Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000791437
Ethics application status
Approved
Date submitted
5/06/2025
Date registered
25/07/2025
Date last updated
25/07/2025
Date data sharing statement initially provided
25/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Problem-Solving Therapy on Quality of Life and prevention of Repeat Heart Attacks and strokes in Haripur, Pakistan
Scientific title
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
Secondary ID [1] 314523 0
Nill
Universal Trial Number (UTN)
Nill
Trial acronym
HEARTS-PK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 337615 0
Stroke 337616 0
Depression 337617 0
Condition category
Condition code
Cardiovascular 333952 333952 0 0
Coronary heart disease
Stroke 334609 334609 0 0
Haemorrhagic
Mental Health 334610 334610 0 0
Depression
Public Health 334611 334611 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 331157 0
Rehabilitation
Intervention code [2] 331158 0
Behaviour
Intervention code [3] 331159 0
Prevention
Comparator / control treatment
Participants in the control group will receive usual care, which consists of standard medical
treatment and routine follow-up as provided by the healthcare facility. This includes ongoing cardiovascular or neurological management, medication adherence support, and general health education but does not include structured psychological interventions such as Problem-Solving Therapy. This allows for a comparison between standard care and the added benefits of a structured psychosocial intervention.
Control group
Active

Outcomes
Primary outcome [1] 341602 0
Change in specific domains of quality of life relevant to stroke/MI survivor participants.
Timepoint [1] 341602 0
Baseline (Week 0, pre-intervention before the intervention commencement), Post-intervention (Week 8, immediately after final session, primary timepoint), Follow-up (3 months after the intervention).
Primary outcome [2] 341603 0
Change in depression among participants.
Timepoint [2] 341603 0
Baseline (Week 0, pre-intervention before the intervention commencement), Post-intervention (Week 8, immediately after final session, primary timepoint), Follow-up (3 months after the intervention).
Primary outcome [3] 341604 0
Change in Participants' coping strategies
Timepoint [3] 341604 0
Baseline (Week 0, pre-intervention before the intervention commencement), Post-intervention (Week 8, immediately after final session, primary timepoint), Follow-up (3 months after the intervention).
Secondary outcome [1] 448053 0
Change in general health related quality of life among participants
Timepoint [1] 448053 0
Baseline (Week 0, pre-intervention before the intervention commencement), Post-intervention (Week 8, immediately after final session), Follow-up (3 months after the intervention).
Secondary outcome [2] 448054 0
Change in depression among participants
Timepoint [2] 448054 0
Baseline (Week 0, pre-intervention before the intervention commencement), Post-intervention (Week 8, immediately after final session), Follow-up (3 months after the intervention).
Secondary outcome [3] 448533 0
Change in various domains of quality of life with resilence among participants
Timepoint [3] 448533 0
Baseline (Week 0, pre-intervention before the intervention commencement), Post-intervention (Week 8, immediately after final session).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A central randomization process will be used. The allocation sequence will be generated by an independent researcher and concealed using sealed, opaque, sequentially numbered envelopes to ensure that the study staff and participants are unaware of upcoming assignments until the point of allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization sequence was used to minimize to ensure allocation concealment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data will be analysed using descriptive statistics, correlation, and multiple regression to explore links among participation, resilience, and quality of life. The effectiveness of Problem-Solving Therapy will be tested with an intention-to-treat approach. Between-group differences will be examined with paired and independent t-tests (or non-parametric equivalents) and ANCOVA to adjust for baseline scores. Recurrence of MI and stroke will be summarised with incidence rates, illustrated with Kaplan-Meier curves, and modelled with Cox regression to identify risk factors. Qualitative interview and focus-group transcripts will undergo thematic analysis in NVivo. A two-sided p < 0.05 will denote statistical significance, and all quantitative analyses will be run in SPSS v28 or R 4.3.

Sample-size determination:
The primary outcome for sample size calculation is the change in depressive symptoms measured by the Beck Depression Inventory (BDI). Based on prior literature, detecting a moderate effect size (Cohen’s d = 0.5) with a = 0.05 (two-sided) and 80% power requires approximately 34 participants per group (total = 68). To account for 15–20% attrition, we plan to recruit 40–45 participants per group, resulting in a total sample size of 80–90 participants. This sample size remains adequate to detect meaningful differences in secondary outcomes such as coping strategies (CISS) and quality of life (SF-36), and it allows for the estimation of event recurrence trends over the 3-month follow-up.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/07/2025
Actual
Date of last participant enrolment
Anticipated
10/08/2025
Actual
Date of last data collection
Anticipated
26/01/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 27083 0
Pakistan
State/province [1] 27083 0
Khyber Pakhtunkhwa, Pakistan

Funding & Sponsors
Funding source category [1] 319075 0
Self funded/Unfunded
Name [1] 319075 0
Country [1] 319075 0
Primary sponsor type
Individual
Name
Shahbaz Ahmad Zakki - The University of Haripur
Address
Country
Pakistan
Secondary sponsor category [1] 321535 0
None
Name [1] 321535 0
Address [1] 321535 0
Country [1] 321535 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317672 0
National Bioethics Committee for Research Islamabad Pakistan
Ethics committee address [1] 317672 0
Ethics committee country [1] 317672 0
Pakistan
Date submitted for ethics approval [1] 317672 0
06/02/2025
Approval date [1] 317672 0
18/03/2025
Ethics approval number [1] 317672 0
4-87/NBCR-1218/24-25/1472

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141766 0
A/Prof Shahbaz Ahmad Zakki
Address 141766 0
Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan
Country 141766 0
Pakistan
Phone 141766 0
+923336362383
Fax 141766 0
Email 141766 0
[email protected]
Contact person for public queries
Name 141767 0
Muhammad Ateeb
Address 141767 0
Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan
Country 141767 0
Pakistan
Phone 141767 0
+923357333383
Fax 141767 0
Email 141767 0
[email protected]
Contact person for scientific queries
Name 141768 0
Shahbaz Ahmad Zakki
Address 141768 0
Department of Public Health and Nutrition, The University of Haripur, 22620 Haripur, Khyber Pakhtunkhwa, Pakistan
Country 141768 0
Pakistan
Phone 141768 0
+923336362383
Fax 141768 0
Email 141768 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval  [email protected] NBCR-1218 Approval letter 18-03-2025.pdf
Informed consent form  [email protected] Informed consent form.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.