A Behavioral Therapy for Insomnia Co-existing With COPD
2019年9月27日 更新者:Mary C. Kapella、University of Illinois at Chicago
Efficacy and Mechanisms of a Behavioral Therapy for Insomnia Co-existing With COPD
Difficulty falling asleep, staying asleep or poor quality sleep (insomnia) is common in people with chronic obstructive pulmonary disease.
Insomnia is related to greater mortality, with four times the risk of mortality for sleep times < 300 minutes.
Insomnia is also related to greater morbidity, with 75% greater health care costs than people without insomnia.
However, insomnia medications are used with caution in COPD due to potential adverse effects.
Common features of COPD such as dyspnea, chronic inflammation, anxiety and depression also affect insomnia and can interfere with therapy outcomes.
While cognitive behavioral therapy for insomnia (CBT-I), a therapy that provides guidance on changing unhelpful sleep-related beliefs and behavior, is effective for people with primary insomnia and people with other chronic illnesses, the efficacy and mechanisms of action of such a therapy are yet unclear in people with both insomnia and COPD.
The objective in this application is to rigorously test efficacy of two components of insomnia therapy - CBT-I and COPD education (COPD-ED) - in people with coexisting insomnia and COPD, and to identify mechanisms responsible for therapy outcomes.
The central hypothesis is that both CBT-I and COPD-ED will have positive, lasting effects on objectively and subjectively measured insomnia and fatigue.
The rationale for the proposed study is that once the efficacy and mechanisms of CBT-I and COPD-ED are known, new and innovative approaches for insomnia coexisting with COPD can be developed, thereby leading to longer, higher quality and more productive lives for people with COPD, and reduced societal cost due to the effects of insomnia.
The investigators plan to test our central hypothesis by completing a randomized controlled comparison of CBT-I, COPD-ED and non-COPD, non-sleep health education attention control (AC) using a highly efficient 4-group design.
Arm 1 comprises 6 weekly sessions of CBT-I+AC; Arm 2=6 sessions of COPD-ED+AC; Arm 3=CBT-I+COPD-ED; and Arm 4=AC.
This design will allow completion of the following Specific Aims: 1. Determine the efficacy of individual treatment components, CBT-I and COPD-ED, on insomnia and fatigue.
2. Define mechanistic contributors to the outcomes after CBT-I and COPD-ED.
The research proposed in this application is innovative because it represents a new and substantive departure from the usual insomnia therapy, namely by testing traditional CBT-I with education to enhance outcomes.
調査の概要
状態
完了
詳細な説明
The investigators plan to test our central hypothesis by completing a randomized controlled comparison of CBT-I, COPD-ED and non-COPD, non-sleep health education attention control (AC) using a highly efficient 4-group design.
Arm 1 comprises 6 weekly sessions of CBT-I+AC; Arm 2=6 sessions of COPD-ED+AC; Arm 3=CBT-I+COPD-ED; and Arm 4=AC.
This design will allow completion of the following Specific Aims: 1. Determine the efficacy of individual treatment components, CBT-I and COPD-ED, on insomnia and fatigue.
2. Define mechanistic contributors to the outcomes after CBT-I and COPD-ED.
研究の種類
介入
入学 (実際)
109
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
-
-
Illinois
-
Chicago、Illinois、アメリカ、60612
- University of Illinois at Chicago
-
-
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
45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:
- mild to very severe COPD.
- age ≥ 45 years of age with no other major healthproblems.
- clinically stable at the time of enrollment into the study.
- insomnia.
Exclusion criteria:
- evidence of restrictive lung disease or asthma.
- pulse oximetry reading of < 90% at rest or < 85% at night for > 5 min.
- evidence of a major sleep disorder other than insomnia.
- hypnotic use.
- acute respiratory infection within the previous 2 months.
- presence of a potentially debilitating disease such as cancer, congestive heart failure, kidney disease, liver failure or cirrhosis; evidence of alcohol or drug abuse, musculoskeletal or degenerative nerve disease.
- a self-reported current diagnosis of major depression or psychiatric disease or a Hospital Anxiety and Depression Scale (HADS) depression score of > 11.
- currently participating in pulmonary rehabilitation.
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:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Cognitive Behavioral Therapy (CBT-I)
Six weekly sessions of Cognitive Behavioral Therapy for Insomnia
|
Six weekly sessions of cognitive behavioral therapy for insomnia
|
実験的:CBT-I + COPD-ED
Six weekly sessions of Cognitive Behavioral Therapy for Insomnia plus COPD Education
|
Six weekly sessions of cognitive behavioral therapy for insomnia
Six weekly sessions of COPD education
|
実験的:COPD Education (COPD-ED)
Six weekly sessions of COPD education
|
Six weekly sessions of COPD education
|
プラセボコンパレーター:Attention Control (AC)
Six weekly sessions of non-sleep, non-COPD health education
|
Six weekly sessions of non-sleep, non-COPD health education
|
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 |
---|---|---|
Insomnia
時間枠:Up to 18 weeks
|
Change in the level of insomnia will be assessed using actigraphy and the Sleep Impairment Index questionnaire.
|
Up to 18 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Fatigue
時間枠:Up to 18 weeks
|
Change in the level of fatigue will be assessed using the Chronic Respiratory Disease Questionnaire Fatigue scale and the PROMIS Fatigue scale.
|
Up to 18 weeks
|
Beliefs about sleep
時間枠:Up to 18 weeks
|
Change in beliefs about sleep will be measured using the DBAS questionnaire
|
Up to 18 weeks
|
Sleep habits
時間枠:Up to 18 weeks
|
Change in sleep habits will be measured using a Sleep Diary and Actigraphy
|
Up to 18 weeks
|
Self-efficacy for sleep
時間枠:Up to 18 weeks
|
Change in self-efficacy for sleep will be measured using the Self-efficacy for Sleep Scale
|
Up to 18 weeks
|
Self-efficacy for COPD management
時間枠:Up to 18 weeks
|
Change in self-efficacy for COPD management will be measured using the Self-efficacy for COPD scale.
|
Up to 18 weeks
|
Emotional arousal
時間枠:Up to 18 weeks
|
Change in emotional arousal will be measured using the PROMIS anxiety and depression scales
|
Up to 18 weeks
|
Inflammation
時間枠:6 weeks
|
Change in inflammation will be measured using C-reactive protein.
|
6 weeks
|
Pulmonary function
時間枠:6 weeks
|
Change in pulmonary function will be measured using pulmonary function tests.
|
6 weeks
|
Daytime functioning
時間枠:Up to 18 weeks
|
Change in daytime functioning will be measured using actigraphy, the Chronic Respiratory Disease Questionnaire Dyspnea Scale and the PROMIS Physical Functioning Scale.
|
Up to 18 weeks
|
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。
捜査官
- 主任研究者:Mary C Kapella, PhD、University of Illinois at Chicago
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
- Kapella MC, Herdegen JJ, Perlis ML, Shaver JL, Larson JL, Law JA, Carley DW. Cognitive behavioral therapy for insomnia comorbid with COPD is feasible with preliminary evidence of positive sleep and fatigue effects. Int J Chron Obstruct Pulmon Dis. 2011;6:625-35. doi: 10.2147/COPD.S24858. Epub 2011 Nov 24.
- Kapella M, Steffen A, Prasad B, Laghi F, Vispute S, Kemner G, Teixeira C, Peters T, Jun J, Law J, Carley D. Therapy for insomnia with chronic obstructive pulmonary disease: a randomized trial of components. J Clin Sleep Med. 2022 Dec 1;18(12):2763-2774. doi: 10.5664/jcsm.10210.
- Kapella MC, Herdegen JJ, Laghi F, Steffen AD, Carley DW. Efficacy and mechanisms of behavioral therapy components for insomnia coexisting with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial. Trials. 2016 May 23;17(1):258. doi: 10.1186/s13063-016-1334-0.
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
2014年6月1日
一次修了 (実際)
2019年7月1日
研究の完了 (実際)
2019年7月1日
試験登録日
最初に提出
2013年10月22日
QC基準を満たした最初の提出物
2013年10月25日
最初の投稿 (見積もり)
2013年10月31日
学習記録の更新
投稿された最後の更新 (実際)
2019年10月2日
QC基準を満たした最後の更新が送信されました
2019年9月27日
最終確認日
2019年9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。