Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00621465
Other study ID # R01 MH059716,#4640R
Secondary ID R01MH059716DSIR
Status Completed
Phase N/A
First received February 20, 2008
Last updated December 28, 2011
Start date April 2002
Est. completion date October 2007

Study information

Verified date December 2011
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 59 Years
Eligibility Inclusion Criteria:

- Diagnosis of psychosis

- Homelessness during the 18 months before study entry

- English speaking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
Usual care
Usual care will include the standard aftercare and community care services.

Locations

Country Name City State
United States Rockland Psychiatric Center Orangeburg New York

Sponsors (2)

Lead Sponsor Collaborator
New York State Psychiatric Institute National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2007 Jun 1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of adverse outcomes after hospital discharge, particularly homelessness Measured over 18 months No
See also
  Status Clinical Trial Phase
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Terminated NCT03230097 - This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year Phase 2
Completed NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Active, not recruiting NCT05726617 - Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Severe Mental Health Disorders N/A
Not yet recruiting NCT03807388 - ReMindCare App for Patients From First Episode of Psychosis Unit. N/A
Recruiting NCT02874573 - Tocilizumab in Schizophrenia Phase 1
Terminated NCT02584114 - Brain Effects of Memory Training in Early Psychosis N/A
Completed NCT02906553 - The Role of Nitric Oxide in Cognition in Schizophrenia N/A
Completed NCT01981356 - Acceptance and Commitment Therapy for the Inpatient Treatment of Psychosis Phase 0
Withdrawn NCT02213887 - Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications Phase 4
Terminated NCT02841956 - Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement N/A
Recruiting NCT02009969 - Serial Comparisons of Abdominal and Neurological MRI Scans N/A
Recruiting NCT02848469 - Irish Omega-3 Study Phase 2
Completed NCT02648321 - Motivational Intervention for Physical Activity in Psychosis N/A
Enrolling by invitation NCT00762866 - Psychiatric Genotype/Phenotype Project Repository
Completed NCT00484302 - Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis N/A
Completed NCT00455234 - Rapid Tranquillization Trial: TREC-India II Phase 3
Completed NCT00130923 - Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder Phase 4
Completed NCT00844922 - Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842) Phase 2
Completed NCT00130676 - A United States Study of Corlux for Psychotic Symptoms in Psychotic Major Depression Phase 3