- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01129804
Network Support for Alcohol Treatment 2
Network Support for Alcohol Treatment: Mechanisms and Effectiveness
The Network Support project is part of an ongoing effort to improve treatment for alcohol dependent patients. The Network Support Project is designed to help patients change their social network from one that reinforces drinking behavior to one that reinforces sobriety.
160 patients will be assigned to one of two treatments. Each of the treatments will last 12 weeks. The first is a Network Support (NS) treatment designed to help patients develop new acquaintances and social networks. It is expected that alcohol dependent patients will benefit from increasing their contact with non-drinking people. This NS condition will be compared to a packaged CBT program for alcoholics (PCBT) that is designed to teach a number of skills to help people stop drinking, but does not address social networks per se.
In order to better understand what is happening to the investigators patients, the investigators will be using daily computerized telephone calls to ask about people's experiences. This will be done both before and after treatment. Patients will also be asked to participate in follow-up interviews every 3 months for 2 years following the end of treatment.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Connecticut
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Farmington, Connecticut, 미국, 06030
- University of Connecticut Health Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18 yo
- meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence
Exclusion Criteria:
- acute medical or psychiatric problems that require inpatient treatment (e.g., acute psychosis, or suicide/homicide risk)
- reading ability below the fifth grade level
- lack of reliable transportation to the treatment site, or excessive commuting distance
- inability to understand English
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Network Support
Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence.
In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers.
These activities would be determined by the patient, with help from the therapist.
Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking.
In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends.
|
Patients in both treatments will be taught skills to help them keep from drinking.
|
|
활성 비교기: Packaged Cognitive-Behavioral Treatment
The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking.
|
Patients in both treatments will be taught skills to help them keep from drinking.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion Days Abstinent (PDA)
기간: Every 3 months out to 2 years
|
PDA is based on data collected in each 90-day timeline follow-back assessment of daily drinking.
PDA is calculated as the number of days out of 90 in which the patient reported 0 drinks.
|
Every 3 months out to 2 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Social Network Change
기간: assessed every 6 months out to 2 years, mean change over 2 years reported
|
Network Support for Abstinence.
Minimum score=0; Maximum score =1.
Higher scores indicate greater support for abstinence.
|
assessed every 6 months out to 2 years, mean change over 2 years reported
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Mark D Litt, Ph.D., Uconn Health
간행물 및 유용한 링크
일반 간행물
- Litt MD, Kadden RM, Kabela-Cormier E, Petry N. Changing network support for drinking: initial findings from the network support project. J Consult Clin Psychol. 2007 Aug;75(4):542-55. doi: 10.1037/0022-006X.75.4.542.
- Litt MD, Kadden RM, Kabela-Cormier E, Petry NM. Changing network support for drinking: network support project 2-year follow-up. J Consult Clin Psychol. 2009 Apr;77(2):229-42. doi: 10.1037/a0015252.
- Litt MD, Kadden RM, Tennen H. Treatment response and non-response in CBT and Network Support for alcohol disorders: targeted mechanisms and common factors. Addiction. 2018 Aug;113(8):1407-1417. doi: 10.1111/add.14224. Epub 2018 Apr 20.
- Litt MD, Kadden RM, Tennen H, Kabela-Cormier E. Network Support II: Randomized controlled trial of Network Support treatment and cognitive behavioral therapy for alcohol use disorder. Drug Alcohol Depend. 2016 Aug 1;165:203-12. doi: 10.1016/j.drugalcdep.2016.06.010. Epub 2016 Jun 18.
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 09-050
- R01AA012827 (미국 NIH 보조금/계약)
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. .
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