Assisting Family Physicians With Gaps in Mental Health Care Generated by the COVID-19 Pandemic: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Consent rate
研究概览
简要总结
During pandemics older adults with chronic physical conditions are a particularly vulnerable population for unmet mental health needs. This is a consequence of a number of factors which include decreased access to their doctors because of restrictions in visits in order to decrease risk of disease transmission and because doctors are seconded to provide medical services in areas of high priority. Since Public Health authorities worry that pandemics may be a reality of the future, this study is being operationalized during the present COVID-19 pandemic in order to see what can be learned about different ways to provide mental health care under such constraints.
The study offers evidence-based approaches to managing feelings of anxiety or depression that may have existed prior to the onset of a pandemic, or that have arisen during a pandemic. It uses principles of cognitive behavioural therapy in which participants are offered self-care tools to help them develop strategies for dealing with their various symptoms. These tools have already been shown by the team to be effective in other contexts in studies DIRECT-sc (Effectiveness of a supported self-care intervention for depression compared to an unsupported intervention in older adults with chronic physical illnesses) and CanDIRECT (Effectiveness of a telephone-supported depression self-care intervention for cancer survivors).
The present study, PanDIRECT (Assisting Family Physicians with Gaps in Mental Health Care Generated by the COVID-19 Pandemic), aims to answer the following questions:
- Can these tools be used in the community care of mental health problems during pandemics?
- Are they acceptable to patients?
- Using a randomized control trial, does lay-coaching of use of these tools improve their use and patient outcomes?
- Do family practitioners value patient information sent to them at the end of the trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65+ years old
- •consented to be recontacted (participant in a previous study)
排除标准
- •moderate to severe cognitive impairment (using BOMC a brief cognitive screen) -unable to read in English or French (self-reported); hearing impairment (as judged by research staff);
- •currently receiving counseling or psychological therapy (as these treatments may conflict with the self-care interventions)
- •currently living in a long term care or other medicalized facility,
- •presenting suicidal intent (as identified through the final item of the PHQ-9 which will be asked at screening).
结局指标
主要结局
Consent rate
时间窗: At recruitment
Number of consenting participants out of total number contacted over the recruitment period
Data completion rate
时间窗: From recruitment launch to completion of follow-up (4 months)
Investigators will report on rates of missing data from baseline and follow-up questionnaires
Fidelity of intervention completion
时间窗: A 8 week follow-up
Logs and checklists will be used to evaluate completion of intervention, as per protocol
Severity of depression symptoms
时间窗: At 8 week follow-up
Using the validated 9 item Patient Health Questionnaire (PHQ-9). Scores range from 0 to 27 - higher score indicates more severe depression
Severity of anxiety symptoms
时间窗: At 8 week follow-up
Using the validated 7 item General Anxiety Disorder (GAD-7) instrument. Scores range from 0 to 21 - higher score indicates more severe anxiety
Use of health care services
时间窗: At 8 week follow-up
Using questions developed by the team and administrative databases to assess use of hospital and mental health care services
Use of the self-care materials
时间窗: At 8 week follow-up
Using adherence questions developed by the team, not scored
次要结局
未报告次要终点
研究者
Mark Yaffe
Professor, Department of Family Medicine, McGill University and Family physician, St. Mary's Hospital Center
St. Mary's Research Center, Canada