- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01903707
Cognitive Remediation in Schizophrenia
Cognitive Remediation in Schizophrenia: Effects on Brain Structure, Brain Function and Social Outcome.
The aim of this project is to undertake a randomized placebo controlled trial of cognitive remediation therapy (CRT) that focuses on working memory training in a sample of community based patients with chronic schizophrenia or other psychoses.
Cognitive deficits are a problem for many people with schizophrenia. This study will use computerized cognitive remediation training (which the participant can carry out at home) over a period of a few months.
연구 개요
상세 설명
The aim of this project is to undertake a randomized placebo controlled trial of cognitive remediation therapy (CRT) that focuses on working memory training in a sample of community based patients with schizophrenia. Pre and Post neuropsychological assessment and Magnetic Resonance Imagery (MRI) will be used to determine the effects of CR training on
- Neuropsychological performance
- Brain Structure using voxel-based morphometry (VBM)
- Brain function using functional MRI (fMRI)
- Social and occupational functioning
The cognitive remediation intervention is a computerised programme whose training level is dynamically varied to suit participants individual ability level. Motivation to learn and generalization to real world function are a particular focus of the intervention and are supported with ongoing therapist interaction in addition to personal training.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Dublin, 아일랜드, 8
- 모병
- Department of Psychiatry, Trinity Centre for Health Sciences, St James Hospital, James St.
-
연락하다:
- April H Hargreaves, PhD
- 전화번호: 35318962624
- 이메일: hargrea@tcd.ie
-
연락하다:
- Rachael Dillon, BSc
- 전화번호: 35318962315
- 이메일: radillon@tcd.ie
-
수석 연구원:
- Gary J Donohue, DClin Psych PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Schizophrenia
- History of Psychosis
- Subjective difficulties with memory or concentration
- Aged 18-60 Years
Exclusion Criteria:
- History of head injury resulting in loss of consciousness
- Substance misuse in the last 3 months
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Cognitive Remediation Therapy
Participants will undertake approximately 30 minutes of computerized CRT training for 8 weeks, 5 days per week.
They will meet a therapist once per week to discuss any difficulties, help motivation.
|
Computerised training undertaken for approximately 30 minutes per day, 5 days per week for 8 weeks
다른 이름들:
|
|
위약 비교기: Placebo Comparator
Participants will meet therapist once per week but will not undertake the Computerized Cognitive remediation training.
|
Participant meets the therapist once per week but does not carry out the CRT intervention.
(Participants are subsequently offered the chance to carry out the CRT intervention post study if they so wish).
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline neuropsychological performance
기간: Directly following study treatment period
|
A battery of neuropsychological tests will be used at baseline and the same tests used directly after the intervention to measure changes in attention and memory.
Tests include Wechsler Adult intelligence scale-III, Wechsler Memory Scale-III, Stroop test, Wisconsin card sorting task and measures of spatial working memory.
|
Directly following study treatment period
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline neuropsychological performance at 3 to 6 months post intervention
기간: 3 to 6 months post study treatment period
|
A battery of neuropsychological tests will be used at baseline and the same tests used at 3 months post intervention to measure changes in attention and memory.
Tests include Wechsler Adult intelligence scale-III, Wechsler Memory Scale-III, Stroop test, Wisconsin card sorting task and measures of spatial working memory.
|
3 to 6 months post study treatment period
|
|
Changes from baseline in brain activation during working memory testing
기간: Directly post study treatment period
|
Changes from baseline in brain activation during working memory testing will be measured using fMRI
|
Directly post study treatment period
|
|
Change from baseline in grey matter volume
기간: Directly following study treatment period
|
Changes in grey matter volume from baseline will be measured at 3 months post intervention using voxel based morphometry.
|
Directly following study treatment period
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in social and occupational functioning
기간: Directly following study treatment period
|
Social and occupational function will be measured at baseline and the same tests used directly following intervention.
Standardised measures will be used including ILS (Independent Living Scales) and the UCSD performance skills assessment brief version(UPSA-B)
|
Directly following study treatment period
|
|
Change from baseline in social and occupational functioning 3 to 6 months post intervention
기간: 3 to 6 months post study treatment period
|
Social and occupational function will be measured at baseline and the same tests used directly following intervention.
Standardised measures will be used including ILS (Independent Living Scales) and the UCSD performance skills assessment brief version(UPSA-B)
|
3 to 6 months post study treatment period
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Gary J Donoghoe, DClin Psych PhD, Trinity College Dublin, Ireland
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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. .
Cognitive Remediation Therapy에 대한 임상 시험
-
Hôpital le VinatierNantes University Hospital; Centre Hospitalier Henri Laborit; University Hospital, Tours; Centre... 그리고 다른 협력자들완전한
-
Masaryk UniversityMasaryk Memorial Cancer Institute모병
-
Masaryk UniversityMasaryk Memorial Cancer Institute모병
-
Guy's and St Thomas' NHS Foundation Trust모병
-
Dokuz Eylul UniversityThe Scientific and Technological Research Council of Turkey완전한
-
Douglas Mental Health University Institute모집하지 않고 적극적으로
-
Johns Hopkins University아직 모집하지 않음
-
Baskent University아직 모집하지 않음경요도 절제술(TUR) 증후군