Psychiatric HospitalizationNCT04456062
Using Caring Contacts to Reduce Psychiatric Morbidity Following Hospitalization During the COVID-19 Pandemic
A study testing Caring Contacts in people with Psychiatric Hospitalization, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychiatric Hospitalization
- What is being tested?
- Caring Contacts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteCanada
- Study dates
- 4 Aug 2020to 31 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- A primary Major Neurocognitive Disorder diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Psychiatric Hospitalization
- Being tested
- Caring Contacts
- Keywords
- Caring Contacts, Suicide Prevention
- Medical subject headings
- Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caring ContactsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Caring Contacts Group | Experimental | Not described Receives: Other: Caring Contacts |
| Standard Treatment Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, day 4, day 21, day 56 post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start4 Aug 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychiatric HospitalizationStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ayal Schaffer, Sunnybrook Health Sciences Centre
- Investigators
- Ayal Schaffer, MD, Principal investigator, Sunnybrook Health Sciences CentreRosalie Steinberg, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456062
- Sponsor's protocol ID
- 1804
- Status last verified
- Aug 2022
- First submitted
- 30 Jun 2020
- Last updated
- 24 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35996823
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Caring Contacts to Reduce Psychiatric Morbidity Following Hospitalization During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04456062
- Acronym / sponsor ID
- 1804
- Conditions
- Psychiatric Hospitalization
- Keywords
- Caring Contacts, Suicide Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 2 Jul 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caring Contacts Group | Experimental | Other: Caring Contacts |
| Standard Treatment Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- A primary Major Neurocognitive Disorder diagnosis
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 |
|---|---|---|
| Caring ContactsCaring 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. | Other | Caring Contacts Group |
Primary outcome
Hopkins Symptom Checklist-25 (HSCL-25)
Time frame: Baseline, day 4, day 21, day 56 post-discharge
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.
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 24 Aug 2022.
- Derived from this study: PubMed 35996823Holman 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.
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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.
Ayal Schaffer, MD principal investigator
Sunnybrook Health Sciences Centre
Rosalie Steinberg, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caring Contacts in people with Psychiatric Hospitalization, run by Sunnybrook Health Sciences Centre 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 5 inclusion and 1 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 24 Aug 2022. 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?
Hopkins Symptom Checklist-25 (HSCL-25) (time frame: Baseline, day 4, day 21, day 56 post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04456062, which also lists 1 linked publication.
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 24 Aug 2022.