Low-intensity Cognitive-behavioural Therapy for Insomnia
2020년 3월 23일 업데이트: Dr. Chung Ka-Fai, The University of Hong Kong
A Randomized Controlled Trial to Compare the Effects of Cognitive Behavioral Therapy Workshop, Sleep Hygiene Education Workshop and Self-Help Cognitive Behavioral Therapy on Adults With Sleep Impairment in Hong Kong
A randomized controlled trial is proposed to compare the effectiveness of workshop-based and self-Help cognitive behavioral therapy for insomnia (CBTI), and sleep hygiene education (SHE) to treat insomnia in Hong Kong adolescent and adult patients, in terms of alleviation of insomnia severity, reduction in associated insomnia symptoms/ complications, and enhancement in quality of life.
Insomnia is prevalent in Hong Kong and can cause severe impacts on patients and society, but there is a dearth of related research in the local population.
Therefore, it is significant to conduct this study.
A total of 210 participants aged > 18 with insomnia will be recruited and randomized into 3 groups to receive one of the 3 treatments.
Outcomes will be measured using relevant questionnaires filled in at the baseline, 6 and 12 weeks afterwards.
The results obtained will be compared within each group and among the 3 groups using statistical testing to determine the most effective treatment option for insomnia.
연구 개요
연구 유형
중재적
등록 (실제)
210
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Hong Kong, 홍콩
- The University of Hong Kong
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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
16년 이상 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Hong Kong residents
- Aged 16 or above
- Satisfy the DSM-5 criteria for insomnia, i.e. inability to fall or keep asleep, or wake up too early for 3 days or more per week, throughout a minimum period of 1 month (instead of 3 months in the diagnostic criteria D) using the Brief Insomnia Questionnaire. This is to include episodic insomnia which is considered as an 'other specified insomnia disorder' in DSM-5.
- Score at least 10 points in Insomnia Severity Index
- Able to read and understand Cantonese
- Have Internet access
Exclusion Criteria:
- Suffer from recently diagnosed and untreated medical, psychiatric or sleep disorders that likely contribute to the onset and maintenance of insomnia, e.g. major depressive disorder, obstructive sleep apnea, restless legs syndrome, chronic pain.
- Currently receiving CBTI or SHE
- Work on irregular rotational shift
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: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: CBTI Workshop
The first intervention group (Group 1) will attend one half-day CBTI workshop in the community setting.
The workshop is subdivided into 4 sessions, covering topics regarding regulation of stimuli, limit of sleeping duration, relaxation, sleep hygiene and alteration of cognitive beliefs (Arnedt, Cuddihy, & Swanson, et al, 2014; Morin, Savard, Ouellet, & Daley, 2003).
One workshop has the capacity of 30 participants.
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CBTI involves habitual, belief and attitude alterations so as to eliminate factors preventing sleep (Morin, Savard, Ouellet, & Daley, 2003).
It is recommended by the American College of Physicians as the first-line therapy for insomnia (Qaseem, Kansagara, Forciea, Cooke, & Denberg, 2016).
CBTI workshops are a relatively novel and emerging way of delivery which involves a greater number of patients than group CBTI, increases availability and accessibility by concentrating the content into half or whole day and taking place in the community settings, and reduces diagnostic labeling and cost (Bonin, Beecham, Swift, Raikundalia, & Brown, 2014; Swift, Stewart, Andiappan, Smith, Espie, & Brown, 2012).
Self-help CBTI involves independent learning of the provided materials via the Internet, video or audio recording, books and pamphlets (Bruin, Bogels, Oort, & Meijer, 2015).
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실험적: Self-Help CBTI
The second intervention group (Group 2) will receive self-help CBTI.
A CBTI webpage will be set up and the subjects are asked to review all the materials in it.
The content is the same as that in Group 1.
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CBTI involves habitual, belief and attitude alterations so as to eliminate factors preventing sleep (Morin, Savard, Ouellet, & Daley, 2003).
It is recommended by the American College of Physicians as the first-line therapy for insomnia (Qaseem, Kansagara, Forciea, Cooke, & Denberg, 2016).
CBTI workshops are a relatively novel and emerging way of delivery which involves a greater number of patients than group CBTI, increases availability and accessibility by concentrating the content into half or whole day and taking place in the community settings, and reduces diagnostic labeling and cost (Bonin, Beecham, Swift, Raikundalia, & Brown, 2014; Swift, Stewart, Andiappan, Smith, Espie, & Brown, 2012).
Self-help CBTI involves independent learning of the provided materials via the Internet, video or audio recording, books and pamphlets (Bruin, Bogels, Oort, & Meijer, 2015).
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활성 비교기: SHE Workshop
The control group (Group 3) will receive SHE.
To ensure uniformity of the therapy model, the participants will also need to attend one half-day face-to-face session, covering topics related to sleep hygiene only.
The capacity is also 30 participants.
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SHE, is commonly provided verbally or through leaflets during consultations (Espie, 2009), and is also included as a part of CBTI (Morin, Savard, Ouellet, & Daley, 2003).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Insomnia severity
기간: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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To identify whether CBTI workshop, self-help CBTI or SHE workshop results in the greatest alleviation of insomnia severity using the Insomnia Severity Index, which allows the patients to rate their perceived severity and satisfaction level towards their current conditions (Arnedt, Cuddihy & Swanson, et al, 2014; Wong, Zhang & Li, et al, 2017).
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Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Symptoms of Mood disorders
기간: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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To identify which of the 3 therapies brings the largest reduction mood disorders through the Hospital Anxiety and Depression Scale.
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Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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Change in Quality of life
기간: Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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To investigate which of the 3 therapies improves the quality of life of patients to the greatest extent using the Short-Form Six-Dimension Health Survey.
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Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 (실제)
2018년 9월 1일
기본 완료 (실제)
2019년 6월 30일
연구 완료 (실제)
2019년 7월 31일
연구 등록 날짜
최초 제출
2018년 11월 7일
QC 기준을 충족하는 최초 제출
2018년 11월 8일
처음 게시됨 (실제)
2018년 11월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 3월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 3월 23일
마지막으로 확인됨
2020년 3월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- UW 18-396
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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