Long-term Effects ReSet Your Mind - Mechanisms

NCT ID: NCT06072209

Last Updated: 2023-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-30

Study Completion Date

2023-09-15

Brief Summary

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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

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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.

Conditions

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Depression Mild Depression Moderate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Behavioral Activation

14 days of daily excercises

Group Type EXPERIMENTAL

Behavioral Activation

Intervention Type 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.

Mindfulness and Gratitude

14 days of daily excercises

Group Type EXPERIMENTAL

Mindfulness and Gratitude

Intervention Type 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

Combination: Behavioral Activation and Mindfulness and Gratitude

14 days of daily excercises

Group Type EXPERIMENTAL

Combination of Behavioral Activation and Mindfulness and Gratitude

Intervention Type BEHAVIORAL

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

Waitlist control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

Combination of Behavioral Activation and Mindfulness and Gratitude

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Philipps University Marburg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Winfried Rief, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Philipps University

Marburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ReSet your Mind - Mechanisms

Identifier Type: -

Identifier Source: org_study_id

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