Long-term Effects ReSet Your Mind - Mechanisms

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

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.

Study Overview

• Status: Completed
• Conditions: Depression Moderate; Depression Mild
• Intervention / Treatment: Behavioral: Combination of Behavioral Activation and Mindfulness and Gratitude; Behavioral: Behavioral Activation; Behavioral: Mindfulness and Gratitude

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 Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Marburg, Germany, 35037
    • Philipps University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral Activation; 14 days of daily excercises	Behavioral: Behavioral Activation; - 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.
Experimental: Mindfulness and Gratitude; 14 days of daily excercises	Behavioral: Mindfulness and Gratitude; - 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
Experimental: Combination: Behavioral Activation and Mindfulness and Gratitude; 14 days of daily excercises	Behavioral: Combination of Behavioral Activation and Mindfulness and Gratitude; This group will do a combination of the two intervention types.
No Intervention: Waitlist control group; 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 Set1: 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic variables	- Gender, age, education, employment, medication, self report lifetime diagnosis of psychiatric conditions, previous experience with psychotherapy etc.	baseline
Perceived system usability (System usability Scale, SUS), general feedback about the online intervention	Items of the SUS range from 1 to 5 (1= strongly disagree to 5 = strongly agree).; After a computation, the SUS score can range from 0 to 100. A SUS score above a 68 is considered above average.; general feedback about the online intervention: free text entries about the online intervention: criticism, change requests, praise, one closed question: "Would you recommend the online intervention to someone else?" Yes/No	post intervention (after 2 weeks)
Problems and obstacles during the intervention	- Frequency of telephone contacts made with the principal contact person (Laura Potsch) and specified problems with the implementation of the daily excercises in the daily online survey	post intervention (after 2 weeks)

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Investigators: Principal Investigator: Winfried Rief, Prof. Dr., Dept. of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled trial; depression; mindfulness; behavioral activation; online intervention; reward processing; reward sensitivity; gratitude
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: ReSet your Mind - Mechanisms

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No