- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05402150
An Online Intervention Targeting Depression and Low Reward Sensitivity
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).
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Winfried Rief, Prof. Dr.
- Email: rief@staff.uni-marburg.de
Study Contact Backup
- Name: Laura Potsch, M.Sc.
- Phone Number: +496421- 2824046
- Email: laura.potsch@uni-marburg.de
Study Locations
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Marburg, Germany, 35037
- Philipps University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 or above
- Fluent in German
- Informed consent
- Depressive symptoms (PHQ-9 > 5)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioral Activation
14 days of daily excercises
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Experimental: Mindfulness and Gratitude
14 days of daily excercises
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Experimental: Combination: Behavioral Activation and Mindfulness and Gratitude
14 days of daily excercises
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This group will do a combination of the two intervention types.
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No Intervention: Waitlist control group
Will receive the intervention (combination) after two weeks of intervention time of the other groups.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in depressive symptoms (Patient Health Questionnaire-9, PHQ-9)
Time Frame: baseline, post intervention (after 2 weeks), 4 months follow up
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baseline, post intervention (after 2 weeks), 4 months follow up
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Change in reward sensitivity (Positive Valence System Scale-21, PVSS-21)
Time Frame: baseline, post intervention (after 2 weeks), 4 months follow up
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baseline, post intervention (after 2 weeks), 4 months follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Somatization psychopathology (Patient Health Questionnaire-15, PHQ-15)
Time Frame: Baseline, post intervention (after 2 weeks), 4 months follow up
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Baseline, post intervention (after 2 weeks), 4 months follow up
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Generalized anxiety disorder psychopathology (Generalizied Anxiety Disorder Scale-7, GAD-7)
Time Frame: Baseline, post intervention (after 2 weeks), 4 months follow up
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Baseline, post intervention (after 2 weeks), 4 months follow up
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Eating disorder psychopathology (Eating Disorder Examination-Questionnaire-8, EDE-Q-8)
Time Frame: Baseline, post intervention (after 2 weeks), 4 months follow up
|
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Baseline, post intervention (after 2 weeks), 4 months follow up
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Social anxiety disorder psychopathology (Mini-Social Phobia Inventory, Mini-SPIN)
Time Frame: Baseline, post intervention (after 2 weeks), 4 months follow up
|
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Baseline, post intervention (after 2 weeks), 4 months follow up
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Treatment expectation (Generic Rating for Treatment Pre-Experiences, Treatment Expectations, and Treatment Effects, G-EEE)
Time Frame: Baseline, post intervention (after 2 weeks)
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- 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."
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Baseline, post intervention (after 2 weeks)
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Treatment credibility and expectancy (Credibility/Expectancy Questionnaire, CEQ)
Time Frame: Baseline
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|
Baseline
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Trait reward responsiveness (Reward Responsiveness Scale, RRS)
Time Frame: Baseline, post intervention (after 2 weeks), 4 months follow up
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Baseline, post intervention (after 2 weeks), 4 months follow up
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Stress level (Perceived-Stress-Scale 10, PSS-10)
Time Frame: Baseline, post intervention (after 2 weeks), 4 months follow up
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Baseline, post intervention (after 2 weeks), 4 months follow up
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Anhedonia (Snaith-Hamilton-Pleasure-Scale, SHAPS-D)
Time Frame: Baseline, post intervention (after 2 weeks), 4 months follow up
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Baseline, post intervention (after 2 weeks), 4 months follow up
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Depressive expectations (Depressive Expectations Scale, DES)
Time Frame: Baseline, post intervention (after 2 weeks), 4 months follow up
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Baseline, post intervention (after 2 weeks), 4 months follow up
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Personality traits (Big Five Inventory 10, BFI-10)
Time Frame: Baseline, post intervention (after 2 weeks), up to four months follow up
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Baseline, post intervention (after 2 weeks), up to four months follow up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence
Time Frame: post intervention (after 2 weeks), 4 months follow up
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post intervention (after 2 weeks), 4 months follow up
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Influence of type of positive activity/type of pleasant situation
Time Frame: during daily excercises (14 days)
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- Type of activities and reflected pleasant situations that have been selected in the daily online surveys (e.g.
social, sports ...)
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during daily excercises (14 days)
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Problems and obstacles during the intervention
Time Frame: post intervention (after 2 weeks), 4 months follow up
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- Frequency of telephone contacts made with the principal contact person (Laura Potsch) and specified problems with the implementation of the daily excercises in the daily online survey
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post intervention (after 2 weeks), 4 months follow up
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Sociodemographic variables
Time Frame: baseline
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- Gender, age, education, employment, medication, self report lifetime diagnosis of psychiatric conditions, previous experience with psychotherapy etc.
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baseline
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Perceived system usability (System usability Scale, SUS), general feedback about the online intervention
Time Frame: post intervention (after 2 weeks)
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post intervention (after 2 weeks)
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Collaborators and Investigators
Investigators
- Principal Investigator: Winfried Rief, Prof. Dr., Dept. of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany
Publications and helpful links
General 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.
- Craske 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.
- Craske 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.
- Eshel 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.
- Geschwind 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.
- Kryza-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.
- Linke 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.
- Renner 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ReSet your Mind
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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