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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2022
Source Sunnybrook Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Caring Contacts
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.

Locations

Country Name City State
Canada Sunnybrook Health Sciences Centre Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

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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