- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01979263
Attention Bias Modification Treatment for Anxious Youth (ABMT)
연구 개요
상태
상세 설명
The purpose of this study is to determine whether or not ABMT computer-based interventions can be used successfully to help reduce anxiety disorder symptoms in children ages 7 to 17. ABMT is different from most other treatments for anxiety because it is not medication or talk therapy. ABMT is a computerized attention training program designed to change how we direct our attention. The purpose of ABMT is to set in place attentional patterns that do not lead to excessive anxiety. Research has shown that it may be highly effective in reducing anxiety. The Intervention will be composed of your child engaging in 6 brief weekly ABMT sessions. The sessions seem like a repetitive computer game.
This study is appropriate for children who may have symptoms of an anxiety disorder, like Generalized Anxiety Disorder, Separation anxiety Disorder, Social Anxiety Disorder, Specific Phobia, or Obsessive-Compulsive Disorder." Children who appear eligible for the study may attend a diagnostic evaluation and assessment if they meet study criteria.
If a child is eligible for the study, he or she will be randomly assigned to either get an "active" form of the computer program or a "placebo" or inactive form of the computer program. The child will come to six weekly appointments at our clinic that are quite brief, about a half hour. Then the child will have an evaluation after the last of the six appointments to see if the computer intervention was helpful in reducing his or her anxiety. We'd then wait a month and then have a final evaluation to see if the child's anxiety has changed over that period of time.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10065
- Payne Whitney Manhattan Child Division
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White Plains, New York, 미국, 10605
- New York Presbyterian Hospital--Westchester Division
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosis on Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual-IV Child and Parent versions of Separation Anxiety Disorder, Social Phobia, Specific Phobia, Obsessive-Compulsive Disorder, or Generalized Anxiety Disorder
- Age 7 to 17
Exclusion Criteria:
- Posttraumatic stress disorder or primary diagnosis of major depressive disorder
- Seizure disorder
- Current treatment with psychotropic medication
- Multiple chronic learning disabilities and/or conduct problems
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Attention Bias Modification
Attention Bias Modification computer task
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Computer task aimed at actively modifying attention bias
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위약 비교기: Placebo Computer Task
Placebo computer task
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Computer task that does not actively modify attention bias
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change in clinical severity ratings on Anxiety Disorder Interview Schedule-Child and Parent Version
기간: after a 6-week intervention and 4-week no-treatment follow-up
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after a 6-week intervention and 4-week no-treatment follow-up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Variation in genes associated with treatment response
기간: week 1
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We will study allelic variation in a gene that has been associated with treatment response to anxiety interventions, the serotonin-transporter-linked promoter region (5-HTTLPR)
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week 1
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공동 작업자 및 조사자
수사관
- 수석 연구원: Megan H Feltenberger, PhD, Weill Medical College of Cornell University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Attention Bias Modification Computer Task에 대한 임상 시험
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Dokuz Eylul UniversityThe Scientific and Technological Research Council of Turkey완전한