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

University of Witten/Herdecke

Status: Unknown

Conditions: Depressive Symptoms; Depression

Treatments: Behavioral: Moodgym; Behavioral: Body, Breath & Mind

Study type: Interventional

Funder types: Other

Identifiers

NCT05293691

Body, Breath & Mind

Details and patient eligibility

About

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.

Enrollment: 303 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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303 participants in 3 patient groups

Body, Breath & Mind

Experimental group

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.

Treatment:

Behavioral: Body, Breath & Mind

Moodgym

Active Comparator group

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).

Treatment:

Behavioral: Moodgym

Waitlist control group

Other group

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.

Treatment:

Behavioral: Body, Breath & Mind