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

NCT ID: NCT06710912

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-05-31

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder (MDD)

Keywords

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acceptance and commitment therapy (ACT) group therapy depression psychological flexibility quality of life

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants in the ACT group attended four sessions of Acceptance and Commitment Therapy over a four-week period with each session lasting around 90-120 minutes. The participants were divided into three subgroups, each of which included approximately 6 to 8 participants. Prior to the intervention, participants in the ACT group received a workbook which consists of information about ACT in summary. Participants in the ACT group had accessibility to the same care similar to the TAU group. Four sessions were held for each subgroup respectively which was conducted by at least two therapists trained in ACT. The ACT module was adapted from Hayes and Harris and were 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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group ACT

Participants of this arm underwent 4 weeks of weekly session of acceptance and commitment therapy (ACT).

Group Type EXPERIMENTAL

Group acceptance and commitment therapy (ACT)

Intervention Type BEHAVIORAL

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.

Treatment-as-usual (TAU) group

The participants in this group received standard treatment for major depressive disorder

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type OTHER

Standard care and follow-up for major depressive disorder

Interventions

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Group acceptance and commitment therapy (ACT)

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.

Intervention Type BEHAVIORAL

Treatment as usual

Standard care and follow-up for major depressive disorder

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiti Sains Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Aisyah Che Rahimi

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universiti Sains Malaysia

Kota Bharu, Kelantan, Malaysia

Site Status

Countries

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Malaysia

References

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Rong J, Cheng P, Li D, Wang X, Zhao D. Global, regional, and national temporal trends in prevalence for depressive disorders in older adults, 1990-2019: An age-period-cohort analysis based on the global burden of disease study 2019. Ageing Res Rev. 2024 Sep;100:102443. doi: 10.1016/j.arr.2024.102443. Epub 2024 Aug 7.

Reference Type BACKGROUND
PMID: 39097004 (View on PubMed)

Other Identifiers

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304/PPSP/6315752

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

USM/JEPeM/22040192

Identifier Type: -

Identifier Source: org_study_id