Brief Intervention for Socially Anxious College Drinkers (BISAD)
Brief Intervention for Socially Anxious Alcohol Abusers
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Ohio
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Cincinnati、Ohio、アメリカ、45221-0376
- Psychology Department, University of Cincinnati
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:1
Brief Intervention for Socially Anxious Drinkers
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integrated alcohol and social anxiety individual intervention
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アクティブコンパレータ:2
Enhanced Alcohol Skills and Education Program
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alcohol-focused group intervention
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
heavy drinking days
時間枠: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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total alcohol consumption
時間枠: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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drinking-related negative consequences
時間枠: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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social (interactional) anxiety
時間枠: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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二次結果の測定
結果測定 |
時間枠 |
---|---|
alcohol expectancies of social evaluative situations
時間枠: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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drink refusal self-efficacy in social situations
時間枠: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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協力者と研究者
スポンサー
捜査官
- 主任研究者:Giao Q. Tran, Ph.D.、University of Cincinnati
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Brief Intervention for Socially Anxious Drinkers (BISAD)の臨床試験
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Washington State UniversityNational Institute on Drug Abuse (NIDA)完了