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

NCT ID: NCT06548282

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-21
• Study Completion Date: 2024-09-21

Brief 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

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.

Conditions

Psychological Distress; Type D Personality; Medication Adherence; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Experimental

Who receives intervention i.e. Acceptance and Commitment Therapy

Group Type: EXPERIMENTAL

Acceptance and commitment therapy

Intervention Type: OTHER

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.

Waitlist Control

Who would receive intervention after study completion

Group Type: ACTIVE_COMPARATOR

Acceptance and commitment therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fatima Jinnah Women University

OTHER

Sponsor Role: lead

Responsible Party

Sehrish Khan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sehrish Khan, PhD Scholar

Role: PRINCIPAL_INVESTIGATOR

Fatima Jinnah women University, Rawalpindi, Pakistan

Locations

Armed Forces Institute of Cardiology

Rawalpindi, Punjab Province, Pakistan

Rawalpindi Institute of Cardiology

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

FJWU/EC/2024/88

Identifier Type: -

Identifier Source: org_study_id