NCT06548282

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2024

Completed
Last Updated

March 4, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

August 7, 2024

Last Update Submit

March 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Study Arms (2)

Experimental

EXPERIMENTAL

Who receives intervention i.e. Acceptance and Commitment Therapy

Other: Acceptance and commitment therapy

Waitlist Control

ACTIVE COMPARATOR

Who would receive intervention after study completion

Other: Acceptance and commitment therapy

Interventions

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.

ExperimentalWaitlist Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Armed Forces Institute of Cardiology

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Rawalpindi Institute of Cardiology

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Medication Adherence

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sehrish Khan, PhD Scholar

    Fatima Jinnah women University, Rawalpindi, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2024

First Posted

August 12, 2024

Study Start

June 21, 2024

Primary Completion

September 21, 2024

Study Completion

September 21, 2024

Last Updated

March 4, 2025

Record last verified: 2025-03

Locations