Psychological DistressNCT06548282
Efficacy of Acceptance and Commitment Therapy for the Management of Quality of Life in Patients Post Myocardial Infarction
A study testing Acceptance and commitment therapy in people with Psychological Distress and Type D Personality, run by Fatima Jinnah Women University at 2 sites in Pakistan.
Trial summary
The present study aims to investigate the efficacy of acceptance and commitment therapy for the management of quality of life in patients post-myocardial infarction Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress, Type D Personality, Medication Adherence
- What is being tested?
- Acceptance and commitment therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPakistan
- Study dates
- 21 Jun 2024to 21 Sep 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
- First-time diagnosed, non-hospitalized patients with myocardial infarction (MI).
- Patients attending follow-up visits at the hospital.
- Patients experiencing distress.
- Patients exhibiting features of Type D personality.
- Patients reporting low levels of:
- Quality of Life (QoL)
Show all 14Show fewer
- Medication adherence
- Social support
- Acceptance
- Psychological flexibility
- Patients aged 18 years and above.
- Both genders.
- Patients who can understand Urdu.
- Patients who can provide informed consent.
Who cannot join
- Hospitalized patients with myocardial infarction (MI).
- Patients with myocardial infarction (MI) and other chronic co-morbid diseases, such as:
- Cancer
- Cognitive deficits
- Chronic psychological disorders
- Patients with silent myocardial infarction.
- Patients younger than 18 years.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Armed Forces Institute of Cardiology
Rawalpindi, Punjab Province, 46000
Rawalpindi Institute of Cardiology
Rawalpindi, Punjab Province, 46000
About this study
The present study aims to investigate the efficacy of acceptance and commitment therapy for the management of quality of life in patients post-myocardial infarction
Read the detailed description
The current quantitative study is carried out in two steps. A cross-sectional survey assesses quality of life and associated factors during the first step. A randomized controlled trial will be done during the second step where patients with myocardial infarction who are identified with type D personality characteristics, psychological distress, low level of medication adherence, low social support, low quality of life, low acceptance and psychological flexibility will be randomly assigned to two groups i.e. waitlist control group and intervention group. The acceptance and commitment therapy would be implemented on participants in the interventional group. As the control group is the waitlist control group; initially no intervention will be given to participants in the control group but the intervention will be given to the control group participants once the study is completed.
- Being tested
- Acceptance and commitment therapy
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and commitment therapyOther
Introduction: Build rapport and complete pre-assessment questionnaires.
First Session:
Introduce therapist, ACT principles, and MI complications. Provide psychoeducation and assign homework.
Second Session:
Review feedback and encourage change. Assign homework.
Third Session:
Discuss acceptance and coping strategies. Assign homework.
Fourth Session:
Discuss cognitive diffusion and unhelpful thoughts. Assign homework.
Fifth Session:
Explore self-concept and mindfulness. Assign homework.
Sixth Session:
Identify and elaborate on values. Assign homework.
Seventh Session:
Discuss values, goals, and barriers. Assign homework.
Eighth Session:
Discuss commitment to action and relapse prevention. Administer post-test and express gratitude.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Who receives intervention i.e. Acceptance and Commitment Therapy Receives: Other: Acceptance and commitment therapy |
| Waitlist Control | Active comparator | Who would receive intervention after study completion Receives: Other: Acceptance and commitment therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Quality of Life Scale Urdu Version
It has 26 items and four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains quality of life and general health items. The minimum value is 26 and the maximum value is 130. Higher scores on the scale indicate higher quality of life and low scores indicate low quality of life.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start21 Jun 2024
- Primary completion21 Sep 2024
- Study completion21 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Women University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sehrish Khan, Fatima Jinnah Women University
- Investigators
- Sehrish Khan, PhD Scholar, Principal investigator, Fatima Jinnah women University, Rawalpindi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548282
- Sponsor's protocol ID
- FJWU/EC/2024/88
- Status last verified
- Mar 2025
- First submitted
- 7 Aug 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acceptance and Commitment Therapy for the Management of Quality of Life in Patients Post Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06548282
- Acronym / sponsor ID
- FJWU/EC/2024/88
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fatima Jinnah Women UniversityUniversity, hospital or other
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 21 Sep 2024 (actual)
- Study completion
- 21 Sep 2024 (actual)
- First posted
- 12 Aug 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 present study aims to investigate the efficacy of acceptance and commitment therapy for the management of quality of life in patients post-myocardial infarction
Detailed description
The current quantitative study is carried out in two steps. A cross-sectional survey assesses quality of life and associated factors during the first step. A randomized controlled trial will be done during the second step where patients with myocardial infarction who are identified with type D personality characteristics, psychological distress, low level of medication adherence, low social support, low quality of life, low acceptance and psychological flexibility will be randomly assigned to two groups i.e. waitlist control group and intervention group. The acceptance and commitment therapy would be implemented on participants in the interventional group. As the control group is the waitlist control group; initially no intervention will be given to participants in the control group but the intervention will be given to the control group participants once the study is completed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Acceptance and commitment therapyWho receives intervention i.e. Acceptance and Commitment Therapy |
| Waitlist Control | Active comparator | Other: Acceptance and commitment therapyWho would receive intervention after study completion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- First-time diagnosed, non-hospitalized patients with myocardial infarction (MI).
- Patients attending follow-up visits at the hospital.
- Patients experiencing distress.
- Patients exhibiting features of Type D personality.
- Patients reporting low levels of:
Key exclusion criteria (7 listed)
- Hospitalized patients with myocardial infarction (MI).
- Patients with myocardial infarction (MI) and other chronic co-morbid diseases, such as:
- Patients with silent myocardial infarction.
- Patients younger than 18 years.
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 |
|---|---|---|
| Acceptance and commitment therapyIntroduction: Build rapport and complete pre-assessment questionnaires. First Session: Introduce therapist, ACT principles, and MI complications. Provide psychoeducation and assign homework. Second Session: Review feedback and encourage change. Assign homework. Third Session: Discuss acceptance and coping strategies. Assign homework. Fourth Session: Discuss cognitive diffusion and unhelpful thoughts. Assign homework. Fifth Session: Explore self-concept and mindfulness. Assign homework. Sixth Session: Identify and elaborate on values. Assign homework. Seventh Session: Discuss values, goals, and barriers. Assign homework. Eighth Session: Discuss commitment to action and relapse prevention. Administer post-test and express gratitude. | Other | Experimental, Waitlist Control |
Primary outcome
World Health Organization Quality of Life Scale Urdu Version
Time frame: 3 months
It has 26 items and four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains quality of life and general health items. The minimum value is 26 and the maximum value is 130. Higher scores on the scale indicate higher quality of life and low scores indicate low quality of life.
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 4 Mar 2025.
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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.
Sehrish Khan, PhD Scholar principal investigator
Fatima Jinnah women University, Rawalpindi, Pakistan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and commitment therapy in people with Psychological Distress and Type D Personality, run by Fatima Jinnah Women University at 2 sites in Pakistan.
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 14 inclusion and 7 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 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
World Health Organization Quality of Life Scale Urdu Version (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2025.