Integration of screening and treatment for mental disorders in type 2 diabetes mellitus: A mixed-methods study in a health care setting of Kolar, South India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Reduction in common mental health disorders like depression, anxiety, stress and/or substance use
研究概览
简要总结
Background:
The higher prevalence of mental health morbidity and substance use disorders (SUDs) among individuals with Type 2 Diabetes Mellitus (T2DM) has garnered considerable attention. There is a need to integrate screening and comprehensive care protocols to address mental health issues and SUDs in T2DM.
Objectives:
To integrate mental health, substance use disorder screening and low-intensity intervention for Type-2 Diabetes Mellitus; to identify operational challenges in healthcare settings and to assess the feasibility and effectiveness of a brief, low-intensity intervention to address common mental health problems and SUDs as compared to usual care in Kolar District, India.
Methods:
This is a sequential mixed methods study with descriptive qualitative (Key Informant Interviews - KIIs and Focused Group Discussions-FGDs) and quantitative (Randomized Controlled Trial-RCT) components. Two hundred twenty-eight persons with Type 2 Diabetes Mellitus seeking health care in District Hospital, Kolar will be recruited for the RCT, and health care providers of various cadre, persons with T2DM, will be included for the qualitative component. Block randomization will allocate the participants into intervention and control groups in a 1:1 ratio. The intervention will be delivered for 20-30 minutes with three sessions two weeks apart on-site or telephonically while the control group receives standard care.
Conclusion:
This is a mixed methods study focusing on integrating screening and low-intensity intervention for mental health problems and SUDs among persons with T2DM. Addressing mental health needs alongside diabetes care may enhance overall health outcomes. Implementing such integrated approaches is essential for promoting holistic healthcare delivery.
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 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Persons aged more than 18 years diagnosed with type 2 diabetes mellitus seeking outpatient care at the District Hospital of Kolar will be included.
排除标准
- •include patients with conditions like Type 1 Diabetes Mellitus, those aged less than 18 years, those unable to give informed consent and hospitalized patients who cannot communicate verbally with the investigator.
结局指标
主要结局
Reduction in common mental health disorders like depression, anxiety, stress and/or substance use
时间窗: Baseline and eight weeks
次要结局
- Association between socio-demographic variables, morbidity profile and common mental disorders like depression, anxiety, stress, substance use (alcohol and tobacco) in both the groups (intervention and control)(Eight weeks after recruitment)
研究者
Pracheth Raghuveer
NIMHANS