Early Recovery Adherence Therapy for Bipolar Alcoholics

May 16, 2008 updated by: University of Pittsburgh

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Western Psychiatric Institute and Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Meet DSM-IV diagnostic criteria for Bipolar disorder and alcohol use disorder
  2. Actively abusing alcohol (drinking on 2 or more occasions per week or having 3 or more drinks per occasion)
  3. Have been stabilized on a mood stabilizer such as Valproate
  4. Absence of any exclusion criteria

Exclusion Criteria:

  1. Schizophrenia,, schizoaffective disorder or any psychotic disorder, unipolar major depression,, mental retardation, and signs of impaired cognitive functioning.

  2. 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

  3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Ihsan M Salloum, MD, MPH, University of Pittsbugh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

May 19, 2008

Last Update Submitted That Met QC Criteria

May 16, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0307095

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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