Cognitive Behavior Therapy for Insomnia in Primary Care (TIRED)
2012年7月30日 更新者：Uppsala University
Treating Insomnia in Primary Care: A Study of Effectiveness and Dissemination
The aim of this study was to investigate the clinical effectiveness of protocol-driven cognitive behavioral therapy (CBT) for insomnia delivered by ordinary primary care personnel (primary care nurses and social workers) in general medical practice with unselected patients, in line with a stepped care approach.
The study design was a randomised controlled parallel group design, with allocation to CBT and waiting list control group (WL).
Following an active treatment-control period, the control group were re-assigned to CBT.
The study hypothesis was that the CBT group would experience less symptoms of insomnia after treatment compared with the WL group.
Primary outcome measure was a brief self-report screening form, Insomnia severity index.
調査の概要
研究の種類
介入
入学 (実際)
66
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Uppsala、スウェーデン、75105
- Uppsala University
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Fulfilled research criteria for chronic insomnia
Exclusion Criteria:
- other untreated sleep disturbance
- pregnancy
- shift work
- concurrent medical or psychiatric condition that could be negatively affected by the treatment
- drug abuse
- severe depression
- dementia
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：CBT
The treatment group received manualized CBT-I using a adapted version of a manual designed for use by primary care personnel.
Treatment comprised information about sleep and insomnia, methods for medication tapering, sleep hygiene, stimulus control, sleep restriction, progressive muscle relaxation, and dealing with sleep interfering thoughts.
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Treatment comprised information about sleep and insomnia, methods for medication tapering, sleep hygiene, stimulus control, sleep restriction, progressive muscle relaxation, and dealing with sleep interfering thoughts.
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|
介入なし：Wait-list
A deferred treatment wait-list condition, with no restrictions placed on the usual care.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in the Insomnia severity index (ISI)
時間枠：After 9 weeks
|
A brief self-report screening form
|
After 9 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in sleep-onset latency (SOL)
時間枠：9 weeks
|
Time to fall asleep, measured with sleep diary
|
9 weeks
|
|
Change from baseline in wake time after sleep onset (WASO)
時間枠：After 9 weeks
|
Time awake during the night, measured with sleep diary
|
After 9 weeks
|
|
Change from baseline in number of awakenings during the night (NWAK)
時間枠：After 9 weeks
|
Measured with sleep diary
|
After 9 weeks
|
|
Change from baseline in Sleep efficiency (SE)
時間枠：After 9 weeks
|
Time actually spent sleeping out of the total time in bed (%), measured with sleep diary
|
After 9 weeks
|
|
Change from baseline in time in bed (TIB)
時間枠：After 9 weeks
|
Measured with sleep diary
|
After 9 weeks
|
|
Change from baseline in total sleep time (TST)
時間枠：After 9 weeks
|
Measured with sleep diary
|
After 9 weeks
|
|
Change from baseline in sleep quality (SQ)
時間枠：After 9 weeks
|
Subjective sleep quality (likert scale)
|
After 9 weeks
|
|
Change from baseline in the fatigue severity scale (FSS)
時間枠：After 9 weeks
|
Self-report questionnaire
|
After 9 weeks
|
|
Change from baseline in the MOS 36-item short-form health survey, SF-36
時間枠：After 9 weeks
|
Questionnaire assessing physical and mental health
|
After 9 weeks
|
|
Change from baseline in the Hospital anxiety and depression scale, HADS
時間枠：After 9 weeks
|
Self-report questionnaire measuring depression and anxiety
|
After 9 weeks
|
|
Change from baseline in the Epworth sleepiness scale, ESS
時間枠：After 9 weeks
|
Self-report questionnaire assessing daytime sleepiness
|
After 9 weeks
|
|
Change form baseline in the Pittsburgh sleep quality index (PSQI)
時間枠：After 9 weeks
|
Self-report form assessing sleep quality
|
After 9 weeks
|
|
Change from baseline in the Minimal insomnia severity scale, MISS
時間枠：After 9 weeks
|
Ultra short screening questionnaire for insomnia
|
After 9 weeks
|
|
Change from baseline in the Insomnia acceptance questionnaire, IQA
時間枠：After 9 weeks
|
A questionnaire intended to assess acceptance of insomnia
|
After 9 weeks
|
|
Change from baseline in Body mass index
時間枠：After 9 weeks
|
After 9 weeks
|
|
|
Change from baseline in sagittal abdominal diameter
時間枠：After 9 weeks
|
Abdominal height (cm)
|
After 9 weeks
|
|
Change from baseline in waist-hip ratio
時間枠：After 9 weeks
|
A ratio of the circumference of the waist to the hips
|
After 9 weeks
|
|
Change from baseline in blood pressure
時間枠：After 9 weeks
|
After 9 weeks
|
|
|
Change from baseline in heart rate
時間枠：After 9 weeks
|
After 9 weeks
|
|
|
Change from baseline in ALAT
時間枠：After 9 weeks
|
Liver function
|
After 9 weeks
|
|
Change from baseline in HbA 1c
時間枠：After 9 weeks
|
Glycated hemoglobin
|
After 9 weeks
|
|
Change from baseline in blood glucose
時間枠：After 9 weeks
|
After 9 weeks
|
|
|
Change from baseline in triglycerides
時間枠：After 9 weeks
|
A type of fat found in the blood
|
After 9 weeks
|
|
Change from baseline in cholesterol (LDL/HDL)
時間枠：After 9 weeks
|
After 9 weeks
|
|
|
Change from baseline in sleep-onset latency (SOL)
時間枠：After 18 months
|
Time to fall asleep, measured with sleep diary
|
After 18 months
|
|
Change from baseline in wake time after sleep onset (WASO)
時間枠：After 18 months
|
Time awake during the night, measured with sleep diary
|
After 18 months
|
|
Change from baseline in number of awakenings during the night (NWAK)
時間枠：After 18 months
|
Measured with sleep diary
|
After 18 months
|
|
Change from baseline in Sleep efficiency (SE)
時間枠：After 18 months
|
Time actually spent sleeping out of the total time in bed (%), measured with sleep diary
|
After 18 months
|
|
Change from baseline in time in bed (TIB)
時間枠：After 18 months
|
Measured with sleep diary
|
After 18 months
|
|
Change from baseline in total sleep time (TST)
時間枠：After 18 months
|
Measured with sleep diary
|
After 18 months
|
|
Change from baseline in sleep quality (SQ)
時間枠：After 18 months
|
Subjective sleep quality (likert scale)
|
After 18 months
|
|
Change from baseline in the fatigue severity scale (FSS)
時間枠：After 18 months
|
Self-report questionnaire
|
After 18 months
|
|
Change from baseline in the MOS 36-item short-form health survey, SF-36
時間枠：After 18 months
|
Questionnaire assessing physical and mental health
|
After 18 months
|
|
Change from baseline in the Hospital anxiety and depression scale, HADS
時間枠：After 18 months
|
Self-report questionnaire measuring depression and anxiety
|
After 18 months
|
|
Change from baseline in the Epworth sleepiness scale, ESS
時間枠：After 18 moths
|
Self-report questionnaire assessing daytime sleepiness
|
After 18 moths
|
|
Change form baseline in the Pittsburgh sleep quality index (PSQI)
時間枠：After 18 months
|
Self-report form assessing sleep quality
|
After 18 months
|
|
Change from baseline in the Minimal insomnia severity scale, MISS
時間枠：After 18 months
|
Ultra short screening questionnaire for insomnia
|
After 18 months
|
|
Change from baseline in the Insomnia acceptance questionnaire, IQA
時間枠：After 18 months
|
A questionnaire intended to assess acceptance of insomnia
|
After 18 months
|
|
Change from baseline in Body mass index
時間枠：After 18 months
|
After 18 months
|
|
|
Change from baseline in sagittal abdominal diameter
時間枠：After 18 months
|
Abdominal height (cm)
|
After 18 months
|
|
Change from baseline in waist-hip ratio
時間枠：After 18 months
|
A ratio of the circumference of the waist to the hips
|
After 18 months
|
|
Change from baseline in blood pressure
時間枠：After 18 months
|
After 18 months
|
|
|
Change from baseline in heart rate
時間枠：After 18 months
|
After 18 months
|
|
|
Change from baseline in ALAT
時間枠：After 18 months
|
Liver function
|
After 18 months
|
|
Change from baseline in HbA 1c
時間枠：After 18 months
|
Glycated hemoglobin
|
After 18 months
|
|
Change from baseline in blood glucose
時間枠：After 18 months
|
After 18 months
|
|
|
Change from baseline in triglycerides
時間枠：After 18 months
|
A type of fat found in the blood
|
After 18 months
|
|
Change from baseline in cholesterol (LDL/HDL)
時間枠：After 18 months
|
After 18 months
|
|
|
Change from baseline in the Insomnia severity index (ISI)
時間枠：After 18 months
|
A brief self-report screening form
|
After 18 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Jan-Erik Broman, PhD、Uppsala University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Espie CA, MacMahon KM, Kelly HL, Broomfield NM, Douglas NJ, Engleman HM, McKinstry B, Morin CM, Walker A, Wilson P. Randomized clinical effectiveness trial of nurse-administered small-group cognitive behavior therapy for persistent insomnia in general practice. Sleep. 2007 May;30(5):574-84. doi: 10.1093/sleep/30.5.574.
- Bothelius K, Kyhle K, Espie CA, Broman JE. Manual-guided cognitive-behavioural therapy for insomnia delivered by ordinary primary care personnel in general medical practice: a randomized controlled effectiveness trial. J Sleep Res. 2013 Dec;22(6):688-96. doi: 10.1111/jsr.12067. Epub 2013 Jul 16.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2008年5月1日
一次修了 (実際)
2011年9月1日
研究の完了 (実際)
2011年9月1日
試験登録日
最初に提出
2012年7月4日
QC基準を満たした最初の提出物
2012年7月30日
最初の投稿 (見積もり)
2012年8月2日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年8月2日
QC基準を満たした最後の更新が送信されました
2012年7月30日
最終確認日
2012年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。