NCT02316574

Brief Summary

Cognitive Behavioral Coping Skills Therapy (CBCST) is a commonly utilized, evidence-based psychosocial therapy (talk therapy) for alcohol dependence. By identifying the neural mechanisms through which CBCST changes drinking behavior, it may be possible to improve its efficacy. CBCST promotes abstinence by teaching "coping skills" for managing alcohol-related thoughts and emotions. In this pilot study, the investigators examine the neural systems that play a role in the learning of coping skills through CBCST, specifically focusing on the role of emotion regulation systems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

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

December 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

July 2, 2021

Status Verified

July 1, 2021

Enrollment Period

6.1 years

First QC Date

December 10, 2014

Last Update Submit

July 1, 2021

Conditions

Keywords

Alcohol dependenceCognitive Behavioral TherapyFunctional neuroimaging

Outcome Measures

Primary Outcomes (1)

  • Percent heavy drinking days

    Assessed during the weekly CBCST treatment

    12 weeks

Study Arms (1)

Cognitive Behavioral Coping Skills

EXPERIMENTAL

Cognitive Behavioral Coping Skills Therapy is an individual psychotherapy for alcohol use disorders that has been previously shown to reduce drinking. The focus of this treatment is the teaching of coping skills for managing alcohol craving and negative emotions as a way to reduce drinking behavior.

Behavioral: Cognitive Behavioral Coping Skills Therapy

Interventions

Cognitive Behavioral Coping Skills Therapy (CBCST) is an individual psychotherapy for alcohol dependence that helps individuals to reduce drinking by addressing the ability to regulate, or "cope" with alcohol cravings and other emotions that promote alcohol use.

Also known as: Cognitive Behavioral Therapy, Relapse Prevention Therapy
Cognitive Behavioral Coping Skills

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Right-handed
  • Meets DSM-V criteria for current Alcohol Use Disorder
  • Currently drinking \>5/4 or more drinks/day for men/women in the last 28 day, on average, at the time of initial screening visit.
  • Current goal of moderating or abstaining from drinking alcohol
  • Seeking treatment for Alcohol Use Disorder
  • Agree to not seek additional treatment, apart from Alcoholics Anonymous
  • English-speaking and able to provide informed consent and comply with study procedures
  • Willing to abstain from alcohol completely for 24 hours on 3 separate occasions

You may not qualify if:

  • Any current Moderate or Severe substance use disorder, other than alcohol, nicotine or caffeine use disorders.
  • Lifetime history of Bipolar Disorder, Schizophrenia or Schizoaffective Disorder
  • A diagnosis of any current psychiatric disorder other than Alcohol Use Disorder (e.g. Major Depressive Disorder, Generalized Anxiety Disorder) that in the investigator's judgment might require intervention with either pharmacological or non-pharmacological therapy over the course of the study.
  • History of severe alcohol withdrawal (e.g. seizure, delirium tremens, multiple detoxifications or ER visits for alcohol withdrawal)
  • Significant risk for suicide or violence
  • Legally mandated to receive treatment
  • Sufficiently socially unstable as to preclude study participation (e.g. homeless).
  • Currently taking any psychotropic medications.
  • Significant cognitive impairment
  • Neurological or medical conditions that would interfere with MRI scanning (e.g. history of stroke, seizure, brain tumor, brain infection, multiple sclerosis, metal device in body, pregnancy, claustrophobia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYPInstitute

New York, New York, 10032, United States

Location

Related Publications (1)

  • Srivastava AB, Sanchez-Pena J, Levin FR, Mariani JJ, Patel GH, Naqvi NH. Drinking reduction during cognitive behavioral therapy for alcohol use disorder is associated with a reduction in anterior insula-bed nucleus of the stria terminalis resting-state functional connectivity. Alcohol Clin Exp Res. 2021 Aug;45(8):1596-1606. doi: 10.1111/acer.14661. Epub 2021 Aug 2.

MeSH Terms

Conditions

Alcoholism

Interventions

Cognitive Behavioral TherapySecondary Prevention

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesTherapeuticsPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • Nasir H. Naqvi, MD, PhD

    Assistant Professor of Pscyhiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research psychiatrist

Study Record Dates

First Submitted

December 10, 2014

First Posted

December 15, 2014

Study Start

December 1, 2014

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

July 2, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations