Clinical trial NCT00137267: A Brief Community Linkage Intervention for Dually Diagnosed Individuals
Official title: A Brief Community Linkage Intervention for Dually Diagnosed Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Psychotic Disorders
Substance-Related Disorders
Bipolar Disorder
Keywords: Schizophrenia / disorders w psychotic features
Substance-related disorders
Community Mental Health Services
Case Management
Health Education
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-08-29
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Treatment Engagement
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of Days Engaged
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bedford
country: United States
facility: Edith Nourse Rogers Memorial Veterans Hospital, Bedford
state: Massachusetts
city: East Orange
country: United States
facility: VA New Jersey Health Care System, East Orange
state: New Jersey
Study officials:
affiliation: Edith Nourse Rogers Memorial Veterans Hospital, Bedford
name: David A. Smelson, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ziedonis DM, Smelson D, Rosenthal RN, Batki SL, Green AI, Henry RJ, Montoya I, Parks J, Weiss RD. Improving the care of individuals with schizophrenia and substance use disorders: consensus recommendations. J Psychiatr Pract. 2005 Sep;11(5):315-39. doi: 10.1097/00131746-200509000-00005.
citation: Smelson DA, Dixon L, Craig T, Remolina S, Batki SL, Niv N, Owen R. Pharmacological treatment of schizophrenia and co-occurring substance use disorders. CNS Drugs. 2008;22(11):903-16. doi: 10.2165/00023210-200822110-00002.
citation: Sussner B, Kline A, Smelson DA, Losonczy M, Salvatore S. The role of psychosocial characteristics in irregular discharge form residentioal services for homeless veterans. Psychological Services. 2008 May 1; 5(4):341-350.
citation: Banerjea R, Pogach LM, Smelson D, Sambamoorthi U. Mental illness and substance use disorders among women veterans with diabetes. Womens Health Issues. 2009 Nov-Dec;19(6):446-56. doi: 10.1016/j.whi.2009.07.007.