- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02582528
Cognitive Remediation in Youth at Risk of Serious Mental Illness
2017년 3월 30일 업데이트: Danijela Piskulic, University of Calgary
Pilot Study of Cognitive Remediation and Motivational Interviewing on Cognition and Functioning in Young People at Risk of Serious Mental Illness
The primary aim of the project is to test the effectiveness of a cognitive remediation treatment (CRT) program, My Brain Solutions (MBS), in addition to motivational interviewing (MI) in improving cognition and functional outcome of individuals at risk of SMI.
An active control treatment consisting of CRT alone will be used.
Hypotheses: 1.
Both study groups will have improvement in cognition at the end of treatment; 2. CRT+MI group will have increased treatment adherence and superior improvements in cognition at the end of treatment and 12 months post baseline compared to the CRT only group; Secondary Hypothesis: 3. Improved cognition will be associated with improved functional outcome.
연구 개요
상태
종료됨
상세 설명
Individuals identified to be at clinical high risk of psychosis (CHR) of psychosis already evidence cognitive deficits, which increase around the time of conversion.
Much less is known about individuals that may be at risk of other serious mental disorders (SMI).
However, early reports are suggesting that young people at risk of SMI who are deemed to have "attenuated syndromes" according to the clinical staging model of mental health disorders already evidence cognitive deficits.
Therefore, cognition is an excellent treatment target.
Furthermore, there is clear evidence, in both established psychiatric disorders such as schizophrenia, depression and bipolar disorder, and in CHR samples, that deficits in cognition are associated to poor functional outcome.
Thus, treatments targeting cognition may consequently improve functional outcome.
This is a pilot project to determine feasibility and sample size for a large randomized controlled trial of cognitive remediation therapy (CRT) in people at risk of SMI with CIHR and AIHS funding targets.
The primary aim of the project is to test the effectiveness of a novel computerized CRT program in improving cognition in youth at risk of SMI following the addition of a counseling intervention, MI, to improve adherence to CRT.
One group will receive CRT and the other CRT plus MI.
Hypotheses: 1.
Both study groups will have improvement in cognition at the end of treatment; 2. CRT+MI group will have increased treatment adherence and superior improvements in cognition at the end of treatment and 12 months post baseline compared to the CRT only group; Secondary Hypothesis: 3. Improved cognition will be associated with improved functional outcome.
This is a longitudinal, single blind, controlled pilot trial of CRT in persons at risk of SMI.
Twenty-eight participants will be recruited from the Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study (PROCAN) study at the Calgary site led by Dr. J. Addington.
Participants in the PROCAN project who meet operationally defined criteria as being at risk of SMI by meeting attenuated syndromes criteria will be included.
Participants will be randomized to either the CRT condition consisting of a novel program called My Brain Fitness (MBS) and motivational interviewing (MI) or a control condition consisting of CRT alone, and will receive training that will be administered over a period of 10 weeks.
Assessments will occur at baseline, post treatment (3 months) and at 12 months after baseline.
Half of all participants will receive individual 1 hr MI once every 2 weeks for the duration of the cognitive remediation component of the study.
The study clinicians who are master level psychologists, will deliver MI ensuring engagement of study participants.
Time spent in therapy will be monitored and recorded.
All of the data necessary for this study will be collected as part of the PROCAN assessment at baseline and 12 months.
The one exception is that we will do an assessment of cognitive function, clinical symptoms and functional outcome at 10 weeks or immediately post treatment, which will take approximately 2.5 hours.
연구 유형
중재적
등록 (실제)
12
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Alberta
-
Calgary, Alberta, 캐나다, T2N 4Z6
- University of Calgary
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
14년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Male and female participants aged 14-25 years with subthreshold mood and psychotic symptoms.
Exclusion Criteria:
- (i) meet criteria for current or lifetime Axis I bipolar or psychotic disorder (other Axis I disorders will not be exclusionary as they may be precursors to mood or psychotic disorders);
- (ii) IQ < 70;
- (iii) past or current history of a significant central nervous system disorder or serious medical disorder; and
- (iv) current pharmacological treatment that would be considered as an adequate trial of treatment for a SMI.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: cognitive remediation treatment and MI
Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS) and motivational interviewing, a client-centered, directive method for enhancing intrinsic motivation to change.
|
Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS)
다른 이름들:
A client-centered, directive method for enhancing intrinsic motivation to change.
다른 이름들:
|
|
활성 비교기: cognitive remediation treatment
Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS)
|
Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS)
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cognitive function assessment pre- and post-CRT in youth at risk of SMI using WebNeuro computerized cognitive battery
기간: one year
|
A web-based battery for assessing general and emotional cognition, completed at any computer using mouse and keyboard.
The assessment has been validated against traditional paper-and-pencil tests and with established reliability, cross-cultural consistency and norms.
|
one year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Social functioning assessment pre- and post-CRT in youth at risk of SMI using Global Functioning: Social (GFS) scale.
기간: one year
|
GFS consists of 10 items that are used to provide a rating of current social functioning.
Scores range between 1 and 10, with 10 indicating superior functioning and 1 representing severe dysfunction.
|
one year
|
|
Social functioning assessment pre- and post-CRT in youth at risk of SMI using Global Functioning: Role (GFR) scale.
기간: one year
|
GFR consists of 10 items that are used to provide a rating of current role or occupational functioning.
Scores range between 1 and 10, with 10 indicating superior functioning and 1 representing severe dysfunction.
|
one year
|
|
Functional capacity assessment pre- and post-CRT in youth at risk of SMI using Social Skills Performance Assessment (SSPA).
기간: one year
|
The SSPA is focused on both verbal and nonverbal social skills that are needed to succeed in two different social interaction tasks.
Higher scores on the SSPA indicate better social skills.
|
one year
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Danijela Piskulic, PhD, University of Calgary
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2016년 2월 1일
기본 완료 (실제)
2017년 3월 1일
연구 완료 (실제)
2017년 3월 1일
연구 등록 날짜
최초 제출
2015년 10월 16일
QC 기준을 충족하는 최초 제출
2015년 10월 19일
처음 게시됨 (추정)
2015년 10월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 4월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 3월 30일
마지막으로 확인됨
2017년 3월 1일
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. .