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

Not Applicable

• Conditions: Depressive Symptoms; Depression

• Registration Number: NCT05293691
• Lead Sponsor: University of Witten/Herdecke

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-24
• Status Verified: 2022-04
• Study Start: 2022-04-25
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-05-03
• Primary Completion: 2022-07-01
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 303

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Brief Patient Health Questionnaire (PHQ-9)	Post-Measurement after 8 weeks	Depression

Secondary Outcome Measures

Name	Time	Method
Brief Patient Health Questionnaire (PHQ-9)	6-Month-Follow-Up	Depression
Short Form (36) Health Survey	Post-Measurement after 8 weeks	Quality of life

Trial Locations

Locations (1)

Private Universität WItten/Herdecke; 🇩🇪 Witten, NRW, Germany