Evaluation of a Visual Remediation Intervention for Schizophrenia
2018年3月28日 更新者:Judy L. Thompson, Ph.D.、Rutgers, The State University of New Jersey
Schizophrenia is a severe psychiatric condition that is associated with significant distress and disability.
In addition to cognitive difficulties in domains such as attention, memory, and problem-solving, individuals with schizophrenia can experience visual-processing abnormalities, including impairments in visual acuity, low-contrast stimulus detection, and perceptual organization (i.e., perceiving visual information in an organized "perceptual whole").
These visual impairments are clinically significant, with research indicating that specific visual-processing alterations are significantly related to poorer performance on higher-level cognitive tasks, impaired facial emotion recognition, impaired reading ability, and worse functional outcomes.
Despite such findings, very few studies have evaluated the therapeutic potential of interventions that are specifically designed to improve visual processing ("visual remediation") for individuals with schizophrenia.
Thus the aim of this study is to evaluate the efficacy of a computerized visual perceptual training program that targets low- and mid-level visual processes to improve visual, cognitive, and emotion-recognition functions in outpatients with schizophrenia through a small randomized controlled trial.
The investigators will recruit up to 40 individuals with schizophrenia or schizoaffective disorder who are receiving treatment in Rutgers University Behavioral Health Care (UBHC) Partial Hospital Program; half will be randomized to receive the computerized visual training, which will be delivered in small groups over a period of 12-14 weeks.
The specific aims of this study are to collect preliminary data on: 1) the feasibility of participant recruitment and retention, and tolerability of the treatment components of the study; and 2) the efficacy of computerized visual training (VT) to improve low- and mid-level visual processes, and higher-level cognitive and social-cognitive performance.
Based on preliminary data, the investigators hypothesize that the target number of participants will be successfully recruited and engaged in the VT intervention (n=16) and control condition (n=16), and that the participants who receive VT will demonstrate greater improvements on measures of low- and mid-level visual, higher-level cognitive, and social-cognitive functions compared to those who receive standard partial-hospital care without VT.
The results of this initial trial will be used to inform the design and application for funding of a larger-scale investigation of visual remediation for individuals with schizophrenia.
調査の概要
研究の種類
介入
入学 (予想される)
40
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
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New Jersey
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Piscataway、New Jersey、アメリカ、08854
- 募集
- Rutgers University Behavioral Health Care (UBHC)
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コンタクト:
- Judy L. Thompson, Ph.D.
- 電話番号:732-235-9297
- メール:judy.thompson@rutgers.edu
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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~60年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Between the ages of 18-60.
- Meets DSM-5 criteria for schizophrenia, schizoaffective disorder, or schizophreniform disorder.
- Currently attends the Rutgers UBHC Partial Hospital Program and plans to continue attending for at least the next 16 weeks.
- If the participant is treated with antipsychotic medication, he/she is on stable treatment with this medication (i.e. no change in medication type, or substantial change in dose, for at least 4 weeks prior to participating in the study and no anticipated change for the next 16 weeks).
- Has capacity to provide informed consent.
- Is fluent in English.
- Has a minimum binocular visual acuity of 20/100, as assessed at baseline using a standard eye chart, with the participant's typical vision correction (e.g., with glasses if the participant typically wears glasses).
Exclusion Criteria:
- Has met DSM-5 criteria for a substance-use disorder within the last 12 months (with the exception of tobacco use disorder, which will be permitted).
- Has a verbal IQ score of < 70 per the Wechsler Test of Adult Reading (WTAR).
- Current or recent history of a medical condition that significantly affects the structure or function of the brain or eye (e.g., ocular or retinal disease, thyroid disease, untreated hypertension, uncontrolled diabetes).
- Current or past neurological or neurodevelopmental disorder such as seizure disorder, cerebral palsy, intellectual disability, or pervasive developmental disorder.
- Has a "lazy eye" or history of severe eye injury.
- Has received electroconvulsive therapy within the last 8 weeks.
- Has a history of head injury with loss of consciousness lasting more than 10 minutes or with neurobehavioral consequences of the injury (e.g., need for follow-up treatment, cognitive or behavioral changes following the injury, etc.).
- Any current use (last month) of non-prescribed amphetamines, opiates, cocaine, sedative-hypnotics, and/or cannabis.
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 |
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実験的:visual training condition
Participants in the visual training condition will participate in the visual training (VT) group, during which they will complete computerized visual training that targets low- and mid-level visual processes.
Each group will include a maximum of 3 participants and will meet 3 times a week over a period of 12-14 weeks.
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The computerized visual training (VT) program that is being evaluated was developed by Aaron Seitz, who is a co-investigator on this project; it includes 1) ULTIMEYES, which targets broad-based visual functions, including low-level processes (e.g., visual acuity, contrast sensitivity), and 2) visual perceptual organization exercises, which target mid-level visual processes.
Both elements of the program also involve higher-level visual functions, such as visual search and visual attention.
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介入なし:control condition
Participants assigned to the control condition will receive standard Partial Hospital care without visual training.
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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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contrast sensitivity
時間枠:approximately 14 weeks (baseline and post-treatment)
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A measure of low-contrast stimulus detection; contrast sensitivity thresholds at varying spatial frequencies will be examined.
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approximately 14 weeks (baseline and post-treatment)
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contour integration
時間枠:approximately 14 weeks (baseline and post-treatment)
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A measure of visual perceptual organization; total number correct, adjusted for guessing, will be examined.
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approximately 14 weeks (baseline and post-treatment)
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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。
捜査官
- 主任研究者:Judy L. Thompson, Ph.D.、Rutgers University
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)
2017年2月23日
一次修了 (予想される)
2019年2月28日
研究の完了 (予想される)
2019年2月28日
試験登録日
最初に提出
2017年4月12日
QC基準を満たした最初の提出物
2017年4月17日
最初の投稿 (実際)
2017年4月18日
学習記録の更新
投稿された最後の更新 (実際)
2018年3月30日
QC基準を満たした最後の更新が送信されました
2018年3月28日
最終確認日
2018年3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
- Pro20160000350
- PC 51-16 (その他の助成金/資金番号:New Jersey Health Foundation)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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。
Visual Trainingの臨床試験
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Fondazione Policlinico Universitario Agostino Gemelli...まだ募集していません
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Second Sight Medical ProductsNational Institute of Neurological Disorders and Stroke (NINDS)積極的、募集していない
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University of MinnesotaNational Institute of Mental Health (NIMH)完了精神病性障害 | 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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VA Office of Research and Development募集
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University of WashingtonNational Institute on Aging (NIA); Kaiser Permanente完了