An Online Intervention Targeting Depression and Low Reward Sensitivity

NCT ID: NCT05402150

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-30
• Study Completion Date: 2023-09-15

Brief 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 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.

Conditions

Depression Mild; Depression Moderate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Behavioral Activation

14 days of daily excercises

Group Type: EXPERIMENTAL

Behavioral Activation

Intervention Type: BEHAVIORAL

• 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.

Mindfulness and Gratitude

14 days of daily excercises

Group Type: EXPERIMENTAL

Mindulness and Gratitude

Intervention Type: BEHAVIORAL

• 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: Behavioral Activation and Mindfulness and Gratitude

14 days of daily excercises

Group Type: EXPERIMENTAL

Combination of Behavioral Activation and Mindfulness and Gratitude

Intervention Type: BEHAVIORAL

This group will do a combination of the two intervention types.

Waitlist control group

Will receive the intervention (combination) after two weeks of intervention time of the other groups.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Combination of Behavioral Activation and Mindfulness and Gratitude

This group will do a combination of the two intervention types.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philipps University Marburg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Winfried Rief, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Dept. of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany

Locations

Philipps University

Marburg, , Germany

Countries

Germany

References

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Reference Type: BACKGROUND

PMID: 27816074 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 27699943 (View on PubMed)

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.

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Reference Type: BACKGROUND

PMID: 20303067 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21767001 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33894554 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28711118 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28515538 (View on PubMed)

Potsch 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.

Reference Type: DERIVED

PMID: 38128402 (View on PubMed)

Other Identifiers

ReSet your Mind

Identifier Type: -

Identifier Source: org_study_id