Feasibility of Providing Cognitive Remediation to People With Schizophrenia in a Clinical Network
Cognitive Remediation in the Schizophrenia Trials Network
調査の概要
状態
条件
詳細な説明
Neurocognitive impairments, or problems with thinking and brain function, are a core component of schizophrenia. Such impairments, which can range from moderate to severe, are strongly associated with decreased benefit from psychiatric rehabilitation and problems with treatment adherence, socialization, employment, quality of life, and relapse. Researchers believe that the failure of medication to improve cognition may occur because medication treatment lacks cognitive stimulation. Cognitive remediation programs are a way to provide that stimulation, and they have shown moderate efficacy in improving cognition in people with schizophrenia. Implementing these cognitive remediation programs as part of schizophrenia treatment has occurred only at individual sites with highly trained research personnel. This study will test whether cognitive remediation programs for schizophrenia can be feasibly implemented at a network of sites that do not specialize in cognitive remediation research. This pilot study will gather preliminary efficacy data, but a larger study is required to draw definitive conclusions about treatment effects.
Participation in this study will last approximately 8 weeks. Participants will be randomly assigned to the Posit Science intervention group or the control group. Those in the Posit Science group will receive targeted cognitive training (TCT)-40 hours of adaptive computer exercises-and participate in a weekly bridging group that helps participants apply cognitive skills to everyday contexts. Length of the TCT may vary, depending on the availability of participants to complete the exercises. Those in the control group will play commercially available video games for the same number of hours and participate in a weekly health and wellness group. All participants will undergo assessments at baseline, mid-treatment, and post-treatment. Assessments will include self-report questionnaires and clinical interviews.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Connecticut
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New Haven、Connecticut、アメリカ、06519
- Yale University/Connecticut Mental Health Center
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Georgia
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Atlanta、Georgia、アメリカ、30329
- Emory University
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Augusta、Georgia、アメリカ、30912
- Medical College of Georgia
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Iowa
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Iowa City、Iowa、アメリカ、52242
- University of Iowa Hospital
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Massachusetts
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Worcester、Massachusetts、アメリカ、01605
- University of Massachusetts
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Minnesota
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Minneapolis、Minnesota、アメリカ、55454
- University of Minnesota School of Medicine
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599-7160
- The University of North Carolina
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Philadelphia VA Medical Center-116A
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Texas
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San Antonio、Texas、アメリカ、78229
- University of Texas Health Science Center at San Antonio
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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:
- Demonstrates adequate decisional capacity to make a choice about participating in the research study
- Diagnosis of schizophrenia or schizoaffective disorder, as defined by DSM-IV-TR criteria and confirmed by the Structured Clinical Interview for DSM-IV (SCID)
- Positive and Negative Syndrome Scale (PANSS) hallucinatory behavior, unusual thought content, and conceptual disorganization ratings of no greater than moderately severe (i.e., item scores must be less than or equal to 5)
Meets all of the following cognitive performance and English language criteria:
- Learned English before age 12
- Able to complete the baseline Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) validly, based on the judgment of the investigator
- Raw score of 37 or greater on the Wide Range Achievement Test, reading subtest, 3rd edition (WRAT-3), used to establish minimum sixth grade reading level and estimated premorbid IQ
- Able to state specific goals relevant to the intervention that participant would like to achieve
- Able to participate in the computerized intervention, based on the judgment of the investigator
Exclusion Criteria:
- Psychiatric hospitalization within 8 weeks of random assignment
- Adjustment to antipsychotic treatment within 4 weeks of random assignment
- Currently taking an anticholinergic medication
- DSM-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months
- History of mental retardation, pervasive developmental disorder, or other neurological disorder (such as a traumatic brain injury, epilepsy, or Parkinson 's disease)
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：ダブル
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：Posit Science Intervention
Participants will receive targeted cognitive training and participate in a bridging group.
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Adaptive computer exercises that systematically increase in task difficulty as each participant's performance ability improves
Weekly group meetings that help participants apply their cognitive skills to everyday functioning, promote group identity, and promote socialization
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アクティブコンパレータ：Control
Participants will play commercially available computer games and participate in weekly groups to discuss health and wellness.
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Commercially available computer games selected based on quality, ability to hold interest, and lack of disturbing content
Weekly group meetings that teach participants health and wellness skills
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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 |
時間枠 |
|---|---|
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Feasibility of a multisite trial using cognitive remediation
時間枠：Measured at post-treatment
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Measured at post-treatment
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Effect of cognitive remediation on functional outcomes, including change from baseline on UCSD Performance Based Skills Assessment (UPSA) total score, Specific Levels of Functioning (SLOF) total score, and Cognitive Assessment Interview (CAI) total score
時間枠：Measured at post-treatment
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Measured at post-treatment
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協力者と研究者
捜査官
- 主任研究者：Richard Keefe, PhD、Duke University
出版物と役立つリンク
一般刊行物
- Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
- Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.
- Keefe RS, Vinogradov S, Medalia A, Buckley PF, Caroff SN, D'Souza DC, Harvey PD, Graham KA, Hamer RM, Marder SM, Miller DD, Olson SJ, Patel JK, Velligan D, Walker TM, Haim AJ, Stroup TS. Feasibility and pilot efficacy results from the multisite Cognitive Remediation in the Schizophrenia Trials Network (CRSTN) randomized controlled trial. J Clin Psychiatry. 2012 Jul;73(7):1016-22. doi: 10.4088/JCP.11m07100. Epub 2012 May 15.
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 (見積もり)
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
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
- N01 MH090001-07
- N01-MH090001-07
- PCC: DSIR AT
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。
Targeted cognitive trainingの臨床試験
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University of MinnesotaNational Institute of Mental Health (NIMH)募集精神病性障害 | 統合失調症 | 統合失調症スペクトラムおよびその他の精神病性障害 | 統合失調感情障害 | 精神病 | 統合失調感情障害 | 統合失調症性障害 | 精神病、感情的 | 精神性気分障害 | 精神病患者番号/その他アメリカ
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Douglas Mental Health University Institute募集
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Endourage, LLC募集長い COVID | ロング Covid19 | ポスト急性COVID-19 | 長距離COVID | 長距離COVID-19 | ポスト急性COVID-19症候群アメリカ
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VA Office of Research and Development募集
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University of WashingtonNational Institute on Aging (NIA); Kaiser Permanente完了