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

NCT05812001 | Not Yet Recruiting DMC

• 1 other identifier: 1679299088
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Rating Scale for Depression score across time points

  The HAMD measures depression in individuals before, during and after treatment. The HAMD is an observer administered instrument. The scale contains 21 items, but is scored based on the first 17 items, which are measured either on 5-point or 3-point scales. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression with a maximum score being 52. Studies on the psychometric properties of the HAMD indicated that its has adequate internal consistency where in most studies, its Cronbach's α was \> 0.7. It also exhibited good convergent and discriminant validity.

  At three time points of assessment: t0 (baseline) = before starting intervention, t1 = 8 weeks after baseline (immediately after completion of intervention), and t2 = 24 weeks after completion of intervention

Secondary Outcomes (3)

• Change in Acceptance and Action Questionnaire score across time points

  At three time points of assessment: t0 (baseline) = before starting intervention, t1 = 8 weeks after baseline (immediately after completion of intervention), and t2 = 24 weeks after completion of intervention

• Change in World Health Organization Quality of Life Questionnaire-BREF score across time points

  At three time points of assessment: t0 (baseline) = before starting intervention, t1 = 8 weeks after baseline (immediately after completion of intervention), and t2 = 24 weeks after completion of intervention

• Change in Hamilton Anxiety Scale score across time points

  At three time points of assessment: t0 (baseline) = before starting intervention, t1 = 8 weeks after baseline (immediately after completion of intervention), and t2 = 24 weeks after completion of intervention

Other Outcomes (3)

• Change in serum BDNF (in pg/mL) across time points

  At three time points of assessment: t0 (baseline) = before starting intervention, t1 = 8 weeks after baseline (immediately after completion of intervention), and t2 = 24 weeks after completion of intervention

• Change in serum VEGF (in pg/mL) across time points

  At three time points of assessment: t0 (baseline) = before starting intervention, t1 = 8 weeks after baseline (immediately after completion of intervention), and t2 = 24 weeks after completion of intervention

• Change in serum C-reactive protein (in mg/L) across time points

  At three time points of assessment: t0 (baseline) = before starting intervention, t1 = 8 weeks after baseline (immediately after completion of intervention), and t2 = 24 weeks after completion of intervention

Study Arms (3)

Exergames-acceptance and commitment therapy (e-ACT) group

EXPERIMENTAL

Exergame is playing of video games that require rigorous physical exercise and are intended as a work-out, such as those in which players race a virtual bicycle on-screen by pedalling a simulator resembling an exercise bike. It not only improve motivation, physical fitness and cognitive function, but it also induces antidepressant effect similar to physical exercise. Acceptance and commitment therapy (ACT) is a third-generation cognitive behavioral approach which uses acceptance and mindfulness processes, and commitment and behavior change processes to produce psychological flexibility. ACT was designed to increase adaptive coping through acceptance, cognitive defusion, mindfulness, and perspective-taking exercises while supporting depression patients in aligning behavior with their personal values. Hence, the combination of both exergame and ACT may provide additional benefit for treatment of depression patients beyond the degree of effectiveness of ACT alone.

Behavioral: Exergames-acceptance and commitment therapy (e-ACT)

Acceptance and commitment therapy (ACT) group

ACTIVE COMPARATOR

It is a third-generation cognitive behavioral approach which uses acceptance and mindfulness processes, and commitment and behavior change processes to produce psychological flexibility. Unlike CBT, which aims to change unhelpful thoughts and feelings, ACT was designed to increase adaptive coping through acceptance, cognitive defusion, mindfulness, and perspective-taking exercises while supporting depression patients in aligning behavior with their personal values. Hence, ACT consists of 8 sessions, one session per week to facilitate depression patients to development and maintenance of health behavioral improvements by targeting internal barriers, such as emotional discomfort and self-defeating thoughts, and by fostering connection and commitment to personal values associated with self-management of positive health behaviors.

Behavioral: Acceptance and commitment therapy (ACT)

Treatment-as-usual control (TAU) group

NO INTERVENTION

The participants in the control group will receive treatment-as-usual in which non-specific ingredients of the psychotherapeutic approach will be administered, such as psychological understanding to the management of an individual patient, identifying current problems, providing opportunities for disclosure, reassurance, and deep breathing exercise. They will be given equal amount of time and attention from the professional figure compared to the intervention groups, whereby they will also attach to an 8-session program (with one session per week for 8 weeks). Each weekly TAU session will be held at the same time (± 2 hours) and at the same venue (in the psychology lab).

Interventions

Exergames-acceptance and commitment therapy (e-ACT) BEHAVIORAL

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.

Exergames-acceptance and commitment therapy (e-ACT) group

Acceptance and commitment therapy (ACT) BEHAVIORAL

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).

Acceptance and commitment therapy (ACT) group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient diagnosed with major depressive disorder (confirmed by Diagnostic and Statistical Manual for Mental Disorder 5th Edition or DSM V).
• Those with score of more than 8 based on Hamilton Depression Rating Scale (HAMD).
• Age 18 to 60 years old
• Those on a stable medication regimen for at least the past 8 weeks and willing to maintain current treatments throughout the study

You may not qualify if:

• Pregnant women
• Those who have current and lifetime history of engaging in any psychotherapy
• Those who consumed alcohol and illicit drugs (Heavy or mild)
• Those who has current and lifetime history of other psychiatric illnesses, such as other depressive disorders (persistent depressive disorder, premenstrual dysphoric disorder), psychotic disorders (schizophrenia, schizophreniform disorder, schizoaffective disorders, brief psychotic disorder, and delusional disorder), bipolar mood disorder, obsessive compulsive disorder, posttraumatic stress disorder, and attention deficit hyperactive disorder, and autism spectrum disorder
• Those who are on medications that can induce psychiatric symptoms, such as cardiovascular agents (clonidine, guanethidine, methyldopa, reserpine, beta blockers), dermatologic agents (isotretinoin), anticonvulsants (levetiracetam), antimigraine medications (triptans), hormonal agents (corticosteroids, oral contraceptives, gonadotropin-releasing hormone agonists, tamoxifen), varenicline, immunological agents (interferons), and levodopa
• Patient who has suicidal tendency

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Université de Reims Champagne-Ardenne: collaborator

Related Publications (1)

• Zhang B, Deng H, Ren J, Legrand FD, Ahmad Yusof H, Zhang R, Leong Bin Abdullah MFI. 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. BMJ Open. 2024 Jun 26;14(6):e080315. doi: 10.1136/bmjopen-2023-080315.

  PMID: 38926142 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Mohammad Farris Iman Leong Bin Abdullah, Dr Psych

CONTACT

+60186669950; farris@usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be kept unaware of the study's randomization into the designated groups, conducted by a research assistant who is not otherwise involved in the study and concealed in an opaque, sequentially numbered envelope. Therefore, participants will not know which group they are allocated to. In addition, the intervention groups (e-ACT or ACT) and the treatment-as-usual control group will receive equal amount of attention and time from the professional figure who administer the program. The researchers will also be "blinded" for the study since the participants' randomized assignment into the designated groups will be conducted by a research assistant who is not otherwise involved in the study. This project's data collection and analysis will also be conducted by that research assistant who is not otherwise involved in the study or data analysis and who is unaware of the study's hypotheses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical lecturer

Model Details: This randomized controlled trial (RCT) is multicentre, three-armed, parallel-group, double-blind RCT.

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 13, 2023
• Study Start: June 1, 2024
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR