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Trial registered on ANZCTR


Registration number
ACTRN12625000656437p
Ethics application status
Submitted, not yet approved
Date submitted
17/01/2025
Date registered
20/06/2025
Date last updated
20/06/2025
Date data sharing statement initially provided
20/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The Feasibility 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 Feasibility of Acceptance and Commitment Therapy (ACT) on Clinical and Psychological Outcomes among Patients with Pulmonary Arterial Hypertension (PAH) in National Heart Institute Malaysia
Secondary ID [1] 313733 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 336344 0
Mental Health 336345 0
Condition category
Condition code
Mental Health 332880 332880 0 0
Anxiety
Cardiovascular 332879 332879 0 0
Other cardiovascular diseases
Mental Health 332881 332881 0 0
Depression
Respiratory 333045 333045 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acceptance and Commitment Therapy (ACT) is a psychotherapy that has been an effective approach for chronic illnesses. This type of therapy focuses on six core principles that promote psychological flexibility among individuals which include the following: (1) acceptance, (2) cognitive defusion, (3) mindfulness, (4) self as context (5) values (6) committed action. The primary aim of ACT is to help patients with PAH achieve psychological flexibility through learning the skills based on the six core principles.

It is a group-based intervention that will be conducted physically with each group accommodating 8 to 10 participants. There will be 3 groups in total, each lasting two hours and spanning a total duration of six weeks.

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.

Summary of the intervention:

Week 1
- Welcoming the participants and introducing the team
- A brief overview of the purpose of the programme and the content of each session
- Explaining the basic ACT core principles
- The nature of symptoms associated with PAH and getting caught in the struggle
- Homework: Attempted solutions and their long-term effects exercise

Week 2
- Reflections on the homework, opportunity for questions
- What is Mindfulness and how is it useful?
- Embedding Mindfulness into daily activities (eating, walking, communication, acts of kindness)
- Group body scan exercise
- Homework: Daily Mindfulness practice sheet

Week 3
- Reflecting on Mindfulness practice
- What is defusion and how to hold self-stories lightly
- Brief Observer self exercise
- Passengers on the bus’ metaphor and group discussion
- Homework based on ‘Passengers on the bus’

Week 4
- Reflection on homework and Mindfulness practice
- Self-compassion explained
- Self-care activities
- Eight practices for recovery and a life well-lived
- Homework: Growing circle of self-care

Week 5
- Reflecting on self-care and self-compassion
- Acceptance as opposed to avoidance
- Acceptance physical exercise
- What are values and why are they important?
- Matrix interview exercise
- Homework: Values clarification exercise

Week 6
- Brief reflection on values
- Committed actions towards a rich, meaningful life
- The willingness and Action Plan exercise
- How will you take this forward?
- Final conclusions and reminder about follow-up

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] 330333 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340409 0
Feasibility of ACT intervention implementation
Timepoint [1] 340409 0
post-intervention, end of 6-week ACT intervention
Primary outcome [2] 340410 0
Feasibility of study methods
Timepoint [2] 340410 0
Post-intervention, end of 6-week ACT intervention
Secondary outcome [1] 443977 0
Change in participants' psychological distress scores from baseline to 1 month follow-up
Timepoint [1] 443977 0
Baseline, 6 weeks after baseline (post-intervention), 1 month after post-intervention
Secondary outcome [2] 444538 0
Change in participants' quality of life scores from baseline to 1 month follow-up
Timepoint [2] 444538 0
Baseline, 6 weeks after baseline (post-intervention), 1 month after post-intervention
Secondary outcome [3] 444537 0
Change in participants' psychological flexibility scores from baseline to 1 month follow-up
Timepoint [3] 444537 0
Baseline, 6 weeks after baseline (post-intervention), 1 month after post-intervention
Secondary outcome [4] 444539 0
Change in participants' clinical parameters from baseline to 1 month follow-up
Timepoint [4] 444539 0
Baseline, 6 weeks after baseline (post-intervention), 1 month after post-intervention

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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (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
1/07/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
10/10/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26828 0
Malaysia
State/province [1] 26828 0

Funding & Sponsors
Funding source category [1] 318201 0
Self funded/Unfunded
Name [1] 318201 0
Faeza Hasnan - Universiti Kebangsaan Malaysia
Country [1] 318201 0
Malaysia
Primary sponsor type
Individual
Name
Faeza Hasnan - Universiti Kebangsaan Malaysia
Address
Country
Malaysia
Secondary sponsor category [1] 320590 0
None
Name [1] 320590 0
Address [1] 320590 0
Country [1] 320590 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316852 0
National University of Malaysia Research Ethics Committee
Ethics committee address [1] 316852 0
Ethics committee country [1] 316852 0
Malaysia
Date submitted for ethics approval [1] 316852 0
03/02/2025
Approval date [1] 316852 0
Ethics approval number [1] 316852 0
Ethics committee name [2] 316854 0
National Heart Institute Research Ethics Committee
Ethics committee address [2] 316854 0
Ethics committee country [2] 316854 0
Malaysia
Date submitted for ethics approval [2] 316854 0
03/02/2025
Approval date [2] 316854 0
Ethics approval number [2] 316854 0

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

Contacts
Principal investigator
Name 139202 0
Ms Faeza Hasnan
Address 139202 0
Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 139202 0
Malaysia
Phone 139202 0
+601117642755
Fax 139202 0
Email 139202 0
[email protected]
Contact person for public queries
Name 139203 0
Faeza Hasnan
Address 139203 0
Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 139203 0
Malaysia
Phone 139203 0
+601117642755
Fax 139203 0
Email 139203 0
[email protected]
Contact person for scientific queries
Name 139204 0
Faeza Hasnan
Address 139204 0
Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 139204 0
Malaysia
Phone 139204 0
+601117642755
Fax 139204 0
Email 139204 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.