NCT01528748

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

4.7 years

First QC Date

February 4, 2012

Last Update Submit

April 15, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Depression Rating

    Change in depression rating scale over time.

    Baseline and 20 weeks

  • Drinking behavior

    Change in number of drinks consumed per day over time.

    Baseline and 20 weeks

Study Arms (1)

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

Interventions

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.

Also known as: CBASP
Chronically Depressed, Alcohol Dependent

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited via a community sample.

You may qualify if:

  • 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

You may not qualify if:

  • Please call study site for additional information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Center for Addiction Research & Education (UVa CARE)

Charlottesville, Virginia, 22911, United States

Location

Related Publications (2)

  • McCullough JP Jr. Treatment for chronic depression using Cognitive Behavioral Analysis System of Psychotherapy (CBASP). J Clin Psychol. 2003 Aug;59(8):833-46. doi: 10.1002/jclp.10176.

    PMID: 12858425BACKGROUND
  • McCullough, Jr., JP. (2001). Skills Training Manual for Diagnosis and Treating Chronic Depression: Cognitive Behavioral Analysis System of Psychotherapy (CBASP). New York: Guilford Press.

    BACKGROUND

MeSH Terms

Conditions

Depressive DisorderDepressive Disorder, MajorDysthymic DisorderAlcohol-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Jennifer K. Penberthy, Ph.D.

    University of Virginia, School of Medicine, Department of Psychiatry & Neurobehavioral Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, School of Medicine

Study Record Dates

First Submitted

February 4, 2012

First Posted

February 8, 2012

Study Start

April 1, 2011

Primary Completion

December 1, 2015

Study Completion

July 1, 2018

Last Updated

April 17, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations