Alcohol Use Disorders in Schizophrenia
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Schizophrenia Mood Disorders Alcohol Abuse Alcohol Dependence |
Behavioral: Supportive Treatment in Addiction Recovery (STAR) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Alcohol Use Disorders in Schizophrenia |
- Symptom ratings, addiction severity, quality of life, social functioning & motivation to change: baseline and post-treatment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Saliva test & Urinalysis: baseline, post-treatment and at each treatment session. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 54 |
| Study Start Date: | March 2004 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Supportive Treatment in Alcohol Recovery (STAR) | Behavioral: Supportive Treatment in Addiction Recovery (STAR) |
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.
Eligibility| Ages Eligible for Study: | 22 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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.
Contacts and Locations| United States, Maryland | |
| University of Maryland, Baltimore | |
| Baltimore, Maryland, United States, 21201 | |
| VA Maryland Healthcare System | |
| Baltimore, Maryland, United States, 21201 | |
| Healthcare for the Homeless | |
| Baltimore, Maryland, United States, 21201 | |
| Mosaic Community Services Inc. | |
| Catonsville, Maryland, United States, 21228 | |
| Principal Investigator: | Melanie Bennett, Ph.D. | University of Maryland |
More Information
Publications:
| Responsible Party: | Melanie Bennett, PhD, University of Maryland School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00280813 History of Changes |
| Other Study ID Numbers: | 21942 |
| Study First Received: | January 19, 2006 |
| Last Updated: | October 24, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Maryland:
|
treatment dual diagnosis |
Additional relevant MeSH terms:
|
Alcohol Drinking Alcoholism Schizophrenia Mood Disorders Drinking Behavior |
Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on June 18, 2013