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Early Recovery Adherence Therapy for Bipolar Alcoholics

Primary Purpose

Bipolar Disorder, Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adherence therapy
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar, Alcoholism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meet DSM-IV diagnostic criteria for Bipolar disorder and alcohol use disorder Actively abusing alcohol (drinking on 2 or more occasions per week or having 3 or more drinks per occasion) Have been stabilized on a mood stabilizer such as Valproate Absence of any exclusion criteria Exclusion Criteria: Schizophrenia,, schizoaffective disorder or any psychotic disorder, unipolar major depression,, mental retardation, and signs of impaired cognitive functioning. Any severe or unstable neurological and medical condition including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome, severe cardiac, liver, kidney, endocrine, hematological, or impending surgery. Inability to read or understand the study forms and consent form Pregnancy The presence of non-alcohol substance use disorders will not constitute exclusion criteria unless it is clearly the drug of choice or it requires medications such as opioid substitution

Sites / Locations

  • UPMC Western Psychiatric Institute and Clinic

Outcomes

Primary Outcome Measures

The proposed intervention with have:
A higher rate of treatment completion,
A higher rate of treatment adherence as indicated by the number of sessions attended,
An improved outcome as indicated by a higher percentage of alcohol free days, less average number of drinks per drinking days, longer period to relapse to heavy alcohol use, and greater improvement in their manic or depressive symptoms

Secondary Outcome Measures

Full Information

First Posted
September 9, 2005
Last Updated
May 16, 2008
Sponsor
University of Pittsburgh
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00167323
Brief Title
Early Recovery Adherence Therapy for Bipolar Alcoholics
Official Title
Early Recovery Adherence Therapy for Bipolar Alcoholics
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

Brief Summary
Effective psychosocial interventions for individuals with an alcohol use disorder co-occurring with a severe mental health problem such as bipolar disorder are lacking. Treatment engagement, adherence, and retention are a major challenge and crucial to achieving a favorable outcome. The early phase of recovery is a key period during which an effective intervention exerts its most significant impact. Our proposed treatment intervention is aimed at addressing early recovery issues, engagement, and treatment and medication adherence in bipolar alcoholics. We propose to develop and refine a theoretically based and procedurally specified individual adherence therapy intervention for co-occurring alcohol use and bipolar disorder in early recovery, to develop standardized procedures, methods, and techniques so that treatment is delivered with a high degree of fidelity and competence, and to test the efficacy of this intervention through a randomized, parallel-group design comparing this new intervention with current regular clinical care.
Detailed Description
Co-occurring alcoholism and bipolar disorder is a significant comorbid condition representing serious clinical challenges and treatment difficulties and is associated with severe disabilities, morbidity, and heightened risk for suicide. Despite the recent increased attention to the problem of psychiatric comorbidity with alcoholism and other substance use disorders, little research has been conducted on this complex form of comorbidity, especially in regard to effective treatment approaches. Enhancing treatment engagement, adherence, and retention is perhaps the most challenging clinical concern faced by clinicians caring for this population. Poor adherence is a major clinical problem among bipolar disorder with alcoholism. Poor adherence is associated with substantial medical expenses and loss of productivity. Factors interfering with treatment adherence range from access to treatment, to health care providers disposition towards these patients, and to symptoms related to both bipolar disorder and alcoholism. Enhancing motivation for treatment and improving treatment adherence are essential components for an initial treatment intervention for this population. Our proposed treatment intervention is based on the principles of Motivational Enhancement Therapy and also integrates psychosocial and pharmacotherapy interventions that have been successfully used with alcoholism and other addictive disorders. It is practical and easy to learn and administer in the framework of general clinical care by health professionals with varied educational backgrounds.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Alcohol Use Disorder
Keywords
Bipolar, Alcoholism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Adherence therapy
Primary Outcome Measure Information:
Title
The proposed intervention with have:
Title
A higher rate of treatment completion,
Title
A higher rate of treatment adherence as indicated by the number of sessions attended,
Title
An improved outcome as indicated by a higher percentage of alcohol free days, less average number of drinks per drinking days, longer period to relapse to heavy alcohol use, and greater improvement in their manic or depressive symptoms

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet DSM-IV diagnostic criteria for Bipolar disorder and alcohol use disorder Actively abusing alcohol (drinking on 2 or more occasions per week or having 3 or more drinks per occasion) Have been stabilized on a mood stabilizer such as Valproate Absence of any exclusion criteria Exclusion Criteria: Schizophrenia,, schizoaffective disorder or any psychotic disorder, unipolar major depression,, mental retardation, and signs of impaired cognitive functioning. Any severe or unstable neurological and medical condition including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome, severe cardiac, liver, kidney, endocrine, hematological, or impending surgery. Inability to read or understand the study forms and consent form Pregnancy The presence of non-alcohol substance use disorders will not constitute exclusion criteria unless it is clearly the drug of choice or it requires medications such as opioid substitution
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ihsan M Salloum, MD, MPH
Organizational Affiliation
University of Pittsbugh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Western Psychiatric Institute and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Early Recovery Adherence Therapy for Bipolar Alcoholics

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