Alcohol ConsumptionPhase 1BISADNCT00872118
Brief Intervention for Socially Anxious College Drinkers
A Phase 1 study testing Brief Intervention for Socially Anxious Drinkers (BISAD) and Enhanced Alcohol Skills Building and Education Program in people with Alcohol Consumption and Alcohol Negative Consequences, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to develop and test a new brief intervention to reduce heavy drinking and social anxiety in college drinkers. Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Alcohol Consumption, Alcohol Negative Consequences, Social Anxiety
- What is being tested?
- Brief Intervention for Socially Anxious Drinkers (BISAD) and Enhanced Alcohol Skills Building and Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Mar 2008
- Phase
- Phase 1
- 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 26 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- at least one heavy drinking episode (4 or more drinks for women and 5 or more for men)
- occasional to frequent drinking related problems
- moderate social anxiety symptoms
Who cannot join
- history of schizophrenia, bipolar disorder, organic brain syndrome or mental retardation
- current illicit substance dependence, severe alcohol dependence, anxiety disorders (except simple phobia), unipolar depression, major medical illness, pregnancy, suicidality, or homicidality
Trial locations and contacts
1 site in 1 country.
United States1 site
Psychology Department, University of Cincinnati
Cincinnati, Ohio, 45221-0376
About this study
Official title: Brief Intervention for Socially Anxious Alcohol Abusers
The purpose of this study is to develop and test a new brief intervention to reduce heavy drinking and social anxiety in college drinkers.
Read the detailed description
Episodic alcohol abuse is common among college students. Recently, brief interventions focusing on motivational strategies and behavior skills to reduce heavy drinking and alcohol-related problems have shown beneficial small to medium effects in college drinkers who reported heavy drinking and/or alcohol-related problems. Most interventions have not taken into account psychiatric comorbidity, in particular social anxiety, a frequent problem for college students that has been linked to excessive alcohol use. This project will extend knowledge on brief interventions by integrating cognitive-behavioral therapeutic strategies for social anxiety with an existing alcohol intervention designed for college students.
The efficacy of a new integrated treatment, the Brief Intervention for Socially Anxious Drinkers (BISAD) was developed and tested. All participants reported heavy alcohol use, alcohol-related problems and social anxiety based on standardized measures. Phase I of the study focused on the development of the treatment manuals and measures of therapy integrity for BISAD and an alcohol-focused intervention, a modified treatment-as-usual at the local university. During this phase therapists were trained to administer the manualized interventions to study participants (N=12). Phase II included further refinement of the therapy integrity measures and data collection for the pilot study (N=41). Participants were randomized to either BISAD (n=21) or a modified treatment-as-usual (n=20) condition. The pilot study provide preliminary data on the efficacy of the proposed intervention in reducing heavy drinking, social anxiety, and their negative consequences at 1-month and 4-month follow-ups after treatment termination. These data provide estimated effect sizes for future testing of BISAD in a full-scale clinical trial. Furthermore, the study results contribute to the conceptualization and methodological development of combined interventions for other substance use and psychiatric problems.
- Being tested
- Brief Intervention for Socially Anxious Drinkers (BISAD), Enhanced Alcohol Skills Building and Education Program
- Keywords
- alcohol consumption, social anxiety, brief intervention, motivational interviewing, cognitive behavioral
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Intervention for Socially Anxious Drinkers (BISAD)Behavioural
integrated alcohol and social anxiety individual intervention
Enhanced Alcohol Skills Building and Education ProgramBehavioural
alcohol-focused group intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Brief Intervention for Socially Anxious Drinkers Receives: Behavioral: Brief Intervention for Socially Anxious Drinkers (BISAD) |
| 2 | Active comparator | Enhanced Alcohol Skills and Education Program Receives: Behavioral: Enhanced Alcohol Skills Building and Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
heavy drinking days
Measured: pre-treatment, 1-month follow-up and 4-month follow-up
total alcohol consumption
Measured: pre-treatment, 1-month follow-up and 4-month follow-up
drinking-related negative consequences
Measured: pre-treatment, 1-month follow-up and 4-month follow-up
social (interactional) anxiety
Measured: pre-treatment, 1-month follow-up and 4-month follow-up
Secondary outcomes (2)
alcohol expectancies of social evaluative situations
Measured: pre-treatment, 1-month follow-up and 4-month follow-up
drink refusal self-efficacy in social situations
Measured: pre-treatment, 1-month follow-up and 4-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startApr 2004
- Primary completionApr 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Giao Q. Tran, Ph.D., Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872118
- Sponsor's protocol ID
- NIAAA-Tran-AA014014
- Other IDs
- R21AA017291, NIH Grant R21AA014014
- Acronym
- BISAD
- Status last verified
- Sep 2010
- First submitted
- 27 Mar 2009
- Last updated
- 16 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Tran, G.Q. (2008). Efficacy of a brief intervention for college hazardous drinkers with social anxiety: A randomized controlled pilot study. Alcoholism: Clinical and Experimental Research, 32 (Supplement), 190A.
Tran, G.Q., Lanman, S.A., Perciful, M.S., Thompson, R.D., & Smith, J.P. (2006). Promising inexpensive methods for recruiting college-age heavy drinkers for brief alcohol and social anxiety interventions. Alcoholism: Clinical and Experimental Research, 30 (Supplement), 101A.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention for Socially Anxious Alcohol Abusers
- ClinicalTrials.gov ID
- NCT00872118
- Acronym / sponsor ID
- BISAD / NIAAA-Tran-AA014014
- Keywords
- alcohol consumption, social anxiety, brief intervention, motivational interviewing, cognitive behavioral
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Apr 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 31 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 develop and test a new brief intervention to reduce heavy drinking and social anxiety in college drinkers.
Detailed description
Episodic alcohol abuse is common among college students. Recently, brief interventions focusing on motivational strategies and behavior skills to reduce heavy drinking and alcohol-related problems have shown beneficial small to medium effects in college drinkers who reported heavy drinking and/or alcohol-related problems. Most interventions have not taken into account psychiatric comorbidity, in particular social anxiety, a frequent problem for college students that has been linked to excessive alcohol use. This project will extend knowledge on brief interventions by integrating cognitive-behavioral therapeutic strategies for social anxiety with an existing alcohol intervention designed for college students.
The efficacy of a new integrated treatment, the Brief Intervention for Socially Anxious Drinkers (BISAD) was developed and tested. All participants reported heavy alcohol use, alcohol-related problems and social anxiety based on standardized measures. Phase I of the study focused on the development of the treatment manuals and measures of therapy integrity for BISAD and an alcohol-focused intervention, a modified treatment-as-usual at the local university. During this phase therapists were trained to administer the manualized interventions to study participants (N=12). Phase II included further refinement of the therapy integrity measures and data collection for the pilot study (N=41). Participants were randomized to either BISAD (n=21) or a modified treatment-as-usual (n=20) condition. The pilot study provide preliminary data on the efficacy of the proposed intervention in reducing heavy drinking, social anxiety, and their negative consequences at 1-month and 4-month follow-ups after treatment termination. These data provide estimated effect sizes for future testing of BISAD in a full-scale clinical trial. Furthermore, the study results contribute to the conceptualization and methodological development of combined interventions for other substance use and psychiatric problems.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Brief Intervention for Socially Anxious Drinkers (BISAD)Brief Intervention for Socially Anxious Drinkers |
| 2 | Active comparator | Behavioral: Enhanced Alcohol Skills Building and Education ProgramEnhanced Alcohol Skills and Education Program |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- at least one heavy drinking episode (4 or more drinks for women and 5 or more for men)
- occasional to frequent drinking related problems
- moderate social anxiety symptoms
Key exclusion criteria (2 listed)
- history of schizophrenia, bipolar disorder, organic brain syndrome or mental retardation
- current illicit substance dependence, severe alcohol dependence, anxiety disorders (except simple phobia), unipolar depression, major medical illness, pregnancy, suicidality, or homicidality
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 Intervention for Socially Anxious Drinkers (BISAD)integrated alcohol and social anxiety individual intervention | Behavioural | 1 |
| Enhanced Alcohol Skills Building and Education Programalcohol-focused group intervention | Behavioural | 2 |
Primary outcome
heavy drinking days
Time frame: pre-treatment, 1-month follow-up and 4-month follow-up
total alcohol consumption
Time frame: pre-treatment, 1-month follow-up and 4-month follow-up
drinking-related negative consequences
Time frame: pre-treatment, 1-month follow-up and 4-month follow-up
social (interactional) anxiety
Time frame: pre-treatment, 1-month follow-up and 4-month follow-up
2 secondary outcomes
alcohol expectancies of social evaluative situations
Time frame: pre-treatment, 1-month follow-up and 4-month follow-up
drink refusal self-efficacy in social situations
Time frame: pre-treatment, 1-month follow-up and 4-month follow-up
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 16 Sep 2010.
- BackgroundTran, G.Q. (2008). Efficacy of a brief intervention for college hazardous drinkers with social anxiety: A randomized controlled pilot study. Alcoholism: Clinical and Experimental Research, 32 (Supplement), 190A.
- BackgroundTran, G.Q., Lanman, S.A., Perciful, M.S., Thompson, R.D., & Smith, J.P. (2006). Promising inexpensive methods for recruiting college-age heavy drinkers for brief alcohol and social anxiety interventions. Alcoholism: Clinical and Experimental Research, 30 (Supplement), 101A.
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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.
Giao Q. Tran, Ph.D. principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brief Intervention for Socially Anxious Drinkers (BISAD) and Enhanced Alcohol Skills Building and Education Program in people with Alcohol Consumption and Alcohol Negative Consequences, run by University of Cincinnati at 1 site 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 3 inclusion and 2 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 16 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
heavy drinking days (time frame: pre-treatment, 1-month follow-up and 4-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00872118, which also lists 2 linked publications.
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 16 Sep 2010.