Retraining Attention to Treat Alcohol Dependence and Social Anxiety (AMP)
|
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. |
| ClinicalTrials.gov Identifier: NCT01886716 |
|
Recruitment Status :
Completed
First Posted : June 26, 2013
Results First Posted : December 28, 2016
Last Update Posted : December 28, 2016
|
Sponsor:
University of Cincinnati
Collaborators:
Miami University
Brown University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Joshua Magee, University of Cincinnati
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
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 (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 |
Resource links provided by the National Library of Medicine
| 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. |
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.
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
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 |
| 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 ) 1R21AA021151 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 26, 2013 Key Record Dates |
| 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 |