Psychiatric Hospitalization Clinical Trial
Official title:
Using Caring Contacts to Reduce Psychiatric Morbidity Following Hospitalization During the COVID-19 Pandemic
NCT number | NCT04456062 |
Other study ID # | 1804 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 4, 2020 |
Est. completion date | July 31, 2021 |
Verified date | August 2022 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 102 |
Est. completion date | July 31, 2021 |
Est. primary completion date | July 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - A primary Major Neurocognitive Disorder diagnosis |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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