不眠症のある成人における改変型 CBTi の評価
変化には最小限の介入が必要：睡眠と認知機能を改善するために不眠症の認知行動療法を修正するパイロットランダム化臨床試験
Cognitive Behavioral Therapy for Insomnia (CBTi) is the gold-standard, first line recommended treatment for insomnia, and has considerably better long-term outcomes than medications. However, CBTi is underutilized, training is limited, and medical professionals are implementing treatment approaches inconsistent with empirically supported guidelines. Moreover, sedating medications are currently the most commonly used treatment for insomnia, which is problematic because the potential side effects can have major implications for the aging population. Additionally, some patients continue to experience insomnia symptoms even when taking sleep medication, which can lead to increase dosages, dependence on, and tolerance to these medications, further emphasizing the importance of CBTi. The proposed project will include two primary aims in establishing a foundation needed to examine individual benefits of the components of CBTi. Improved treatment outcomes utilizing specific core components of CBTi may result in improvements of insomnia disorder and cognitive functioning and would provide a major step forward in understanding the mechanisms underlying the etiology and maintenance of insomnia as well as how risks associated with mild cognitive impairment and cognitive decline might be mitigated. Lastly, this proposed project allows for proof of concept and for collaborations to be made within the medical and mental health communities in Pocatello, ID and surrounding areas, decreasing barriers to treatment and improving treatment dissemination.
調査の概要
状態
詳細な説明
Sleep is a biological need, crucial for maintaining overall health and resiliency. Sleep disorders disrupt this normal functioning. Insomnia disorder is the most prevalent sleep disorder and yields costs to the U.S. Healthcare System in billions of dollars per year. Chronic insomnia has been linked to numerous physical and psychological health outcomes as well as increased mortality.
There is also evidence that insomnia is a risk factor for worse inflammation, worse neurological functioning, cognitive performance, and mild cognitive impairment, including cognitive decline, Alzheimer's disease, and faster genetic and brain aging. Moreover, in patients with Alzheimer's disease those with insomnia showed a faster progression to dementia. Better sleep health provides neuroprotection against this decline. Impairment in objective and subjective cognitive performance, highlights the utility of treating insomnia to potentially improve cognitive outcomes during midlife and insomnia symptoms are a modifiable risk factor for cognitive decline, mild cognitive impairment, and Alzheimer's disease and related dementia.
Cognitive Behavioral Therapy for Insomnia (CBTi) is the gold-standard, first line recommended treatment for insomnia, and has considerably better long-term outcomes than medications. CBTi decreases insomnia symptom severity by 50%. CBTi also appears to improve cognitive functioning. However, CBTi is underutilized, training is limited, and medical professionals are implementing treatment approaches inconsistent with empirically supported guidelines. Insomnia symptoms are being inadequately treated while misinformation and misconceptions about insomnia disorder, CBTi, and actual therapeutic effects are being propagated. Moreover, sedating medications are currently the most commonly used treatment for insomnia, which is problematic because the potential side effects can have major implications for the aging population. Additionally, some patients continue to experience insomnia symptoms even when taking sleep medication, which can lead to increase dosages, dependence on, and tolerance to these medications, further emphasizing the importance of CBTi. There is also a need for more readily accessible, short-term, modified treatments for insomnia disorder. A modified format of CBTi may assist in dissemination of effective treatments while also providing the potential for adapting this treatment to specific client characteristics. To address this need, we will modify CBTi and conduct a pilot randomized clinical trial to test these modifications.
The proposed project will include two primary aims in establishing a foundation needed to examine individual benefits of the components of CBTi. These aims will aid in the continuation of investigation to better assess treatment outcomes, create transdiagnostic treatment plans, and provide individualized health care through accessible psychotherapy. Obtaining a better understanding of the predictors of successful treatment may improve our understanding of the underlying mechanisms of successful treatment. Ultimately, this improved understanding may help to improve treatment for insomnia disorder, improve cognitive functioning, and potentially reduced risk for cognitive decline associated with mild cognitive impairment, Alzheimer's disease, and related dementias. Improved treatment outcomes utilizing specific core components of CBTi may result in improvements of insomnia disorder and cognitive functioning and would provide a major step forward in understanding the mechanisms underlying the etiology and maintenance of insomnia as well as how risks associated with mild cognitive impairment and cognitive decline might be mitigated. Lastly, this proposed project allows for proof of concept and for collaborations to be made within the medical and mental health communities in Pocatello, ID and surrounding areas, decreasing barriers to treatment and improving treatment dissemination.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Idaho
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Pocatello、Idaho、アメリカ、83201
- Idaho State University Psychology Clinic
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- At least 18 years of age;
- Seeking treatment for an insomnia complaint, assessed by self-report;
- Probable insomnia disorder, assessed by the SCI, total score ≤ 16;
- Stable on any prescribed, non-sedating medications (≥ 1 month), assessed by self-report and structured clinical interview;
- Access to an Apple iPhone or iPad (iOS needed for daily sleep diaries app)
Exclusion Criteria:
- Inability to speak and read English;
- Moderate to severe brain damage/cognitive impairment, assessed by the MoCA. total score < 18;
- Inability to follow research protocol (e.g., cannot attend weekly therapy sessions, no-show for appointments, consistent failure to complete assessments, unwillingness to do home sleep study);
- Refraining from participation in other behavioral health treatment or medication(s) during participation (unless prescribed/referred by provider);
- High risk for suicide within the past 3 months, assessed by C-SSRS
- Diagnosed with a serious mental illness (i.e., psychotic disorder, bipolar disorder);
- Current pregnancy, assessed by self-report, because sleep disturbances due to pregnancy may be the result of different processes;
- Other untreated sleep disorders (e.g., sleep apnea), assessed by clinical interview. (Participants meeting criteria for a sleep disorder requiring intervention will be referred for care through the local Medical Centers or their preferred sleep disorders center.);
- Residence >30 min driving time from university campus
研究計画
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 |
|---|---|
|
アクティブコンパレータ：Stimulus Control
Stimulus control.45 People with insomnia may fail to associate the bedroom with sleep, and instead may associate it with worrying, planning, or recreation. Stimulus control includes the following instructions: (1) go to bed only when sleepy; (2) only use your bed or bedroom for sleep (or sex); (3) if you do not fall asleep quickly (i.e., 15 minutes), leave the bed, do something in another room, and return to bed only when you feel a strong sleep urge; (4) if you do not fall asleep quickly upon returning to bed, repeat instruction 3; (5) use your alarm to awaken at the same time every morning regardless of duration of sleep obtained; and (6) do not take long naps. |
Stimulus control.45 People with insomnia may fail to associate the bedroom with sleep, and instead may associate it with worrying, planning, or recreation. Stimulus control includes the following instructions: (1) go to bed only when sleepy; (2) only use your bed or bedroom for sleep (or sex); (3) if you do not fall asleep quickly (i.e., 15 minutes), leave the bed, do something in another room, and return to bed only when you feel a strong sleep urge; (4) if you do not fall asleep quickly upon returning to bed, repeat instruction 3; (5) use your alarm to awaken at the same time every morning regardless of duration of sleep obtained; and (6) do not take long naps. |
|
アクティブコンパレータ：Sleep Restriction
Sleep restriction.46 People with insomnia often spend too much time awake in bed. Sleep restriction modifies the participant's sleep window so total time in bed is no more than 30 minutes beyond their average total sleep time to consolidate sleep, thus improving depth, continuity, and consistency. As the participant's sleep efficiency improves with treatment (i.e., the percentage of total time spent asleep within the sleep window), their sleep window is also increased. However, the shortened sleep window often causes increased anxiety. |
Sleep restriction.46 People with insomnia often spend too much time awake in bed. Sleep restriction modifies the participant's sleep window so total time in bed is no more than 30 minutes beyond their average total sleep time to consolidate sleep, thus improving depth, continuity, and consistency. As the participant's sleep efficiency improves with treatment (i.e., the percentage of total time spent asleep within the sleep window), their sleep window is also increased. However, the shortened sleep window often causes increased anxiety. |
|
アクティブコンパレータ：Sleep Compression
Sleep compression.47,48 Sleep compression encourages time-in-bed restrictions. Unlike sleep restriction, sleep compression allows a gradual reduction in time-in-bed over the course of multiple weeks. Typically, average total sleep time and total time in bed values are calculated from one or more weeks of daily sleep diaries. The difference between these two values is then divided by the number of weeks remaining and the allotted time in bed duration is compressed by this calculated value weekly, by delaying bedtime or advancing wake time. |
Sleep compression.47,48 Sleep compression encourages time-in-bed restrictions. Unlike sleep restriction, sleep compression allows a gradual reduction in time-in-bed over the course of multiple weeks. Typically, average total sleep time and total time in bed values are calculated from one or more weeks of daily sleep diaries. The difference between these two values is then divided by the number of weeks remaining and the allotted time in bed duration is compressed by this calculated value weekly, by delaying bedtime or advancing wake time. |
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介入なし：Waitlist Control
Waitlist Control. Those randomly assigned to the WLC group will be told that they must wait 4 weeks for treatment, which is a fraction of the typical wait period in routine clinical care. During this time the participants are asked to maintain their regular schedule. At the end of 4 weeks, they will complete the baseline assessments again, which will serve as the post-waitlist assessment and then scheduled with a clinician to receive CBTi. |
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 |
|---|---|---|
|
Sleep Efficiency
時間枠：Baseline, Week 8, 1 Month Follow Up
|
Sleep efficiency represents a ratio of total sleep time and total time in bed. Measured 0-100% with higher percentages indicating better sleep efficiency. |
Baseline, Week 8, 1 Month Follow Up
|
|
Insomnia Severity
時間枠：Baseline, Weeks 1-6 of treatment, Week 8, 1 Month Follow Up
|
Insomnia severity measured by the Insomnia Severity Index. Measured 0-28 with higher scores indicating worse insomnia severity. |
Baseline, Weeks 1-6 of treatment, Week 8, 1 Month Follow Up
|
|
Multidimensional Sleep Health
時間枠：Baseline, Weeks 1-6 of treatment, Week 8, 1 Month Follow Up
|
RU-SATED will be used to assess sleep health among adults. Measured 0-12 with higher scores indicating better sleep health. |
Baseline, Weeks 1-6 of treatment, Week 8, 1 Month Follow Up
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cognitive Functioning
時間枠：Baseline, Week 8
|
Cognitive functioning will be assess with Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). Measured by domain via T-Score. |
Baseline, Week 8
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Improvements in Subjective Sleep
時間枠：Baseline, Weeks 1-6 of treatment, Week 8, 1 Month Follow Up
|
Subjective sleep will be assessed using a daily sleep diary. |
Baseline, Weeks 1-6 of treatment, Week 8, 1 Month Follow Up
|
|
Improvements in Objective Sleep
時間枠：Baseline, Week 8
|
Objective sleep will be measured with EEG and/or actigraphy. |
Baseline, Week 8
|
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Treatment Adherence and Attendance
時間枠：Weeks 1-6 of treatment
|
Treatment adherence will be assess by the clinician based on how closely and consistently the participants complete aspects of therapy. Attendance will be calculated by number of sessions attended. |
Weeks 1-6 of treatment
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Sarah Emert、Idaho State University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB-FY2024-124
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Pilot study data will be used for additional grant proposals.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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