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CompletedNCT06710912Group ACTUpdated Nov 29, 2024

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

An interventional study of Group acceptance and commitment therapy (ACT) and Treatment as usual in Major Depressive Disorder (MDD), sponsored by Universiti Sains Malaysia. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by Universiti Sains Malaysia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Jun 2022, registered Nov 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Major Depressive Disorder (MDD)

Keywords

  • acceptance and commitment therapy (ACT)
  • group therapy
  • depression
  • psychological flexibility
  • quality of life
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 44 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Universiti Sains Malaysia is the lead sponsor of 171 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Group ACT

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

    Behavioral: Group acceptance and commitment therapy (ACT)

  • Active comparator
    Treatment-as-usual (TAU) group

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

    Other: Treatment as usual

Interventions

  • BehavioralGroup 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.

  • OtherTreatment as usual

    Standard care and follow-up for major depressive disorder

06

What researchers measure

Primary outcomes

  1. Depressive symptoms

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

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

  2. Quality of life

    The outcome was measured by using brief WHO Quality of Life (WHOQOL) questionnaire (Malay version)

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

  3. Psychological flexibility

    The outcome was measured using Acceptance and Action Questionnaire II Malay Version (AAQ-II)

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

Secondary outcomes

  1. Depressive symptoms (3 months)

    It was measured using BDI at 3 months post-intervention

    Time frame: 3 months post intervention

  2. Quality of life (3 months)

    It was measured using WHOQOL at 3 months post-intervention

    Time frame: 3 months post intervention

  3. Psychological flexibility (3 months)

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

    Time frame: 3 months post intervention

07

Study locations

1 site
  • Hospital Universiti Sains Malaysia
    Kota Bharu, Kelantan 16150, Malaysia
08

References and documents

Publications

  • 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. PubMed 39097004 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06710912
Lead sponsor
Universiti Sains Malaysia
Responsible party
Aisyah Che Rahimi (Dr, Universiti Sains Malaysia) — Principal investigator
First posted
Nov 29, 2024
Start date
Jun 1, 2022
Primary completion
Jan 7, 2024
Completion
May 31, 2024
Last update
Nov 29, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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