NCT05402150

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

October 3, 2023

Status Verified

October 1, 2023

Enrollment Period

12 months

First QC Date

May 23, 2022

Last Update Submit

October 2, 2023

Conditions

Depression MildDepression Moderate

Keywords

reward sensitivityreward processingdepressionrandomized controlled trialonline interventionbehavioral activationmindfulnessgratitude

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    baseline, post intervention (after 2 weeks), 4 months follow up

Secondary Outcomes (11)

  • Somatization psychopathology (Patient Health Questionnaire-15, PHQ-15)

    Baseline, post intervention (after 2 weeks), 4 months follow up

  • Generalized anxiety disorder psychopathology (Generalizied Anxiety Disorder Scale-7, GAD-7)

    Baseline, post intervention (after 2 weeks), 4 months follow up

  • Eating disorder psychopathology (Eating Disorder Examination-Questionnaire-8, EDE-Q-8)

    Baseline, post intervention (after 2 weeks), 4 months follow up

  • Social anxiety disorder psychopathology (Mini-Social Phobia Inventory, Mini-SPIN)

    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)

    Baseline, post intervention (after 2 weeks)

  • +6 more secondary outcomes

Other Outcomes (5)

  • Adherence

    post intervention (after 2 weeks), 4 months follow up

  • Influence of type of positive activity/type of pleasant situation

    during daily excercises (14 days)

  • Problems and obstacles during the intervention

    post intervention (after 2 weeks), 4 months follow up

  • +2 more other outcomes

Study Arms (4)

Behavioral Activation

EXPERIMENTAL

14 days of daily excercises

Behavioral: Behavioral Activation

Mindfulness and Gratitude

EXPERIMENTAL

14 days of daily excercises

Behavioral: Mindulness and Gratitude

Combination: Behavioral Activation and Mindfulness and Gratitude

EXPERIMENTAL

14 days of daily excercises

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.

Interventions

Behavioral ActivationBEHAVIORAL

* 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.

Behavioral Activation
Mindulness and GratitudeBEHAVIORAL

* 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.

Mindfulness and Gratitude
Combination of Behavioral Activation and Mindfulness and GratitudeBEHAVIORAL

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

Combination: Behavioral Activation and Mindfulness and Gratitude

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or above
  • Fluent in German
  • Informed consent
  • Depressive symptoms (PHQ-9 \> 5)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philipps University

Marburg, 35037, Germany

Location

Related Publications (9)

  • 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.

    PMID: 27816074BACKGROUND

  • 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.

    PMID: 27699943BACKGROUND

  • 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.

    PMID: 30998048BACKGROUND

  • 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.

    PMID: 20303067BACKGROUND

  • 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.

    PMID: 21767001BACKGROUND

  • 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.

    PMID: 33894554BACKGROUND

  • 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.

    PMID: 28711118BACKGROUND

  • 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.

    PMID: 28515538BACKGROUND

  • 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.

    PMID: 38128402DERIVED

MeSH Terms

Conditions

Depression

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Winfried Rief, Prof. Dr.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

June 2, 2022

Study Start

May 30, 2022

Primary Completion

May 15, 2023

Study Completion

September 15, 2023

Last Updated

October 3, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)