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).
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Stockholm、スウェーデン、171 76
- Karolinska Institutet, department of clinical neuroscience
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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:
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
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：処理
- 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：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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アクティブコンパレータ：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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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Alcohol Use Identification Test (AUDIT)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time Line Follow Back (TLFB)
時間枠：Post, 3, 6 and 12 months
|
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)
時間枠：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)
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Drug Use Identification Test (DUDIT)
時間枠：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
時間枠：Post
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Biological marker outcomes post-treatment.
B-PEth and CDT.
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Post
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Anne H Berman, PhD、Karolinska Institutet
出版物と役立つリンク
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。