Depression, Diabetes Distress, Medication Adherence, Mental Health Issue, Quality of Life
Conditions
Keywords
Type 2 Diabetes Mellitus, mental health problems
Brief 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.
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.
Interventions
BEHAVIORALPsycho-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
Government College University Faisalabad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
A randomized controlled trial (RCT) will be conducted using a two-arm parallel group design. The study will include an intervention group receiving a structured psycho-social program and a wait-list control group receiving standard care. Equal allocation (1:1 ratio) will be maintained, with 40 participants in each group (n = 40 per group), for a total sample size of 80. Purposive sampling will be used to recruit participants aged 30 to 40 years diagnosed with Type 2 diabetes and experiencing mild-to-moderate psychological distress. The intervention group will participate in 6-8 psycho-social sessions delivered concurrently, focusing on improving mental health outcomes, reducing depression and anxiety, and enhancing coping strategies, while the control group will remain on a wait-list
Eligibility
Sex/Gender
ALL
Age
30 Years to 40 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Distress Scale | 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 |
| Patient Health Questionnaire | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Health Anxiety Inventory | 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 |
| Revised Version of Diabetes Quality of Life Questionnaire | 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 |
| Multidimensional Scale of Perceived Social Support | 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 |
| Diabetes Stigma Assessment Scale | 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 |
| Hill-Bone Medication Adherence Scale (HB-MAS) | 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. |
Countries
Pakistan
Contacts
CONTACTQasir Abbas Dr Dr Qasir Abbas, PhD Clinical Psychology
CONTACTSana Latif Sana Latif, PhD Applied Psychology
Outcome results
None listed