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

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04609371
• Other study ID #: SMHC-20-10
• Status: Completed
• Phase: N/A
• Start date: October 21, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: September 2021
• Source: St. Mary's Research Center, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• self-care tools
self-care tools only
• lay telephone coaching
coaching

Locations

Country	Name	City	State
Canada	St Mary's Hospital Research Centre	Montréal

Sponsors (1)

Lead Sponsor	Collaborator
St. Mary's Research Center, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consent rate	Number of consenting participants out of total number contacted over the recruitment period	At recruitment
Primary	Data completion rate	Investigators will report on rates of missing data from baseline and follow-up questionnaires	From recruitment launch to completion of follow-up (4 months)
Primary	Fidelity of intervention completion	Logs and checklists will be used to evaluate completion of intervention, as per protocol	A 8 week follow-up
Primary	Severity of depression symptoms	Using the validated 9 item Patient Health Questionnaire (PHQ-9). Scores range from 0 to 27 - higher score indicates more severe depression	At baseline
Primary	Severity of depression symptoms	Using the validated 9 item Patient Health Questionnaire (PHQ-9). Scores range from 0 to 27 - higher score indicates more severe depression	At 8 week follow-up
Primary	Severity of anxiety symptoms	Using the validated 7 item General Anxiety Disorder (GAD-7) instrument. Scores range from 0 to 21 - higher score indicates more severe anxiety	At baseline
Primary	Severity of anxiety symptoms	Using the validated 7 item General Anxiety Disorder (GAD-7) instrument. Scores range from 0 to 21 - higher score indicates more severe anxiety	At 8 week follow-up
Primary	Use of health care services	Using questions developed by the team and administrative databases to assess use of hospital and mental health care services	At baseline
Primary	Use of health care services	Using questions developed by the team and administrative databases to assess use of hospital and mental health care services	At 8 week follow-up
Primary	Use of the self-care materials	Using adherence questions developed by the team, not scored	At 8 week follow-up