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Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode (CT&E)

2017年12月5日 更新者：Keith Nuechterlein, Ph.D.、University of California, Los Angeles
This is a randomized controlled 6-month trial of the efficacy of a novel intervention combining neuroplasticity-based cognitive training with aerobic exercise, compared to the same systematic cognitive training alone. The primary treatment targets are overall cognitive deficit level and independent living skills. The investigators hypothesize that combining neuroplasticity-based computerized cognitive training and neurotrophin-enhancing physical exercise will produce large cognitive and functional improvements, even relative to cognitive training alone. Adding aerobic exercise to a cognitive training program will have the additional benefit of helping to ameliorate medication side effects, reduce the risk for developing metabolic syndrome, and help to prevent the deterioration in physical health that usually follows the onset of schizophrenia and its pharmacologic treatment. The investigators target the period shortly after a first episode of schizophrenia to maximize the generalization of cognitive improvement to functional outcome, before chronic disability is established.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

The Cognitive Training and Exercise intervention involves 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The second 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. Aerobic exercise occurs as two 30-minute sessions at the clinic and two at home weekly. Intensity of aerobic exercise is tailored to maintain an individualized target heart rate zone and is monitored by a heart rate recorder. A weekly one-hour Bridging Skills Group with other members of the treatment condition is designed to aid generalization of training to everyday life situations.

研究の種類

介入

入学 (実際)

48

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • California
      • Los Angeles、California、アメリカ、90095-6968
        • University of California, Los Angeles

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～45年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. a first episode of a psychotic illness that began within the past two years;
  2. a diagnosis by Diagnostic and Statistical Manual of Mental Disorders of schizophrenia, schizoaffective disorder, mainly depressed type, or schizophreniform disorder;
  3. between 18 and 45 years of age;
  4. sufficient acculturation and fluency in the English language to avoid invalidating research measures of thought, language, and speech disorder or of verbal cognitive abilities; and
  5. residence within commuting distance of the Aftercare Research Program at the University of California, Los Angeles.

Exclusion Criteria:

  1. evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
  2. evidence of alcohol or substance use disorder within the six months prior to the first episode and evidence that substance abuse triggered the psychotic episode or makes the schizophrenia diagnosis ambiguous;
  3. mental retardation, i.e. premorbid intelligence quotient less than 70.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：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 and Exercise
24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The 2nd 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. Aerobic exercise occurs as two 30-minute sessions at the clinic and two at home weekly. Intensity of aerobic exercise is tailored to maintain an individualized target heart rate zone and is monitored by a heart rate recorder. A weekly one-hour Bridging Skills Group is designed to aid generalization of training to everyday life situations. All members receive individual case management and supportive psychotherapy, and family psychoeducation.
行動：ケース管理と支持的心理療法
個々のセラピストは、患者の個々の心理的問題と日常の機能的ニーズを対象とした毎週のケース管理と治療を提供します
行動：Family psychoeducation
All immediate family members will be invited to family psychoeducation sessions.
行動：Cognitive training
The Cognitive Training and Exercise intervention involves 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The second 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. A weekly one-hour Bridging Skills Group with other members of the treatment condition is designed to aid generalization of training to everyday life situations.
他の名前：
  • 認知修復
行動：Aerobic exercise
Aerobic exercise occurs as two 30-minute sessions at the clinic and two at home weekly. Intensity of aerobic exercise is tailored to maintain an individualized target heart rate zone and is monitored by a heart rate recorder.
他の名前：
  • 体操
アクティブコンパレータ：Cognitive Training
24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The 2nd 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. A weekly one-hour Bridging Skills Group is designed to aid generalization of training to everyday life situations. All members receive individual case management and supportive psychotherapy, and family psychoeducation.
行動：ケース管理と支持的心理療法
個々のセラピストは、患者の個々の心理的問題と日常の機能的ニーズを対象とした毎週のケース管理と治療を提供します
行動：Family psychoeducation
All immediate family members will be invited to family psychoeducation sessions.
行動：Cognitive training
The Cognitive Training and Exercise intervention involves 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The second 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. A weekly one-hour Bridging Skills Group with other members of the treatment condition is designed to aid generalization of training to everyday life situations.
他の名前：
  • 認知修復

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
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
時間枠：6 months
The overall composite score from the MCCB is a summary of cognitive performance across seven domains.
6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Brain-derived neurotrophic factor (BDNF)
時間枠：6 months
BDNF is a principal growth factor known to mediate the effects of exercise in the brain.
6 months
Cardiorespiratory fitness
時間枠：6 months
Cardiorespiratory fitness, a secondary physical health outcome variable, will be measured using a ramped version of the traditional Bruce treadmill protocol.
6 months
University of California, San Diego (UCSD) Performance-Based Skills Assessment (UPSA)
時間枠：6 months
The UCSD Performance-Based Skills Assessment (UPSA)assesses five all-purpose skills that are important for functioning in the community: general organization, finance, social/communications, transportation, and household chores.
6 months
Facial Emotion Identification Test
時間枠：6 months
The Facial Emotion Identification Test involves choice of emotions in facial expressions of 6 different emotions (happy, sad, angry, afraid, surprised, disgusted) plus neutral expressions.
6 months
Prosody Task
時間枠：6 months
The Prosody Task involves identifying emotions in audio recordings of male and female actors portraying 5 emotions.
6 months
Global Functioning Scale
時間枠：6 months
A 10-point rating scale to evaluate role and social functioning
6 months
Modified Social Adjustment Scale - Work Outcome
時間枠：6 months
A measure of the quantity and type of work at a job, school, or in the home
6 months
Independent Living Skills Survey
時間枠：6 months
The Independent Living Skills Survey is a 76-item measure based on patient interview, which provides a more detailed assessment of 11 daily living skill domains
6 months
Quality of Life Scale
時間枠：6 months
The Quality of Life scale135, a 53-item interview-based inventory, assesses a patient's subjective satisfaction in several key domains
6 months
Role Functioning Scale: Work Productivity, Social Relationships, Family Relationships
時間枠：6 months
The Role Functioning Scale is a global clinician-rated measure of everyday functioning in several domains.
6 months
Independent Living rating from Role Functioning Scale
時間枠：6 months
The Independent Living rating assesses daily living skills and extent of living independently based on a clinician interview.
6 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of California, Los Angeles

協力者

National Institute of Mental Health (NIMH)

捜査官

  • 主任研究者：Keith H Nuechterlein, Ph.D.、University of California, Los Angeles

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2013年11月1日

一次修了 (実際)

2016年11月1日

研究の完了 (実際)

2017年7月1日

試験登録日

最初に提出

2013年11月19日

QC基準を満たした最初の提出物

2014年10月16日

最初の投稿 (見積もり)

2014年10月17日

学習記録の更新

投稿された最後の更新 (実際)

2017年12月7日

QC基準を満たした最後の更新が送信されました

2017年12月5日

最終確認日

2017年12月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 1R34MH102529-01 (米国 NIH グラント/契約)
  • R34MH102529 (米国 NIH グラント/契約)

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。

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