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Clinical Trial of CBASP for Individuals With Co-occurring Chronic Depression and Alcohol Dependence

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Virginia
Sponsor:
Information provided by (Responsible Party):
Jennifer Kim Penberthy, University of Virginia
ClinicalTrials.gov Identifier:
NCT01528748
First received: February 4, 2012
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

This study examines the effectiveness of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) in reducing both alcohol consumption and depressive symptoms in adults who are chronically depressed and alcohol dependent.


Condition Intervention
Depressive Disorder
Major Depressive Disorder
Dysthymic Disorder
Alcohol-Related Disorders
Alcoholism
Behavioral: Cognitive Behavioral Analysis System of Psychotherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Trial of CBASP for Individuals With Co-occurring Chronic Depression and Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Depression Rating [ Time Frame: Baseline and 20 weeks ] [ Designated as safety issue: No ]
    Change in depression rating scale over time.

  • Drinking behavior [ Time Frame: Baseline and 20 weeks ] [ Designated as safety issue: No ]
    Change in number of drinks consumed per day over time.


Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chronically Depressed, Alcohol Dependent
Participants who have been formally diagnosed with a clinical diagnosis of Chronic Depression and Alcohol Dependence.
Behavioral: Cognitive Behavioral Analysis System of Psychotherapy
Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is a behavioral intervention that addresses the unique behavioral characteristics of chronically depressed individuals, most of which are highly relevant for alcoholics as well. CBASP has a structured, individualized, and collaborative (patient and clinician) design. The intervention emphasizes teaching effective coping strategies and employing motivational, cognitive, behavioral, and interpersonal techniques. Individual therapy (1 hour) sessions occur on a weekly basis for a total of 20 sessions over a period of 21 weeks.
Other Name: CBASP

Detailed Description:

This study examines the effectiveness of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) in reducing both alcohol consumption and depressive symptoms in adults who are chronically depressed and alcohol dependent. Participants will receive a 20-session course of CBASP psychotherapy over a period of 21 weeks and will be assessed for severity of pretreatment psychological abuse and trauma as well as pre and posttreatment interpersonal functioning. Two primary hypotheses are to be tested: 1) demonstrate that CBASP is effective in reducing depressive symptoms (Hamilton Rating Scale for Depression-24 ratings) and alcohol consumption (drinks per drinking day) in this chronically depressed alcohol dependent cohort when posttreatment ratings are compared to pretreatment levels; and 2) demonstrate that acquisition of feeling safe with the therapist and acquisition of the ability to perceive the interpersonal consequences of one's behavior will significantly increase from pre to posttreatment levels and will be associated with reductions in drinking and depressive symptoms.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants will be recruited via a community sample.

Criteria

Inclusion Criteria:

  • Clinical diagnosis of a current major depressive disorder (e.g., Major Depression, Dysthymic Disorder) for a minimum of two years
  • Clinical diagnosis of alcohol dependence during the last thirty days
  • Interest in changing one's drinking and alleviating depressive symptoms

Exclusion Criteria:

  • Please call study site for additional information
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528748

Contacts
Contact: Jennifer K. Penberthy, Ph.D. (434) 243-4646 jkp2n@virginia.edu

Locations
United States, Virginia
University of Virginia Center for Addiction Research & Education (UVa CARE) Recruiting
Charlottesville, Virginia, United States, 22911
Contact: Jennifer K. Penberthy, Ph.D.    434-243-4646    jkp2n@virginia.edu   
Principal Investigator: Jennifer K. Penberthy, Ph.D.         
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Jennifer K. Penberthy, Ph.D. University of Virginia, School of Medicine, Department of Psychiatry & Neurobehavioral Sciences
  More Information

Publications:
McCullough, Jr., JP. (2000). Treatment for Chronic Depression: Cognitive Behavioral Analysis System of Psychotherapy (CBASP). New York: Guilford Press.

Responsible Party: Jennifer Kim Penberthy, Associate Professor, School of Medicine, University of Virginia
ClinicalTrials.gov Identifier: NCT01528748     History of Changes
Other Study ID Numbers: 15599
Study First Received: February 4, 2012
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dysthymic Disorder
Alcohol-Related Disorders
Alcoholism
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Chemically-Induced Disorders
Mental Disorders
Mood Disorders
Pathologic Processes
Substance-Related Disorders

ClinicalTrials.gov processed this record on November 23, 2014