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Development and Validation of Psycho-Social Program (PSP)

NCT07456410 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-06

No results posted yet for this study

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.

Conditions

  • Mental Health Issue
  • Depression
  • Diabetes Distress
  • Quality of Life
  • Medication Adherence

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

Sponsors & Collaborators

  • Government College University Faisalabad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-25
Primary Completion
2026-07-28
Completion
2026-08-28

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07456410 on ClinicalTrials.gov