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

Study Overview
=================
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.

Official Title
-----------------
Body, Breath & Mind - A Randomized Control Trial to Test the Efficacy of an Online Self-help Program for Negative Affect and Depression

Conditions
-----------------
Depressive Symptoms, Depression

Intervention / Treatment
-----------------
* Behavioral: Body, Breath & Mind
* Behavioral: Moodgym


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Body, Breath & Mind<br>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<br>* 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.<br>|
| Active Comparator: Moodgym<br>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<br>* 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).<br>|
| Other: Waitlist control group<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Patient Health Questionnaire (PHQ-9) | Depression | Post-Measurement after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form (36) Health Survey | Quality of life | Post-Measurement after 8 weeks | 
| Brief Patient Health Questionnaire (PHQ-9) | Depression | 6-Month-Follow-Up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, quality of life, online, self-help program, randomized control trial, QiGong