Internet-Based Relapse Prevention vs Face to Face Therapy at an Employee Assistance Program (FoBeMA)
Internet-Based Relapse Prevention With Therapist Support vs Face to Face Therapy at an Employee Assistance Program: A Randomized Controlled Non-inferiority Trial
Objectives: This study will evaluate the efficacy of internet-based relapse prevention with therapist support, as compared to face-to-face therapy at an employee assistance program. The design is a two-armed randomized controlled design, and outcomes are measured in terms of changes in problematic alcohol use, as well as depression and quality of life.
Method: Participants with problematic alcohol use who, after an initial evaluation consisting of five face-to-face sessions with a licensed psychologist where alcohol and collateral problems are extensively assessed, are recommended treatment for problematic alcohol use. Consenting participants will be randomized into one of two groups: 1. Internet delivered relapse prevention with therapist support or 2. Face-to-face therapy. Outcomes on alcohol use, depression and quality of life as well as information on user satisfaction will be gathered post treatment. Follow up will be at 3, 6 and 12 months after completion.
Our hypothesis is that the internet-based program with therapist support and the face-to-face therapy will be equally effective in reducing alcohol use (non-inferiority).
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Stockholm, 스웨덴, 171 76
- Karolinska Institutet, department of clinical neuroscience
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Problematic alcohol use and having been recommended psychotherapy by the assessing psychologist.
Exclusion Criteria:
Inadequate Swedish language skills No Internet access Reading and/or writing difficulties Major depression Current suicidal thoughts and/or plans Primary problematic drug use PTSD-related problems Psychosis Cognitive disability
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 |
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실험적: eChange web-based relapse prevention
A relapse intervention program consisting of 14 modules.
Patients will have access to therapist support through an internal secure messaging system.
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A web-based relapse intervention program consisting of 14 modules.
The patient will have access to therapist support through a secure messaging system
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활성 비교기: Face-to-face therapy
Face-to-face psychotherapy, consisting of 20 sessions.
The content will be vary for different therapists, but all have an evidence-based approach to therapy
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Face-to-face psychotherapy, consisting of 20 sessions.
The content will be different for different therapists, but all have an evidence based approach to therapy
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Alcohol Use Identification Test (AUDIT)
기간: Post, 3, 6 and 12 months
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Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)
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Post, 3, 6 and 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Time Line Follow Back (TLFB)
기간: Post, 3, 6 and 12 months
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Change in total TLFB score, as a summarized measure of alcohol consumption
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Post, 3, 6 and 12 months
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Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)
기간: Post, 3, 6 and 12 months
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Change in total MADRS-S score, as a summarized measure of depression
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Post, 3, 6 and 12 months
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World Health Quality of Life Scale (WHOQOL-BREF)
기간: Post, 3, 6 and 12 months
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Change in total WHOQOL-BREF score, as a summarized measure of quality of life
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Post, 3, 6 and 12 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Drug Use Identification Test (DUDIT)
기간: Post, 3, 6 and 12 months
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Change in total DUDIT score, as a summarized measure of drug (including alcohol consumption and alcohol-related problems)
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Post, 3, 6 and 12 months
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Biological tests for alcohol markers
기간: Post
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Biological marker outcomes post-treatment.
B-PEth and CDT.
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Post
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공동 작업자 및 조사자
수사관
- 수석 연구원: Anne H Berman, PhD, Karolinska Institutet
간행물 및 유용한 링크
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. .
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