Efficacy of Acceptance and Commitment Therapy for the Management of Quality of Life in Patients Post Myocardial Infarction

March 3, 2025 updated by: Sehrish Khan, Fatima Jinnah Women University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Armed Forces Institute of Cardiology
      • Rawalpindi, Punjab, Pakistan, 46000
        • Rawalpindi Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. First-time diagnosed, non-hospitalized patients with myocardial infarction (MI).
  2. Patients attending follow-up visits at the hospital.
  3. Patients experiencing distress.
  4. Patients exhibiting features of Type D personality.

  5. Patients reporting low levels of:

    • Quality of Life (QoL)
    • Medication adherence
    • Social support
    • Acceptance
    • Psychological flexibility
  6. Patients aged 18 years and above.
  7. Both genders.
  8. Patients who can understand Urdu.
  9. Patients who can provide informed consent.

Exclusion Criteria:

  1. Hospitalized patients with myocardial infarction (MI).

  2. Patients with myocardial infarction (MI) and other chronic co-morbid diseases, such as:

    • Cancer
    • Cognitive deficits
    • Chronic psychological disorders
  3. Patients with silent myocardial infarction.
  4. Patients younger than 18 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Who receives intervention i.e. Acceptance and Commitment Therapy
Other: Acceptance and commitment therapy

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.
Active Comparator: Waitlist Control
Who would receive intervention after study completion
Other: Acceptance and commitment therapy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatima Jinnah Women University

Investigators

  • Principal Investigator: Sehrish Khan, PhD Scholar, Fatima Jinnah Women University, Rawalpindi, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2024

Primary Completion (Actual)

September 21, 2024

Study Completion (Actual)

September 21, 2024

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJWU/EC/2024/88

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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