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Completed

NCT Number: NCT06710912

Group Acceptance and Commitment Therapy (ACT) Among 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:

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.

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Key information

Conditions

Major Depressive Disorder (MDD) Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group acceptance and commitment therapy (ACT)

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

Other

Standard care and follow-up for major depressive disorder

Primary outcomes

  1. Depressive symptoms

    Time frame: From enrollment to the end of treatment at 4 weeks

    The outcome was measured by using Beck Depression Inventory (BDI)

  2. Quality of life

    Time frame: 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)

  3. Psychological flexibility

    Time frame: 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 outcomes

  1. Depressive symptoms (3 months)

    Time frame: 3 months post intervention

    It was measured using BDI at 3 months post-intervention

  2. Quality of life (3 months)

    Time frame: 3 months post intervention

    It was measured using WHOQOL at 3 months post-intervention

  3. Psychological flexibility (3 months)

    Time frame: 3 months post intervention

    It was measured using AAQ-II at 3 months post-intervention

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Official study title

The Effectiveness of Group Acceptance and Commitment Therapy (ACT) Among Mild to Moderate Depressive Patients in Kelantan, Malaysia

Acronym: Group ACT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 29, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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