Assessment of the effectiveness of CBT related to stress in Type 2 Diabetes Mellitus.
试验速览
- 阶段
- Phase 3 4
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Statistical significance will be determined using independent and paired t-tests. A standard deviation of less than 0.005 will be considered significant.
研究概览
简要总结
The study aims to investigate the efficacy of Cognitive Behavioural Therapy (CBT) in managing stress among individuals with Type 2 Diabetes Mellitus (T2DM) in India. The primary objective is to assess the impact of CBT on perceived stress levels and glycemic control in T2DM patients.
Methodologically, we will conduct a randomized controlled trial involving T2DM patients aged 18-65 years. Participants will be randomly assigned to either the intervention group or the control group. The intervention group will receive six sessions of CBT administered by trained therapists over a period of one month, while the control group will receive standard diabetes care without CBT intervention.
Outcome measures will include perceived stress levels assessed using the Perceived Stress Scale (PSS-10), depression and anxiety symptoms measured using the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) scales, respectively, self-worth assessed using the Rosenberg Self-Esteem (RSE) scale, gratitude practices measured using the Gratitude Questionnaire-6 (GQ-6), and glycemic control evaluated through Hemoglobin A1c (HbA1c) levels.
Additionally, demographic data and information on diabetes-related factors such as duration of diagnosis, medication adherence, and lifestyle habits will be collected through structured interviews and medical records review.
The study will be conducted in a real-world clinical setting to enhance the generalizability of findings. Ethical approval is obtained, and informed consent is obtained from all participants before enrollment. Data analysis will be performed using appropriate statistical methods to compare outcomes between the intervention and control groups, with significance set at p < 0.05.
Overall, the study design and methodology ensure rigorous evaluation of the effectiveness of CBT in managing stress and improving glycemic control among T2DM patients in India, with potential implications for enhancing diabetes care globally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed with Type 2 Diabetes for more than a month- Hba1c levels.
- •6.5 and above.
排除标准
- •Any other types of Diabetes.
结局指标
主要结局
Statistical significance will be determined using independent and paired t-tests. A standard deviation of less than 0.005 will be considered significant.
时间窗: On Day 0 of Week 1, we will calculate PSS-10 scores. After the CBT intervention, we will calculate the scores on Day 30 of Week 4.On Day 0 of Week 1, we will calculate PSS-10 scores. After the CBT intervention, we will calculate the scores on Day 30 of Week 4.
次要结局
- Scales like Generalized Anxiety and Patient Health Questionnaire will have less scores(Better health)
研究者
Dr. Prasanna Deshpande
Dr DY Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune, Maharashtra, India