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

This study has been completed.
Sponsor:
Collaborators:
Miami University
Brown University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Joshua Magee, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01886716
First received: June 17, 2013
Last updated: December 15, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention
Alcohol Drinking Anxiety Disorders Behavioral: Anxiety Attention Training Behavioral: Alcohol Attention Training Behavioral: Control Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Bias Modification: A Novel Intervention for Alcohol Dependence and Social Anxiety

Resource links provided by NLM:


Further study details as provided by Joshua Magee, University of Cincinnati:

Primary Outcome Measures:
  • 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).

  • 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.


Enrollment: 115
Study Start Date: July 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886716

Locations
United States, Ohio
University of Cincinnati Department of Family and Community Medicine
Cincinnati, Ohio, United States, 45206
Sponsors and Collaborators
University of Cincinnati
Miami University
Brown University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Joshua C Magee, Ph.D. University of Cincinnati
  More Information

Responsible Party: Joshua Magee, Assistant Research Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01886716     History of Changes
Other Study ID Numbers: 1R21AA021151 ( US NIH Grant/Contract Award Number )
Study First Received: June 17, 2013
Results First Received: July 15, 2016
Last Updated: December 15, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Joshua Magee, University of Cincinnati:
Alcohol Abuse
Alcohol Dependence
Alcohol Drinking
Social Anxiety
Social Phobia
Anxiety Disorders

Additional relevant MeSH terms:
Anxiety Disorders
Alcoholism
Alcohol Drinking
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 28, 2017