Social Anxiety DisorderNCT00862212
Phased Treatment for Social Anxiety Disorder and Coping Behaviors in a Medical Setting
A study testing Brief Alcohol Intervention in people with Social Anxiety Disorder and Alcohol Use Disorders, run by Medical University of South Carolina at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder, Alcohol Use Disorders
- What is being tested?
- Brief Alcohol Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2009to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
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.
Read the 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.
- Conditions
- Social Anxiety Disorder, Alcohol Use Disorders
- Being tested
- Brief Alcohol Intervention
- Keywords
- anxiety, social anxiety, social anxiety disorder, coping behaviors, alcohol abuse
- Medical subject headings
- Phobia, Social, Alcoholism, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Alcohol InterventionBehavioural
Also called Helping Patients That Drink Too Much, NIAAA Guide
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.
| Study group | Role | What they receive |
|---|---|---|
| Brief Alcohol Intervention | Experimental | 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. Receives: Behavioral: Brief Alcohol Intervention |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
alcohol use, as indexed by (1) Drinks per Week and (2) Drinks per Drinking Day
Measured: 22 weeks
Secondary outcomes (1)
alcohol intervention effect on hazardous drinker status
Measured: Weeks 6-22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Sarah Book, Medical University of South Carolina
- Investigators
- Carrie L Randall, Ph.D., Principal investigator, Medical University of South CarolinaMatthew Kushner, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862212
- Sponsor's protocol ID
- R01AA013379-05A1
- Status last verified
- Apr 2013
- First submitted
- 13 Mar 2009
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phased Treatment for Social Anxiety Disorder and Coping Behaviors in a Medical Setting
- ClinicalTrials.gov ID
- NCT00862212
- Acronym / sponsor ID
- R01AA013379-05A1
- Conditions
- Social Anxiety Disorder, Alcohol Use Disorders
- Keywords
- anxiety, social anxiety, social anxiety disorder, coping behaviors, alcohol abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jan 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 16 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Alcohol Intervention | Experimental | Behavioral: Brief Alcohol InterventionHalf 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. |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Alcohol InterventionAlso: Helping Patients That Drink Too Much, NIAAA GuideAt 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. | Behavioural | Brief Alcohol Intervention |
Primary outcome
alcohol use, as indexed by (1) Drinks per Week and (2) Drinks per Drinking Day
Time frame: 22 weeks
1 secondary outcome
alcohol intervention effect on hazardous drinker status
Time frame: Weeks 6-22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie L Randall, Ph.D. principal investigator
Medical University of South Carolina
Matthew Kushner, Ph.D. principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Alcohol Intervention in people with Social Anxiety Disorder and Alcohol Use Disorders, run by Medical University of South Carolina at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alcohol use, as indexed by (1) Drinks per Week and (2) Drinks per Drinking Day (time frame: 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2013.