Phased Treatment for Social Anxiety Disorder and Coping Behaviors in a Medical Setting
The purpose of this study is to treat individuals with social anxiety disorder with a Food and Drug Administration-approved medication for the treatment of social anxiety disorder, the antidepressant paroxetine, and to evaluate the impact of an intervention designed to help those individuals cope with anxiety without the use of common coping behaviors.
Social Anxiety Disorder
Alcohol Use Disorders
Behavioral: Brief Alcohol Intervention
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phased Treatment for Social Anxiety Disorder and Coping Behaviors in a Medical Setting|
- alcohol use, as indexed by (1) Drinks per Week and (2) Drinks per Drinking Day [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
- alcohol intervention effect on hazardous drinker status [ Time Frame: Weeks 6-22 ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2009|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: Brief Alcohol Intervention
Half of the subjects will be randomly assigned to receive a brief physician-delivered alcohol intervention designed by the NIAAA to be delivered by primary care and mental health providers.
Behavioral: Brief Alcohol Intervention
At the Week 6 visit, all subjects who are randomized to the Experimental Group will receive the experimental brief alcohol intervention. The intervention will be in addition to a standard 20-minute physician visit, for a maximum of 30 minutes. The physician will use the Updated NIAAA Clinician's Guide to ask about drinking and will draw the connection between social anxiety and drinking and how they relate to each other. Subjects will be asked to consider making changes in their drinking and if they agree, a goal will be set and progress toward that goal will be monitored at subsequent visits.
Other Name: Helping Patients That Drink Too Much, NIAAA Guide
|No Intervention: Control Group|
Psychiatric and alcohol use problems co-occur in a significant number of individuals seeking treatment in mental health treatment settings. However, there is a paucity of research to guide clinical practice. This is especially true for psychiatrists treating patients with anxiety disorders who also present with co-occurring hazardous drinking. If alcohol is being used as a coping strategy, as it is frequently in individuals with social anxiety, it follows that successful treatment of the social anxiety should resolve dysfunctional drinking. However, results from our study completed during the current funding period did not support this hypothesis and suggested, instead, that additional intervention for hazardous drinking is necessary. The proposed project is a natural "next step" in this line of research, and the design and methods are guided and informed by the results our previous work as well as by recently-collected preliminary data. The proposed study will evaluate the phased approach to the treatment of these co-occurring disorders. Social anxiety will be treated first, then, in the Experimental group, the physician will introduce a brief alcohol intervention at a standard time in the course of social anxiety treatment. The hypothesis being tested is that drinking will decrease more in the Experimental group than in the Control group, where only the social anxiety is treated and discussed. The design of the study follows from the results of the project completed in the previous funding period. The intent of the design was to balance scientific rigor with real-world practicality. Individuals who are specifically seeking treatment for social anxiety and who also drink at hazardous drinking levels will be recruited from the community from two treatment sites, one in South Carolina and one in Minnesota. All subjects in the trial will receive 22 weeks of flexible dosing with paroxetine, an FDA-approved medication for the treatment of social anxiety shown to be effective in our previous trial. Half of the subjects will be randomized to receive at Week 6, in addition to routine social anxiety treatment, a brief physician-delivered alcohol intervention following the Updated NIAAA Clinical Guide for Helping Patients Who Drink Too Much. Research assessments will coincide with physician visits and will also include 34 and 46-week post-treatment follow-up visits. The study is a novel test of the phased treatment model, is one of the first studies to address the treatment of co-occurring anxiety and hazardous drinking in a mental health treatment setting, and uses both social anxiety and alcohol interventions that are easily adoptable in real-world mental health clinical practice. If the hypothesis is supported, the study has broad implications for treatment of other co-occurring anxiety and mood disorders and hazardous drinking.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862212
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55454|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Carrie L Randall, Ph.D.||Medical University of South Carolina|
|Principal Investigator:||Matthew Kushner, Ph.D.||University of Minnesota - Clinical and Translational Science Institute|