A Brief Community Linkage Intervention for Dually Diagnosed Individuals

Schizophrenia Clinical Trial

— TLC  

Official title:

A Brief Community Linkage Intervention for Dually Diagnosed Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137267
• Other study ID #: IIR 02-145
• Status: Completed
• Phase: N/A
• First received: August 25, 2005
• Last updated: April 29, 2015
• Start date: June 2005
• Est. completion date: June 2009

Study information

• Verified date: April 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Edith Nourse Rogers Memorial Veterans Hospital, Bedford	Bedford	Massachusetts
United States	VA New Jersey Health Care System, East Orange	East Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. Review. — View 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.

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. Review — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Engagement	Number of inpatient and outpatient treatment sessions attended during the 8-week treatment period	8 weeks	No
Secondary	Number of Days Engaged	Number of days veteran was involved with the program, from initial consent to last day of contact	8 weeks	No

External Links

•   This website is intended as a source of information for anyone interested in learning more about the MISSION model (previously called TLC).