Conditions: Serious Mental IllnessNCT01820468
Adapting a Model for Veterans on a Psychiatric Inpatient Unit
A study testing Adapted critical time intervention team in people with Conditions: Serious Mental Illness, run by VA Connecticut Healthcare System.
Trial summary
This randomized controlled study tests an adapted critical time intervention model for veterans discharged from a psychiatric inpatient unit. It is hypothesized that veterans on the inpatient unit who are assigned to such a community-based team will have shorter lengths of inpatient stay and better mental health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conditions: Serious Mental Illness
- What is being tested?
- Adapted critical time intervention team
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Mar 2016
- 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
- Admitted to the psychiatric inpatient unit for at least 4 days
- Willing to participate in community-based treatment
Who cannot join
- Actively suicidal or homicidal
- Dementia
- Drug or alcohol detoxification
- Physician emergency certificate
About this study
Official title: Adapting a Critical Time Intervention Model for Veterans on a Psychiatric Inpatient Unit
This randomized controlled study tests an adapted critical time intervention model for veterans discharged from a psychiatric inpatient unit. It is hypothesized that veterans on the inpatient unit who are assigned to such a community-based team will have shorter lengths of inpatient stay and better mental health. There have been few developments of community-based models of care in the post-deinstitutionalization era of short inpatient stays and the results of the study may inform how inpatient stays can be further reduced.
- Conditions
- Conditions: Serious Mental Illness
- Being tested
- Adapted critical time intervention team
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted critical time intervention teamBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Adapted critical time intervention team | Experimental | Community-based team will help facilitate early inpatient discharge and re-entry into the community. Receives: Behavioral: Adapted critical time intervention team |
| Regular inpatient care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of inpatient stay
Measured: 1 month follow-up
Secondary outcomes (1)
Mental health functioning
Measured: 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2014 (estimated)
- Study completionMar 2016 (estimated)
Why it stopped: This study was terminated before any participants were enrolled due to unforseen problems with participant enrollment and study design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conditions: Serious Mental IllnessStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jack Tsai, Ph.D., Principal investigator, VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820468
- Sponsor's protocol ID
- 01715
- Status last verified
- Dec 2014
- First submitted
- 25 Mar 2013
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting a Critical Time Intervention Model for Veterans on a Psychiatric Inpatient Unit
- ClinicalTrials.gov ID
- NCT01820468
- Acronym / sponsor ID
- 01715
- Conditions
- Conditions: Serious Mental Illness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was terminated before any participants were enrolled due to unforseen problems with participant enrollment and study design.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 28 Mar 2013 (estimated)
- 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.
This randomized controlled study tests an adapted critical time intervention model for veterans discharged from a psychiatric inpatient unit. It is hypothesized that veterans on the inpatient unit who are assigned to such a community-based team will have shorter lengths of inpatient stay and better mental health. There have been few developments of community-based models of care in the post-deinstitutionalization era of short inpatient stays and the results of the study may inform how inpatient stays can be further reduced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted critical time intervention team | Experimental | Behavioral: Adapted critical time intervention teamCommunity-based team will help facilitate early inpatient discharge and re-entry into the community. |
| Regular inpatient care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admitted to the psychiatric inpatient unit for at least 4 days
- Willing to participate in community-based treatment
Key exclusion criteria (4 listed)
- Actively suicidal or homicidal
- Dementia
- Drug or alcohol detoxification
- Physician emergency certificate
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 |
|---|---|---|
| Adapted critical time intervention team | Behavioural | Adapted critical time intervention team |
Primary outcome
Length of inpatient stay
Time frame: 1 month follow-up
1 secondary outcome
Mental health functioning
Time frame: 1 month follow up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
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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.
Jack Tsai, Ph.D. principal investigator
VA Connecticut Healthcare System
Questions about this trial
What is this clinical trial studying?
A study testing Adapted critical time intervention team in people with Conditions: Serious Mental Illness, run by VA Connecticut Healthcare System.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Length of inpatient stay (time frame: 1 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2015.