Clinical trial NCT05402150: An Online Intervention Targeting Depression and Low Reward Sensitivity
Official title: Evaluation of an Online Intervention Targeting Depression and Low Reward Sensitivity - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression Mild
Depression Moderate
Keywords: reward sensitivity
reward processing
depression
randomized controlled trial
online intervention
behavioral activation
mindfulness
gratitude
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in depressive symptoms (Patient Health Questionnaire-9, PHQ-9)
timeFrame: baseline, post intervention (after 2 weeks), 4 months follow up
measure: Change in reward sensitivity (Positive Valence System Scale-21, PVSS-21)
timeFrame: baseline, post intervention (after 2 weeks), 4 months follow up
Secondary outcomes:
measure: Somatization psychopathology (Patient Health Questionnaire-15, PHQ-15)
timeFrame: Baseline, post intervention (after 2 weeks), 4 months follow up
measure: Generalized anxiety disorder psychopathology (Generalizied Anxiety Disorder Scale-7, GAD-7)
timeFrame: Baseline, post intervention (after 2 weeks), 4 months follow up
measure: Eating disorder psychopathology (Eating Disorder Examination-Questionnaire-8, EDE-Q-8)
timeFrame: Baseline, post intervention (after 2 weeks), 4 months follow up
measure: Social anxiety disorder psychopathology (Mini-Social Phobia Inventory, Mini-SPIN)
timeFrame: Baseline, post intervention (after 2 weeks), 4 months follow up
measure: Treatment expectation (Generic Rating for Treatment Pre-Experiences, Treatment Expectations, and Treatment Effects, G-EEE)
timeFrame: Baseline, post intervention (after 2 weeks)
measure: Treatment credibility and expectancy (Credibility/Expectancy Questionnaire, CEQ)
timeFrame: Baseline
measure: Trait reward responsiveness (Reward Responsiveness Scale, RRS)
timeFrame: Baseline, post intervention (after 2 weeks), 4 months follow up
measure: Stress level (Perceived-Stress-Scale 10, PSS-10)
timeFrame: Baseline, post intervention (after 2 weeks), 4 months follow up
measure: Anhedonia (Snaith-Hamilton-Pleasure-Scale, SHAPS-D)
timeFrame: Baseline, post intervention (after 2 weeks), 4 months follow up
measure: Depressive expectations (Depressive Expectations Scale, DES)
timeFrame: Baseline, post intervention (after 2 weeks), 4 months follow up
measure: Personality traits (Big Five Inventory 10, BFI-10)
timeFrame: Baseline, post intervention (after 2 weeks), up to four months follow up
Other outcomes:
measure: Adherence
timeFrame: post intervention (after 2 weeks), 4 months follow up
measure: Influence of type of positive activity/type of pleasant situation
timeFrame: during daily excercises (14 days)
measure: Problems and obstacles during the intervention
timeFrame: post intervention (after 2 weeks), 4 months follow up
measure: Sociodemographic variables
timeFrame: baseline
measure: Perceived system usability (System usability Scale, SUS), general feedback about the online intervention
timeFrame: post intervention (after 2 weeks)
Locations:
city: Marburg
country: Germany
facility: Philipps University
Study officials:
affiliation: Dept. of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany
name: Winfried Rief, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.