Psychotic DisordersNCT00621465
Critical Time Intervention in the Transition From Hospital to Community in People With Severe Mental Illness
A study testing Critical Time Intervention (CTI) in people with Psychotic Disorders, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of a psychosocial treatment, Critical Time Intervention, in easing the transition from hospital to community in people with severe mental disorders. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Critical Time Intervention (CTI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Oct 2007
- 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 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of psychosis
- Homelessness during the 18 months before study entry
- English speaking
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rockland Psychiatric Center
Orangeburg, New York, 10962
About this study
Official title: CTI in the Transition From Hospital to Community
This study will evaluate the effectiveness of a psychosocial treatment, Critical Time Intervention, in easing the transition from hospital to community in people with severe mental disorders.
Read the detailed description
Severe mental illness (SMI) encompasses a wide range of mental disorders and disabilities, but commonly includes disorders that involve symptoms of psychosis. Psychotic symptoms may involve hallucinations, a lost sense of reality, or other distressing symptoms. About 6% of people experiencing psychotic symptoms seek inpatient treatment at a psychiatric hospital. Hospital treatment for a person with SMI often focuses on rapid improvement of negative symptoms and promotion of the necessary skills to successfully return to the community after leaving the hospital. Despite preparation for community integration, the transition from hospital to community remains a difficult time for many people with SMIs, with those affected having an increased chance for suicide, homelessness, and relapse. Critical Time Intervention (CTI), a psychosocial treatment program that aims to restore skills for community living and to assist in seeking service and support in the community, may be more effective than usual care in preventing these adverse outcomes after hospital discharge. This study will compare the effectiveness of CTI versus usual services in preventing homelessness and other adverse outcomes after leaving a psychiatric hospital among people with SMI and psychosis.
Participation in this study will last 18 months. Potential participants will undergo an initial 15- to 30-minute interview that will include questions about current mental, physical, and living conditions; history of psychiatric services; and alcohol and drug use. Eligible participants will then undergo the first full interview, which will include a full review of medical records and will last between 2 and 3 hours. After this interview, participants will be assigned randomly to receive CTI or usual services. For participants assigned to CTI, a CTI specialist will visit participants in the hospital and in their homes and will stay in contact with participants for 9 months after hospital discharge. During visits with the CTI specialist, participants will receive training in community living skills and help finding service and support in the community. Participants assigned to usual services will receive the usual care and community services offered to people recently leaving a psychiatric hospital.
After leaving the hospital, participants in both groups will be asked to participate in 15 follow-up interviews, which will include repeat questions from the 2 initial interviews. Interviews will be conducted once every 6 weeks until 18 months after hospital discharge and will last between 60 and 90 minutes.
- Conditions
- Psychotic Disorders
- Being tested
- Critical Time Intervention (CTI), Usual care
- Keywords
- Psychosis, Homelessness, Case Management, Severe Mental Illness
- Medical subject headings
- Psychotic Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical Time Intervention (CTI)Behavioural
CTI is designed specifically to enhance the continuity and focus of care during the transition from psychiatric hospital to community care. CTI does not replace community treatment and support, but instead is meant to complement available services. CTI will provide training in community living skills and in team-managed transfer of caregiving from hospitals to services and supports in the community. Participants will receive CTI for 9 months after hospital discharge.
Usual careBehavioural
Usual care will include the standard aftercare and community care services.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants will receive standard aftercare and community care services. Receives: Behavioral: Usual care |
| 2 | Experimental | Participants will receive usual care and the Critical Time Intervention. Receives: Behavioral: Critical Time Intervention (CTI); Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse outcomes after hospital discharge, particularly homelessness
Measured: Measured over 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startApr 2002
- Primary completionOct 2007
- Study completionOct 2007
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 Psychotic DisordersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Daniel Herman, DSW, Principal investigator, NYS Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621465
- Sponsor's protocol ID
- R01 MH059716,#4640R
- Other IDs
- R01MH059716, DSIR SE-MS
- Status last verified
- Dec 2011
- First submitted
- 20 Feb 2008
- Last updated
- 30 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Herman D, Conover S, Felix A, Nakagawa A, Mills D. Critical Time Intervention: an empirically supported model for preventing homelessness in high risk groups. J Prim Prev. 2007 Jul;28(3-4):295-312. doi: 10.1007/s10935-007-0099-3. Epub 2007 Jun 1.
PubMed 17541827
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CTI in the Transition From Hospital to Community
- ClinicalTrials.gov ID
- NCT00621465
- Acronym / sponsor ID
- R01 MH059716,#4640R
- Conditions
- Psychotic Disorders
- Keywords
- Psychosis, Homelessness, Case Management, Severe Mental Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2002
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 22 Feb 2008 (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 study will evaluate the effectiveness of a psychosocial treatment, Critical Time Intervention, in easing the transition from hospital to community in people with severe mental disorders.
Detailed description
Severe mental illness (SMI) encompasses a wide range of mental disorders and disabilities, but commonly includes disorders that involve symptoms of psychosis. Psychotic symptoms may involve hallucinations, a lost sense of reality, or other distressing symptoms. About 6% of people experiencing psychotic symptoms seek inpatient treatment at a psychiatric hospital. Hospital treatment for a person with SMI often focuses on rapid improvement of negative symptoms and promotion of the necessary skills to successfully return to the community after leaving the hospital. Despite preparation for community integration, the transition from hospital to community remains a difficult time for many people with SMIs, with those affected having an increased chance for suicide, homelessness, and relapse. Critical Time Intervention (CTI), a psychosocial treatment program that aims to restore skills for community living and to assist in seeking service and support in the community, may be more effective than usual care in preventing these adverse outcomes after hospital discharge. This study will compare the effectiveness of CTI versus usual services in preventing homelessness and other adverse outcomes after leaving a psychiatric hospital among people with SMI and psychosis.
Participation in this study will last 18 months. Potential participants will undergo an initial 15- to 30-minute interview that will include questions about current mental, physical, and living conditions; history of psychiatric services; and alcohol and drug use. Eligible participants will then undergo the first full interview, which will include a full review of medical records and will last between 2 and 3 hours. After this interview, participants will be assigned randomly to receive CTI or usual services. For participants assigned to CTI, a CTI specialist will visit participants in the hospital and in their homes and will stay in contact with participants for 9 months after hospital discharge. During visits with the CTI specialist, participants will receive training in community living skills and help finding service and support in the community. Participants assigned to usual services will receive the usual care and community services offered to people recently leaving a psychiatric hospital.
After leaving the hospital, participants in both groups will be asked to participate in 15 follow-up interviews, which will include repeat questions from the 2 initial interviews. Interviews will be conducted once every 6 weeks until 18 months after hospital discharge and will last between 60 and 90 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Usual careParticipants will receive standard aftercare and community care services. |
| 2 | Experimental | Behavioral: Critical Time Intervention (CTI), Behavioral: Usual careParticipants will receive usual care and the Critical Time Intervention. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of psychosis
- Homelessness during the 18 months before study entry
- English speaking
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Critical Time Intervention (CTI)CTI is designed specifically to enhance the continuity and focus of care during the transition from psychiatric hospital to community care. CTI does not replace community treatment and support, but instead is meant to complement available services. CTI will provide training in community living skills and in team-managed transfer of caregiving from hospitals to services and supports in the community. Participants will receive CTI for 9 months after hospital discharge. | Behavioural | 2 |
| Usual careUsual care will include the standard aftercare and community care services. | Behavioural | 1, 2 |
Primary outcome
Number of adverse outcomes after hospital discharge, particularly homelessness
Time frame: Measured over 18 months
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 30 Dec 2011.
- Background: PubMed 17541827Herman D, Conover S, Felix A, Nakagawa A, Mills D. Critical Time Intervention: an empirically supported model for preventing homelessness in high risk groups. J Prim Prev. 2007 Jul;28(3-4):295-312. doi: 10.1007/s10935-007-0099-3. Epub 2007 Jun 1.
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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.
Daniel Herman, DSW principal investigator
NYS Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Critical Time Intervention (CTI) in people with Psychotic Disorders, run by New York State Psychiatric Institute at 1 site in United States.
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 3 inclusion and 0 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 30 Dec 2011. 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 United States. 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?
Number of adverse outcomes after hospital discharge, particularly homelessness (time frame: Measured over 18 months). 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 NCT00621465, 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 30 Dec 2011; AzTrials last refreshed its copy on 7 Nov 2026.