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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Alcohol Drinking; Anxiety Disorders	Behavioral: Anxiety Attention Training; Behavioral: Alcohol Attention Training; Behavioral: Control Training	Not Applicable

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	115 participants
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
Study Start Date :	July 2013
Actual Primary Completion Date :	December 2014
Actual Study Completion Date :	December 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Primary Outcome Measures :

1. 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).
2. 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted:	June 26, 2013
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