A Trial of "Opening Doors to Recovery" for Persons With Serious Mental

Status Completed

Clinical Trial Summary

Insufficient community-based support after inpatient discharge for persons with serious mental illnesses (SMI) may lead to re-hospitalization, excessive criminal justice involvement, homelessness, and an inability to embrace recovery. In fact, many of these especially vulnerable persons find themselves in a cycle of repeated hospital stays, arrests, and even homelessness, with little support for real recovery. Public mental health systems are struggling to address these problems. Evidence-based, comparatively inexpensive, time-limited community support models are needed to reduce institutional recidivism and facilitate recovery. The Georgia chapter of the National Alliance on Mental Illness (NAMI-GA) developed Opening Doors to Recovery (ODR), and we have collected extensive preliminary data on it. ODR is now being tested in a randomized controlled trial (RCT) taking place in southeast Georgia where ODR was first developed. The primary goals of ODR are to prevent institutional recidivism (i.e., going back into the hospital) and to promote recovery among persons with SMI like schizophrenia and bipolar disorder. The ODR intervention is comprised of several components that work together to address barriers to successful integration into the community among individuals with SMI and repeated inpatient hospitalizations. A team of 3 specially trained "Community Navigation Specialists" (CNSs, also called Navigators) provides intensive, mobile, community support to persons with SMI with a defined history of inpatient recidivism (i.e., repeated hospital stays). We are carrying out a fully powered trial of ODR in a 7-county catchment area in southeast Georgia, which is an ideal real-world location to carry out the study. During the 5-year study period, we will randomize 240 persons with SMI and a history of ≥2 inpatient stays in the past 12 months to ODR (n=120, followed for 12 months, with a maximum CNS caseload of 40) versus community care in traditional intensive case management or case management (ICM/CM, n=120). Assessments are conducted at baseline (just before hospital discharge), and at 4, 8, 12, and 18 months.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04612777
Study type	Interventional
Source	New York State Psychiatric Institute
Contact
Status	Completed
Phase	N/A
Start date	June 15, 2014
Completion date	May 31, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05111548` - Brain Stimulation and Cognitive Training - Efficacy	N/A
Completed	`NCT02855762` - Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder	N/A
Recruiting	`NCT05915013` - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response	Phase 1
Recruiting	`NCT05206747` - Ottawa Sunglasses at Night for Mania Study	N/A
Completed	`NCT02513654` - Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects	Phase 1
Recruiting	`NCT06313918` - Exercise Therapy in Mental Disorders-study	N/A
Completed	`NCT02304432` - Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine	Early Phase 1
Recruiting	`NCT06197048` - Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder	N/A
Completed	`NCT03497663` - VIA Family - Family Based Early Intervention Versus Treatment as Usual	N/A
Completed	`NCT04284813` - Families With Substance Use and Psychosis: A Pilot Study	N/A
Completed	`NCT02212041` - Electronic Cigarettes in Smokers With Mental Illness	N/A
Recruiting	`NCT05030272` - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings	N/A
Recruiting	`NCT04298450` - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention	N/A
Active, not recruiting	`NCT03641300` - Efficacy of Convulsive Therapies for Bipolar Depression	N/A
Not yet recruiting	`NCT04432116` - Time and Virtual Reality in Schizophrenia and Bipolar Disorder	N/A
Completed	`NCT02970721` - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Terminated	`NCT02893371` - Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Terminated	`NCT02909504` - Gao NARASD Lithium Study	Phase 4
Recruiting	`NCT02481245` - BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study	Phase 2
Recruiting	`NCT03088657` - Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Trial of "Opening Doors to Recovery" for Persons With Serious Mental Illnesses — ODR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms