Back to resultsBehavioral Treatment of Drug Abuse in Severe and Persistent Mental Illness (SPMI) Patients
Primary Purpose
Schizophrenia, Mood Disorders, Substance Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Treatment for Substance Abuse in SPMI (BTSAS)
Supportive Treatment in Addiction Recovery (STAR)
Critical Time Intervention (CTI)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring treatment, dual diagnosis
Eligibility Criteria
Inclusion Criteria: a diagnosis of schizophrenia or schizoaffective disorder or a diagnosis of other severe mental disorder including bipolar disorder, major depression, or severe anxiety disorder (by definition, the patient has worked 25% or less of the past year; and/or the patient receives payment for mental disability) a diagnosis of current dependence for opiates, cocaine, or marijuana ability and willingness to attend treatment sessions for 6 months ability and willingness to provide consent to participate enrolled in mental health care Exclusion Criteria: documented history of severe neurological disorder or severe head trauma with loss of consciousness severe or profound mental retardation as indicated by chart review inability to effectively participate in the baseline assessments due to intoxication or psychiatric symptoms on two successive appointments had a substantial trial in either intervention of the Evaluation of Behavioral Treatment for Substance Abuse in Schizophrenia protocol (H-20680) inability to attend group sessions due to transportation or other logistical problems inability to attend scheduled treatment sessions on a regular basis for any reason, or to appropriately participate in research activities due to behavioral or psychiatric problems
Sites / Locations
- Health Care for the Homeless
- University of Maryland, Baltimore
- VA Maryland Health Care System
- Mosaic Community Services
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
Behavioral Treatment for Substance Abuse in SPMI (BTSAS)
Behavioral Treatment for Substance Abuse in SPMI (BTSAS) + Critical Time Intervention (CTI)
Supportive Treatment in Addiction Recovery (STAR)
Outcomes
Primary Outcome Measures
Urinalysis
Secondary Outcome Measures
Full Information
NCT ID
NCT00295139
First Posted
February 19, 2006
Last Updated
February 2, 2022
Sponsor
University of Maryland, Baltimore
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00295139
Brief Title
Behavioral Treatment of Drug Abuse in Severe and Persistent Mental Illness (SPMI) Patients
Official Title
Behavioral Treatment of Drug Abuse in SPMI Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to determine if the multifaceted treatment for substance abuse in dual disordered patients is more effective in reducing drug use than a supportive control treatment. The researchers will also determine if adding a case management component (Critical Time Intervention; CTI) to the intervention will increase treatment engagement and retention.
Detailed Description
Drug and alcohol abuse by people with severe and persistent mental illness (SPMI) is one of the most significant problems facing the public mental health system. We have been conducting a project to develop a multifaceted treatment for substance abuse in dual disordered patients (Behavioral Treatment for Substance Abuse in Schizophrenia; BTSAS). Results have shown that the treatment is well-accepted by patients and has a significant effect on drug use. While BTSAS has been effective at retaining subjects and fostering reduced drug use, a major problem that occurred was low rates of engagement. The main purpose of this study is to determine if BTSAS is more effective in reducing drug use than a supportive control treatment and to determine if adding a case management component (Critical Time Intervention; CTI) will increase treatment engagement and retention in BTSAS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Mood Disorders, Substance Dependence
Keywords
treatment, dual diagnosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
293 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Behavioral Treatment for Substance Abuse in SPMI (BTSAS)
Arm Title
2
Arm Type
Experimental
Arm Description
Behavioral Treatment for Substance Abuse in SPMI (BTSAS) + Critical Time Intervention (CTI)
Arm Title
3
Arm Type
Active Comparator
Arm Description
Supportive Treatment in Addiction Recovery (STAR)
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Treatment for Substance Abuse in SPMI (BTSAS)
Intervention Description
Multifaceted treatment for substance abuse in dual disordered patients which contains 6 components: 1) a urinalysis contingency to enhance motivation to change and increase the salience of goals; 2) structured goal setting to identify realistic, short term goals for decreased substance use; 3) motivational interviewing to enhance motivation to reduce use; 4) social skills and drug refusal skills to enable development of relationships with people who do not use drugs, and to provide success experiences that can increase self-efficacy for change; 5) education about the reasons for substance use and the particular dangers of substance use for people with SPMI; and 6) relapse prevention training that focuses on behavioral skills for coping with urges and dealing with high risk situations and lapses. BTSAS is specifically structured to reduce the load on memory and attention, and minimize demands on higher level cognitive processes.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Treatment in Addiction Recovery (STAR)
Intervention Description
Manualized substance abuse treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Critical Time Intervention (CTI)
Intervention Description
Case management component
Primary Outcome Measure Information:
Title
Urinalysis
Time Frame
Baseline, 2 and 4 months, post and 6-month follow-up, and at each treatment session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a diagnosis of schizophrenia or schizoaffective disorder or a diagnosis of other severe mental disorder including bipolar disorder, major depression, or severe anxiety disorder (by definition, the patient has worked 25% or less of the past year; and/or the patient receives payment for mental disability)
a diagnosis of current dependence for opiates, cocaine, or marijuana
ability and willingness to attend treatment sessions for 6 months
ability and willingness to provide consent to participate
enrolled in mental health care
Exclusion Criteria:
documented history of severe neurological disorder or severe head trauma with loss of consciousness
severe or profound mental retardation as indicated by chart review
inability to effectively participate in the baseline assessments due to intoxication or psychiatric symptoms on two successive appointments
had a substantial trial in either intervention of the Evaluation of Behavioral Treatment for Substance Abuse in Schizophrenia protocol (H-20680)
inability to attend group sessions due to transportation or other logistical problems
inability to attend scheduled treatment sessions on a regular basis for any reason, or to appropriately participate in research activities due to behavioral or psychiatric problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan S. Bellack, Ph.D.
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Care for the Homeless
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
VA Maryland Health Care System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Mosaic Community Services
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9801714
Citation
Bellack AS, Gearon JS. Substance abuse treatment for people with schizophrenia. Addict Behav. 1998 Nov-Dec;23(6):749-66. doi: 10.1016/s0306-4603(98)00066-5.
Results Reference
background
PubMed Identifier
9890583
Citation
Bellack AS, DiClemente CC. Treating substance abuse among patients with schizophrenia. Psychiatr Serv. 1999 Jan;50(1):75-80. doi: 10.1176/ps.50.1.75.
Results Reference
background
PubMed Identifier
10547116
Citation
Gearon JS, Bellack AS. Women with schizophrenia and co-occurring substance use disorders: an increased risk for violent victimization and HIV. Community Ment Health J. 1999 Oct;35(5):401-19. doi: 10.1023/a:1018778310859.
Results Reference
background
Citation
Bellack, A.S. (2000) Behavioral treatment for substance abuse in schizophrenia. The Addictions Newsletter, 7, 20-22
Results Reference
background
PubMed Identifier
10828416
Citation
Gearon JS, Bellack AS. Sex differences in illness presentation, course, and level of functioning in substance-abusing schizophrenia patients. Schizophr Res. 2000 May 25;43(1):65-70. doi: 10.1016/s0920-9964(99)00175-9.
Results Reference
background
PubMed Identifier
11196292
Citation
Gearon JS, Bellack AS, Rachbeisel J, Dixon L. Drug-use behavior and correlates in people with schizophrenia. Addict Behav. 2001 Jan-Feb;26(1):51-61. doi: 10.1016/s0306-4603(00)00084-8.
Results Reference
background
PubMed Identifier
11306219
Citation
Bennett ME, Bellack AS, Gearon JS. Treating substance abuse in schizophrenia. An initial report. J Subst Abuse Treat. 2001 Mar;20(2):163-75. doi: 10.1016/s0740-5472(00)00167-7.
Results Reference
background
PubMed Identifier
12663840
Citation
Gearon JS, Kaltman SI, Brown C, Bellack AS. Traumatic life events and PTSD among women with substance use disorders and schizophrenia. Psychiatr Serv. 2003 Apr;54(4):523-8. doi: 10.1176/appi.ps.54.4.523.
Results Reference
background
PubMed Identifier
12851019
Citation
Gearon JS, Nidecker M, Bellack A, Bennett M. Gender differences in drug use behavior in people with serious mental illnesses. Am J Addict. 2003 May-Jun;12(3):229-41.
Results Reference
background
PubMed Identifier
16585472
Citation
Bellack AS, Bennett ME, Gearon JS, Brown CH, Yang Y. A randomized clinical trial of a new behavioral treatment for drug abuse in people with severe and persistent mental illness. Arch Gen Psychiatry. 2006 Apr;63(4):426-32. doi: 10.1001/archpsyc.63.4.426.
Results Reference
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Behavioral Treatment of Drug Abuse in Severe and Persistent Mental Illness (SPMI) Patients
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