Phased Treatment for Social Anxiety Disorder and Coping Behaviors in a Medical Setting

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Sarah Book, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00862212
First received: March 13, 2009
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Social Anxiety Disorder
Alcohol Use Disorders
Behavioral: Brief Alcohol Intervention

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • alcohol use, as indexed by (1) Drinks per Week and (2) Drinks per Drinking Day [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • alcohol intervention effect on hazardous drinker status [ Time Frame: Weeks 6-22 ] [ Designated as safety issue: Yes ]

Enrollment: 83
Study Start Date: January 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65.
  • Meets DSM-IV criteria for Social Anxiety Disorder, generalized type.
  • LSAS score greater than or equal to 60.
  • Reports drinking at least 15 standard drinks/week or 5 standard drinks/drinking day for men, and at least 8 standard drinks/week or 4 standard drinks/drinking day for women in the past 30 days.
  • AUDIT score between 8 and 15 inclusive for men and 4 and 15 inclusive for women.
  • Reports no prior medical alcohol detoxification or formal alcohol treatment including regular attendance at self-help groups.
  • Treatment seeking for relief of social anxiety, not for alcohol problems.
  • Endorses drinking to cope with anxiety at least 40% of the time during or before a social situation, using the Drinking to Cope survey.
  • Able to provide informed consent and fill out self-rating forms in English.

Exclusion Criteria:

  • Drug dependence in the past 90 days on any drug besides caffeine or nicotine.
  • Lifetime diagnosis of bipolar disorder or schizophrenia.
  • Significant suicide risk as assessed by the SCID.
  • Current use of psychotropic medications.
  • Pregnancy, nursing or refusal to use effective birth control if female.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862212

Locations
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
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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
  More Information

No publications provided

Responsible Party: Sarah Book, Prinicpal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00862212     History of Changes
Other Study ID Numbers: R01AA013379-05A1
Study First Received: March 13, 2009
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
anxiety
social anxiety
social anxiety disorder
coping behaviors
alcohol abuse

Additional relevant MeSH terms:
Alcohol Drinking
Anxiety Disorders
Phobic Disorders
Drinking Behavior
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014