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Long-term Effects ReSet Your Mind - Mechanisms

Primary Purpose

Depression Mild, Depression Moderate

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Behavioral Activation
Mindfulness and Gratitude
Combination of Behavioral Activation and Mindfulness and Gratitude
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression Mild focused on measuring reward sensitivity, reward processing, depression, randomized controlled trial, online intervention, behavioral activation, mindfulness, gratitude

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Philipps University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Behavioral Activation

Mindfulness and Gratitude

Combination: Behavioral Activation and Mindfulness and Gratitude

Waitlist control group

Arm Description

14 days of daily excercises

14 days of daily excercises

14 days of daily excercises

Will receive the intervention (combination) after two weeks of intervention time of the other groups.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
Amount of physical activity reported during intervention exercises
- Type of activities and reflected pleasant situations that have been selected in the daily online surveys
Amount of social encounters reported during intervention exercises
- Type of activities and reflected pleasant situations that have been selected in the daily online surveys

Secondary Outcome Measures

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
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.
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."
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)
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.

Full Information

First Posted
October 2, 2023
Last Updated
October 9, 2023
Sponsor
Philipps University Marburg Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT06072209
Brief Title
Long-term Effects ReSet Your Mind - Mechanisms
Official Title
Long-term Effects of an Online Intervention Targeting Depression and Reward Sensitivity - Predictors and Mechanisms of Treatment Success
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
September 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philipps University Marburg Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression Mild, Depression Moderate
Keywords
reward sensitivity, reward processing, depression, randomized controlled trial, online intervention, behavioral activation, mindfulness, gratitude

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Activation
Arm Type
Experimental
Arm Description
14 days of daily excercises
Arm Title
Mindfulness and Gratitude
Arm Type
Experimental
Arm Description
14 days of daily excercises
Arm Title
Combination: Behavioral Activation and Mindfulness and Gratitude
Arm Type
Experimental
Arm Description
14 days of daily excercises
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Description
Will receive the intervention (combination) after two weeks of intervention time of the other groups.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation
Intervention Description
- 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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness and Gratitude
Intervention Description
- 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
Intervention Type
Behavioral
Intervention Name(s)
Combination of Behavioral Activation and Mindfulness and Gratitude
Intervention Description
This group will do a combination of the two intervention types.
Primary Outcome Measure Information:
Title
Depressive symptoms (Patient Health Questionnaire-9, PHQ-9)
Description
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.
Time Frame
baseline, post intervention (after 2 weeks), 4 months follow-up
Title
Reward sensitivity (Positive Valence System Scale-21, PVSS-21)
Description
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.
Time Frame
baseline, post intervention (after 2 weeks), 4 months follow-up
Title
Anhedonia (Snaith-Hamilton-Pleasure-Scale, SHAPS-D)
Description
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.
Time Frame
baseline, post intervention (after 2 weeks), 4 months follow-up
Title
Change in Stress level (Perceived-Stress-Scale 10, PSS-10)
Description
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.
Time Frame
baseline, post intervention (after 2 weeks), 4 months follow-up
Title
Change in Depressive Expectations (Depressive Expectations Scale, DES)
Description
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.
Time Frame
baseline, post intervention (after 2 weeks), 4 months follow-up
Title
Amount of physical activity reported during intervention exercises
Description
- Type of activities and reflected pleasant situations that have been selected in the daily online surveys
Time Frame
during intervention
Title
Amount of social encounters reported during intervention exercises
Description
- Type of activities and reflected pleasant situations that have been selected in the daily online surveys
Time Frame
during intervention
Secondary Outcome Measure Information:
Title
Personality traits (Big Five Inventory 10, BFI-10)
Description
Items range from 1 (disagree strongly) to 5 (agree strongly). Scales: openness to experience, conscientiousness, extraversion, agreeableness and neuroticism
Time Frame
Baseline, post intervention (after 2 weeks), four months follow-up]
Title
Adherence
Description
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.
Time Frame
post intervention (after 2 weeks), 4 months follow-up
Title
Treatment expectation (Generic Rating for Treatment Pre-Experiences, Treatment Expectations, and Treatment Effects, G-EEE)
Description
- 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."
Time Frame
Baseline, post intervention (after 2 weeks), 4 months follow-up
Title
Treatment credibility and expectancy (Credibility/Expectancy Questionnaire, CEQ)
Description
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)
Time Frame
Baseline
Title
Trait reward responsiveness (Reward Responsiveness Scale, RRS)
Description
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.
Time Frame
Baseline, post intervention (after 2 weeks), 4 months follow-up
Other Pre-specified Outcome Measures:
Title
Sociodemographic variables
Description
- Gender, age, education, employment, medication, self report lifetime diagnosis of psychiatric conditions, previous experience with psychotherapy etc.
Time Frame
baseline
Title
Perceived system usability (System usability Scale, SUS), general feedback about the online intervention
Description
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
Time Frame
post intervention (after 2 weeks)
Title
Problems and obstacles during the intervention
Description
- 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
Time Frame
post intervention (after 2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried Rief, Prof. Dr.
Organizational Affiliation
Dept. of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philipps University
City
Marburg
ZIP/Postal Code
35037
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Long-term Effects ReSet Your Mind - Mechanisms

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