Better Sleep in Psychiatric Care - ADHD. (BSIP-ADHD)
2019년 10월 21일 업데이트: Susanna Jernelöv, Karolinska Institutet
Better Sleep in Psychiatric Care - ADHD. A Randomized Naturalistic Study of a Psychological Group Treatment for Sleep Problems in Psychiatric Patients With Attention Deficit Hyperactivity Disorder.
Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia (CBT-i).
Many patients in psychiatric care have sleep problems including insomnia, but are rarely given the choice to participate in CBT to improve their sleep.
Patients with ADHD is a patient group with high levels of sleep difficulties.
Sleep problems in this patient group can be both more general such as insomnia, but can also be related to the ADHD itself and to the use of ADHD medication.
In a previous pilot study, the investigators developed a version of CBT-i that would target sleep problems in this population.
The basis was CBT-i, but with more emphasis on sleep promoting behaviors specific to ADHD (e.g.
appropriate timing of ADHD-medication), techniques that would also alleviate sleep phase problems, (e.g. the systematic use of light and darkness), and techniques to target more general sleep disturbing habits (e.g.
not winding down before bed time), that are also common in patients with ADHD.
This treatment was well tolerated and gave moderate effects on insomnia severity in the pilot study.
In a naturalistic randomized controlled trial, the investigators now evaluate the effects of this psychological treatment on sleep and symptoms of ADHD in patients at the ADHD-clinics, Northern Stockholm Psychiatry, Sweden.
연구 개요
연구 유형
중재적
등록 (실제)
58
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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Stockholm, 스웨덴, 113 21
- Department of ADHD, Northern Stockholm Psychiatry
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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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Being a patient at the ADHD-clinics Northern Stockholm Psychiatry
- Experiencing sleep problems (subjective report)
Exclusion Criteria:
- None
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 |
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실험적: Behavioral: Adjusted CBT-i for ADHD
Cognitive Behavioral group intervention for sleep problems in ADHD, based on Cognitive Behavioral Therapy for insomnia and behavioral treatment for Sleep Phase Disorders.
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This is a version of CBT for insomnia (CBT-i) developed during the pilot phase of this Project.
Traditional CBT-i is adjusted for use in the adult ADHD population.
This behavioral intervention adresses not only traditional aspects of insomnia, but also sleep phase problems and other aspects of sleep specifically relevant to the ADHD-population.
Treatment is given as 10 weekly group sessions with telephone calls from the therapist between sessions to increase adherence and adress individual patient needs.
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다른: Treatment as Usual
Treatment as Usual.
(After about ten weeks, participants in this condition are offered the experimental group treatment.)
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Usual care at the ADHD-clinic.
This mostly entails managing pharmacological treatment for ADHD, comorbid psychiatric problems and/or sleep problems.
The clinic also provides different group treatments, for instance mindfulness groups and groups for developing behavioral strategies for managing ADHD symptoms, and individual therapy.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Insomnia Severity Index
기간: Changes from base-line to 10 weeks and 3 months
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7-item, self-rated questionnaire measuring change in insomnia severity.
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Changes from base-line to 10 weeks and 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Actigraphy
기간: Continuously from treatment start (week 1) to the last week of treatment (week 10)
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An actigraph is placed on the participant's arm for one week.
It measures participants' activity in the form of movements.
It can be used for acquiring data on sleep and daytime activity, including calculated sleep latency, total sleep time, sleep efficiency, wake after sleep onset, variability in sleep timing and daytime activity.
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Continuously from treatment start (week 1) to the last week of treatment (week 10)
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Sleep diary
기간: Changes from base-line to 10 weeks and 3 months
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Daily self-ratings on a number of sleep parameters, resulting in several measures including sleep latency, wake after sleep onset, total sleep time, sleep efficiency, subjective sleep quality and variability in sleep timing
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Changes from base-line to 10 weeks and 3 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Brunnsviken brief quality of life scale
기간: Changes from base-line to 10 weeks and 3 months
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12-items self-rating questionnaire measuring quality of life.
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Changes from base-line to 10 weeks and 3 months
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Adult ADHD Self-Report Scale
기간: Changes from base-line to 10 weeks and 3 months
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18-items self-report questionnaire measuring ADHD-symptoms.
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Changes from base-line to 10 weeks and 3 months
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Dysfunctional Beliefs and Attitudes about Sleep
기간: Changes from base-line to 10 weeks and 3 months
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10-items self-rating questionnaire measuring sleep related cognitions.
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Changes from base-line to 10 weeks and 3 months
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Sleep Problems Acceptance Questionnaire
기간: Changes from base-line to 10 weeks and 3 months
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8-items self-rating questionnaire measuring acceptance of sleep problems.
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Changes from base-line to 10 weeks and 3 months
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Sleep habits and behaviors
기간: Changes from base-line to 10 weeks and 3 months
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Self-rating questionnaire regarding the use of sleep promoting behaviors.
The questionnaire was constructed for the current project and consists of two parts.
The first part includes 16 statements such as "Last week I got out of bed within 15 minutes of waking up" to be answered by number of days the last week this was true (i.e. from 0 to 7).
The other part is to be answered on a 6-point Likert scale from "Not at all true" to "Entirely true", with 7 statements like "I get out of bed the same time every morning".
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Changes from base-line to 10 weeks and 3 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Susanna Jernelöv, PhD, LP, Karolinska Institutet
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
- Adler LA, Spencer T, Faraone SV, Kessler RC, Howes MJ, Biederman J, Secnik K. Validity of pilot Adult ADHD Self- Report Scale (ASRS) to Rate Adult ADHD symptoms. Ann Clin Psychiatry. 2006 Jul-Sep;18(3):145-8. doi: 10.1080/10401230600801077.
- Lindner P, Frykheden O, Forsstrom D, Andersson E, Ljotsson B, Hedman E, Andersson G, Carlbring P. The Brunnsviken Brief Quality of Life Scale (BBQ): Development and Psychometric Evaluation. Cogn Behav Ther. 2016 Apr;45(3):182-95. doi: 10.1080/16506073.2016.1143526. Epub 2016 Feb 17.
- Espie CA, Inglis SJ, Harvey L, Tessier S. Insomniacs' attributions. psychometric properties of the Dysfunctional Beliefs and Attitudes about Sleep Scale and the Sleep Disturbance Questionnaire. J Psychosom Res. 2000 Feb;48(2):141-8. doi: 10.1016/s0022-3999(99)00090-2.
- Bothelius K, Jernelov S, Fredrikson M, McCracken LM, Kaldo V. Measuring Acceptance of Sleep Difficulties: The Development of the Sleep Problem Acceptance Questionnaire. Sleep. 2015 Nov 1;38(11):1815-22. doi: 10.5665/sleep.5170.
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 12월 1일
기본 완료 (실제)
2018년 11월 21일
연구 완료 (실제)
2018년 11월 21일
연구 등록 날짜
최초 제출
2017년 1월 6일
QC 기준을 충족하는 최초 제출
2017년 1월 9일
처음 게시됨 (추정)
2017년 1월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 10월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 10월 21일
마지막으로 확인됨
2019년 10월 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. .
ADHD에 대한 임상 시험
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Innosphere아직 모집하지 않음
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The Hong Kong Polytechnic University모병
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)모병
Adjusted CBT-i for ADHD에 대한 임상 시험
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Karolinska InstitutetRegion Stockholm완전한
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VA Office of Research and DevelopmentVA Finger Lakes Healthcare System모병
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Indiana UniversityIndiana Clinical and Translational Sciences Institute종료됨
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University of ArizonaAmerican Academy of Sleep Medicine알려지지 않은
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The University of Hong KongChinese University of Hong Kong; Stanford University; Goldsmiths, University of London모병