Evaluation of an Online Intervention Targeting Depression and Low Reward Sensitivity - A Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Depression Mild
- Sponsor
- Philipps University Marburg Medical Center
- Enrollment
- 224
- Locations
- 1
- Primary Endpoint
- Change in reward sensitivity (Positive Valence System Scale-21, PVSS-21)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Somatization psychopathology (Patient Health Questionnaire-15, PHQ-15)(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))
- Eating disorder psychopathology (Eating Disorder Examination-Questionnaire-8, EDE-Q-8)(Baseline, post intervention (after 2 weeks), 4 months follow up)
- Anhedonia (Snaith-Hamilton-Pleasure-Scale, SHAPS-D)(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)
- Social anxiety disorder psychopathology (Mini-Social Phobia Inventory, Mini-SPIN)(Baseline, post intervention (after 2 weeks), 4 months follow up)
- Trait reward responsiveness (Reward Responsiveness Scale, RRS)(Baseline, post intervention (after 2 weeks), 4 months follow up)
- Treatment credibility and expectancy (Credibility/Expectancy Questionnaire, CEQ)(Baseline)
- Depressive expectations (Depressive Expectations Scale, DES)(Baseline, post intervention (after 2 weeks), 4 months follow up)
- Personality traits (Big Five Inventory 10, BFI-10)(Baseline, post intervention (after 2 weeks), up to four months follow up)
- Stress level (Perceived-Stress-Scale 10, PSS-10)(Baseline, post intervention (after 2 weeks), 4 months follow up)