A randomized controlled trial to evaluate a technology-enabled platform to manage depreSsion with or without beHavioural actiVation In patieNtS with cancer in India (Pilot)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- A. Change in PHQ-9 depression scores in both the intervention arms compared to the control arm.
研究概览
简要总结
Aims and HypothesisThe goal of this project is to develop and test a technology-enabled mental health care delivery platform, with or without behavioral activation (BA), for patients in India with breast, cervix, ovarian, lung, prostrate, colon, head, and neck cancer and comorbid depression, and to assess the effectiveness and cost-effectiveness of this platform in clinical practice. HypothesisThe primary hypotheses are that compared to usual care, both technology-enabled platform and behavioral activation will show improved depression scores on Patient Health Questionnaire-9 at 6-months. OutcomesThere are two primary outcomes. The first primary outcome is change in scores on the PHQ9, between baseline and at 6 months since randomization in both intervention arms compared to control arm. The second co-primary outcome is change in scores on the WHO5, between baseline and at 6 months since randomization in both the intervention arms compared to control arm.
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
- •Consenting adult patients (18 years and above) suffering from breast, cervix, ovarian, lung, prostrate, colon, head, and neck cancer with comorbid depression as per screen positive cut-off score on PHQ9/GAD7 attending the relevant departments of the 3 hospitals.
- •Newly diagnosed (clinically or confirmed by radiological/pathological reports) patients (within 3 months, which includes patients with recurring/ secondary cancer) will be recruited from both inpatient and outpatients.
排除标准
- •Patients at imminent risk of suicide based on clinical assessment, or showing aggressive behavior, or lacking insight due to psychotic features;
- •Patients who score 2 or more on the Eastern Cooperative Oncology Group Performance Status (ECOG-PS);
- •Patients and caregivers who are unable to read Hindi/ English/ Punjabi/ Kannada/ Telegu (that would prevent them from responding to the self-monitoring questions).
- •Patients who are unable to speak and communicate because of the disease and treatment which hinders their participation.
结局指标
主要结局
A. Change in PHQ-9 depression scores in both the intervention arms compared to the control arm.
时间窗: A. Baseline (just before randomization) and at 6 months since randomization. | B. Baseline (just before randomization) and at 6 months since randomization.
B. Change in WHO-5 wellbeing scores in both the intervention arms compared to control arm.
时间窗: A. Baseline (just before randomization) and at 6 months since randomization. | B. Baseline (just before randomization) and at 6 months since randomization.
次要结局
- A. Changes in PHQ-9 depression scores.(B. Changes in Quality of life WHOQol-Bref scores.)
研究者
Prof Pallab K Maulik
George Institute for Global Health, India