Low Cost App based Intervention Dialog Plus For Anxiety And Depression In Outpatient Psychiatric Setting Pragmatic Multisite Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 336
- 试验地点
- 4
- 主要终点
- Manchester Short Assessment of Quality of Life (MANSA)
研究概览
简要总结
This study protocol describes a multisite, pragmatic cluster randomized controlled trial to evaluate the effectiveness and feasibility of DIALOG Plus, a low-cost app-based intervention for people with anxiety and depression in outpatient psychiatric settings. The study is coordinated by the Schizophrenia Research Foundation India and funded by ICMR. It includes four sites in Chennai and Puducherry. The intervention involves monthly sessions using DIALOG Plus, which aims to improve quality of life and mental health through structured communication between mental health professionals and patients. The trial compares this intervention with active control. Primary outcomes include improvements in quality of life and clinical symptoms. The study involves phases of preparation, implementation of the cluster RCT, process evaluation, and data analysis.
The study will involve mental health professionals using the app-based intervention called DIALOG Plus in their routine sessions with patients (Patients with ICD 10 diagnoses of F30-F39 and F40-F49 are recruited). In the interventino group the DIALOG Plus app will be used to structure the conversation that takes place during the session. This involves going through patient satisfaction in various life domains and then discussing them further using a four-step solution-focused approach. In the control group, mental health professionals will only use the app to complete the satisfaction in life domains scale with patients.
Data will be collected at baseline, at 3 months mid point of the intervention, and at 6 months end point of the intervention. Data collection will include different tools to measure quality of life and symptom severity. Further interviews will take place with patients and mental health professionals at the end of the intervention period at 6 months to gain a more in-depth understanding of their experience of using DIALOG Plus.
A total of 24 mental health professionals and 336 patients will be recruited for the study. Each site will have 6 mental health professionals and 84 patient participants. A cluster will have one mental health professional and 14 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals with depression or anxiety disorders(ICD-10 F30-F39,F40-F49)excluding bipolar disorder.
- •Currently experiencing anxiety and or depression.
- •Receiving treatment in the out-patient services of the sites.
- •Currently not an inpatient.
- •Score less than or equal to 5 on MANSA.
- •Capacity to provide informed consent.
- •Ability to communicate in Tamil or English.
排除标准
- •Major medical or Psychiatric comorbidities Current alcohol or substance use disorder (except nicotine) Pregnant or lactating mothers.
结局指标
主要结局
Manchester Short Assessment of Quality of Life (MANSA)
时间窗: Baseline - 0 months | Midline - 3 months | Endline - 6 months
次要结局
- Depression Anxiety and Stress Scale (DASS 21).
- Hamiltion Anxiety Rating Scale (HAM-A)(Baseline - 0 months)
- Hamilton Depression Rating Scale((HAM-D))
研究者
Dr Padmavati Ramachandran
Schizophrenia Research Foundation (India)