Using Caring Contacts to Reduce Psychiatric Morbidity Following Hospitalization During the COVID-19 Pandemic
1 other identifier
interventional
102
1 country
1
Brief Summary
Subjects will be recently discharged patients from Sunnybrook Inpatient Psychiatry Unit. Subjects will be randomized in a 1:1 ratio to either the Caring Contact intervention or usual care. 75 subjects will be enrolled in each arm. In additional to usual discharge-related care, subjects in the caring contact group will receive brief emails that convey a message of hope and provide resources. These emails will be sent on days 4, 21, and 56 post-discharge. The specific content of these emails will be pre-determined varying slightly by time point. In contrast, the control group will only receive usual discharge-related care, including discharge planning and also a sheet of resources normally provided to patients. A widely used and validated measure will be employed to assess depression and anxiety symptoms. The 25-item self-report Hopkins Symptom Checklist will be emailed to all subjects at baseline, day 4, 21, and 56 post-discharge, along with the Caring Contact communication. It is hypothesized that there will be a significantly greater reduction in mental health symptoms among patients receiving Caring Contacts compared to those who receive usual care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2020
CompletedFirst Posted
Study publicly available on registry
July 2, 2020
CompletedStudy Start
First participant enrolled
August 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2021
CompletedAugust 24, 2022
August 1, 2022
12 months
June 30, 2020
August 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hopkins Symptom Checklist-25 (HSCL-25)
The HSCL-25 is a widely-used and validated self-report questionnaire using a Likert scale to measure symptoms of anxiety and depression. Change scores in anxiety and depression will be used to assess effectiveness of intervention.
Baseline, day 4, day 21, day 56 post-discharge
Study Arms (2)
Caring Contacts Group
EXPERIMENTALStandard Treatment Group
NO INTERVENTIONInterventions
Caring Contacts are brief email communications sent to the patient post-discharge. They convey messages of hope, support, promote a sense of belonging, and provide information on resources for care. They are not written uniquely for each patient but are purposefully crafted to intervene on those specific vulnerabilities that form the core of many patients' experiences with intense emotional distress and suicidal thoughts.
Eligibility Criteria
You may qualify if:
- Provision of written informed consent
- Inpatient status in Sunnybrook Inpatient Psychiatry Unit at time of recruitment
- Have an email or mailing address
- Ability to read and understand English
- The ability to understand and comply with the requirements of the study and capable of providing informed consent
You may not qualify if:
- A primary Major Neurocognitive Disorder diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Related Publications (1)
Holman S, Steinberg R, Sinyor M, Lane H, Starritt K, Kennedy SH, Niederkrotenthaler T, Zaretsky A, Castel S, Schaffer A. Caring Contacts to Reduce Psychiatric Morbidity Following Hospitalization During the COVID-19 Pandemic: A Pilot Randomized Controlled Trial. Can J Psychiatry. 2023 Mar;68(3):152-162. doi: 10.1177/07067437221121111. Epub 2022 Aug 22.
PMID: 35996823DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ayal Schaffer, MD
Sunnybrook Health Sciences Centre
- PRINCIPAL INVESTIGATOR
Rosalie Steinberg, MD
Sunnybrook Health Sciences Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Psychiatrist
Study Record Dates
First Submitted
June 30, 2020
First Posted
July 2, 2020
Study Start
August 4, 2020
Primary Completion
July 31, 2021
Study Completion
July 31, 2021
Last Updated
August 24, 2022
Record last verified: 2022-08