Study protocol on the efficacy of exergames-acceptance and commitment therapy program for the treatment of major depressive disorder: comparison with acceptance and commitment therapy alone and treatment-as-usual in a multicentre randomised controlled trial.
Humans
Depressive Disorder, Major
/ therapy
Quality of Life
Acceptance and Commitment Therapy
/ methods
Adult
Double-Blind Method
Male
Female
Video Games
Randomized Controlled Trials as Topic
Middle Aged
Treatment Outcome
Multicenter Studies as Topic
Exercise Therapy
/ methods
Brain-Derived Neurotrophic Factor
/ blood
Biomarkers
/ blood
Anxiety disorders
Depression & mood disorders
MENTAL HEALTH
Randomized Controlled Trial
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
26 Jun 2024
26 Jun 2024
Historique:
medline:
27
6
2024
pubmed:
27
6
2024
entrez:
26
6
2024
Statut:
epublish
Résumé
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. 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 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. NCT05812001 (ClinicalTrials.gov). Registered on 12 April 2023.
Sections du résumé
BACKGROUND
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
METHODS
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
ETHICS AND DISSEMINATION
BACKGROUND
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
BACKGROUND
NCT05812001 (ClinicalTrials.gov). Registered on 12 April 2023.
Identifiants
pubmed: 38926142
pii: bmjopen-2023-080315
doi: 10.1136/bmjopen-2023-080315
doi:
Substances chimiques
Brain-Derived Neurotrophic Factor
0
Biomarkers
0
Banques de données
ClinicalTrials.gov
['NCT05812001']
Types de publication
Journal Article
Clinical Trial Protocol
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
e080315Informations de copyright
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.