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

Primary Purpose

Schizophrenia, Psychotic Disorders, Substance-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time limited case management
Health Education
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia focused on measuring Schizophrenia / disorders w psychotic features, Substance-related disorders, Community Mental Health Services, Case Management, Health Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female patients over 18 years old. Patients who have a substance abuse disorder and a diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder. Patients seeking outpatient treatment for the above disorders from the VA. Physically mobile Agree to take public transportation if they do not have other private sources. Exclusion Criteria: Patients who only have either a mental health problem, or a substance abuse problem, but not both. Patients who do not have a residence where they can stay upon discharge from the hospital. 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. Patients exclusively engaged in methadone maintenance programs. Patients who represent a serious suicide risk.

Sites / Locations

  • Edith Nourse Rogers Memorial Veterans Hospital, Bedford
  • VA New Jersey Health Care System, East Orange

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Treatment Engagement
Number of inpatient and outpatient treatment sessions attended during the 8-week treatment period

Secondary Outcome Measures

Number of Days Engaged
Number of days veteran was involved with the program, from initial consent to last day of contact

Full Information

First Posted
August 25, 2005
Last Updated
April 29, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00137267
Brief Title
A Brief Community Linkage Intervention for Dually Diagnosed Individuals
Acronym
TLC
Official Title
A Brief Community Linkage Intervention for Dually Diagnosed Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Time limited case management
Other Intervention Name(s)
TLC
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Other Intervention Name(s)
TAU+A
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Engagement
Description
Number of inpatient and outpatient treatment sessions attended during the 8-week treatment period
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of Days Engaged
Description
Number of days veteran was involved with the program, from initial consent to last day of contact
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients over 18 years old. Patients who have a substance abuse disorder and a diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder. Patients seeking outpatient treatment for the above disorders from the VA. Physically mobile Agree to take public transportation if they do not have other private sources. Exclusion Criteria: Patients who only have either a mental health problem, or a substance abuse problem, but not both. Patients who do not have a residence where they can stay upon discharge from the hospital. 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. Patients exclusively engaged in methadone maintenance programs. Patients who represent a serious suicide risk.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A. Smelson, PsyD
Organizational Affiliation
Edith Nourse Rogers Memorial Veterans Hospital, Bedford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edith Nourse Rogers Memorial Veterans Hospital, Bedford
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730
Country
United States
Facility Name
VA New Jersey Health Care System, East Orange
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16184072
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.
Results Reference
result
PubMed Identifier
18840032
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.
Results Reference
result
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.
Results Reference
result
PubMed Identifier
19879456
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.
Results Reference
result
Links:
URL
http://www.missionmodel.org
Description
This website is intended as a source of information for anyone interested in learning more about the MISSION model (previously called TLC).

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A Brief Community Linkage Intervention for Dually Diagnosed Individuals

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