- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00872118
Brief Intervention for Socially Anxious College Drinkers (BISAD)
Brief Intervention for Socially Anxious Alcohol Abusers
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Ohio
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Cincinnati, Ohio, États-Unis, 45221-0376
- Psychology Department, University of Cincinnati
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 1
Brief Intervention for Socially Anxious Drinkers
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integrated alcohol and social anxiety individual intervention
|
Comparateur actif: 2
Enhanced Alcohol Skills and Education Program
|
alcohol-focused group intervention
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
heavy drinking days
Délai: 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
Délai: 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
Délai: 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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social (interactional) anxiety
Délai: pre-treatment, 1-month follow-up and 4-month follow-up
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pre-treatment, 1-month follow-up and 4-month follow-up
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
alcohol expectancies of social evaluative situations
Délai: 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
Délai: pre-treatment, 1-month follow-up and 4-month follow-up
|
pre-treatment, 1-month follow-up and 4-month follow-up
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Giao Q. Tran, Ph.D., University of Cincinnati
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NIAAA-Tran-AA014014
- R21AA017291 (Subvention/contrat des NIH des États-Unis)
- NIH Grant R21AA014014
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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