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

NCT06710912 | Completed

• 2 other identifiers: USM/JEPeM/22040192304/PPSP/6315752
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Major Depressive Disorder (MDD)

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Depressive symptoms

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

  From enrollment to the end of treatment at 4 weeks

• Quality of life

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

  From enrollment to the end of treatment at 4 weeks

• Psychological flexibility

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

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (3)

• Depressive symptoms (3 months)

  3 months post intervention

• Quality of life (3 months)

  3 months post intervention

• Psychological flexibility (3 months)

  3 months post intervention

Study Arms (2)

Group ACT

EXPERIMENTAL

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

Behavioral: Group acceptance and commitment therapy (ACT)

Treatment-as-usual (TAU) group

ACTIVE COMPARATOR

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

Other: Treatment as usual

Interventions

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.

Group ACT

Treatment as usual OTHER

Standard care and follow-up for major depressive disorder

Treatment-as-usual (TAU) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Hospital Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 39097004 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: June 1, 2022
• Primary Completion: January 7, 2024
• Study Completion: May 31, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)