Rural Veterans With Post-traumatic Stress Disorder (PTSD) And Comorbid Mild Traumatic Brain Injury (TBI): A Feasibility Study
Remote Administration Of Cognitive Training Tasks In Rural Veterans With PTSD And Comorbid Mild TBI: A Feasibility Study
調査の概要
詳細な説明
Many military personnel have experienced traumatic brain injury (TBI) and posttraumatic stress disorder (PTSD) as a result of the current Afghanistan and Iraq wars. TBI occurs when a sudden force causes the brain to move, causing damage to brain cells. PTSD is an anxiety disorder associated with serious traumatic events. Blast explosions can lead to TBI. People who experience TBI as a result of a blast injury are more likely to experience PTSD than people who have TBI not due to blast. TBI and PTSD may be associated with memory problems in some patients. Because therapy for PTSD sometimes requires learning new ways to think about things and making new responses, being able to remember the new information being learned is important. It is possible that improving memory may also improve PTSD treatment.
This is a prospective study of Operation Enduring Freedom and Operation Iraqi Freedom (Afghanistan and Iraq wars; OEF/OIF) veterans who will undergo two neuropsychological and psychiatric assessments prior and subsequent to a cognitive training intervention. This is a feasibility study to ascertain whether OEF/OIF veterans diagnosed with mild TBI and comorbid PTSD and who live in rural locations will adhere to the schedule demands required of a computer-based cognitive training protocol.
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
-
-
Texas
-
Houston、Texas、アメリカ、77030
- Michael E. DeBakey VA Medical Center
-
-
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:
- Rural residence
- Willingness to commit to the time requirements of the study
- Undergoing treatment for posttraumatic stress disorder (PTSD) as assessed by a clinician, diagnosed with mild traumatic brain injury (TBI)
- Native English speaker
- 20-40 years
- Normal or corrected to normal vision and hearing.
Exclusion Criteria:
- Substance dependence
- Major depression with suicidal ideation
- Psychotic disorder
- History of neurological disorder other than mild traumatic brain injury (TBI) due to blast from Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) (i.e., Afghanistan and Iraq wars) deployment
- History of known or suspected learning disorder.
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Cognitive training
Cognitive Intervention Tasks Participants will be asked to perform the Brain Fitness (PositScience) cognitive training tasks an hour each day, five days per week for 8-10 weeks.
Six tasks manipulating auditory and verbal information will be presented, and stimuli from all tasks are presented auditorily.
All tasks are designed to begin with the lowest level of difficulty required to attain 85% accuracy, and as performance improves, difficulty increases to maintain 85% accuracy, with difficulty decreasing if accuracy decreases.
|
Participants will be asked to perform the Brain Fitness (PositScience) cognitive training tasks an hour each day, five days per week for 8-10 weeks.
Six tasks manipulating auditory and verbal information will be presented, and stimuli from all tasks are presented auditorily.
All tasks are designed to begin with the lowest level of difficulty required to attain 85% accuracy, and as performance improves, difficulty increases to maintain 85% accuracy, with difficulty decreasing if accuracy decreases.
|
|
アクティブコンパレータ：Control
The control group will perform computerized tasks that utilize cognitive performance, but were not systematically developed to improve cognitive performance.
|
Participants will be asked to perform computerized tasks that involve auditory and verbal performance one hour each day, five days per week for 8-10 weeks.
Six tasks requiring auditory and verbal information will be presented.
|
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 |
|---|---|---|
|
Compliance rates
時間枠：Up to ten weeks
|
Compliance is defined as number of times per week and number of hours per day of task performance
|
Up to ten weeks
|
|
Qualitative assessment
時間枠：Up to ten weeks
|
Participants' reactions to the study will be gathered with Likert scale ratings of perceived problems of delivery, ease of program use, and perceived improvement of cognition.
Open-ended responses to structured questions on likes and dislikes, suggestions for improvement, and overall satisfaction will also be implemented.
|
Up to ten weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Improvement in performance over time
時間枠：Up to ten weeks
|
Performance at the beginning of the training session of each task will be compared to performance at the completion of the training session of each task.
|
Up to ten weeks
|
|
Relation of performance to mental health
時間枠：At ten weeks
|
Scores on pre- and post- mental health measures will also be related to task performance
|
At ten weeks
|
協力者と研究者
捜査官
- 主任研究者：Mary R Newsome, PhD、Michael E. DeBakey VA Medical Center
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。