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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01886716

First Posted: June 26, 2013

Last Update Posted: December 28, 2016

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.

Collaborators:

Miami University

Brown University

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Information provided by (Responsible Party):

Joshua Magee, University of Cincinnati

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 (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:

MedlinePlus related topics: Alcoholism and Alcohol Abuse Anxiety

U.S. FDA Resources

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

Information from the National Library of Medicine

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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

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): 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 ( U.S. NIH Grant/Contract )
First Submitted:	June 17, 2013
First Posted:	June 26, 2013
Results First Submitted:	July 15, 2016
Results First Posted:	December 28, 2016
Last Update Posted:	December 28, 2016
Last Verified:	December 2016
Individual Participant Data (IPD) Sharing Statement:
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

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