Behavioral Treatment of Drug Abuse in Severe and Persistent Mental Illness (SPMI) Patients

NCT ID: NCT00295139

Last Updated: 2022-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 293 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2010-03-31

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.

Conditions

Schizophrenia; Mood Disorders; Substance Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Behavioral Treatment for Substance Abuse in SPMI (BTSAS)

Group Type: EXPERIMENTAL

Behavioral Treatment for Substance Abuse in SPMI (BTSAS)

Intervention Type: BEHAVIORAL

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.

2

Behavioral Treatment for Substance Abuse in SPMI (BTSAS) + Critical Time Intervention (CTI)

Group Type: EXPERIMENTAL

Behavioral Treatment for Substance Abuse in SPMI (BTSAS)

Intervention Type: BEHAVIORAL

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.

Critical Time Intervention (CTI)

Intervention Type: BEHAVIORAL

Case management component

3

Supportive Treatment in Addiction Recovery (STAR)

Group Type: ACTIVE_COMPARATOR

Supportive Treatment in Addiction Recovery (STAR)

Intervention Type: BEHAVIORAL

Manualized substance abuse treatment as usual

Interventions

Behavioral Treatment for Substance Abuse in SPMI (BTSAS)

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

Supportive Treatment in Addiction Recovery (STAR)

Manualized substance abuse treatment as usual

Intervention Type: BEHAVIORAL

Critical Time Intervention (CTI)

Case management component

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Melanie Bennett

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alan S. Bellack, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

Health Care for the Homeless

Baltimore, Maryland, United States

University of Maryland, Baltimore

Baltimore, Maryland, United States

VA Maryland Health Care System

Baltimore, Maryland, United States

Mosaic Community Services

Catonsville, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 9801714 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9890583 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10547116 (View on PubMed)

Bellack, A.S. (2000) Behavioral treatment for substance abuse in schizophrenia. The Addictions Newsletter, 7, 20-22

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 10828416 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11196292 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11306219 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12663840 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12851019 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16585472 (View on PubMed)

Other Identifiers

HP-00041195

Identifier Type: -

Identifier Source: org_study_id