Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000340437p
Ethics application status
Submitted, not yet approved
Date submitted
17/01/2025
Date registered
22/04/2025
Date last updated
22/04/2025
Date data sharing statement initially provided
22/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effectiveness of Acceptance and Commitment Therapy (ACT) on Clinical and Psychological Outcomes among Patients with Pulmonary Arterial Hypertension (PAH) in National Heart Institute Malaysia
Scientific title
The Effectiveness of Acceptance and Commitment Therapy (ACT) on Clinical and Psychological Outcomes among Patients with Pulmonary Arterial Hypertension (PAH) in National Heart Institute Malaysia: A Randomized Controlled Trial
Secondary ID [1] 313692 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 336341 0
Mental Health 336342 0
Condition category
Condition code
Cardiovascular 332875 332875 0 0
Other cardiovascular diseases
Mental Health 332876 332876 0 0
Anxiety
Mental Health 332877 332877 0 0
Depression
Respiratory 333050 333050 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be conducted by clinical psychologists who are trained in the ACT approach with a minimum of 2 years of experience and with at least 4 years of experience in the field of mental health.

It is a group-based intervention that will be conducted face-to-face with each group accommodating 8 to 10 participants. There will be 5 groups in total, each lasting two hours and spanning a total duration of six weeks.

For this study, the intervention will be adapted from ‘A Mindful ACT’, which is a brief psychosocial intervention designed for people living with chronic condition. The intervention sessions consist of the following:

Week 1: Introduction of ACT approach
Week 2: Practicing mindfulness to be embedded in daily activities
Week 3: Learning cognitive defusion
Week 4: Integrating self-care and self-compassion
Week 5: Exploring acceptance and values
Week 6: Engaging in committed actions

Process-Evaluation Components for Complex Interventions proposed by Reelick et al. (2011) will be utilised to monitor the feasibility of ACT intervention implementation including:
- Quality of delivery of the intervention components
- Implementation barriers and facilitators for delivery of intervention components
- Adherence to intervention components
- Barriers and facilitators for adherence to intervention components
Intervention code [1] 330331 0
Treatment: Other
Comparator / control treatment
The participants allocated in this group will be receiving the usual standard care by the Patient Counsellor and/or Pulmonary Hypertension Nurses, as determined by the healthcare providers at National Heart Institute, Malaysia.

The usual standard care includes:
- Conducting regular assessments of patients’ symptoms and overall health status
- Educating patients and families about pulmonary hypertension, including its symptoms, potential complications, and treatment options
- Providing guidance on lifestyle modifications, such as exercise, diet, and the importance of medication adherence
- Provide emotional support to patients and their families, helping them cope with the challenges of living with a chronic, often progressive, condition
Control group
Active

Outcomes
Primary outcome [1] 340403 0
Psychological Flexibility
Timepoint [1] 340403 0
Baseline (pre-test), 6 weeks after baseline (post-test, primary endpoint), 1 month after post-test
Primary outcome [2] 340404 0
Quality of Life
Timepoint [2] 340404 0
Baseline (pre-test), 6 weeks after baseline (post-test, primary endpoint), 1 month after post-test
Primary outcome [3] 340407 0
Psychological Distress
Timepoint [3] 340407 0
Baseline (pre-test), 6 weeks after baseline (post-test, primary endpoint), 1 month after post-test
Secondary outcome [1] 443975 0
Clinical Outcomes
Timepoint [1] 443975 0
Baseline (pre-test), 6 weeks after baseline (post-test), 1 month after post-test

Eligibility
Key inclusion criteria
1. Individuals must be 18 years and above
2. Individuals must be diagnosed with PAH
3. Individuals who are clinically stable with low to intermediate risk as determined by REVEAL 2.0
4. Individuals who are proficient in English or Malay language (in terms of reading, writing, and speaking)
5. Individuals who are capable of committing to six consecutive weekly sessions
6. Individuals who provide full consent to participate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Individuals who are formally diagnosed with mental disorders
2. Individuals who are undergoing psychiatric medications or treatments
3. Individuals who are currently receiving psychological interventions

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
30/07/2025
Actual
Date of last data collection
Anticipated
10/10/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 26827 0
Malaysia
State/province [1] 26827 0

Funding & Sponsors
Funding source category [1] 318159 0
Self funded/Unfunded
Name [1] 318159 0
Faeza Hasnan
Country [1] 318159 0
Malaysia
Primary sponsor type
Individual
Name
Faeza Hasnan - Universiti Kebangsaan Malaysia
Address
Country
Malaysia
Secondary sponsor category [1] 320541 0
None
Name [1] 320541 0
Address [1] 320541 0
Country [1] 320541 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316806 0
National University of Malaysia Research Ethics Committee
Ethics committee address [1] 316806 0
Ethics committee country [1] 316806 0
Malaysia
Date submitted for ethics approval [1] 316806 0
03/02/2025
Approval date [1] 316806 0
Ethics approval number [1] 316806 0
Ethics committee name [2] 316851 0
National Heart Institute Research Ethics Committee
Ethics committee address [2] 316851 0
Ethics committee country [2] 316851 0
Malaysia
Date submitted for ethics approval [2] 316851 0
31/01/2025
Approval date [2] 316851 0
Ethics approval number [2] 316851 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139062 0
Ms Faeza Hasnan
Address 139062 0
Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 139062 0
Malaysia
Phone 139062 0
+601117642755
Fax 139062 0
Email 139062 0
[email protected]
Contact person for public queries
Name 139063 0
Faeza Hasnan
Address 139063 0
Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 139063 0
Malaysia
Phone 139063 0
+601117642755
Fax 139063 0
Email 139063 0
[email protected]
Contact person for scientific queries
Name 139064 0
Faeza Hasnan
Address 139064 0
Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 139064 0
Malaysia
Phone 139064 0
+601117642755
Fax 139064 0
Email 139064 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.