Development and Validation of Psycho-Social Program (PSP)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-40
SponsorGovernment College University Faisalabad
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Psycho-Social Program
BehavioralParticipants 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
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Psycho-Social Program groupExperimental treatment 1 intervention
Group B: Waitlist Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Diabetes Distress Scale
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
Time frame
At pre-assessment, after five weeks at post assessment2
Patient Health Questionnaire
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.
Time frame
At pre-assessment, after five weeks at post assessmentSecondary outcomes
1
Short Health Anxiety Inventory
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
Time frame
At pre-assessment, after five weeks at post assessment2
Revised Version of Diabetes Quality of Life Questionnaire
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
Time frame
At pre-assessment, after five weeks at post assessment3
Multidimensional Scale of Perceived Social Support
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
Time frame
At pre-assessment, after five weeks at post assessment4
Diabetes Stigma Assessment Scale
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
Time frame
At pre-assessment, after five weeks at post assessmentSponsors and contacts
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Source ClinicalTrials.gov
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