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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05293691
• Other study ID #: Body, Breath & Mind
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2022
• Source: University of Witten/Herdecke
• Contact: Johannes Michalak, Prof. Dr.
• Phone: + 49 (0)2302 /926-787
• Email: Johannes.Michalak[@]uni-wh.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 303
• Est. completion date: March 31, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Symptoms

Intervention

Behavioral:
• Body, 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.
• Moodgym
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).

Locations

Country	Name	City	State
Germany	Private Universität WItten/Herdecke	Witten	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University of Witten/Herdecke

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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

Löbner M, Pabst A, Stein J, Dorow M, Matschinger H, Luppa M, Maroß A, Kersting A, König 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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Patient Health Questionnaire (PHQ-9)	Depression	Post-Measurement after 8 weeks
Secondary	Short Form (36) Health Survey	Quality of life	Post-Measurement after 8 weeks
Secondary	Brief Patient Health Questionnaire (PHQ-9)	Depression	6-Month-Follow-Up