Viewing Study NCT00137267


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Study NCT ID: NCT00137267
Status: COMPLETED
Last Update Posted: 2015-05-15
First Post: 2005-08-25
Is NOT Gene Therapy: False
Has Adverse Events: True

Brief Title: A Brief Community Linkage Intervention for Dually Diagnosed Individuals
Sponsor: US Department of Veterans Affairs
Organization:

Study Overview

Official Title: A Brief Community Linkage Intervention for Dually Diagnosed Individuals
Status: COMPLETED
Status Verified Date: 2015-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: TLC
Brief Summary: 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.
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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: