Clinical trial NCT04609371: PanDirect: Self-care Tools and Telephone Coaching for Depression and Anxiety During Pandemics
Official title: Assisting Family Physicians With Gaps in Mental Health Care Generated by the COVID-19 Pandemic: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Coaching
Pandemic
Depression, Anxiety
Self-care Tools
Lead sponsor: St. Mary's Research Center, Canada
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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:

1. Can these tools be used in the community care of mental health problems during pandemics?
2. Are they acceptable to patients?
3. Using a randomized control trial, does lay-coaching of use of these tools improve their use and patient outcomes?
4. Do family practitioners value patient information sent to them at the end of the trial


Eligibility criteria: Inclusion Criteria:

* 65+ years old
* consented to be recontacted (participant in a previous study)

Exclusion criteria:

* 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).

Primary outcomes:
measure: Consent rate
timeFrame: At recruitment
measure: Data completion rate
timeFrame: From recruitment launch to completion of follow-up (4 months)
measure: Fidelity of intervention completion
timeFrame: A 8 week follow-up
measure: Severity of depression symptoms
timeFrame: At baseline
measure: Severity of depression symptoms
timeFrame: At 8 week follow-up
measure: Severity of anxiety symptoms
timeFrame: At baseline
measure: Severity of anxiety symptoms
timeFrame: At 8 week follow-up
measure: Use of health care services
timeFrame: At baseline
measure: Use of health care services
timeFrame: At 8 week follow-up
measure: Use of the self-care materials
timeFrame: At 8 week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: St Mary's Hospital Research Centre
Study officials:
References: