Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care
2019年5月29日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
303
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Stockholm、スウェーデン、171 77
- Karolinska Institutet
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：独身
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：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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アクティブコンパレータ：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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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 |
時間枠 |
|---|---|
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Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
時間枠：3 months post-randomization
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3 months post-randomization
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
時間枠：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
時間枠：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
時間枠：24 months post-randomization
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24 months post-randomization
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Alcohol Use Disorders Identification Test score
時間枠：3 months post-randomization
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3 months post-randomization
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Alcohol Use Disorders Identification Test score
時間枠：6 months post-randomization
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6 months post-randomization
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Alcohol Use Disorders Identification Test score
時間枠：12 months post-randomization
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12 months post-randomization
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Alcohol Use Disorders Identification Test score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：24 months post-randomization
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24 months post-randomization
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Score on Montgomery-Åsberg Depression Rating Scale
時間枠：3 months post-randomization
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3 months post-randomization
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Score on Montgomery-Åsberg Depression Rating Scale
時間枠：6 months post-randomization
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6 months post-randomization
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Score on Montgomery-Åsberg Depression Rating Scale
時間枠：12 months post-randomization
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12 months post-randomization
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Score on Montgomery-Åsberg Depression Rating Scale
時間枠：24 months post-randomization
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24 months post-randomization
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Score on Generalised Anxiety Disorder 7-item scale
時間枠：3 months post-randomization
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3 months post-randomization
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Score on Generalised Anxiety Disorder 7-item scale
時間枠：6 months post-randomization
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6 months post-randomization
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Score on Generalised Anxiety Disorder 7-item scale
時間枠：12 months post-randomization
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12 months post-randomization
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Score on Generalised Anxiety Disorder 7-item scale
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：24 months post-randomization
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24 months post-randomization
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Cost for treatment
時間枠：3 months post-randomization
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3 months post-randomization
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Cost for treatment
時間枠：6 months post-randomization
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6 months post-randomization
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Cost for treatment
時間枠：12 months post-randomization
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12 months post-randomization
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Cost for treatment
時間枠：24 months post-randomization
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24 months post-randomization
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年11月1日
一次修了 (予想される)
2019年12月1日
研究の完了 (予想される)
2019年12月1日
試験登録日
最初に提出
2016年1月11日
QC基準を満たした最初の提出物
2016年2月1日
最初の投稿 (見積もり)
2016年2月2日
学習記録の更新
投稿された最後の更新 (実際)
2019年5月30日
QC基準を満たした最後の更新が送信されました
2019年5月29日
最終確認日
2019年5月1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。
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