Cognitive Rehabilitation:ACTION Training for Soldiers With Executive Dysfunction (ACTION)
調査の概要
詳細な説明
The primary aims of this feasibility study are as follows:
Aim 1: Finalize ACTION training curriculum; develop manuals; field test .
- Work with implementation intentions research expert and a military consultant to develop a training task gradation schema which informs the identification and modification of existing implementation intentions training tasks so that they have military face validity.
- Finalize the adherence support methods and other training worksheets and materials.
- Field test training tasks and adherence support methods on small cohort of civilians with mTBI-sc from CKRC to assure feasibility.
- Finalize ACTION sequence training manuals; assure intra-rater and inter-rater reliability for scoring quality of implementation intentions statements.
Aim 2: Evaluate ACTION sequence training instructional methods (the extent to which SM with mTBI-sc are able to learn to establish IF-THEN statements that have the potential to trigger automatic enactment of goal-actions and the extent to which SM with mTBI-sc report the training experience as satisfactory and beneficial).
- Enroll up to 28 participants in the study (SM with mTBI-sc who are referred to MSI at TBIC-FC).
- Evaluate whether or not participants can correctly craft implementation intentions by using a rubric to score implementation intentions developed by participants during clinic sessions and during home practice; administer participation satisfaction survey at posttest.
Aim 3: Test the efficacy of ACTION sequence training by evaluating the extent to which training 1) improves SM's with mTBI-sc ability to perform a complex test of executive function (e.g. Hotel Test) and 2) advances progress towards self-identified goals in daily life (via Canadian Occupational Performance measure [COPM] and Goal Attainment Scaling [GAS]) as compared to a control condition. Additionally, determine level of adherence to completing daily homework practice ans assigned prospective memory tasks.
- Collect pre-post data on the Hotel Test, COPM, GAS on all participants.
- Collect data on completion of homework assignments
- Collect data on completion of prospective memory tasks
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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Kentucky
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Fort Campbell North、Kentucky、アメリカ、42223
- Fort Campbell Intrepid Spirit
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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:The sample population at the Traumatic Brain Injury Clinic- Fort Campbell (TBIC-FC) will consist of active duty army soldiers, reservists, national guardsmen, airmen, and retirees; the majority of the sample population will be active duty army soldiers. Study volunteers will be recruited from among service members assessed in the TBIC-FC and referred to the Cognitive Clinic for performance problems secondary to reported / suspected combat-related mTBI-sc.
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Exclusion Criteria:Not willing to sign consent to participate.
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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:Implementation Intentions
This group will receive training in Implementation Intentions during 3 sessions, 1 day/week, over 3 weeks.
They will receive usual care through the standard program, 1 day/week during these 3 weeks.
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Implementation Intention training will include: Demonstration and practice using examples and personal goals identified at first session. Worksheets will be provided to practice IF-THEN statements to set Implementation Intentions. Additionally, at the end of each session, the participant will be instructed to perform and event based or time based task. The objective is to see if those receiving II training are more likely to carry out the assigned task than those who do not receive II training. They will also be expected to practice II at least 5 days/week using personal goals. |
介入なし:Usual Care
This group will participate in the usual group intervention provided to Service members experiencing executive dysfunction associated with mild traumatic brain injury, 2 days / week during 3 weeks.
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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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Change in performance of the Hotel Task
時間枠:Baseline and end of 3 weeks
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The Hotel Task requires the participant to perform a set of 6 tasks in 10 minutes with the instruction to perform all tasks with no expectation for completing any of the tasks.
This task tests the ability of the participant to shift.
Measurements associated with this task include time spent on each task and number of tasks completed.
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Baseline and end of 3 weeks
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Change in the Canadian Occupational Performance Measure
時間枠:Baseline and end of 3 weeks
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Participants will provide their self-perceived performance on three everyday tasks identified and prioritized as problematic.
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Baseline and end of 3 weeks
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Change in Goal Attainment Scaling
時間枠:Baseline and end of 3 weeks
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Attainment of five goals linked to selected five everyday tasks
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Baseline and end of 3 weeks
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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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Performance of assigned tasks given at the end of each of the 6 II sessions
時間枠:End of sessions 1 and 2 for each of weeks 1, 2, and 3
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Monitoring performance of the assigned event or time based task, Yes(2 points)/No(0 points)/Partial(1 point)
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End of sessions 1 and 2 for each of weeks 1, 2, and 3
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Performance of homework
時間枠:4 days / week for each of the 3 weeks of study participation
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Participant will be expected to call in and report having done assignment
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4 days / week for each of the 3 weeks of study participation
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Mary Radomski, OTR/L, PhD、Allina Health
- 主任研究者:Mark Showers, MS, OTR/L、Fort Campbell
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 (実際)
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。
Implementation Intentions(II)の臨床試験
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Sun Pharmaceutical Industries LimitedMoebius Medical Ltd.; Nordic Bioscience Clinical Development (NBCD)完了
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St. Olavs HospitalSmith & Nephew, Inc.まだ募集していません
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Psychiatric Centre RigshospitaletUniversity of Copenhagen; IT University of Copenhagen完了
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Training and Implementation Associates募集従来の対面トレーニング | 家族療法のトレーニングと実装プラットフォーム (FTTIP)アメリカ
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Smith & Nephew, Inc.引きこもった関節形成術 | 膝 | 置換シンガポール, 中国, インド
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The University of Tennessee, Knoxville完了変形性膝関節症 | 人工膝関節全置換術 | 膝アメリカ