Mental Health Wellness 1NCT04609371
PanDirect: Self-care Tools and Telephone Coaching for Depression and Anxiety During Pandemics
A study testing self-care tools and lay telephone coaching in people with Mental Health Wellness 1 and Coaching, run by St. Mary's Research Center, Canada at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mental Health Wellness 1, Coaching, Pandemic
- What is being tested?
- self-care tools and lay telephone coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 21 Oct 2020to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65+ years old
- consented to be recontacted (participant in a previous study)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assisting Family Physicians With Gaps in Mental Health Care Generated by the COVID-19 Pandemic: A Randomized Controlled Trial
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).
Read more
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
- Being tested
- self-care tools, lay telephone coaching
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-care toolsBehavioural
self-care tools only
lay telephone coachingBehavioural
coaching
| Study group | Role | What they receive |
|---|---|---|
| self-care tools | Experimental | 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. Receives: Behavioral: self-care tools |
| coaching | Experimental | 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. Receives: Behavioral: self-care tools; Behavioral: lay telephone coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent rate
Number of consenting participants out of total number contacted over the recruitment period
Measured: At recruitment
Data completion rate
Investigators will report on rates of missing data from baseline and follow-up questionnaires
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 8 week follow-up
Use of the self-care materials
Using adherence questions developed by the team, not scored
Measured: At 8 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start21 Oct 2020
- Primary completion1 Mar 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Mary's Research Center, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Yaffe, St. Mary's Research Center, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609371
- Sponsor's protocol ID
- SMHC-20-10
- Status last verified
- Sep 2021
- First submitted
- 19 Oct 2020
- Last updated
- 21 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assisting Family Physicians With Gaps in Mental Health Care Generated by the COVID-19 Pandemic: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04609371
- Acronym / sponsor ID
- SMHC-20-10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- St. Mary's Research Center, CanadaUniversity, hospital or other
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self-care tools | Experimental | Behavioral: self-care toolsArms 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. |
| coaching | Experimental | Behavioral: self-care tools, Behavioral: lay telephone coachingParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65+ years old
- consented to be recontacted (participant in a previous study)
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-care toolsself-care tools only | Behavioural | coaching, self-care tools |
| lay telephone coachingcoaching | Behavioural | coaching |
Primary outcome
Consent rate
Time frame: At recruitment
Number of consenting participants out of total number contacted over the recruitment period
Data completion rate
Time frame: From 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 completion
Time frame: A 8 week follow-up
Logs and checklists will be used to evaluate completion of intervention, as per protocol
Severity of depression symptoms
Time frame: At baseline
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
Time frame: At 8 week follow-up
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
Time frame: At baseline
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
Time frame: At 8 week follow-up
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
Time frame: At baseline
Using questions developed by the team and administrative databases to assess use of hospital and mental health care services
Use of health care services
Time frame: At 8 week follow-up
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
Time frame: At 8 week follow-up
Using adherence questions developed by the team, not scored
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Mental Health Wellness 1
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
RecruitingObservational study
Friends/Family of Individuals at Risk of Suicide Training Program
Caregiver, Caregiver Mental Health
Recruiting
GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Wellness in Adults
Sleep Disturbance, Stress
Not yet recruitingPhase 1
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
Schizophrenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-care tools and lay telephone coaching in people with Mental Health Wellness 1 and Coaching, run by St. Mary's Research Center, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent rate (time frame: At recruitment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.