Major Depressive Disorder (MDD)Group ACTNCT06710912
Group Acceptance and Commitment Therapy (ACT) Among Depressive Patients in Kelantan, Malaysia
A study testing Group acceptance and commitment therapy (ACT) and Treatment as usual in people with Major Depressive Disorder (MDD), run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Group acceptance and commitment therapy (ACT) and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jun 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150
About this study
Official title: The Effectiveness of Group Acceptance and Commitment Therapy (ACT) Among Mild to Moderate 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:
- 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?
- 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?
- 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?
Read more
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
- 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.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Group acceptance and commitment therapy (ACT), Treatment as usual
- Keywords
- acceptance and commitment therapy (ACT), group therapy, depression, psychological flexibility, quality of life
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group acceptance and commitment therapy (ACT)Behavioural
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 usualOther
Standard care and follow-up for major depressive disorder
| Study group | Role | What they receive |
|---|---|---|
| Group ACT | Experimental | Participants of this arm underwent 4 weeks of weekly session of acceptance and commitment therapy (ACT). Receives: 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 Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
The outcome was measured by using Beck Depression Inventory (BDI)
Measured: 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)
Measured: 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)
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (3)
Depressive symptoms (3 months)
It was measured using BDI at 3 months post-intervention
Measured: 3 months post intervention
Quality of life (3 months)
It was measured using WHOQOL at 3 months post-intervention
Measured: 3 months post intervention
Psychological flexibility (3 months)
It was measured using AAQ-II at 3 months post-intervention
Measured: 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Jun 2022
- Primary completion7 Jan 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aisyah Che Rahimi, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710912
- Sponsor's protocol ID
- USM/JEPeM/22040192
- Other IDs
- 304/PPSP/6315752
- Acronym
- Group ACT
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Group Acceptance and Commitment Therapy (ACT) Among Mild to Moderate Depressive Patients in Kelantan, Malaysia
- ClinicalTrials.gov ID
- NCT06710912
- Acronym / sponsor ID
- Group ACT / USM/JEPeM/22040192
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- acceptance and commitment therapy (ACT), group therapy, depression, psychological flexibility, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 7 Jan 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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?
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group ACT | Experimental | Behavioral: Group acceptance and commitment therapy (ACT)Participants of this arm underwent 4 weeks of weekly session of acceptance and commitment therapy (ACT). |
| Treatment-as-usual (TAU) group | Active comparator | Other: Treatment as usualThe participants in this group received standard treatment for major depressive disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Group ACT |
| Treatment as usualStandard care and follow-up for major depressive disorder | Other | Treatment-as-usual (TAU) group |
Primary outcome
Depressive symptoms
Time frame: From enrollment to the end of treatment at 4 weeks
The outcome was measured by using Beck Depression Inventory (BDI)
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)
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)
3 secondary outcomes
Depressive symptoms (3 months)
Time frame: 3 months post intervention
Quality of life (3 months)
Time frame: 3 months post intervention
Psychological flexibility (3 months)
Time frame: 3 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 39097004Rong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group acceptance and commitment therapy (ACT) and Treatment as usual in people with Major Depressive Disorder (MDD), run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06710912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.