Group Acceptance and Commitment Therapy (ACT) Among Depressive Patients in Kelantan, Malaysia

Not Applicable

Completed

• Conditions: Major Depressive Disorder (MDD)

• Registration Number: NCT06710912
• Lead Sponsor: Universiti Sains Malaysia

Brief Summary

The goal of this clinical trial is to learn if group acceptance and commitment therapy works to improve depressive symptoms, psychological flexibility and quality of life in adults. The main questions it aims to answer are:

1. What is the effectiveness of group Acceptance and Commitment Therapy (ACT) in reducing depressive symptoms among depressive patients in Kelantan from pre- to post-intervention and at 3 months follow-up?

2. What is the mean difference of quality of life among depressive patients in Kelantan who undergo group ACT from pre- to post-intervention and at 3 months follow-up?

3. What is the effectiveness of group ACT in improving the psychological flexibility among depressive patients in Kelantan from pre- to post intervention and at 3 months follow-up?

Researchers will compare group ACT group to a treatment-as-usual (TAU) group to see if group ACT works to improve depressive symptoms, quality of life and psychological flexibility.

Participants will:

* Attend weekly ACT sessions for four weeks or undergo standard treatment for major depressive disorder.

* Fill up four questionnaires before the intervention, after a month and at 3-month follow-up.

Detailed Description

General Objectives To study the effectiveness of group Acceptance and Commitment Therapy in the treatment of depression among depressive patients in Kelantan.

Specific Objectives

1. To evaluate the effectiveness of group Acceptance and Commitment Therapy (ACT) in reducing the symptoms of depression in patients in Kelantan from pre- to post-intervention and at 3 months follow-up.

2. To determine the effectiveness of group Acceptance and Commitment Therapy (ACT) in improving the quality of life of patients with depression in Kelantan from pre- to post-intervention and at 3 months follow-up.

3. To assess the effectiveness of group Acceptance and Commitment Therapy (ACT) in improving the psychological flexibility of patients with depression in Kelantan from pre- to post intervention and at 3 months follow-up.

This quasi-experimental study used a two-group design, comparing group ACT with TAU at baseline, post-intervention, and a 3-month follow-up. Conducted at the Psychiatry Clinic, Hospital Universiti Sains Malaysia, from June 2022 to May 2024, the study included 44 participants with mild to moderate depression. Twenty-two participants allocated in the ACT group received weekly group ACT sessions over four weeks, while twenty-two participants were assigned to the TAU group. Outcomes were measured using the Malay versions of the Beck Depression Inventory I (BDI), WHO Quality of Life-BREF (WHOQOL-BREF), and Acceptance and Action Questionnaire II (AAQ-II) at baseline, post-intervention, and at 3-month follow-up. Data was analyzed using two-way Repeated Measures Analysis of Variance (RM ANOVA) to assess changes in these outcomes across the different time points.

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2024-01-07
• Study Completion: 2024-05-31
• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-29
• Last Update Posted: 2024-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• had a Beck Depression Inventory (BDI) score ranging from 10 to 29, indicating mild to moderate depression.
• Proficient in the Malay language
• Willing to commit to the study.

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Exclusion Criteria

• Have concomitant psychotic symptoms.
• Participated and enrolled in Cognitive Behavioural Therapy.
• previously had participated in Acceptance Commitment Therapy.
• had underlying substance use disorder or active substance use.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depressive symptoms	From enrollment to the end of treatment at 4 weeks	The outcome was measured by using Beck Depression Inventory (BDI)
Quality of life	From enrollment to the end of treatment at 4 weeks	The outcome was measured by using brief WHO Quality of Life (WHOQOL) questionnaire (Malay version)
Psychological flexibility	From enrollment to the end of treatment at 4 weeks	The outcome was measured using Acceptance and Action Questionnaire II Malay Version (AAQ-II)

Secondary Outcome Measures

Name	Time	Method
Depressive symptoms (3 months)	3 months post intervention	It was measured using BDI at 3 months post-intervention
Quality of life (3 months)	3 months post intervention	It was measured using WHOQOL at 3 months post-intervention
Psychological flexibility (3 months)	3 months post intervention	It was measured using AAQ-II at 3 months post-intervention

Trial Locations

Locations (1)

Hospital Universiti Sains Malaysia; 🇲🇾 Kota Bharu, Kelantan, Malaysia