A Brief Community Linkage Intervention for Dually Diagnosed Individuals (TLC)

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: August 13, 2014
Last verified: August 2014
  Purpose

Surveys suggest that up to 80% of veterans with a persistent mental illness have a co-occurring substance use disorder. Substance abuse among this population is problematic and often results in poor engagement in treatment and thus, frequent hospitalizations and an unstable illness course. Regarding treatment engagement, data from a VA New Jersey facility indicated that 50% of those veterans discharged from the acute psychiatric hospital unit to outpatient care did not attend their initial screening appointment and another 30% dropped out within six weeks. To assist with the transition from inpatient to outpatient care, we previously developed an eight-week augmentation intervention entitled, Time-Limited Case Management (TLC). TLC integrates evidence-based interventions of 1) Dual Recovery Therapy; 2) Critical Time Intervention Case Management along with 3) Peer Support with the goal of assisting individuals with the transition from inpatient to outpatient care.


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 ]

Enrollment: 102
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:

This study involved a randomized attention controlled trial of 102 individuals recruited on the inpatient psychiatry service at the New Jersey VA with a substance abuse disorder and a severe and persistent mental illness. Subjects were randomly assigned to one of two conditions: 1) treatment-as-usual in inpatient and outpatient services plus 8 weeks of Time Limited Care-Coordination (TLC), a brief linkage augmentation intervention or 2) treatment-as-usual along with 8 weeks of matched attention in the form of health education sessions (TAU+A). The data analytic plan included descriptive and advanced statistical analysis.

Objective # 1: To determine whether those in TLC have better attendance in inpatient sessions compared to those receiving Treatment-As-Usual Plus Attention (TAU+A).

Objective # 2: To determine whether those in TLC have better attendance in outpatient sessions compared to those receiving Treatment-As-Usual Plus Attention (TAU+A).

Objective # 3: To determine whether TLC, compared to Treatment-As-Usual Plus Attention (TAU+A) reduces rehospitalizations and has an effect on the use of the Emergency Room use.

Objective # 4: To determine whether TLC achieves a reduction in drug usage and related problems as compared to those receiving TAU+A.

A total of 102 veterans were randomly assigned to one of two conditions: (1) Time Limited Care-Coordination (TLC), an eight-week co-occurring disorders intervention or (2) Treatment As Usual + Matched Attention (TAU+A) control condition in the form of health education sessions. However, both groups also received treatment as usual in inpatient and outpatient settings. Sixty-nine percent of TLC participants attended an outpatient appointment within 14 days of discharge, compared to only 33% of MA participants (P<0.01). TLC participants were also more likely to be engaged in outpatient services at the end of the intervention period (44 vs. 22%, P<0.01). This study provided evidence that an eight-week intervention could improve treatment engagement. Additional research has been conducted examining an enhanced 12-month version of TLC, called Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking (MISSION).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional 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: August 13, 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:
Schizophrenia
Disease
Bipolar Disorder
Substance-Related Disorders
Psychotic Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Pathologic Processes
Affective Disorders, Psychotic
Mood Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on September 18, 2014