Retraining Attention to Treat Alcohol Dependence and Social Anxiety (AMP)

December 15, 2016 updated by: Joshua Magee, University of Cincinnati

Cognitive Bias Modification: A Novel Intervention for Alcohol Dependence and Social Anxiety

The purpose of this research is to test a computerized intervention for people with co-occurring social anxiety and alcohol dependence. The intervention seeks to reduce symptoms by shifting attention away from alcohol-relevant and/or socially threatening cues. The investigators expect that participants receiving alcohol or anxiety training will experience reductions in those specific symptoms compared to participants in a control condition. The investigators also expect that participants receiving combined alcohol and anxiety training will show the largest reductions in alcohol and anxiety symptoms, relative to participants in any other condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Alcohol Use Disorders (AUDs) and Social Anxiety Disorder are disabling and chronic conditions. In spite of these common and significantly overlapping problems, insight into the mechanisms linking alcohol dependence and social anxiety symptoms is minimal, and there are not well established treatment guidelines for this population. In this study, the investigators seek to develop a computerized intervention for individuals with symptoms of social anxiety and alcohol dependence. The intervention attempts to reduce symptoms by shifting attention away from alcohol-relevant and/or socially threatening cues. The investigators expect that participants receiving alcohol or anxiety training will experience reductions in those specific symptoms compared to participants in a control condition. The investigators also expect that participants receiving combined alcohol and anxiety training will show the largest reductions in alcohol and anxiety symptoms, relative to participants in any other condition.

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

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
    • Ohio
      • Cincinnati, Ohio, United States, 45206
        • University of Cincinnati Department of Family and Community Medicine

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current alcohol dependence
  • Elevated social anxiety symptoms
  • Willingness to consider cutting down on drinking

Exclusion Criteria:

  • Current psychosis
  • Unmanaged manic symptoms
  • Significant cognitive impairment
  • Other drug use in past month
  • Receiving cognitive behavioral therapy for alcohol use disorder or social anxiety
  • Unable to read

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anxiety Attention Training only
Participants will receive Anxiety Attention Training and placebo Alcohol training.
Behavioral: Anxiety Attention Training
Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.
Experimental: Alcohol Attention Training only
Participants will receive Alcohol Attention Training and placebo Anxiety training.
Behavioral: Alcohol Attention Training
Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol.
Experimental: Anxiety + Alcohol Attention Training
Participants will receive both Anxiety Attention Training and Alcohol Attention Training.
Behavioral: Anxiety Attention Training
Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.
Behavioral: Alcohol Attention Training
Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol.
Placebo Comparator: Control Training
Participants will receive placebo Anxiety Training and placebo Alcohol training.
Behavioral: Control Training
Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liebowitz Social Anxiety Scale
Time Frame: Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)
The experimenter-administered Liebowitz Social Anxiety Scale (Liebowitz, 1987) was the primary measure to assess social anxiety symptoms. This well-validated instrument assesses fear and avoidance across a range of 24 social and performance situations during the course of the previous week. A total LSAS score was computed, ranging from 0 (no fear or avoidance) to 144 (the greatest level of fear and avoidance).
Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)
The Daily Drinking Questionnaire
Time Frame: Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)
The Daily Drinking Questionnaire (Collins, Parks, & Marlatt, 1985) was the primary measure used to assess weekly alcohol consumption. This calendar-based measure was administered by the experimenter once per week to monitor changes in symptoms. The measure assessed the total number of drinks in the past week.
Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)

Collaborators and Investigators

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

Sponsor

University of Cincinnati

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Brown University
Miami University

Investigators

  • Principal Investigator: Joshua C Magee, Ph.D., University of Cincinnati

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

July 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (Estimate)

June 26, 2013

Study Record Updates

Last Update Posted (Estimate)

December 28, 2016

Last Update Submitted That Met QC Criteria

December 15, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R21AA021151 (U.S. NIH Grant/Contract)

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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