Long-term Effects ReSet Your Mind - Mechanisms

Study Overview
=================
Brief Summary
-----------------
See: ClinicalTrials.gov ID: NCT05402150 Relevant for this Paper: This investigation aims to evaluate the stability of the effectiveness of different two-week online interventions in a four months follow-up regarding reward sensitivity, anhedonia and depression. The authors will further investigate factors influencing treatment success regarding reward sensitivity. The investigators assume that the more depressive expectations and stress improve during our online intervention, the more change in reward insensitivity is experienced at follow-up. In addition, it is hypothesized that the more people engaged in physical activities and social encounters during the two-week online intervention, the more change in reward insensitivity is experienced at follow-up.

Detailed Description
-----------------
See for main study: ClinicalTrials.gov ID: NCT05402150. A possible maintaining role in depressive symptoms plays reward hyposensitivity. Therefore, treatments should include evidence-based psychological interventions that target and modify reward insensitivity. Prior research lacks studies investigating reward sensitivity as main outcome measure, especially in the web-based format. This is why this study investigated an online intervention with the following groups regarding effectively increasing reward sensitivity compared to a waitlist control condition: a) mindfulness-based interventions, b) behavioral activation, c) a combination of both. The daily exercises were supported via videos and worksheets. Here, the investigators explore the effects after a four-months follow-up. In addition, this paper will deal with the long-term prediction of reward sensitivity, a feature not considered in our main paper preregistered with the ID NCT05402150. Factors, which are considered to play a big role in reward sensitivity are perceived stress, depressive expectations, physical activity and the frequency of social encounters.

Official Title
-----------------
Long-term Effects of an Online Intervention Targeting Depression and Reward Sensitivity - Predictors and Mechanisms of Treatment Success

Conditions
-----------------
Depression Mild, Depression Moderate

Intervention / Treatment
-----------------
* Behavioral: Behavioral Activation
* Behavioral: Mindfulness and Gratitude
* Behavioral: Combination of Behavioral Activation and Mindfulness and Gratitude


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Activation<br>14 days of daily excercises | Behavioral: Behavioral Activation<br>* - 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.<br>|
| Experimental: Mindfulness and Gratitude<br>14 days of daily excercises | Behavioral: Mindfulness and Gratitude<br>* - 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<br>|
| Experimental: Combination: Behavioral Activation and Mindfulness and Gratitude<br>14 days of daily excercises | Behavioral: Combination of Behavioral Activation and Mindfulness and Gratitude<br>* This group will do a combination of the two intervention types.<br>|
| No Intervention: Waitlist control group<br>Will receive the intervention (combination) after two weeks of intervention time of the other groups. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Anhedonia (Snaith-Hamilton-Pleasure-Scale, SHAPS-D) | Items range from Definitely Agree, Agree, Disagree, and Strongly Disagree. Either of the Disagree responses receive a score of 1 and either of the Agree responses receive a score of 0. SHAPS-D total score ranges from 0 to 14. Consequently, a higher score means a greater state anhedonia. | baseline, post intervention (after 2 weeks), 4 months follow-up | 
| Change in Stress level (Perceived-Stress-Scale 10, PSS-10) | Items range from 1 to 5 (1= never, 2 = almost never, 3 = sometimes, 4 = fairly often, 5 = very often) Items 4, 5, 7 and 8 are reverse scored for the total score. PH=perceived helplessness subscale; PSE=perceived self-efficacy subscale PH subscale is computed by summing up Items 1, 2, 3, 6, 9 and 10; the PSE subscale is computed by summing up items 4, 5, 7 and 8 PSS-10 total score is the sum of all PH and reversed PSE items Consequently, a higher score means a greater level of stress. | baseline, post intervention (after 2 weeks), 4 months follow-up | 
| Change in Depressive Expectations (Depressive Expectations Scale, DES) | Items range from 1 to 5 (1 = I disagree , 2 = I partially disagree, 3 = neutral, 4 = I partially agree, 5 = I agree). DES total score ranges from 25 to 125 Consequently, a higher score means more dysfunctional depressive expectations. | baseline, post intervention (after 2 weeks), 4 months follow-up | 
| Amount of physical activity reported during intervention exercises | - Type of activities and reflected pleasant situations that have been selected in the daily online surveys | during intervention | 
| Amount of social encounters reported during intervention exercises | - Type of activities and reflected pleasant situations that have been selected in the daily online surveys | during intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Personality traits (Big Five Inventory 10, BFI-10) | Items range from 1 (disagree strongly) to 5 (agree strongly). Scales: openness to experience, conscientiousness, extraversion, agreeableness and neuroticism | Baseline, post intervention (after 2 weeks), four months follow-up] | 
| Adherence | Number of completed online surveys regarding the intervention exercises (T1 to T14: daily online surveys over the course of two weeks) Self report of implementation of daily exercises in post intervention survey and follow up survey. | post intervention (after 2 weeks), 4 months follow-up | 
| Treatment expectation (Generic Rating for Treatment Pre-Experiences, Treatment Expectations, and Treatment Effects, G-EEE) | - 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. | Baseline, post intervention (after 2 weeks), 4 months follow-up | 
| Treatment credibility and expectancy (Credibility/Expectancy Questionnaire, CEQ) | Items range from 1 to 9 (Item 1 of Set 1: 1= not at all logical, 5 = somewhat logical, 9 = very logical, Item 2 of Set 1: 1= not at all useful, 5 = somewhat useful, 9 = very useful, Item 3 of Set 1: 1 = not at all confident, 5 = somewhat confident, 9 = very confident, Item 1 of Set 2: 1 = not at all, 5 = somewhat, 9 = very much), Item 4 of Set 1 and Item 2 of Set 2 give a choice of 0% to 100% in steps of 10 %. CEQ composite score can be derived for each factor (expectancy and credibility) | Baseline | 
| Trait reward responsiveness (Reward Responsiveness Scale, RRS) | Items range from 1 to 4 (1= strong disagreement, 2 = mild disagreement, 3 = mild agreement, 4 = strong agreement) RRS total score ranges from 8 to 32. Consequently, a higher score means a higher reward responsiveness. | Baseline, post intervention (after 2 weeks), 4 months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
reward sensitivity, reward processing, depression, randomized controlled trial, online intervention, behavioral activation, mindfulness, gratitude