Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01528748
Other study ID # 15599
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2011
Est. completion date July 2018

Study information

Verified date April 2019
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date July 2018
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 21 Years to 65 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States University of Virginia Center for Addiction Research & Education (UVa CARE) Charlottesville Virginia

Sponsors (1)

Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (3)

McCullough JP Jr. Treatment for chronic depression using Cognitive Behavioral Analysis System of Psychotherapy (CBASP). J Clin Psychol. 2003 Aug;59(8):833-46. — View Citation

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

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

Outcome

Type Measure Description Time frame Safety issue
Primary Depression Rating Change in depression rating scale over time. Baseline and 20 weeks
Primary Drinking behavior Change in number of drinks consumed per day over time. Baseline and 20 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05537558 - Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
Terminated NCT02192099 - Open Label Extension for GLYX13-C-202, NCT01684163 Phase 2
Completed NCT03142919 - Lipopolysaccharide (LPS) Challenge in Depression Phase 2
Recruiting NCT05547035 - Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders N/A
Terminated NCT02940769 - Neurobiological Effects of Light on MDD N/A
Recruiting NCT05892744 - Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression Phase 4
Recruiting NCT05537584 - SMART Trial to Predict Anhedonia Response to Antidepressant Treatment Phase 4
Active, not recruiting NCT05061706 - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder Phase 3
Completed NCT04479852 - A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder Phase 2
Recruiting NCT04032301 - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans Phase 1
Recruiting NCT05527951 - Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study N/A
Completed NCT03511599 - Cycloserine rTMS Plasticity Augmentation in Depression Phase 1
Recruiting NCT04392947 - Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation N/A
Recruiting NCT05895747 - 5-HTP and Creatine for Depression R33 Phase Phase 2
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Recruiting NCT05813093 - Interleaved TMS-fMRI in Ultra-treatment Resistant Depression N/A
Recruiting NCT05135897 - The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Enrolling by invitation NCT04509102 - Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder Early Phase 1
Recruiting NCT06145594 - EMA-Guided Maintenance TMS for Depression N/A
Recruiting NCT06026917 - Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET) Phase 4