An interventional study of Psycho-Social Program in Mental Health Issue, Depression and Diabetes Distress, sponsored by Government College University Faisalabad. Not yet recruiting at 1 site in Pakistan. Open to participants aged 30 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Government College University Faisalabad · Not applicable, Interventional, and Health services research
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.
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 80 is close to the median of 81 across 7,063 interventional studies indexed under Depression.
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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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Participants will receive Psycho-Social Program
Behavioral: Psycho-Social Program
The control group will not receive the intervention during the study period.
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
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 assessment
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 assessment
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 assessment
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 assessment
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 assessment
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 assessment
Hill-Bone Medication Adherence Scale (HB-MAS)
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.
Time frame: At pre-assessment, after five weeks at post assessment
Plan to share: No
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Government College University Faisalabad