Development and Validation of Psycho-Social Program (PSP) for Mental Health Problems Among Patients With Type 2 Diabetes Mellitus (T2DM): A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Diabetes Distress Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Psycho-Social Program group
Participants will receive Psycho-Social Program
干预措施: Psycho-Social Program (Behavioral)
Waitlist Control Group
The control group will not receive the intervention during the study period.
结局指标
主要结局
Diabetes Distress Scale
时间窗: 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
时间窗: 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.
次要结局
- Short Health Anxiety Inventory(At pre-assessment, after five weeks at post assessment)
- Revised Version of Diabetes Quality of Life Questionnaire(At pre-assessment, after five weeks at post assessment)
- Multidimensional Scale of Perceived Social Support(At pre-assessment, after five weeks at post assessment)
- Diabetes Stigma Assessment Scale(At pre-assessment, after five weeks at post assessment)
- Hill-Bone Medication Adherence Scale (HB-MAS)(At pre-assessment, after five weeks at post assessment)
研究者
Qasir Abbas
Tenured Associate Professor -Clinical Psychology
Government College University Faisalabad