Remediation of Emotional Processing Deficits in MS
Remediation of Emotional Processing Deficits in MS: A Randomized Clinical Trial
調査の概要
詳細な説明
This study will test the effectiveness of an emotional processing intervention in individuals with MS in a double blind placebo controlled randomized clinical trial RCT). We will utilize an intervention which has been successfully used in other populations, including Schizophrenia and Traumatic Brain Injury. Our pilot data shows that this intervention is effective in individuals with MS, as well.
All participants will undergo a baseline evaluation assessing emotional processing abilities, cognitive functioning, and psychological functioning. Participants will then be randomized into two groups. During the treatment phase, the experimental group will receive the proposed intervention while the control group will receive a "placebo" treatment. Neuropsychological assessment will be repeated at the end of the intervention.
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
-
-
New Jersey
-
East Hanover、New Jersey、アメリカ、07936
- Kessler Foundation
-
-
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:
- between the ages of 18-65.
- diagnosis of Relapsing-Remitting Multiple Sclerosis.
- can read and speak English fluently.
Exclusion Criteria:
- history of prior stroke or other neurological disease or injury.
- 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 |
|---|---|
|
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).
|
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).
|
|
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).
|
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 |
|---|---|---|
|
Emotional Processing
時間枠：Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
|
Change in scores on computerized tests of emotional processing
|
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Emotional Function
時間枠：Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
|
Change in scores on self-report of emotional functioning, measured via questionnaire
|
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
|
|
Self report of Quality of Life
時間枠：Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
|
Change in scores on self-report of quality of life, measured via questionnaire
|
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Helen Genova, PhD、Research Scientist
研究記録日
主要日程の研究
研究開始 (実際)
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 (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。