Treating Emotional Processing Impairments in Individuals With TBI
Treating Emotional Processing Impairments in Individuals With TBI: A Randomized Controlled Trial
調査の概要
詳細な説明
Emotional processing deficits have a significant negative impact on the lives of persons with TBI. There is emerging research indicating that, in addition to cognitive and behavioral impairments, social and emotional difficulties following TBI are common and are related to significant problems in social relationships, poor social participation, impaired empathy, and a high degree of caregiver stress. Emotional processing is a critical component of social cognition, including the abilities to both identify and discriminate basic universal emotions. The stability of emotional processing deficits following TBI indicates that these impairments likely impact individuals with TBI consistently across the lifespan, and do not appear to resolve with time.
The goals of the trial are to (a) Evaluate the effectiveness of an emotional processing intervention to improve performance on tests of emotional processing in individuals with TBI, (b) Evaluate the improvement of secondary outcomes of psychological, cognitive, and functional abilities following the emotional processing intervention in individuals with TBI, (c) To examine differences in brain activation patterns during emotional processing following treatment in individuals with TBI, BOLD activation in the experimental group will be compared to BOLD patterns of the control group during performance of the QFDT, a facial affect recognition task.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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New Jersey
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East Hanover、New Jersey、アメリカ、07936
- 募集
- Kessler Foundation
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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:
- diagnosis of Traumatic Brain Injury (TBI)
- can read and speak English fluently
Exclusion Criteria:
- prior stroke or neurological disease.
- history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder
- significant alcohol or drug abuse history
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：トリプル
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：Experimental Group
Participants in the experimental group will receive emotional processing training exercises administered on a laptop computer.
They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).
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Participants in the experimental group will receive computerized exercises administered on a laptop computer.
They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).
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プラセボコンパレーター：Control Group
Participants in the control group will meet with the examiner the same frequency and for the same duration as those in the experimental group. They will receive placebo control exercises administered on a laptop computer. . |
Participants in the control group will receive computerized control exercises administered on a laptop computer.
They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 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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Facial Expression Identification Task (FEIT)
時間枠：Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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The FEIT assesses one's ability to correctly identify and discriminate emotions from faces.
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Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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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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Emotion Regulation Questionnaire (ERQ)
時間枠：Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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The ERQ is a self-report measure of the use of 2 emotional regulation strategies: cognitive reappraisal and expressive suppression.
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Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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Satisfaction with Life Scale (SWLS)
時間枠：Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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The SWLS is a self-report measure of quality of life.
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Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Helen Genova, PhD、Kessler Foundation
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
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。