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Effectiveness of Problem-Solving Therapy on Quality of Life and prevention of Repeat Heart Attacks and strokes in Haripur, Pakistan

Evaluating the Effectiveness of Problem-Solving Therapy on Quality of Life and Prevention of Repeat Heart Attacks and strokes in patients diagnosed with myocardial infarction and/or stroke in Haripur, Pakistan

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000791437
Acronym
HEARTS-PK
Enrollment
150
Registered
2025-07-25
Start date
2025-07-26
Completion date
2025-08-10
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study addresses the often-overlooked mental health challenges faced by myocardial infarction (MI) and stroke survivors in Haripur, Pakistan, by evaluating the effectiveness of Problem-Solving Therapy (PST). Using a mixed-methods, randomized controlled trial design, the study will assess PST’s impact on coping skills, depression, quality of life, and recurrence of cardiovascular events. Post-MI and post-stroke patients with depression will be randomized into intervention and control groups, with the intervention group receiving tailored PST sessions. Data will be collected at baseline and follow-up using validated psychological scales and physiological measures. Findings aim to inform integrated mental health care for cardiovascular patients in Pakistan’s primary health settings and support wider adoption of evidence-based psychological interventions like PST.

Interventions

This study will utilize a randomized controlled trial (RCT) with a mixed-methods design, to comprehensively assess the impact of resilience and participation on quality of life (QoL) among post-myocardial infarction (MI) and post-stroke patients experiencing depression. The research will be conducted at the outpatient cardiology department of the District Headquarter Hospital in Haripur, Pakistan. Participants will be randomly assigned to either an intervention or control group. Those in the int

This study will utilize a randomized controlled trial (RCT) with a mixed-methods design, to comprehensively assess the impact of resilience and participation on quality of life (QoL) among post-myocardial infarction (MI) and post-stroke patients experiencing depression. The research will be conducted at the outpatient cardiology department of the District Headquarter Hospital in Haripur, Pakistan. Participants will be randomly assigned to either an intervention or control group. Those in the intervention group will receive structured Problem-Solving Therapy (PST) in addition to standard care, while the control group will continue receiving treatment as usual (TAU) without any added psychological intervention. The PST intervention will consist of eight weekly face-to-face group sessions, each lasting approximately 90 minutes, conducted in a semi-open group format (9–10 participants per group) over a span of two months. These sessions will be delivered by trained master-level psychologists who will undergo an 80-hour structured training program supervised by a senior clinical psychologist with at least two years of clinical experience. The PST curriculum is adapted from evidence-based models and will cover key components such as problem orientation, structured problem-solving steps, goal setting, generation and evaluation of solutions, action planning, and coping skill enhancement. Additional “booster” sessions will be provided via phone at weeks 10 and 14 post-intervention to reinforce skill retention. To monitor adherence, session attendance will be logged, homework compliance tracked through checklists, and 10% of the sessions will be audio-recorded and evaluated for fidelity. Missed sessions will be followed up by the research team within 24 hours to ensure continuity. The study will unfold in three main phases: pre-intervention (baseline screening and assessment), intervention implementation, and post-intervention follow-up. The primary aims are to evaluate the short-term effectiveness of PST in enhancing coping strategies, reducing depressive symptoms, and improving overall resilience and quality of life. A secondary objective includes monitoring the recurrence of MI and stroke during the intervention period and through a three-month follow-up. Data will be collected at baseline, immediately post-intervention, and at three-month follow-up. Data will be collected using validated instruments such as the Stroke-Specific Quality of Life Scale (SSQOL), the Short Form Health Survey (SF-36), Coping Inventory for Stressful Situations (CISS), Beck Depression Inventory (BDI), and the Center for Epidemiological Studies Depression Scale (CES-D). Physiological indicators, including blood pressure, BMI, body fat percentage, and waist circumference, will be objectively measured by the research team. Additionally, recurrence of cardiac or stroke events will be tracked through self-reports and verified by reviewing participants' medical records. The entire study is expected to span approximately seven months.

Sponsors

Shahbaz Ahmad Zakki - The University of Haripur
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Adults aged 18 years and older (<65) diagnosed with myocardial infarction and/or stroke. (A definite diagnosis of IHD including recent (< 1 year) acute MI and admitted to hospital with first ever or recurrent stroke (other than subarachnoid hemorrhage) within the past month). 2. Receiving outpatient rehabilitation treatment. 3. Presence of clinical depression (major depressive disorder, minor depression or dysthymia) or current minor depression with or without anxiety symptoms.

Exclusion criteria

1. Comorbid diagnoses of drug addiction or abuse, organic brain damage, psychosis, persistent antisocial behavior or persistent self-harm. 2. Receiving any formal concurrent psychotherapy.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026