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

April 15, 2019 updated by: Jennifer Kim Penberthy, University of Virginia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

8

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
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • University of Virginia Center for Addiction Research & Education (UVa CARE)

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

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited via a community sample.

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • CBASP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Rating
Time Frame: Baseline and 20 weeks
Change in depression rating scale over time.
Baseline and 20 weeks
Drinking behavior
Time Frame: Baseline and 20 weeks
Change in number of drinks consumed per day over time.
Baseline and 20 weeks

Collaborators and Investigators

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

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Jennifer K. Penberthy, Ph.D., University of Virginia, School of Medicine, Department of Psychiatry & Neurobehavioral Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

February 4, 2012

First Submitted That Met QC Criteria

February 4, 2012

First Posted (Estimate)

February 8, 2012

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15599

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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