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

Not Applicable
Conditions
Depressive Symptoms
Depression
Interventions
Behavioral: Body, Breath & Mind
Behavioral: Moodgym
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

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
Arm && Interventions
GroupInterventionDescription
Body, Breath & MindBody, Breath & MindThe 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.
MoodgymMoodgymMoodgym 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).
Waitlist control groupBody, Breath & MindParticipants 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.
Primary Outcome Measures
NameTimeMethod
Brief Patient Health Questionnaire (PHQ-9)Post-Measurement after 8 weeks

Depression

Secondary Outcome Measures
NameTimeMethod
Brief Patient Health Questionnaire (PHQ-9)6-Month-Follow-Up

Depression

Short Form (36) Health SurveyPost-Measurement after 8 weeks

Quality of life

Trial Locations

Locations (1)

Private Universität WItten/Herdecke

🇩🇪

Witten, NRW, Germany

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