Clinical trial NCT05293691: Efficacy of an Online Self-help Program for Negative Affect and Depression
Official title: Body, Breath & Mind - A Randomized Control Trial to Test the Efficacy of an Online Self-help Program for Negative Affect and Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Symptoms
Depression
Keywords: depression
quality of life
online
self-help program
randomized control trial
QiGong
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Brief Patient Health Questionnaire (PHQ-9)
timeFrame: Post-Measurement after 8 weeks
Secondary outcomes:
measure: Short Form (36) Health Survey
timeFrame: Post-Measurement after 8 weeks
measure: Brief Patient Health Questionnaire (PHQ-9)
timeFrame: 6-Month-Follow-Up
Other outcomes:
Locations:
city: Witten
country: Germany
facility: Private Universität WItten/Herdecke
state: NRW
Study officials:
References:
citation: Lobner M, Pabst A, Stein J, Dorow M, Matschinger H, Luppa M, Maross A, Kersting A, Konig 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.
citation: Hofheinz C, Heidenreich T, & Michalak J. Werteorientierte Verhaltensaktivierung bei depressiven St rungen: Therapiemanual: mit E-Book inside und Arbeitsmaterial. Beltz. 2017.
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.