NCT05293691

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
303

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

March 15, 2022

Last Update Submit

April 26, 2022

Conditions

Depressive SymptomsDepression

Keywords

depressionquality of lifeonlineself-help programrandomized control trialQiGong

Outcome Measures

Primary Outcomes (1)

  • Brief Patient Health Questionnaire (PHQ-9)

    Depression

    Post-Measurement after 8 weeks

Secondary Outcomes (2)

  • Short Form (36) Health Survey

    Post-Measurement after 8 weeks

  • Brief Patient Health Questionnaire (PHQ-9)

    6-Month-Follow-Up

Study Arms (3)

Body, Breath & Mind

EXPERIMENTAL

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.

Behavioral: Body, Breath & Mind

Moodgym

ACTIVE COMPARATOR

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).

Behavioral: Moodgym

Waitlist control group

OTHER

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.

Behavioral: Body, Breath & Mind

Interventions

Body, Breath & MindBEHAVIORAL

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.

Body, Breath & MindWaitlist control group
MoodgymBEHAVIORAL

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).

Moodgym

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Universität WItten/Herdecke

Witten, North Rhine-Westphalia, 58448, Germany

RECRUITING

Related Publications (3)

  • 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.

    PMID: 29902736BACKGROUND

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

    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.

    BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Johannes Michalak, Prof. Dr.

CONTACT

+ 49 (0)2302 /926-787Johannes.Michalak@uni-wh.de

Study Design

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

Study Record Dates

First Submitted

March 15, 2022

First Posted

March 24, 2022

Study Start

April 25, 2022

Primary Completion

July 1, 2022

Study Completion

March 31, 2023

Last Updated

May 3, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)