Cognitive Training for Mood and Anxiety Disorders
2017年7月19日 更新者:Icahn School of Medicine at Mount Sinai
The purpose of this study is to investigate the effects of a computerized cognitive training program (an attention and memory exercise performed on a computer) on thinking and memory in individuals with mood and anxiety disorders, and to begin to test whether this training affects symptoms of depression or anxiety.
調査の概要
状態
完了
詳細な説明
The objective of this research protocol is to collect feasibility and pilot data investigating the efficacy of a computerized cognitive training paradigm.
The training paradigm aims to enhance cognitive control for emotional information-processing and reduce the negative affective biases observed among those experiencing mood and anxiety symptoms and disorders.
This protocol will also investigate whether improvements in cognitive control and affective bias are associated with changes in mood and anxiety symptoms.
Participants will undergo 6 weeks of cognitive training sessions, with three sessions per week.
研究の種類
介入
入学 (実際)
28
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
-
-
New York
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New York、New York、アメリカ、10029
- Icahn School of Medicine at Mount Sinai
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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~80年 (大人、高齢者)
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:
- Primary, current Axis I diagnosis of a mood disorder (e.g., major depressive disorder (MDD); bipolar disorder, currently depressed) or anxiety disorder (PTSD; Generalized Anxiety Disorder (GAD); Social Phobia) according to DSM-IV criteria and SCID-IV diagnosis OR must be free of any psychiatric condition (for the healthy volunteer group)
- Age 18-80
- Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process
Exclusion Criteria:
- A history of drug or alcohol abuse or dependence (DSM-IV criteria) within the previous 6 months
- Visual impairment that would affect the ability to observe the computerized exercises
- Motor impairment that would affect the ability to provide a response by quickly pressing a button
- Patients with mood congruent or mood incongruent psychotic features
- Primary, current Axis I diagnosis other than MDD, Bipolar Disorder (currently depressed), PTSD, GAD or Social Phobia
- The presence of axis II personality disorder psychopathology that, in the opinion of the investigator, will interfere with study participation
- Acute suicidal or homicidal risk (evidenced by suicidal or homicidal attempt within 6 months of screening)
- Pregnancy in women. Pregnant women are excluded from the study because research has shown that hormonal changes that occur during pregnancy can mimic and/or influence symptoms of depression. Including patterns of mood and cognition. These mood and cognitive changes could mask the effect of the cognitive training in this study, so pregnant women will be excluded for that reason. A urine pregnancy test will be administered at screening
- Enrolled participants can be currently taking standard antidepressant or mood stabilizer medication regimens, or benzodiazepine treatment for sleep as needed but not exceeding 3 nights per week. Medication regimens must be stable at the time of study enrollment (i.e., no medication has been started within 8 weeks, stopped within 6 weeks or titrated up or down within 4 weeks of study entry). No medications will be started or discontinued for the purpose of enrollment into the study
- Subjects must exhibit no or only moderate alcohol use during study participation. Subjects with current excessive use of alcohol (> 8 ounces/day) or participants abusing substances will be ineligible for participation, as such drug use could confound the results. A urine toxicology test will be administered at screening to test for drugs of abuse
- Participants exhibiting depression symptoms in the severe range (Ham-D > 27) will be excluded from participation as an investigational study such as this may not be suitable
- Participants exhibiting chronic MDD episodes (defined as a current episode lasting 5+ years) will be excluded from participation as an investigational study such as this may not be suitable
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:トリプル
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:emotional memory training exercise
study training exercise - Emotional Faces Memory Task (EFMT)
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|
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アクティブコンパレータ:memory training exercise
an active control exercise (CT)
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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 |
|---|---|---|
|
Proportion of completers to measure feasibility
時間枠:week 6
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comparing the proportion of completers (15-18 sessions) between the in-person participants and the participants completing the exercise on their own computers
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week 6
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Depression Symptom Severity
時間枠:baseline and week 6
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Depression symptom severity comparison at week 6 to baseline as measured by the Hamilton Depression Rating Scale (Ham-D) and Quick Inventory of Depressive Symptoms (QIDS-C)
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baseline and week 6
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Change in Anxiety Symptom Severity
時間枠:baseline and week 6
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Anxiety symptom severity comparison at week 6 to baseline as measured by the Hamilton Anxiety Rating Scale (Ham-A) and Treatment Outcome PTSD Scale (TOP-8)
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baseline and week 6
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Change in Negative Affective Bias
時間枠:baseline and week 6
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Negative affective bias comparison at week 6 to baseline as measured by the Self-referential Information Processing Task, Affective Go/No-Go, Emotional Stroop, Emotion Faces Recognition Task, Cognitive Style Questionnaire, Ruminative Responses Scale, and Attention Bias Variability Task
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baseline and week 6
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Change in Neurocognition
時間枠:baseline and week 6
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neurocognition comparison at week 6 to baseline using Digit Span, Letter-Number Sequencing, Hopkins Verbal Learning Test, and Intra-Extra Dimensional Set-Shifting
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baseline and week 6
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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:Brian Iacoviello, PhD、Icahn School of Medicine at Mount Sinai
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
2014年9月1日
一次修了 (実際)
2016年4月20日
研究の完了 (実際)
2016年4月20日
試験登録日
最初に提出
2014年10月1日
QC基準を満たした最初の提出物
2014年10月2日
最初の投稿 (見積もり)
2014年10月3日
学習記録の更新
投稿された最後の更新 (実際)
2017年7月21日
QC基準を満たした最後の更新が送信されました
2017年7月19日
最終確認日
2017年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- GCO 14-0994
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