Long-term Effects ReSet Your Mind - Mechanisms

Not Applicable

Completed

• Conditions: Depression Mild; Depression Moderate
• Interventions: Behavioral: Behavioral Activation; Behavioral: Mindfulness and Gratitude; Behavioral: Combination of Behavioral Activation and Mindfulness and Gratitude

• Registration Number: NCT06072209
• Lead Sponsor: Philipps University Marburg Medical Center

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.

Study Timeline

• Study Start: 2022-05-30
• Primary Completion: 2023-05-15
• Study Completion: 2023-09-15
• Status Verified: 2023-10
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-02
• Last Update Submitted: 2023-10-09
• Study First Posted: 2023-10-10
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Behavioral Activation	Behavioral Activation	14 days of daily excercises
Mindfulness and Gratitude	Mindfulness and Gratitude	14 days of daily excercises
Combination: Behavioral Activation and Mindfulness and Gratitude	Combination of Behavioral Activation and Mindfulness and Gratitude	14 days of daily excercises

Primary Outcome Measures

Name	Time	Method
Amount of social encounters reported during intervention exercises	during intervention	- Type of activities and reflected pleasant situations that have been selected in the daily online surveys
Depressive symptoms (Patient Health Questionnaire-9, PHQ-9)	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.
Anhedonia (Snaith-Hamilton-Pleasure-Scale, SHAPS-D)	baseline, post intervention (after 2 weeks), 4 months follow-up	* 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.
Change in Depressive Expectations (Depressive Expectations Scale, DES)	baseline, post intervention (after 2 weeks), 4 months follow-up	* 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.
Amount of physical activity reported during intervention exercises	during intervention	- Type of activities and reflected pleasant situations that have been selected in the daily online surveys
Reward sensitivity (Positive Valence System Scale-21, PVSS-21)	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 Stress level (Perceived-Stress-Scale 10, PSS-10)	baseline, post intervention (after 2 weeks), 4 months follow-up	* 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.

Secondary Outcome Measures

Name	Time	Method
Adherence	post intervention (after 2 weeks), 4 months follow-up	* 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.
Personality traits (Big Five Inventory 10, BFI-10)	Baseline, post intervention (after 2 weeks), four months follow-up]	* Items range from 1 (disagree strongly) to 5 (agree strongly).; * Scales: openness to experience, conscientiousness, extraversion, agreeableness and neuroticism
Treatment expectation (Generic Rating for Treatment Pre-Experiences, Treatment Expectations, and Treatment Effects, G-EEE)	Baseline, post intervention (after 2 weeks), 4 months follow-up	- 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."
Treatment credibility and expectancy (Credibility/Expectancy Questionnaire, CEQ)	Baseline	* 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)
Trait reward responsiveness (Reward Responsiveness Scale, RRS)	Baseline, post intervention (after 2 weeks), 4 months follow-up	* 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.

Trial Locations

Locations (1)

Philipps University; 🇩🇪 Marburg, Germany