Long-term Effects ReSet Your Mind - Mechanisms

NCT06072209 | Completed

• 1 other identifier: ReSet your Mind - Mechanisms
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression Mild; Depression Moderate

Keywords

reward sensitivity; reward processing; depression; randomized controlled trial; online intervention; behavioral activation; mindfulness; gratitude

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Personality traits (Big Five Inventory 10, BFI-10)

  Baseline, post intervention (after 2 weeks), four months follow-up]

• Adherence

  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), 4 months follow-up

• Treatment credibility and expectancy (Credibility/Expectancy Questionnaire, CEQ)

  Baseline

• Trait reward responsiveness (Reward Responsiveness Scale, RRS)

  Baseline, post intervention (after 2 weeks), 4 months follow-up

Other Outcomes (3)

• Sociodemographic variables

  baseline

• Perceived system usability (System usability Scale, SUS), general feedback about the online intervention

  post intervention (after 2 weeks)

• Problems and obstacles during the intervention

  post intervention (after 2 weeks)

Study Arms (4)

Behavioral Activation

EXPERIMENTAL

14 days of daily excercises

Behavioral: Behavioral Activation

Mindfulness and Gratitude

EXPERIMENTAL

14 days of daily excercises

Behavioral: Mindfulness and Gratitude

Combination: Behavioral Activation and Mindfulness and Gratitude

EXPERIMENTAL

14 days of daily excercises

Behavioral: Combination of Behavioral Activation and Mindfulness and Gratitude

Waitlist control group

NO INTERVENTION

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

Interventions

Behavioral Activation BEHAVIORAL

\- 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.

Behavioral Activation

Mindfulness and Gratitude BEHAVIORAL

\- 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

Mindfulness and Gratitude

Combination of Behavioral Activation and Mindfulness and Gratitude BEHAVIORAL

This group will do a combination of the two intervention types.

Combination: Behavioral Activation and Mindfulness and Gratitude

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipps University Marburg: lead

Study Sites (1)

Philipps University

Marburg, 35037, Germany

Location

MeSH Terms

Conditions

Depression

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Winfried Rief, Prof. Dr.

  Dept. of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 10, 2023
• Study Start: May 30, 2022
• Primary Completion: May 15, 2023
• Study Completion: September 15, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)