Citation

Zhang B, Deng H, Ren J, Legrand FD, Ahmad Yusof H, Zhang R, Leong Bin Abdullah MFI. BMJ Open 2024; 14(6): e080315.

Copyright

(Copyright © 2024, BMJ Publishing Group)

DOI

10.1136/bmjopen-2023-080315

PMID

38926142

Abstract

BACKGROUND: The prevalence of major depressive disorder (MDD) is on the rise globally, and the use of antidepressant medications for its treatment does not usually result in full remission. However, the combination of physical exercise and psychotherapy for the treatment of MDD increase the rate of full remission among patients. This three-armed, parallel-group, double-blinded randomised controlled trial (RCT) aims to assess and compare the effects between the combination of exergame and acceptance and commitment therapy (e-ACT) programme, ACT only and treatment-as-usual (TAU) control groups on the severity of depression and anxiety symptoms, the degree of experiential avoidance and quality of life (QoL) and the serum levels of depression biomarkers (such as brain-derived neurotrophic factor, C-reactive protein and vascular endothelial growth factor) among patients with MDD across three time points.

METHODS AND ANALYSIS: This RCT will recruit 126 patients with MDD who will be randomised using stratified permuted block randomisation into three groups, which are the combined e-ACT programme, ACT-only and TAU control groups in a 1:1:1 allocation ratio. The participants in the e-ACT and ACT-only intervention groups will undergo once a week intervention sessions for 8 weeks. Assessments will be carried out through three time points, such as the pre-intervention assessment (t(0)), assessment immediately after completion of the intervention at 8 weeks (t(1)) and assessment at 24 weeks after completion of the intervention (t(2)). During each assessment, the primary outcome to be assessed includes the severity of depression symptoms, while the secondary outcomes to be assessed are the severity of anxiety symptoms, experiential avoidance, QoL and depression biomarkers. ETHICS AND DISSEMINATION: Approval of this study was obtained from the Human Research Ethics Committee of Universiti Sains Malaysia (USM/JEPeM/PP/23050420). The findings of the study will be published in academic peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05812001 (ClinicalTrials.gov). Registered on 12 April 2023.

Language: en

Keywords

Humans; Adult; Female; Male; Middle Aged; Randomized Controlled Trials as Topic; Treatment Outcome; Double-Blind Method; Anxiety disorders; Multicenter Studies as Topic; Video Games; *Quality of Life; *Acceptance and Commitment Therapy/methods; *Depressive Disorder, Major/therapy; Biomarkers/blood; Brain-Derived Neurotrophic Factor/blood; Depression & mood disorders; Exercise Therapy/methods; MENTAL HEALTH; Randomized Controlled Trial