Clinical trial NCT06710912: Group Acceptance and Commitment Therapy (ACT) Among Depressive Patients in Kelantan, Malaysia
Official title: The Effectiveness of Group Acceptance and Commitment Therapy (ACT) Among Mild to Moderate Depressive Patients in Kelantan, Malaysia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder (MDD)
Keywords: acceptance and commitment therapy (ACT)
group therapy
depression
psychological flexibility
quality of life
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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:

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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Depressive symptoms
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Quality of life
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Psychological flexibility
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
measure: Depressive symptoms (3 months)
timeFrame: 3 months post intervention
measure: Quality of life (3 months)
timeFrame: 3 months post intervention
measure: Psychological flexibility (3 months)
timeFrame: 3 months post intervention
Other outcomes:
Locations:
city: Kota Bharu
country: Malaysia
facility: Hospital Universiti Sains Malaysia
state: Kelantan
Study officials:
References:
citation: 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.