Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00862212
Study type Interventional
Source Medical University of South Carolina
Contact
Status Completed
Phase N/A
Start date January 2009
Completion date July 2012

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06274112 - Using TMS to Understand Neural Processes of Social Motivation N/A
Completed NCT02554929 - Treatment of Social Anxiety Disorder and Selective Mutism N/A
Completed NCT00684541 - Interpretation Modification Program for Social Phobia N/A
Completed NCT00684320 - Attention Disengagement Training for Social Phobia N/A
Completed NCT03247075 - Internet-delivered CBT vs Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - An RCT N/A
Completed NCT02811458 - Clinical Trial of Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders N/A
Withdrawn NCT04622930 - Waitlist-Control Trial of Smartphone CBT for Social Anxiety Disorder (SAD) N/A
Active, not recruiting NCT05018312 - Modified Collaborative Assessment VS Standard Assessment on Readiness For Psychotherapy Among Patients With Anxiety N/A
Active, not recruiting NCT05124639 - Clinical Trial of a Group Self-management Support Program for Anxiety Disorders N/A
Completed NCT05858294 - The Safety, Acceptability and Efficacy of Alena N/A
Active, not recruiting NCT05600114 - Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder Phase 2
Not yet recruiting NCT06081348 - Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders Phase 2
Not yet recruiting NCT02924610 - Brief Intervention to Reduce Fear Phase 4
Active, not recruiting NCT02592564 - Brain Plasticity and Cellular Aging After Internet-delivered CBT for Social Anxiety Disorder N/A
Recruiting NCT02305537 - Building an Outcomes Assessment Infrastructure to Assess Anxiety Treatment N/A
Terminated NCT03764644 - Web-based Attention Bias Modification Treatment for Childhood Anxiety Disorders N/A
Unknown status NCT01712321 - Study of Vilazodone to Treat Social Anxiety Disorder N/A
Completed NCT01320800 - CBT for Social Anxiety Disorder Delivered by School Counselors Phase 2
Completed NCT00485615 - An Open Label Trial of Omega 3(o3mega+Joy)in the Treatment of Social Phobia Phase 2
Completed NCT00485888 - Flushing in Social Anxiety Disorder on Cipralex Phase 2