Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05293691
Enrollment
303
Registered
2022-03-24
Start date
2022-04-25
Completion date
2023-03-31
Last updated
2022-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Depressive Symptoms

Keywords

depression, quality of life, online, self-help program, randomized control trial, QiGong

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.

Interventions

BEHAVIORALBody, 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.

BEHAVIORALMoodgym

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).

Sponsors

University of Witten/Herdecke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Brief Patient Health Questionnaire (PHQ-9)Post-Measurement after 8 weeksDepression

Secondary

MeasureTime frameDescription
Short Form (36) Health SurveyPost-Measurement after 8 weeksQuality of life
Brief Patient Health Questionnaire (PHQ-9)6-Month-Follow-UpDepression

Countries

Germany

Contacts

Primary ContactJohannes Michalak, Prof. Dr.
Johannes.Michalak@uni-wh.de+ 49 (0)2302 /926-787

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026