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NCT07456410
NA

Development and Validation of Psycho-Social Program (PSP)

Sponsor: Government College University Faisalabad

View on ClinicalTrials.gov

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.

Official title: Development and Validation of Psycho-Social Program (PSP) for Mental Health Problems Among Patients With Type 2 Diabetes Mellitus (T2DM): A Randomised Controlled Trial

Key Details

Gender

All

Age Range

30 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-03-25

Completion Date

2026-08-28

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

BEHAVIORAL

Psycho-Social Program

Participants in the intervention group will receive 6-8 sessions of psycho-social program (PSP) designed to improve mental health outcomes in patients with Type 2 diabetes. The session-wise agenda includes: Session 1 - Psychoeducation about diabetes and mental health; Session 2 - Behavioral Activation to increase engagement in health-promoting activities; Session 3 - Cognitive Conceptualization and Restructuring to identify and challenge negative thoughts; Session 4 - Stress Management; Session 5 - Time and Lifestyle Management; Session 6 - Problem-Solving Skills; and Session 7 - Relapse Prevention and Follow-up Planning to maintain progress and adaptive coping

Locations (1)

Government College University Faisalabad

Faisalabad, Punjab Province, Pakistan