Development and Validation of Psycho-Social Program (PSP) (PSP-T2DM)

March 4, 2026 updated by: Qasir Abbas, Government College University Faisalabad

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to evaluate the effectiveness of a structured psycho-social program (PSP) in improving mental health outcomes among patients with Type 2 diabetes mellitus (T2DM.) A total of 80 participants, aged 30-40 years, will be recruited from academic and clinical settings in Faisalabad, Pakistan, using purposive sampling. Participants will be randomly assigned to two groups: the intervention group (n=40) will receive 6-8 sessions of the psycho-social program targeting depression, anxiety, diabetes-related distress, medication adherence and quality of life, while the control group (n=40) will receive standard care without the intervention.

Participants with mild-to-moderate psychological distress will be included, whereas those with severe psychiatric conditions, co-morbidities, or under psychiatric medication will be excluded. Pre- and post-intervention assessments using validated instruments will measure changes in mental health outcomes, coping skills, and overall quality of life. The study is expected to show that the psycho-social program reduces psychological distress, enhances adaptive coping, and improves well-being, providing evidence-based guidance for mental health support in Type 2 diabetes patients.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Qasir Abbas Dr Dr Qasir Abbas, PhD Clinical Psychology
  • Phone Number: +10245 +923337683133
  • Email: qasirabbas47@yahoo.com

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Faisalabad, Punjab Province, Pakistan, 38000
        • Government College University Faisalabad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psycho-Social Program group
Participants will receive Psycho-Social Program
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
No Intervention: Waitlist Control Group
The control group will not receive the intervention during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Distress Scale
Time Frame: At pre-assessment, after five weeks at post assessment
The Diabetes Distress Scale (DDS) is a 17-item self-report questionnaire that measures emotional distress related to managing diabetes, including worries about treatment, support, and daily disease management. Items are rated on a 6-point Likert scale, with higher scores indicating greater distress. It is widely used to assess the effectiveness of interventions on diabetes-related emotional well-being
At pre-assessment, after five weeks at post assessment
Patient Health Questionnaire
Time Frame: At pre-assessment, after five weeks at post assessment
The Patient Health Questionnaire (PHQ-9) is a 9-item self-report measure used to assess the presence and severity of depressive symptoms over the past two weeks. Each item is rated on a 4-point Likert scale from 0 ("not at all") to 3 ("nearly every day"), with higher scores indicating greater severity of depression. The PHQ-9 is widely used in research and clinical practice to screen, monitor, and evaluate treatment outcomes for depression.
At pre-assessment, after five weeks at post assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Health Anxiety Inventory
Time Frame: At pre-assessment, after five weeks at post assessment
The SHAI contains 18 items that assess health anxiety independently of physical health status. Items assess worry about health, awareness of bodily sensations or changes, and feared consequences of having an illness. The SHAI has demonstrated good reliability, criterion validity, and sensitivity to treatment
At pre-assessment, after five weeks at post assessment
Revised Version of Diabetes Quality of Life Questionnaire
Time Frame: At pre-assessment, after five weeks at post assessment
Diabetes quality of life Questionnaire (RV-DQOL) instrument has been used to measure quality of life among diabetes patients. It consists of 13 items has three domains such as Satisfaction, Impact, Worry. Patients respond to all items on a 5-point Likert scale. A score of 1 indicates no impact, no worries, or always satisfied. A score of 5 represents always affected, always worried, or never satisfied. The reliability was 0.92 and 0.84, for worry, 0.98 and 0.60, for satisfaction and, for "impact", 0.99 and 0.57, respectively
At pre-assessment, after five weeks at post assessment
Multidimensional Scale of Perceived Social Support
Time Frame: At pre-assessment, after five weeks at post assessment
We will measure perceived social support using MSPSS 12-item, 7-point Likert-type scale (1 = Very strongly disagree, 2 = Strongly disagree, 3 = Mildly disagree, 4 = neutral, 5 = Mildly agree, 6 = Strongly agree, and 7 = Very strongly agree). A composite score is obtained by adding the scores on all 12 items and dividing it by 12. Cronbach alpha for the scale is 0.72 for our sample
At pre-assessment, after five weeks at post assessment
Diabetes Stigma Assessment Scale
Time Frame: At pre-assessment, after five weeks at post assessment
This scale assesses the perceived stigma experienced by individuals with diabetes across three dimensions: social rejection, self-stigma, and discrimination. The DSAS-2 consists of 19 items rated on a 6-point Likert scale, ranging from 1 (Strongly Disagree) to 6 (Strongly Agree). Higher scores indicate greater perceived stigma. The DSAS-2 has been widely used and validated in various populations with diabetes
At pre-assessment, after five weeks at post assessment
Hill-Bone Medication Adherence Scale (HB-MAS)
Time Frame: At pre-assessment, after five weeks at post assessment
The Hill-Bone Medication Adherence Scale (HB-MAS) is a self-report instrument designed to assess patients' adherence to prescribed medication regimens, particularly in chronic conditions like diabetes and hypertension. It includes items on medication-taking behavior, missed doses, and barriers to adherence, rated on a Likert scale. Higher scores indicate better adherence, and the scale is widely used to evaluate the effectiveness of interventions aimed at improving medication management and treatment compliance.
At pre-assessment, after five weeks at post assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Government College University Faisalabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 25, 2026

Primary Completion (Estimated)

July 28, 2026

Study Completion (Estimated)

August 28, 2026

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCUF-PSPT2DM-2026
  • Ethical Review Committee GCUF (Other Identifier: Government College University Faisalabad)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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