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Mental Health DisorderNCT06526026

An Innovative Mental Health Virtual Ward: Evaluation of Patient-Centered Outcomes

A study testing Virtual crisis stabilization support with a multi-disciplinary team in people with Mental Health Disorder and Mental Health Impairment, run by University of Manitoba at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to evaluate if admission to the Mental Health Virtual Ward (MH vWard) for mental health crisis stabilization is having a meaningful positive impact on patient reported outcomes and healthcare utilization. The objectives of this study are: 1. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Virtual crisis stabilization support with a multi-disciplinary team
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteCanada
Study dates
22 Jul 2024to 29 Jul 2025
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

  • Individuals admitted to the Mental Health Virtual Ward.

Who cannot join

  • None.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Crisis Stabilization Unit

    Winnipeg, Manitoba, R3G 0N2

Other trials in Canada

About this study

The goal of this study is to evaluate if admission to the Mental Health Virtual Ward (MH vWard) for mental health crisis stabilization is having a meaningful positive impact on patient reported outcomes and healthcare utilization. The objectives of this study are:

  1. Prospectively measure demographic, recovery, service delivery, and systems use outcomes in a cohort of MH vWard admissions.
  2. establish this cohort for use in future research.
Read more

As part of the intervention, participants will receive care in the MH vWard for an average of 5 days following a visit to an emergency department or crisis centre for a mental health crisis. While admitted to the MH vWard, participants will:

  1. Engage in individual therapy and care planning with a clinician or psychiatry team.
  2. Have engagement with formal (community providers) and informal supports (family, friends) for collateral and collaboration.
  3. Receive medication reconciliation and management.
  4. Participate in group programming.
  5. Receive referrals for follow-up services.
  6. Have access to after hours support.
  7. Have access to the Telus Home Health Monitoring (HHM) App, which is custom designed to complement the services provided by the program.
Being tested
Virtual crisis stabilization support with a multi-disciplinary team
Medical subject headings
Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual crisis stabilization support with a multi-disciplinary teamBehavioural

    Daily 1:1 sessions with multidisciplinary team via a range of virtual modalities (videoconferencing, phone, text, email), group programming, self-management resources, remote home monitoring app, referrals and linkages to community programs.

Study groups in NCT06526026
Study groupRoleWhat they receive
Mental Health Virtual WardExperimentalAdmission to the Mental Health Virtual Ward
Receives: Behavioral: Virtual crisis stabilization support with a multi-disciplinary team

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The World Health Organization-Five (WHO-5) Well-Being Index

    The World Health Organization-Five (WHO-5) Well-Being Index is a questionnaire used for the assessment of subjective psychological well-being.

    Five questions are answered on a scale of 1-5 (0 meaning the individual agrees with the statement "at no time", 5 meaning they agree with the statement "all of the time").

    Minimum value: 0 Maximum value: 25 A higher score represents better quality of life and well-being, a lower score represents lower quality of life and well-being.

    Measured: 1 week, 5 weeks and 6 months from date of discharge

Secondary outcomes (3)

  1. Post-discharge Healthcare Utilization (self-report)

    Number of participants who self-report further healthcare utilization following discharge from the virtual ward (all participants)

    Systems use outcomes will include: emergency department visits, crisis centre visits, and psychiatric hospitalizations collected by self-report. Patients can answer questionnaires electronically, over the phone, or in person with a member of the research team.

    Measured: 1 week post discharge, 5 weeks post discharge and 6 months from date of discharge

  2. Post-discharge Healthcare Utilization (administrative data)

    Number of participants with administrative data supporting further healthcare utilization following discharge from the virtual ward (urban participants only)

    Systems use outcomes will include: emergency department visits, crisis centre visits, and psychiatric hospitalizations collected via healthcare administrative data. This data will be used to collect some systems use outcomes data on participants lost to follow-up in the study, as well as allow for the assessment of recall bias when compared to self-reporting of healthcare utilization.

    Measured: 1 week post discharge, 5 weeks post discharge and 6 months from date of discharge

  3. Maryland Assessment of Recovery Scale-Twelve (MARS-12)

    Maryland Assessment of Recovery Scale-Twelve (MARS-12) contains a list of statements about an individuals subjective attitude and beliefs towards their own health an wellness.

    Twelve questions are answered on a scale from 1-5 (1 meaning the participant "not at all" agrees with the statement, 5 meaning the participant "very much" agrees with the statement).

    Minimum value: 12 Maximum value: 60 A higher score represents a higher personal recovery post-discharge, a lower score represent a lower personal recovery post-discharge.

    Measured: 1 week post discharge, 5 weeks post discharge, 6 months post-discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2024
  2. Study start22 Jul 2024
  3. Primary completion29 Jul 2025
  4. Study completion29 Jul 2025

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06526026
Sponsor's protocol ID
HS26297
Status last verified
Jul 2025
First submitted
23 Jul 2024
Last updated
6 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Castillo BA, Shterenberg R, Bolton JM, Dewa CS, Pullia K, Hensel JM. Virtual Acute Psychiatric Ward: Evaluation of Outcomes and Cost Savings. Psychiatr Serv. 2023 Oct 1;74(10):1045-1051. doi: 10.1176/appi.ps.20220332. Epub 2023 Apr 5.

    PubMed 37016824

  • Pullia K, Clavio A, Bolton JM, Hunzinger E, Svenne S, Hensel JM. Providing crisis care in a pandemic: a virtual based crisis stabilization unit. Front Health Serv. 2023 May 16;3:1030396. doi: 10.3389/frhs.2023.1030396. eCollection 2023.

    PubMed 37260632

  • Palay J, Taillieu TL, Afifi TO, Turner S, Bolton JM, Enns MW, Smith M, Lesage A, Bakal JA, Rush B, Adair CE, Vigod SN, Clelland S, Rittenbach K, Kurdyak P, Sareen J. Prevalence of Mental Disorders and Suicidality in Canadian Provinces. Can J Psychiatry. 2019 Nov;64(11):761-769. doi: 10.1177/0706743719878987. Epub 2019 Oct 16.

    PubMed 31619055

  • Butler A, Adair C, Jones W, et al. Towards quality mental health services in Canada: a comparison of performance indicators across 5 provinces. Vancouver, BC: Centre for Applied

  • Shared Health (2018). Shared Health Mental Health Program STATs 2018.

  • Crisis Response Services (2022). Crisis Response Services Annual Performance Report April 1, 2021-Mrach 31, 2022

  • Canadian Institute for Health Information, 2016.

  • Hensel JM, Bolton JM, Svenne DC, Ulrich L. Innovation through virtualization: Crisis mental health care during Covid-19. Canadian Journal of Community Mental Health. 2020 Nov 2;39(2):71-5.

  • Arsenault-Lapierre G, Henein M, Gaid D, Le Berre M, Gore G, Vedel I. Hospital-at-Home Interventions vs In-Hospital Stay for Patients With Chronic Disease Who Present to the Emergency Department: A Systematic Review and Meta-analysis. JAMA Netw Open. 2021 Jun 1;4(6):e2111568. doi: 10.1001/jamanetworkopen.2021.11568.

    PubMed 34100939

  • Lee K, Bolton SL, Shterenberg R, Bolton JM, Hensel JM. Early Learning From a Low-Resource COVID-Response Virtual Mental Health Crisis Ward: Mixed Methods Study. JMIR Form Res. 2022 Nov 4;6(11):e39861. doi: 10.2196/39861.

    PubMed 36252139

  • Ramsay C, Pickard R, Robertson C, Close A, Vale L, Armstrong N, Barocas DA, Eden CG, Fraser C, Gurung T, Jenkinson D, Jia X, Lam TB, Mowatt G, Neal DE, Robinson MC, Royle J, Rushton SP, Sharma P, Shirley MD, Soomro N. Systematic review and economic modelling of the relative clinical benefit and cost-effectiveness of laparoscopic surgery and robotic surgery for removal of the prostate in men with localised prostate cancer. Health Technol Assess. 2012;16(41):1-313. doi: 10.3310/hta16410.

    PubMed 23127367

  • Frank L, Basch E, Selby JV; Patient-Centered Outcomes Research Institute. The PCORI perspective on patient-centered outcomes research. JAMA. 2014 Oct 15;312(15):1513-4. doi: 10.1001/jama.2014.11100. No abstract available.

    PubMed 25167382

  • Bhattacharyya O, Hayden L, Hensel J. Health Services and Designing for Uncertainty: How a "lean startup" approach can help create an effective community-based program. Stanford Social Innovation Review. 2015;doi:10.48558/kw2z-6a08

  • Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial): large scale pragmatic randomised controlled trial. BMJ. 2016 Jan 12;352:i195. doi: 10.1136/bmj.i195. No abstract available.

    PubMed 26759375

  • Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.

    PubMed 25831962

Questions about this trial

What is this clinical trial studying?

A study testing Virtual crisis stabilization support with a multi-disciplinary team in people with Mental Health Disorder and Mental Health Impairment, run by University of Manitoba 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 1 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 6 Aug 2025. 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?

The World Health Organization-Five (WHO-5) Well-Being Index (time frame: 1 week, 5 weeks and 6 months from date of 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 NCT06526026, which also lists 19 linked publications.

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 6 Aug 2025.

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