An interventional study of self-care tools and lay telephone coaching in Mental Health Wellness 1, Coaching and Pandemic, sponsored by St. Mary's Research Center, Canada. Completed at 1 site in Canada. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2021-09-21.
Sponsored by St. Mary's Research Center, Canada · Not applicable, Interventional, and Supportive care
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:
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 90 is close to the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →St. Mary's Research Center, Canada is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Arms Assigned Interventions Experimental: self-care tools The tools are adapted from those successfully deployed in the DIRECTsc depression self-care project focusing on patients with depressive symptoms, but abbreviated to meet the needs of the proposed short-term intervention for a broader sample of patients to include those with anxiety symptoms and with minimal symptoms. Tools will include individual chapters of the Antidepressant Skills Workbook; the mood monitoring tool; a workbook on managing worry; relaxation audio files and information on exercise and healthy eating. In view of the short duration of the intervention (8 weeks), a maximum of 2 tools will be sent to each participant. An algorithm will determine which self-care tools, matched to the specific mental health symptoms reported by participants, will be sent to the participants.
Behavioral: self-care tools
Participants will receive the algorithm-determined self-care tools, matched to the specific mental health symptoms reported by participants as in the first arm. They will ALSO be offered up to 3 coach calls. Coaching by a trained lay coach will be structured and guided by a manual. Trained lay coaches will call participants in the week following delivery of the toolkit to guide them through the self-care toolkit over an 8-week period. Coaches will contact participants a maximum of 3 times, with calls expected to average 15-20 minutes. Call content will be guided by a structured coaching manual adapted from those used in the team's previous two RCTs of the self-care materials. The coaches will follow structured agendas, keep records of all contacts.
Behavioral: self-care tools · Behavioral: lay telephone coaching
self-care tools only
coaching
Consent rate
Number of consenting participants out of total number contacted over the recruitment period
Time frame: At recruitment
Data completion rate
Investigators will report on rates of missing data from baseline and follow-up questionnaires
Time frame: From recruitment launch to completion of follow-up (4 months)
Fidelity of intervention completion
Logs and checklists will be used to evaluate completion of intervention, as per protocol
Time frame: A 8 week follow-up
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
Time frame: At baseline
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
Time frame: At 8 week follow-up
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
Time frame: At baseline
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
Time frame: At 8 week follow-up
Use of health care services
Using questions developed by the team and administrative databases to assess use of hospital and mental health care services
Time frame: At baseline
Use of health care services
Using questions developed by the team and administrative databases to assess use of hospital and mental health care services
Time frame: At 8 week follow-up
Use of the self-care materials
Using adherence questions developed by the team, not scored
Time frame: At 8 week follow-up
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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St. Mary's Research Center, Canada