- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00872118
Brief Intervention for Socially Anxious College Drinkers (BISAD)
Brief Intervention for Socially Anxious Alcohol Abusers
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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-
Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45221-0376
- Psychology Department, University of Cincinnati
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 1
Brief Intervention for Socially Anxious Drinkers
|
integrated alcohol and social anxiety individual intervention
|
|
Aktiver Komparator: 2
Enhanced Alcohol Skills and Education Program
|
alcohol-focused group intervention
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
heavy drinking days
Zeitfenster: pre-treatment, 1-month follow-up and 4-month follow-up
|
pre-treatment, 1-month follow-up and 4-month follow-up
|
|
total alcohol consumption
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: pre-treatment, 1-month follow-up and 4-month follow-up
|
pre-treatment, 1-month follow-up and 4-month follow-up
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
alcohol expectancies of social evaluative situations
Zeitfenster: pre-treatment, 1-month follow-up and 4-month follow-up
|
pre-treatment, 1-month follow-up and 4-month follow-up
|
|
drink refusal self-efficacy in social situations
Zeitfenster: pre-treatment, 1-month follow-up and 4-month follow-up
|
pre-treatment, 1-month follow-up and 4-month follow-up
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Giao Q. Tran, Ph.D., University Of Cincinnati
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NIAAA-Tran-AA014014
- R21AA017291 (US NIH Stipendium/Vertrag)
- NIH Grant R21AA014014
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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