Exergames-acceptance and Commitment Therapy Program for Treatment of Major Depressive Disorder

Summary

Background: The prevalence of depressive disorder, particularly major depressive disorder is on the rise globally and the use of antidepressant medication for treatment does not usually resulting in full remission. However, combination of antidepressant medication and psychotherapy for treatment of major depressive disorder (MDD) increase the rate of full remission compared to antidepressant monotherapy. This three-armed, parallel-group, double-blind, randomized control trial (RCT) aims to assess and compare the effects of combination of exergame and acceptance and commitment (e-ACT) training programme and ACT only on psychiatric symptoms (depression and anxiety), experiential avoidance (EA), quality of life (QoL), and biomarkers of depression (such as BDNF, CRP, and VEGF) among MDD patients.

Methods: This RCT will recruit 120 patients diagnosed with MDD who will be randomized using stratified permuted block randomization into three groups, which are combined e-ACT training programme, ACT only and treatment-as-usual 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 first assessment before intervention began (t0), second assessment immediately after completion of intervention at 8 weeks (t1) and third assessment 24 weeks after completion of intervention (t2). During each assessment, the primary outcome assessed is the severity of depression symptoms, while the secondary outcomes assessed are severity of anxiety symptoms, QoL, EA, and biomarkers of depression.

Conditions

• Major Depressive Disorder

Interventions

BEHAVIORAL

Exergames-acceptance and commitment therapy (e-ACT)

In the e-ACT training program, participants will perform a 30-minute per session Nintendo-program on TV for three days per week and a 50-minute ACT session per week for 8 weeks which will take place in the psychology labs of AMDI, USM. The ACT session will be held after 30 minutes break following the completion of the final exergame session of the week. Hence, the total duration of each weekly e-ACT training session will be approximately 2 hours. In addition, each weekly e-ACT training session will be held at the same time (± 2 hours) and at the same venue.

BEHAVIORAL

Acceptance and commitment therapy (ACT)

As for the ACT intervention, each ACT session will run for 50 minutes, one session per week for 8 weeks. Each weekly ACT session will be held at the same time (± 2 hours) and at the same venue (in the psychology lab).

Sponsors & Collaborators

• Université de Reims Champagne-Ardenne

  collaborator OTHER

• Universiti Sains Malaysia

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-01

Primary Completion

2025-05-31

Completion

2026-05-31