A Brief Community Linkage Intervention for Dually Diagnosed Individuals

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00137267
First received: August 25, 2005
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

An eight-week study with baseline, 2-month, 6-month, and 12 month follow-up assessments, in which dually diagnosed patients who meet inclusion criteria and sign informed consent will be randomly assigned to one of two groups: one group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group), or to a group that receives treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). The length of the health education sessions (four group session and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging. Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition. Comparison between the TLC (treatment group) and health education group (control group) will be examined via the following hypotheses:

Hypothesis # 1: To further evaluate the impact of the TLC intervention in helping transition individuals from an Acute Psychiatry Day Treatment.

Hypothesis 2: Individuals in the TLC group will have larger improvements on the Global Assessment of Functioning (GAF) compared to those in the control group.

Hypothesis #3: Individuals in the TLC group will have reduced substance use and fewer relapses compared to controls.

Hypothesis #4: Individuals in TLC group will make greater improvements than the control group in other significant life domains, including medical status, family/social adjustment, employment and criminal justice involvement.


Condition Intervention
Schizophrenia
Psychotic Disorders
Substance-Related Disorders
Bipolar Disorder
Behavioral: Time limited case management
Behavioral: Health Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Brief Community Linkage Intervention for Dually Diagnosed Individuals

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Show rate at outpatient day treatment center within one week post-hospitalization.Differences in TLC group completion at 2 months.Number of day treatment attended at 6 month and 12 months.Number days re-hospitalized at 6 month and 12 month. [ Time Frame: 1 week post hospitalization, 2 months, 6 months, 12 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global Level of Functioning at 2 months, 6 month and 12 months.Number of days alcohol use at 2 months, 6 months, 12 monthsNumber of days drug use at 2 months, 6 months, 12 months [ Time Frame: 2 months, 6 months, 12 months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: June 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.
Behavioral: Time limited case management
This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.
Other Name: TLC
Active Comparator: Arm 2
This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging.
Behavioral: Health Education
This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging.
Other Name: TAU+A

Detailed Description:

Substance abuse is common among individuals with serious mental illnesses (SMI) and often contributes to poor treatment outcome and high attrition. Local and national data suggest that treatment attrition frequently occurs when dually diagnosed individuals transition from in-patient hospital settings to outpatient treatment. To address this vulnerable period, improve longer term treatment outcomes and reduce costly inpatient treatment days, we developed an 8-week community linkage intervention, called Time-Limited Case Management (TLC) to assist in transitioning individuals from acute inpatient to outpatient services. The rationale for the development of a short-term approach to address this problem stems from the observation that many dually diagnosed patients have different needs from non-substance abusing SMI individuals. For example, dually diagnosed patients are often higher functioning with more sophisticated social skills, but are less treatment compliant; treatment non-compliance and substance abuse, often precipitates symptom exacerbations, instability and re-hospitalization. Such patients are likely to benefit from brief interventions that facilitate community and outpatient treatment engagement yet, unlike the more functionally impaired they often do not need indefinite support once they have made a successful transition to the community.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients over 18 years old.
  2. Patients who have a substance abuse disorder and a diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder.
  3. Patients seeking outpatient treatment for the above disorders from the VA.
  4. Physically mobile
  5. Agree to take public transportation if they do not have other private sources.

Exclusion Criteria:

  1. Patients who only have either a mental health problem, or a substance abuse problem, but not both.
  2. Patients who do not have a residence where they can stay upon discharge from the hospital.
  3. Patients who are not sufficiently medically or psychiatrically stable to participate in residential or outpatient treatment. Those patients could be re-evaluated for the study once stabilized.
  4. Patients exclusively engaged in methadone maintenance programs.
  5. Patients who represent a serious suicide risk.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137267

Locations
United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford
Bedford, Massachusetts, United States, 01730
United States, New Jersey
VA New Jersey Health Care System, East Orange
East Orange, New Jersey, United States, 07018
Sponsors and Collaborators
Investigators
Principal Investigator: David A. Smelson, PsyD Edith Nourse Rogers Memorial Veterans Hospital, Bedford
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00137267     History of Changes
Other Study ID Numbers: IIR 02-145
Study First Received: August 25, 2005
Last Updated: April 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Schizophrenia / disorders w psychotic features
Substance-related disorders
Community Mental Health Services
Case Management
Health Education

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Schizophrenia
Substance-Related Disorders
Affective Disorders, Psychotic
Mood Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on April 17, 2014