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Dismantling the Components and Dosing of CBT for Co-Occurring Disorders (CBT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02161211
Recruitment Status : Active, not recruiting
First Posted : June 11, 2014
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
The purpose of this study is to establish a brief CBT intervention that can largely, if not fully eliminate the deleterious effect of common co-occurring anxiety disorders on alcohol use disorder treatment outcomes.

Condition or disease Intervention/treatment Phase
CBT Decoupling CBT Anxiety Reduction CBT Combined Behavioral: De-coupling Behavioral: Anxiety Reduction Behavioral: Combined Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Dismantling the Components and Dosing of CBT for Co-Occurring Disorders
Actual Study Start Date : July 2014
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: De-coupling
Six sessions of CBT for anxiety-alcohol de-coupling
Behavioral: De-coupling
Six sessions of CBT for anxiety-alcohol de-coupling

Experimental: Anxiety Reduction
Six sessions of CBT for anxiety reduction.
Behavioral: Anxiety Reduction
Six sessions of CBT for anxiety reduction.

Experimental: Combined
Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each.
Behavioral: Combined
Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each.




Primary Outcome Measures :
  1. Relapse Status [ Time Frame: 4 month follow-up ]
    Relapse status will be assessed using categorical relapse status (yes vs. no) and a continuous measurement of relapse severity (i.e., percent/number days drinking and drinks per drinking day).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnostic and Statistical Manual IV diagnosis of panic disorder, generalized anxiety disorder, and/or social anxiety disorder within the past 30 days;
  • inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug) dependence
  • alcohol use in the 30 days preceding the study
  • ability to provide informed consent
  • minimum of a sixth grade reading level (deemed necessary to complete study materials);
  • willingness to provide contact information to confirm study follow-up appointments
  • lives within proximity to the Twin Cities (e.g., within about an hour's drive) for the purpose attending follow-up visits

Exclusion Criteria:

  • lifetime history of psychosis or mania by history
  • cognitive or physical impairment that precludes study participation
  • currently and seriously suicidal (i.e., plan and intent)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161211


Locations
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United States, Minnesota
Lodging Plus Program, Fairview Hospital
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Matt Kurshner, PhD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02161211    
Other Study ID Numbers: PSYCH-2016-22016
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Keywords provided by University of Minnesota:
alcohol
anxiety