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

Primary Purpose

Depressive Symptoms, Depression

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Body, Breath & Mind
Moodgym
Sponsored by
University of Witten/Herdecke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring depression, quality of life, online, self-help program, randomized control trial, QiGong

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Private Universität WItten/HerdeckeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Body, Breath & Mind

Moodgym

Waitlist control group

Arm Description

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 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).

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.

Outcomes

Primary Outcome Measures

Brief Patient Health Questionnaire (PHQ-9)
Depression

Secondary Outcome Measures

Short Form (36) Health Survey
Quality of life
Brief Patient Health Questionnaire (PHQ-9)
Depression

Full Information

First Posted
March 15, 2022
Last Updated
April 26, 2022
Sponsor
University of Witten/Herdecke
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1. Study Identification

Unique Protocol Identification Number
NCT05293691
Brief Title
Efficacy of an Online Self-help Program for Negative Affect and Depression
Official Title
Body, Breath & Mind - A Randomized Control Trial to Test the Efficacy of an Online Self-help Program for Negative Affect and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Witten/Herdecke

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Depression
Keywords
depression, quality of life, online, self-help program, randomized control trial, QiGong

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
303 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Body, Breath & Mind
Arm Type
Experimental
Arm Description
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.
Arm Title
Moodgym
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Waitlist control group
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Body, Breath & Mind
Intervention Description
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
Intervention Name(s)
Moodgym
Intervention Description
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).
Primary Outcome Measure Information:
Title
Brief Patient Health Questionnaire (PHQ-9)
Description
Depression
Time Frame
Post-Measurement after 8 weeks
Secondary Outcome Measure Information:
Title
Short Form (36) Health Survey
Description
Quality of life
Time Frame
Post-Measurement after 8 weeks
Title
Brief Patient Health Questionnaire (PHQ-9)
Description
Depression
Time Frame
6-Month-Follow-Up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johannes Michalak, Prof. Dr.
Phone
+ 49 (0)2302 /926-787
Email
Johannes.Michalak@uni-wh.de
Facility Information:
Facility Name
Private Universität WItten/Herdecke
City
Witten
State/Province
NRW
ZIP/Postal Code
58448
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johannes Michalak, Prof. Dr.
Phone
+ 49 (0)2302 /926-787
Email
Johannes.Michalak@uni-wh.de

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29902736
Citation
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.
Results Reference
background
Citation
Hofheinz C, Heidenreich T, & Michalak J. Werteorientierte Verhaltensaktivierung bei depressiven St rungen: Therapiemanual: mit E-Book inside und Arbeitsmaterial. Beltz. 2017.
Results Reference
background
Citation
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.
Results Reference
background

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

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