Early Recovery Adherence Therapy for Bipolar Alcoholics

NCT00167323 | Completed

• 1 other identifier: 0307095
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Alcohol Use Disorder

Keywords

Bipolar; Alcoholism

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Adherence therapy BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

UPMC Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Alcoholism

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Ihsan M Salloum, MD, MPH

  University of Pittsbugh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: July 1, 2003
• Study Completion: July 1, 2007
• Last Updated: May 19, 2008

Record last verified: 2008-05

Locations

US (1)