Development and Validation of Psycho-Social Program (PSP) (NCT07456410) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Development and Validation of Psycho-Social Program (PSP)
Pakistan80 participantsStarted 2026-03-25
Plain-language summary
The study aims to determine the effectiveness of a structured psycho-social program (PSP) in improving mental health outcomes among patients with Type 2 diabetes mellitus (T2DM). The intervention is designed to reduce symptoms of depression, anxiety, and diabetes-related distress (DD) by addressing maladaptive thoughts, emotional responses, and coping behaviors associated with chronic illness management. Through structured sessions incorporating cognitive restructuring, stress management techniques, behavioral activation, and adaptive coping strategies, participants will learn to manage emotional distress more effectively while improving treatment adherence and daily functioning. The intervention is expected to enhance psychological well-being, promote healthier coping mechanisms, and support better overall adjustment to living with T2DM.
Who can participate
Age range
30 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: Participants must be adults aged 30-40 years with Type 2 diabetes, experiencing mild-to-moderate mental health problems related to diabetes will be eligible.
Exclusion Criteria: Participants will be excluded if they have severe psychiatric disorders, serious medical comorbidities, are taking psychiatric medications that may affect outcomes, or are unable to participate in the intervention sessions.
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diabetes Distress Scale
Timeframe: At pre-assessment, after five weeks at post assessment
2
Patient Health Questionnaire
Timeframe: At pre-assessment, after five weeks at post assessment
Trial details
NCT IDNCT07456410
SponsorGovernment College University Faisalabad
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-07-28
Contact for this trial
Qasir Abbas Dr Dr Qasir Abbas, PhD Clinical Psychology