Group Acceptance and Commitment Therapy (ACT) Among Depressive Patients in Kelantan, Malaysia (Group ACT)
The Effectiveness of Group Acceptance and Commitment Therapy (ACT) Among Mild to Moderate Depressive Patients in Kelantan, Malaysia
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:
- 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?
- 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?
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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
- 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.
- 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.
- 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kelantan
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Kota Bharu, Kelantan, Malaysia, 16150
- Hospital Universiti Sains Malaysia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group ACT
Participants of this arm underwent 4 weeks of weekly session of acceptance and commitment therapy (ACT).
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The ACT intervention module utilized in this study was adapted from Hayes foundational work on ACT and Harris.
A summary of the general contents and exercises in each week was in accordance with the 6 core processes of Acceptance and Commitment Therapy based on Hayes.
It was conducted in the Malay language.
The same workbook with guided exercise and homework were used by all the therapists to assure standardization of the intervention to ensure that each group received similar contents in each session.
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Active Comparator: Treatment-as-usual (TAU) group
The participants in this group received standard treatment for major depressive disorder
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Standard care and follow-up for major depressive disorder
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive symptoms
Time Frame: From enrollment to the end of treatment at 4 weeks
|
The outcome was measured by using Beck Depression Inventory (BDI)
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From enrollment to the end of treatment at 4 weeks
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Quality of life
Time Frame: From enrollment to the end of treatment at 4 weeks
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The outcome was measured by using brief WHO Quality of Life (WHOQOL) questionnaire (Malay version)
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From enrollment to the end of treatment at 4 weeks
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Psychological flexibility
Time Frame: From enrollment to the end of treatment at 4 weeks
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The outcome was measured using Acceptance and Action Questionnaire II Malay Version (AAQ-II)
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From enrollment to the end of treatment at 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive symptoms (3 months)
Time Frame: 3 months post intervention
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It was measured using BDI at 3 months post-intervention
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3 months post intervention
|
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Quality of life (3 months)
Time Frame: 3 months post intervention
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It was measured using WHOQOL at 3 months post-intervention
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3 months post intervention
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Psychological flexibility (3 months)
Time Frame: 3 months post intervention
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It was measured using AAQ-II at 3 months post-intervention
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3 months post intervention
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- USM/JEPeM/22040192
- 304/PPSP/6315752 (Other Grant/Funding Number: Universiti Sains Malaysia)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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