Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care
2019년 5월 29일 업데이트: Kristina Sinadinovic, Karolinska Institutet
Comparing Effectiveness and Costs of Internet-based Treatment for Problematic Alcohol Use and Face-to-face Treatment in Addiction Care: A Randomized Controlled Trial
The purpose of this trial is to compare the effectiveness and costs of a five-module Internet-based treatment program (including therapist support) for harmful alcohol use with the effectiveness and cost of the same treatment content delivered face-to-face in specialized addiction treatment. The hypotheses to be tested through this trial are that:
- The Internet-based treatment program (including therapist support) is as effective (reducing alcohol consumption) as the same treatment content delivered face-to-face in specialized addiction treatment.
- The Internet-based treatment program (including therapist support) is associated with lower cost per treated individual in relation to the achieved effects (in terms of reduced alcohol consumption) compared with the same treatment content delivered face-to-face in specialized addiction treatment.
The design is a two-armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use as well as alcohol dependence, depression, anxiety, quality of life and costs for the treatments. A minimum of 350 participants will be recruited and randomized into two groups:
Intervention group 1: All participants in this group will have access to the five-module Internet-based treatment program for harmful alcohol use and have access to a therapist with training in psychotherapy (CBT) who assists and counsels the participant throughout the program.
Intervention group 2: All participants in this group will attend five face-to-face treatment sessions in specialized addiction treatment.
연구 개요
연구 유형
중재적
등록 (실제)
303
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Stockholm, 스웨덴, 171 77
- Karolinska Institutet
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- 18 years or older
- 16 points on Alcohol Use Disorders Identification Test or at least 3 criteria on the International Classification of Diseases (ICD-10) for Alcohol Dependence
- Resident in Stockholm County
Exclusion Criteria:
- Lack of understanding of the Swedish language.
- Doctor's assessment that there is a risk for severe withdrawal symptoms, risk for suicide or mental illness requiring separate care.
- Doctor's assessment that there is a need for medication for alcohol dependence.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Internet-based treatment
A five-module Internet-based treatment program for harmful alcohol use (including therapist support) based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.
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A treatment for harmful alcohol use based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.
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활성 비교기: Face-to-face treatment
Same treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment.
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A treatment for harmful alcohol use based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
기간: 3 months post-randomization
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3 months post-randomization
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
기간: 6 months post-randomization
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6 months post-randomization
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Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
기간: 12 months post-randomization
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12 months post-randomization
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Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
기간: 24 months post-randomization
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24 months post-randomization
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Alcohol Use Disorders Identification Test score
기간: 3 months post-randomization
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3 months post-randomization
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Alcohol Use Disorders Identification Test score
기간: 6 months post-randomization
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6 months post-randomization
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Alcohol Use Disorders Identification Test score
기간: 12 months post-randomization
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12 months post-randomization
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Alcohol Use Disorders Identification Test score
기간: 24 months post-randomization
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24 months post-randomization
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Number of criteria for alcohol dependence according to International Classification of Diseases - 10
기간: 3 months post-randomization
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3 months post-randomization
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Number of criteria for alcohol dependence according to International Classification of Diseases - 10
기간: 6 months post-randomization
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6 months post-randomization
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Number of criteria for alcohol dependence according to International Classification of Diseases - 10
기간: 12 months post-randomization
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12 months post-randomization
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Number of criteria for alcohol dependence according to International Classification of Diseases - 10
기간: 24 months post-randomization
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24 months post-randomization
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Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
기간: 3 months post-randomization
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3 months post-randomization
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Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
기간: 6 months post-randomization
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6 months post-randomization
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Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
기간: 12 months post-randomization
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12 months post-randomization
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Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
기간: 24 months post-randomization
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24 months post-randomization
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Number of days absent from work due to illness
기간: 3 months post-randomization
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3 months post-randomization
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Number of days absent from work due to illness
기간: 6 months post-randomization
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6 months post-randomization
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Number of days absent from work due to illness
기간: 12 months post-randomization
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12 months post-randomization
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Number of days absent from work due to illness
기간: 24 months post-randomization
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24 months post-randomization
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Score on Montgomery-Åsberg Depression Rating Scale
기간: 3 months post-randomization
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3 months post-randomization
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Score on Montgomery-Åsberg Depression Rating Scale
기간: 6 months post-randomization
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6 months post-randomization
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Score on Montgomery-Åsberg Depression Rating Scale
기간: 12 months post-randomization
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12 months post-randomization
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Score on Montgomery-Åsberg Depression Rating Scale
기간: 24 months post-randomization
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24 months post-randomization
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Score on Generalised Anxiety Disorder 7-item scale
기간: 3 months post-randomization
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3 months post-randomization
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Score on Generalised Anxiety Disorder 7-item scale
기간: 6 months post-randomization
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6 months post-randomization
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Score on Generalised Anxiety Disorder 7-item scale
기간: 12 months post-randomization
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12 months post-randomization
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Score on Generalised Anxiety Disorder 7-item scale
기간: 24 months post-randomization
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24 months post-randomization
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Score on EQ-5D measuring the quality of life
기간: 3 months post-randomization
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3 months post-randomization
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Score on EQ-5D measuring the quality of life
기간: 6 months post-randomization
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6 months post-randomization
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Score on EQ-5D measuring the quality of life
기간: 12 months post-randomization
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12 months post-randomization
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Score on EQ-5D measuring the quality of life
기간: 24 months post-randomization
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24 months post-randomization
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Cost for treatment
기간: 3 months post-randomization
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3 months post-randomization
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Cost for treatment
기간: 6 months post-randomization
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6 months post-randomization
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Cost for treatment
기간: 12 months post-randomization
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12 months post-randomization
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Cost for treatment
기간: 24 months post-randomization
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24 months post-randomization
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 11월 1일
기본 완료 (예상)
2019년 12월 1일
연구 완료 (예상)
2019년 12월 1일
연구 등록 날짜
최초 제출
2016년 1월 11일
QC 기준을 충족하는 최초 제출
2016년 2월 1일
처음 게시됨 (추정)
2016년 2월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 5월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 5월 29일
마지막으로 확인됨
2019년 5월 1일
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. .
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