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

Primary Purpose

Mental Health Wellness 1, Coaching, Pandemic

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
self-care tools
lay telephone coaching
Sponsored by
St. Mary's Research Center, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mental Health Wellness 1

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • St Mary's Hospital Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

self-care tools

coaching

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Consent rate
Number of consenting participants out of total number contacted over the recruitment period
Data completion rate
Investigators will report on rates of missing data from baseline and follow-up questionnaires
Fidelity of intervention completion
Logs and checklists will be used to evaluate completion of intervention, as per protocol
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
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
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
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
Use of health care services
Using questions developed by the team and administrative databases to assess use of hospital and mental health care services
Use of health care services
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
Using adherence questions developed by the team, not scored

Secondary Outcome Measures

Full Information

First Posted
October 19, 2020
Last Updated
September 20, 2021
Sponsor
St. Mary's Research Center, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT04609371
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 21, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Mary's Research Center, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Wellness 1, Coaching, Pandemic, Depression, Anxiety, Self-care Tools

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
self-care tools
Arm Type
Experimental
Arm Description
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.
Arm Title
coaching
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
self-care tools
Intervention Description
self-care tools only
Intervention Type
Behavioral
Intervention Name(s)
lay telephone coaching
Intervention Description
coaching
Primary Outcome Measure Information:
Title
Consent rate
Description
Number of consenting participants out of total number contacted over the recruitment period
Time Frame
At recruitment
Title
Data completion rate
Description
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)
Title
Fidelity of intervention completion
Description
Logs and checklists will be used to evaluate completion of intervention, as per protocol
Time Frame
A 8 week follow-up
Title
Severity of depression symptoms
Description
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
Title
Severity of depression symptoms
Description
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
Title
Severity of anxiety symptoms
Description
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
Title
Severity of anxiety symptoms
Description
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
Title
Use of health care services
Description
Using questions developed by the team and administrative databases to assess use of hospital and mental health care services
Time Frame
At baseline
Title
Use of health care services
Description
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
Title
Use of the self-care materials
Description
Using adherence questions developed by the team, not scored
Time Frame
At 8 week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
St Mary's Hospital Research Centre
City
Montréal
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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