- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07623928
Developing a Virtual Reality-assisted Intervention for Emotion Regulation Difficulties in Psychosis (MANOEUVRE)
MANaging emOtions in Everyday Life Using Virtual REality (MANOEUVRE): Developing a VR-assisted Intervention for Emotion Regulation Difficulties in Psychosis
Supporting people with psychosis to manage their emotions using virtual reality
Many people who have experienced psychosis feel overwhelmed by their emotions. Emotions get in the way of doing what matters to them. They want support to manage emotions differently. There is evidence that people with psychosis find talking therapies that teach skills for managing emotions helpful. People said it helped them to understand and manage their emotions. However, they also wanted more help to apply skills they learned to their lives.
It is hard to help people to use therapy skills in real-life situations. Therapists cannot be present when the skills are needed. One solution is to use virtual reality (VR) to bridge the gap between the clinic and real-life. VR involves using a headset to see and hear a very life-like computer-generated simulation of everyday life situations. People with psychosis find VR therapies engaging and helpful. It can feel safer to try things out in VR.
Guided by the feedback of people with psychosis, this research will evaluate a novel therapy to help people with psychosis manage their emotions. Face-to- face therapy will be combined with VR so that people can practice emotion regulation skills safely with "live" coaching from a therapist. This should support people to use these skills when they need them.
Fifteen people with psychosis will be offered the therapy. Everyone will be asked what they think of it and complete questionnaires before and after therapy to see what impact it had on their lives.
A lived experience advisory group will support all aspects of the research process.
연구 개요
상세 설명
Background Many people with psychosis report difficulties understanding and managing their emotions (emotion regulation difficulties), yet evidence-based interventions are lacking. Brief interventions that teach emotion regulation skills show promise but service users report wanting additional support to apply what they have learned in therapy to their lives.
Aim: To test the initial feasibility and acceptability of a VR-assisted therapy (called MANaging emOtions in Everyday life Using Virtual REality; MANOEUVRE) for emotion regulation difficulties in psychosis
Methods A mixed methods case series will be undertaken. The study will recruit people with psychosis from NHS community care teams (in England). Assessments will be at baseline, post therapy and 3-month follow up. Feasibility and acceptability of a future trial will be assessed based on uptake/ recruitment, data completeness and qualitative feedback. Feasibility and assessment of the therapy will be assessed based on adherence, acceptability (sessional feedback ratings, qualitative interview feedback, side effect and satisfaction ratings), safety (adverse effects), implementation resources and fidelity.
Participants will complete measures of emotion regulation difficulties, adaptive emotion regulation skill use, psychological distress, personal recovery goal achievement and quality of life. To assess feasibility, individual-level changes will be calculated using the reliable change index to assess whether changes are more likely to reflect measurement error or actual clinical change. Group-level changes will be assessed using means and standard deviations and effect sizes (Cohen's d) with confidence intervals . A post therapy semi-structured interview will explore participants' experience of receiving MANOEUVRE.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Dr Caroline Lawlor
- 전화번호: +44 7388 960630
- 이메일: caroline.lawlor@kcl.ac.uk
연구 연락처 백업
- 이름: Professor Dame Til Wykes
- 전화번호: +44 20 7848 0596
- 이메일: Til.Wkyes@kcl.ac.uk
연구 장소
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Greater London
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London, Greater London, 영국, SE5 8AF
- Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London
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연락하다:
- Dr Caroline Lawlor
- 전화번호: +44 7388960630
- 이메일: caroline.lawlor@kcl.ac.uk
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Currently under the care of South London and Maudsley (SLaM) National Health Service (NHS) outpatient services.
- Clinical diagnosis of psychosis (schizophrenia spectrum disorder) (as assessed by their clinical team)
- Willing to have the interview audio recorded (if taking part in post therapy interview)
- Willing and able to provide informed consent to participate in the study (as assessed by their clinical team)
Exclusion Criteria:
- Clinical presentation (e.g., immediate serious risk to self) (as assessed by their clinical team)
- History of photosensitive epilepsy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: MANOEUVRE therapy
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Virtual reality assisted psychological therapy for emotion regulation difficulties
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difficulties in Emotion Regulation Scale 16 item version (DERS-16)
기간: Pre therapy, immediately after therapy, 3 month follow up
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Self reported emotion regulation difficulties
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Pre therapy, immediately after therapy, 3 month follow up
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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DBT Ways of Coping Checklist - DBT Skills Subscale
기간: Pre therapy, immediately after therapy, follow up
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Adaptive use of emotion regulation skills
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Pre therapy, immediately after therapy, follow up
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Clinical Outcomes in Routine Evaluation-10 item version (CORE-10)
기간: Pre therapy, immediately after therapy, 3 month follow up
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Psychological distress
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Pre therapy, immediately after therapy, 3 month follow up
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Goal Attainment Scaling (GAS)
기간: Pre therapy, immediately after therapy, 3 month follow up
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Personal recovery goal achievement
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Pre therapy, immediately after therapy, 3 month follow up
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Recovering Quality of Life (ReQoL-10)
기간: Pre therapy, immediately after therapy, 3 month follow up
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Quality of life
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Pre therapy, immediately after therapy, 3 month follow up
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공동 작업자 및 조사자
수사관
- 연구 의자: Professor Dame Til Wykes, King's College London
- 연구 책임자: Professor Matteo Cella, King's College London
- 수석 연구원: Dr Caroline Lawlor, King's College London
간행물 및 유용한 링크
일반 간행물
- Lawlor C, Hepworth C, Smallwood J, Carter B, Jolley S. Self-reported emotion regulation difficulties in people with psychosis compared with non-clinical controls: A systematic literature review. Clin Psychol Psychother. 2020 Mar;27(2):107-135. doi: 10.1002/cpp.2408. Epub 2020 Feb 12.
- Lawlor C, Vitoratou S, Duffy J, Cooper B, De Souza T, Le Boutillier C, Carter B, Hepworth C, Jolley S. Managing emotions in psychosis: Evaluation of a brief DBT-informed skills group for individuals with psychosis in routine community services. Br J Clin Psychol. 2022 Sep;61(3):735-756. doi: 10.1111/bjc.12359. Epub 2022 Feb 7.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- NIHR305247
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
정신병에 대한 임상 시험
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ACADIA Pharmaceuticals Inc.모병Lewy Body Dementia Psychosis미국, 체코, 세르비아, 프랑스, 불가리아, 이탈리아
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ACADIA Pharmaceuticals Inc.초대로 등록
MANOEUVRE therapy에 대한 임상 시험
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Johns Hopkins University아직 모집하지 않음
-
Baskent University아직 모집하지 않음경요도 절제술(TUR) 증후군
-
Foundation University Islamabad모병
-
Philadelphia University, Jordan모병뇌성마비(CP) | 웅크린 걸음걸이 | 근육 약화 | 인내심 있는 | Diaplegia | 전방 골반 경사요르단