Retraining Attention to Treat Alcohol Dependence and Social Anxiety

NCT01886716 | Completed Results

• 1 other identifier: 1R21AA021151
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking; Anxiety Disorders

Keywords

Alcohol Abuse; Alcohol Dependence; Alcohol Drinking; Social Anxiety; Social Phobia; Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

• Liebowitz Social Anxiety Scale

  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

  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)

Study Arms (4)

Anxiety Attention Training only

EXPERIMENTAL

Participants will receive Anxiety Attention Training and placebo Alcohol training.

Behavioral: Anxiety Attention Training

Alcohol Attention Training only

EXPERIMENTAL

Participants will receive Alcohol Attention Training and placebo Anxiety training.

Behavioral: Alcohol Attention Training

Anxiety + Alcohol Attention Training

EXPERIMENTAL

Participants will receive both Anxiety Attention Training and Alcohol Attention Training.

Behavioral: Anxiety Attention Training; Behavioral: Alcohol Attention Training

Control Training

PLACEBO COMPARATOR

Participants will receive placebo Anxiety Training and placebo Alcohol training.

Behavioral: Control Training

Interventions

Anxiety Attention Training BEHAVIORAL

Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.

Anxiety + Alcohol Attention Training; Anxiety Attention Training only

Alcohol Attention Training BEHAVIORAL

Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol.

Alcohol Attention Training only; Anxiety + Alcohol Attention Training

Control Training BEHAVIORAL

Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol.

Control Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead
• Miami University: collaborator
• Brown University: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Cincinnati Department of Family and Community Medicine

Cincinnati, Ohio, 45206, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Anxiety Disorders; Alcoholism; Phobia, Social

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Dr. Elise Clerkin
• Organization: Miami University

clerkiem@miamioh.edu

513-529-2483

Study Officials

• Joshua C Magee, Ph.D.

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 26, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 28, 2016
• Results First Posted: December 28, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)