Adapting an Effective CBT for Comorbidity to a Computer-Delivered Format
2022年9月8日 更新者：University of Minnesota
Up to one-half of those in treatment for alcohol use disorder (AUD) has a co-occurring anxiety disorder ("comorbidity"), a condition that marks a high degree of treatment resistance, severity and relapse risk in AUD treatment patients.
The investigators conceptualize comorbidity as a feed-forward system ("vicious cycle", [VC]) of interacting negative affect/stress, drinking motives/behavior, coping skills deficits, environmental circumstances, and neurobiological adaptations.
Based on this model, the investigators developed and validated the VC cognitive-behavioral therapy (VC-CBT) to disrupt this system at several key linkage points.
In a recently completed randomized controlled trial (RCT), the investigators found that adding the VC-CBT to standard AUD inpatient treatment resulted in better alcohol outcomes 4 months following treatment than did adding an anxiety treatment or standard AUD treatment alone.
With a number needed to treat (NNT) index of 8 (relative to standard AUD treatment alone), the VC-CBT could, if broadly disseminated, have a large positive impact on AUD treatment.
Unfortunately, several significant barriers related to the resource- and expertise-intensive delivery of the VC-CBT limit its dissemination potential and, hence, the impact of this otherwise effective treatment.
Therefore, to maximize the public health and scientific potential of the investigators work, the investigators propose to adapt the therapist-delivered VC-CBT to a computer-delivered format to facilitate reliable and economical dissemination of the VC-CBT while maintaining its established efficacy.
調査の概要
詳細な説明
The first phase of the work (Year 1) will be to adapt the 6-session therapist-delivered VC-CBT for delivery on an internet-based computer platform.
This work will be done using a standard iterative process for developing e-content in partnership with local technology experts experienced in producing engaging and effective e-learning products.
Approximately 5 patients will be employed in this phase.
The second phase (Years 2 and 3) will be devoted to a single arm pilot trial to test the efficacy of the refined computer-delivered VC-CBT.
The investigators will recruit AUD treatment patients with co-occurring anxiety disorder to receive the computer-delivered VC-CBT (50 patients).
Participants will complete follow-up assessments one and four months following treatment.
Participants will rate user satisfaction and will be evaluated on skill and knowledge acquisition as well as use of the tools in the follow-up period.
Success in the proposed work will serve as pilot data in support of a rigorous randomized clinical trial.
The proposed work aims to provide an easy and inexpensive computer-delivered version of the VC-CBT that has comparable efficacy to the validated but resource-intensive therapist-delivered version.
Achieving this will enable the VC-CBT therapy to benefit more AUD treatment patients and to be more easily studied by other investigators.
研究の種類
介入
入学 (実際)
59
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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Minnesota
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Minneapolis、Minnesota、アメリカ、55408
- University of Minnesota
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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～65年 (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:
- Diagnostic and Statistical Manual-IV diagnosis of panic disorder (with or without agoraphobia), generalized anxiety disorder, or social anxiety disorder within the past 30 days
- Diagnostic and Statistical Manual-IV diagnosis of alcohol dependence within the last 30 days
- inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug) dependence
- alcohol use in the 30 days preceding the beginning of their Lodging Plus (LP) treatment
- willingness and ability to provide informed consent
- minimum of a sixth grade English reading level (deemed necessary to complete study materials); as determined by their being able to read and understand the consent form
- familiarity with computer keyboarding as determined by history
- lives within reasonable driving distance of the Twin Cities and ability to travel to Fairview to allow for in-person follow-up interviews
Exclusion Criteria:
- Active psychosis or mania in the three months preceding the study
- Physical impairment (e.g., blindness, deafness) that interferes with study participation based on self-report or as judged by PI or study physician
- current significant suicide risk (i.e., intention and plan) as deemed by the PI and study physician to be serious and ongoing
- primary PTSD as determined by the Structured Clinical Interview for DSM (SCID) interview
- suspected cognitive impairment that interferes with study participation as informed by the SCID interview or as judged by the PI or study physician
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：Computer-based VC-CBT
Computer-based VC-CBT: Three, one-hour computerized therapy sessions delivered on an interactive computerized platform with therapy blocks dedicated to each of three primary modules/goals: 1) psycho-education, 2) skills learning, and 3) individualized practice
|
Computer-based VC-CBT: Three, one-hour computerized therapy sessions delivered on an interactive computerized platform with therapy blocks dedicated to each of three primary modules/goals: 1) psycho-education, 2) skills learning, and 3) individualized practice
|
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 |
|---|---|---|
|
User ratings
時間枠：up to 4 days post-treatment
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Likert scale ratings of understanding, engagement, and applicability to current problems
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up to 4 days post-treatment
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Knowledge Acquisition
時間枠：up to 4 days post-treatment
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Multiple choice and True/False questions to assess knowledge communicated in program
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up to 4 days post-treatment
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Skills Acquisition
時間枠：up to 4 days post-treatment
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Skill demonstration rated by study staff for accuracy
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up to 4 days post-treatment
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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
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 (実際)
2018年4月16日
一次修了 (実際)
2021年4月26日
研究の完了 (実際)
2021年7月26日
試験登録日
最初に提出
2017年8月3日
QC基準を満たした最初の提出物
2017年9月27日
最初の投稿 (実際)
2017年10月3日
学習記録の更新
投稿された最後の更新 (実際)
2022年9月13日
QC基準を満たした最後の更新が送信されました
2022年9月8日
最終確認日
2022年9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。