychol. 2011 Oct;79(5):618-28. doi: 10.1037/a0024595.
- Background: PubMed 33894554Kryza-Lacombe M, Pearson N, Lyubomirsky S, Stein MB, Wiggins JL, Taylor CT. Changes in neural reward processing following Amplification of Positivity treatment for depression and anxiety: Preliminary findings from a randomized waitlist controlled trial. Behav Res Ther. 2021 Jul;142:103860. doi: 10.1016/j.brat.2021.103860. Epub 2021 Apr 15.
- Background: PubMed 28711118Linke J, Wessa M. Mental Imagery Training Increases Wanting of Rewards and Reward Sensitivity and Reduces Depressive Symptoms. Behav Ther. 2017 Sep;48(5):695-706. doi: 10.1016/j.beth.2017.04.002. Epub 2017 Apr 18.
- Background: PubMed 28515538Renner F, Ji JL, Pictet A, Holmes EA, Blackwell SE. Effects of Engaging in Repeated Mental Imagery of Future Positive Events on Behavioural Activation in Individuals with Major Depressive Disorder. Cognit Ther Res. 2017;41(3):369-380. doi: 10.1007/s10608-016-9776-y. Epub 2016 Apr 9.
- Derived from this study: PubMed 38128402Potsch L, Rief W. Effectiveness of behavioral activation and mindfulness in increasing reward sensitivity and reducing depressive symptoms - A randomized controlled trial. Behav Res Ther. 2024 Feb;173:104455. doi: 10.1016/j.brat.2023.104455. Epub 2023 Dec 13.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Winfried Rief, Prof. Dr. principal investigator
Dept. of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation, Mindulness and Gratitude and Combination of Behavioral Activation and Mindfulness and Gratitude in people with Depression Mild and Depression Moderate, 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 3 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms (Patient Health Questionnaire-9, PHQ-9) (time frame: baseline, post intervention (after 2 weeks), 4 months follow up). 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?
On the ClinicalTrials.gov record for NCT05402150, which also lists 9 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 3 Oct 2023.