- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00872118
Brief Intervention for Socially Anxious College Drinkers (BISAD)
Brief Intervention for Socially Anxious Alcohol Abusers
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Ohio
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Cincinnati, Ohio, 미국, 45221-0376
- Psychology Department, University of Cincinnati
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 1
Brief Intervention for Socially Anxious Drinkers
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integrated alcohol and social anxiety individual intervention
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|
활성 비교기: 2
Enhanced Alcohol Skills and Education Program
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alcohol-focused group intervention
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
heavy drinking days
기간: 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
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
alcohol expectancies of social evaluative situations
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Giao Q. Tran, Ph.D., University of Cincinnati
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .