Skip to content

PanDirect: Self-care Tools and Telephone Coaching for Depression and Anxiety During Pandemics

Assisting Family Physicians With Gaps in Mental Health Care Generated by the COVID-19 Pandemic: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04609371
Enrollment
90
Registered
2020-10-30
Start date
2020-10-21
Completion date
2021-05-01
Last updated
2021-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coaching, Depression, Anxiety, Mental Health Wellness 1, Pandemic, Self-care Tools

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

Interventions

BEHAVIORALself-care tools

self-care tools only

coaching

Sponsors

St. Mary's Research Center, Canada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Consent rateAt recruitmentNumber of consenting participants out of total number contacted over the recruitment period
Data completion rateFrom 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 completionA 8 week follow-upLogs and checklists will be used to evaluate completion of intervention, as per protocol
Severity of depression symptomsAt baselineUsing the validated 9 item Patient Health Questionnaire (PHQ-9). Scores range from 0 to 27 - higher score indicates more severe depression
Severity of anxiety symptomsAt baselineUsing 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 servicesAt baselineUsing questions developed by the team and administrative databases to assess use of hospital and mental health care services
Use of the self-care materialsAt 8 week follow-upUsing adherence questions developed by the team, not scored

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026