NCT04456062

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

August 4, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

12 months

First QC Date

June 30, 2020

Last Update Submit

August 23, 2022

Conditions

Keywords

Caring ContactsSuicide Prevention

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

EXPERIMENTAL
Other: Caring Contacts

Standard Treatment Group

NO INTERVENTION

Interventions

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.

Caring Contacts Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Suicide Prevention

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Ayal Schaffer, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR
  • Rosalie Steinberg, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

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

Locations