Alcohol Use Disorders in Schizophrenia

Not Applicable

Completed

• Conditions: Alcohol Dependence; Schizophrenia; Mood Disorders; Alcohol Abuse
• Interventions: Behavioral: Supportive Treatment in Addiction Recovery (STAR)

• Registration Number: NCT00280813
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

The purpose of the study is to evaluate a new treatment to help patients who have problems because of their use of alcohol. The treatment is called Behavioral Treatment for Alcohol Abuse in Schizophrenia (BTAAS).We are interested in determining whether BTAAS is more effective in reducing use than a supportive control treatment.

Detailed Description

Alcohol abuse and dependence in people with schizophrenia is a serious public health problem that is associated with poor treatment compliance, increased rates of relapse, increased levels of violence, and poor overall health and life functioning. Treating alcohol use disorders in people with schizophrenia is especially problematic, as schizophrenia is marked by symptoms and neurocognitive and psychosocial deficits that make it difficult for patients to engage in the higher level cognitive processes or the sustained, self-directed behaviors generally required to reduce drinking. To date there are no interventions for alcohol use disorders with solid empirical support that have been designed for or adapted to meet the needs of this multiply-handicapped population. In this study we will develop and pilot test a multifaceted behavioral intervention for treating schizophrenia patients with alcohol use disorders that will incorporate strategies that have been found to be effective in reducing drinking, but tailor them to meet the needs of this population. The intervention will contain several components, including: (1) pre-treatment motivational interviewing to increase engagement and motivation; (2) short-term goal setting at each session; (3) social skills and alcohol refusal skills training; (4) education and coping skills training for managing depression, stress and other forms of negative affect; (5) relapse prevention training; (6) case management aimed at networking with social supports in the participant's environment and linking patients with activities and social networks in the community in order to create a reinforcing, non-drinking environment.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2006-01-19
• Study First Submitted QC: 2006-01-19
• Study First Posted: 2006-01-23
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• DSM-IV diagnosis of schizophrenia or schizoaffective disorder OR other severe 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 received payment for mental disability)
• Current (last month) Alcohol Abuse or Dependence or Alcohol Abuse or Dependence criteria met within the last 3 months as determined by the Structured Clinical Interview for DSM-IV.
• Ability to provide informed consent
• Stable housing

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Exclusion Criteria

• Current neurological disorder or cognitive impairment due to head injury or loss of consciousness that would impact ability to effectively participate in the intervention
• 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
• patient is homeless.
• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supportive Treatment in Alcohol Recovery (STAR)	Supportive Treatment in Addiction Recovery (STAR)	-

Primary Outcome Measures

Name	Time	Method
Symptom ratings, addiction severity, quality of life, social functioning & motivation to change: baseline and post-treatment.	1 year

Secondary Outcome Measures

Name	Time	Method
Saliva test & Urinalysis: baseline, post-treatment and at each treatment session.	1 year

Trial Locations

Locations (4)

University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States

Healthcare for the Homeless; 🇺🇸 Baltimore, Maryland, United States

VA Maryland Healthcare System; 🇺🇸 Baltimore, Maryland, United States

Mosaic Community Services Inc.; 🇺🇸 Catonsville, Maryland, United States