- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04386668
Let It Out (LIO) and COVID19: Testing an Online Emotional Disclosure-based Intervention During the COVID19 Pandemic (LIO-C)
Let It Out (LIO) and COVID19: a Randomised Controlled Trial of an Online Emotional Disclosure-based Intervention for Adults During the COVID19 Pandemic
A randomised controlled trial designed to test whether an online expressive writing intervention (LIO-C) can reduce distress for English-speaking adults during the global COVID19 pandemic.
Hypothesis: LIO-C will improve distress (as measured by K10) in adults at 1 week post-intervention compared to a neutral writing control during the COVID19 pandemic.
연구 개요
상세 설명
The world is currently experiencing unprecedented challenges caused by the global coronavirus (COVID19) pandemic. Many countries are enforcing measures to restrict movement of people to reduce the spread of the outbreak, including lock-downs, social distancing and self-isolation. These methods, although necessary to slow the spread of disease, will have negative effects on psychological well-being of large populations. Shortage of health care professionals and measures to restrict interpersonal contact means facilitated psychological interventions will not be feasible for many, at least during the height of the pandemic. There is therefore a need for self-directed psychological interventions that can be practically and quickly implemented online.
Emotional disclosure-based therapies, such as expressive writing (EW), hold potential as low-cost, easy to implement means of support, with minimal requirement for facilitation. In its original format, EW involved writing daily for 15-20 minutes for 3-4 days about a traumatic event. Since its development, it has been adapted in many ways, including writing about positive events and writing about stress from a compassionate stance. There is evidence that such interventions can provide significant psychological and physical benefits in healthy populations and reduce the effects of natural disasters on health and well-being. However, to our knowledge this form of psychological intervention has not been tested during a rapidly evolving crisis or pandemic.
The aim of this study is to test whether an online self-compassion and EW based intervention (LIO-C) can reduce the negative effects of the COVID19 pandemic on health and well-being. The intervention is based on an existing intervention, LIO, that we previously developed for use in advanced disease populations, in collaboration with clinical and health psychologists, and patient and public representatives. For this study, we have adapted the intervention for people living through the current COVID19 pandemic by altering the writing prompts, and translating the intervention to an online hub. As this is an unfacilitated intervention, the instructions involve writing from a compassionate stance to minimise any potential short term negative effects associated with writing about difficult experiences.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kent
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London, Kent, 영국, TN14 6DW
- University College London
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- English speaking adults over the age of 18
- Able to read and write clearly in English
Exclusion Criteria:
- None
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: LIO-C
Participants receive LIO-C writing intervention
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Participants complete three online 20-minute writing sessions in response to prompts asking them to write about their experiences during the COVID19 pandemic from a self-compassionate perspective
다른 이름들:
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위약 비교기: Neutral writing control
Participants receive neutral writing control intervention
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Participants complete three online 20-minute writing sessions in response to neutral writing prompts
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Kessler Psychological Distress Scale (K10)
기간: 1 week post-intervention
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10-item self-report distress scale
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1 week post-intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Kessler Psychological Distress Scale (K10)
기간: Immediately and 8 weeks post-intervention
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10-item self-report distress scale
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Immediately and 8 weeks post-intervention
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Perceived Stress Scale (PSS-10)
기간: Immediately, 1 week and 8 weeks post-intervention
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Self-report stress scale
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Immediately, 1 week and 8 weeks post-intervention
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Pittsburgh Sleep Quality Index (PSQI)
기간: Immediately, 1 week and 8 weeks post-intervention
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Self-report sleep scale
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Immediately, 1 week and 8 weeks post-intervention
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Self-compassion scale (SCS)
기간: Immediately, 1 week and 8 weeks post-intervention
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Self-report self-compassion scale
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Immediately, 1 week and 8 weeks post-intervention
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UCLA Loneliness Scale (UCLA LS)
기간: Immediately, 1 week and 8 weeks post-intervention
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Self-report loneliness scale
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Immediately, 1 week and 8 weeks post-intervention
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Uptake of existing mental health services (MHS)
기간: Immediately, 1 week and 8 weeks post-intervention
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Self-report measure of MHS usage
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Immediately, 1 week and 8 weeks post-intervention
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Mood and meaning
기간: Immediately after each writing session
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3-item, 7-point, Likert scale measuring how personal and meaningful participants' felt their writing was and their mood
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Immediately after each writing session
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Acceptability
기간: Immediately post-intervention
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Via an online feedback form
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Immediately post-intervention
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공동 작업자 및 조사자
수사관
- 수석 연구원: Nuriye Kupeli, Marie Curie Palliative Care Research Department, UCL
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 15281/003
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 액세스 기준
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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