- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00872118
Brief Intervention for Socially Anxious College Drinkers (BISAD)
Brief Intervention for Socially Anxious Alcohol Abusers
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Ohio
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Cincinnati, Ohio, Forente stater, 45221-0376
- Psychology Department, University of Cincinnati
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 1
Brief Intervention for Socially Anxious Drinkers
|
integrated alcohol and social anxiety individual intervention
|
Aktiv komparator: 2
Enhanced Alcohol Skills and Education Program
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alcohol-focused group intervention
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
heavy drinking days
Tidsramme: pre-treatment, 1-month follow-up and 4-month follow-up
|
pre-treatment, 1-month follow-up and 4-month follow-up
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total alcohol consumption
Tidsramme: pre-treatment, 1-month follow-up and 4-month follow-up
|
pre-treatment, 1-month follow-up and 4-month follow-up
|
drinking-related negative consequences
Tidsramme: pre-treatment, 1-month follow-up and 4-month follow-up
|
pre-treatment, 1-month follow-up and 4-month follow-up
|
social (interactional) anxiety
Tidsramme: pre-treatment, 1-month follow-up and 4-month follow-up
|
pre-treatment, 1-month follow-up and 4-month follow-up
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
alcohol expectancies of social evaluative situations
Tidsramme: pre-treatment, 1-month follow-up and 4-month follow-up
|
pre-treatment, 1-month follow-up and 4-month follow-up
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drink refusal self-efficacy in social situations
Tidsramme: pre-treatment, 1-month follow-up and 4-month follow-up
|
pre-treatment, 1-month follow-up and 4-month follow-up
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Giao Q. Tran, Ph.D., University of Cincinnati
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NIAAA-Tran-AA014014
- R21AA017291 (U.S. NIH-stipend/kontrakt)
- NIH Grant R21AA014014
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