Efficacy of an Online Self-help Program for Negative Affect and Depression

NCT ID: NCT05293691

Last Updated: 2022-05-03

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-25

Study Completion Date

2023-03-31

Brief Summary

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The aim of the study is to test Body, breath \& mind (BBM, internet-based self-help program) for its efficacy in reducing depressive symptoms and improving quality of life. BBM combines methods of value-oriented behavioral activation with exercises from the Chinese healing practice Qi Gong,. BBM will be compared to an active control treatment (moodgym) and a waiting list control group. We expect significant differences to the waiting list control group. In comparison to the active control treatment we expect no significant differences.

Detailed Description

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Conditions

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Depressive Symptoms Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Body, Breath & Mind

The program "Body, Breath \& Mind" is a minimally guided self-help program to improve mood. It contains a total of eight modules, which are to be completed in a weekly rhythm. Each module includes Qi Gong exercises, and instructions and exercises for value-based behavioral activation used in behavioral therapy for depression (Hofheinz, Heidenreich \& Michalak, 2017). If possible, the entire program should be completed within a period of 8 weeks.

Group Type EXPERIMENTAL

Body, Breath & Mind

Intervention Type BEHAVIORAL

The program "Body, Breath \& Mind" is a minimally guided self-help program to improve mood. It contains a total of eight modules, which are to be completed in a weekly rhythm. Each module includes Qi Gong exercises, and instructions and exercises for value-based behavioral activation used in behavioral therapy for depression (Hofheinz, Heidenreich \& Michalak, 2017). If possible, the entire program should be completed within a period of 8 weeks.

Moodgym

Moodgym is an interactive training program for the prevention and reduction of depressive symptoms. It is based on the methods and techniques of cognitive behavioral therapy and includes five modules: feelings, thoughts, developing alternative thoughts, deal with stress and relationship. In addition to the modules, there is a workbook section where personal results and responses are stored.The effectiveness of the programme has been proven in clinical trials (Loebner et al., 2018).

Group Type ACTIVE_COMPARATOR

Moodgym

Intervention Type BEHAVIORAL

Moodgym is an interactive training program for the prevention and reduction of depressive symptoms. It is based on the methods and techniques of cognitive behavioral therapy and includes five modules: feelings, thoughts, developing alternative thoughts, deal with stress and relationship. In addition to the modules, there is a workbook section where personal results and responses are stored. The effectiveness of the programme has been proven in clinical trials (Loebner et al., 2018).

Waitlist control group

Participants in the waitlist control group are given access to the Body, Breath \& Mind program after eight weeks, provided they have participated in the previous surveys in the form of a diagnostic pre-, peri-, and post-module.

Group Type OTHER

Body, Breath & Mind

Intervention Type BEHAVIORAL

The program "Body, Breath \& Mind" is a minimally guided self-help program to improve mood. It contains a total of eight modules, which are to be completed in a weekly rhythm. Each module includes Qi Gong exercises, and instructions and exercises for value-based behavioral activation used in behavioral therapy for depression (Hofheinz, Heidenreich \& Michalak, 2017). If possible, the entire program should be completed within a period of 8 weeks.

Interventions

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Body, Breath & Mind

The program "Body, Breath \& Mind" is a minimally guided self-help program to improve mood. It contains a total of eight modules, which are to be completed in a weekly rhythm. Each module includes Qi Gong exercises, and instructions and exercises for value-based behavioral activation used in behavioral therapy for depression (Hofheinz, Heidenreich \& Michalak, 2017). If possible, the entire program should be completed within a period of 8 weeks.

Intervention Type BEHAVIORAL

Moodgym

Moodgym is an interactive training program for the prevention and reduction of depressive symptoms. It is based on the methods and techniques of cognitive behavioral therapy and includes five modules: feelings, thoughts, developing alternative thoughts, deal with stress and relationship. In addition to the modules, there is a workbook section where personal results and responses are stored. The effectiveness of the programme has been proven in clinical trials (Loebner et al., 2018).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All persons who suffer from depressive symptoms (subthreshold and clinical depression; PHQ-9 ≥10)
* German speaking
* Internet and email access

Exclusion Criteria

* The DSM-defined criteria A9 acute suicidality and A5 psychomotor agitation in the context of a depressive disorder, verified using the Diagnostic Interview in Mental Disorders in form of the Mini-DIPS (Margraf \& Cwik, 2017)
* psychotic disorders, verified using the Diagnostic Interview in Mental Disorders in form of the Mini-DIPS (Margraf \& Cwik, 2017)
* major depression with psychotic features, verified using the Diagnostic Interview in Mental Disorders in form of the Mini-DIPS (Margraf \& Cwik, 2017)
* eating disorders, verified using the Diagnostic Interview in Mental Disorders in form of the Mini-DIPS (Margraf \& Cwik, 2017)
* current or past schizo-affective disorder, verified using the Diagnostic Interview in Mental Disorders in form of the Mini-DIPS (Margraf \& Cwik, 2017)
* current substance use disorder, verified using the Diagnostic Interview in Mental Disorders in form of the Mini-DIPS (Margraf \& Cwik, 2017)
* inability to participate in the program due to physical, practical, or other reasons.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Witten/Herdecke

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Private Universität WItten/Herdecke

Witten, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Johannes Michalak, Prof. Dr.

Role: CONTACT

+ 49 (0)2302 /926-787

Facility Contacts

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Johannes Michalak, Prof. Dr.

Role: primary

+ 49 (0)2302 /926-787

References

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Lobner M, Pabst A, Stein J, Dorow M, Matschinger H, Luppa M, Maross A, Kersting A, Konig HH, Riedel-Heller SG. Computerized cognitive behavior therapy for patients with mild to moderately severe depression in primary care: A pragmatic cluster randomized controlled trial (@ktiv). J Affect Disord. 2018 Oct 1;238:317-326. doi: 10.1016/j.jad.2018.06.008. Epub 2018 Jun 5.

Reference Type BACKGROUND
PMID: 29902736 (View on PubMed)

Hofheinz C, Heidenreich T, & Michalak J. Werteorientierte Verhaltensaktivierung bei depressiven St rungen: Therapiemanual: mit E-Book inside und Arbeitsmaterial. Beltz. 2017.

Reference Type BACKGROUND

Margraf J, Cwik CC, Pflug V & Schneider S. Structured clinical interviews for mental disorders across the lifespan: Psychometric quality and further developments of the DIPS Open Access interviews. Zeitschrift für Klinische Psychologie und Psychotherapie. 2017; 46(3), 176-186.

Reference Type BACKGROUND

Other Identifiers

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Body, Breath & Mind

Identifier Type: -

Identifier Source: org_study_id

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