Emotional Awareness Therapy Study (TREAT)
A Feasibility Study Exploring Emotional Health Training After Moderate to Severe Traumatic Brain Injury
The purpose of this study is to learn about the potential benefits of two different training programs in helping improve emotional health and well-being in people who have had a traumatic brain injury.
Participants will be assigned to one of two programs based on the time since their injury. One of the programs will teach participants how to recognize and label emotions; the other will teach healthy ways of living. Participants may improve their emotional well-being and contribute to the knowledge needed to achieve better emotional health outcomes for people with TBI.
For eligible participants, the study includes 4 assessments. Assessments may take 30-60 minutes and will be done using secure videoconferencing, phone calls, and/or electronic surveys. The first assessment will ask questions about demographics, the participant's brain injury, and some medical history. All assessments will include questions about emotions, emotional awareness, resilience, loneliness, and how participants manage emotions, in addition to broader wellness questions and questions about how participants interact with others.
Regardless of the program, the training includes 8 one-on-one sessions with a trained staff member over the course of about 1 month. Each session will last approximately 60-90 minutes. These sessions will start shortly after completing the first assessment. Preferably, participants will complete 1-2 training sessions a week, depending on availability and preference. These sessions will include education, discussion, and practice exercises.
After the program is finished, participants will be asked to complete the same surveys completed at baseline for three follow-up time points (immediately following the program, 3 months after the program, and 6 months after). Total participation in the study will last approximately 8 months.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Grace Wells, BS
- 電話番号：68682 732-321-7000
- メール：grace.wells1@hmhn.org
研究場所
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New Jersey
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Edison、New Jersey、アメリカ、08820
- 募集
- Hackensack Meridian Health - JFK Johnson Rehabilitation Institute
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主任研究者：
- Dawn Neumann, PhD, FACRM
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コンタクト：
- Grace Wells, BS
- 電話番号：68682 732-321-7000
- メール：grace.wells1@hmhn.org
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コンタクト：
- Sarah Enock, BS
- 電話番号：848-893-6577
- メール：tbiresearchjfkjri@hmhn.org
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Moderate or Severe TBI
- ≥18 years old
- ≥6 months post-TBI
- Speaks and understands English
- Medications that can influence mood should be stable (6+ weeks)
- Elevated alexithymia
- Demonstrate an understanding of the study and their rights (e.g. ability to answer the following questions correctly after a review of the study details during pre-screening process)
Exclusion Criteria:
- Premorbid neurological disorder other than TBI
- Degenerative neurologic condition
- Active or uncontrolled major psychiatric disorder
- Conditions that pose safety concern to self or others, such as suicide risk
- Visual, hearing, communication, or cognitive impairments that would impede participation
- Active involvement in an intensive rehabilitation program
- Individuals who recently started psychotherapy and/or mental health counseling
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：非ランダム化
- 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：TREAT-A
Eight lessons delivered by a trained team member (interventionist) to the participant over ~4 weeks.
It involves psycho-educational lessons and skill-building exercises to achieve the following objectives based on the characteristics of alexithymia.: 1) learn benefits of emotional awareness; 2) improve threshold for earlier detection of emotional responses; 3) label and differentiate emotions; 4) experience range of emotions; and 5) distinguish emotions from thoughts, actions and sensations.
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The TREAT-A program will teach participants how to recognize, label, and differentiate their emotions.
The program will cover ways to reduce feeling "confused" or numb, and decrease the feelings of anger, stress and being overwhelmed.
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アクティブコンパレータ：TREAT-B
Provides education on TBI and overall brain health through instructional sessions, discussion, and structured tasks geared towards living healthy and improving general well-being.
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The TREAT-B program will teach participants strategies to improve their overall brain health and functioning.
It will also teach participants how to develop and work towards individualized short-term and long-term goals aimed at improving their quality of life.
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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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Ineligibility and Attrition Rates
時間枠：Through study completion, an average of 8 months
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Data will be tracked on the number of individuals who were ineligible (and reasons for ineligibility) as well as withdrawals (reasons for withdrawal) and /or number of participants who become "lost" (no longer able to contact).
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Through study completion, an average of 8 months
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Satisfaction Survey and Interview
時間枠：immediate post-treatment
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Range: Min/ Max = 1 to 5 Lower scores are worse; higher scores are more satisfied
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immediate post-treatment
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Interventionist Evaluation of Session Participation
時間枠：intervention training sessions 1-8 (approximately 8 months)
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Range: Min/Max = 6 to 24 Internal assessment completed by the interventionist at the end of each training session.
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intervention training sessions 1-8 (approximately 8 months)
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Patient Global Impression of Change (PGIC) emotional functioning and quality of life
時間枠：immediate post-treatment
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Range: Min/ Max = 1 to 7 Lower scores are worse; higher scores are better.
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immediate post-treatment
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Care-partner Global Impression of Change (CGIC) emotional functioning and quality of life
時間枠：immediate post-treatment
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Range: Min/ Max = 1 to 7 Lower scores are worse; higher scores are better.
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immediate post-treatment
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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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Toronto Alexithymia Scale-20
時間枠：1) baseline 2) immediate post-treatment, 3) 3 months post-treatment; 4) 6- months post-treatment.
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Range: Min/ Max = 20 to 100 Lower scores indicate less alexithymia (good); higher scores indicate greater alexithymia (bad)
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1) baseline 2) immediate post-treatment, 3) 3 months post-treatment; 4) 6- months post-treatment.
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Difficulty with Emotion Regulation Scale (DERS; Co-Primary outcome)
時間枠：1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
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Range: Min/ Max = 36 to 180 Lower scores indicate less dysregulation (good); higher scores indicate more dysregulation (bad)
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1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
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Brief Resilience Scale
時間枠：1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
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Range: Min/ Max = 6 to 30 Lower scores indicate worse resilience; higher scores indicate better resilience
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1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months
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協力者と研究者
捜査官
- 主任研究者：Dawn Neumann, PhD, FACRM、Hackensack Meridian Health
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
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