Evaluating the Impact of Digital Behavioral Interventions to Address Insomnia and Depression in Breast Cancer Survivors Using an Adaptive Design
2026年7月22日 更新者：Philip Chow, Ph.D.、University of Virginia
Co-occurring symptoms of insomnia and depression is very common in breast cancer survivors, and it is critical that scalable and easily accessible digital behavioral interventions are made available.
Digital health interventions are scalable and accessible.
Moreover, behavioral digital interventions have been shown to be effective in reducing symptoms of insomnia and depression, respectively, in breast cancer survivors, suggesting strong potential for public impact, though their potential for addressing co-occurring symptoms of insomnia/depression has not been tested.
The purpose of this study is to evaluate the efficacy of a digital insomnia program and a digital mental health program in multiple ways: 1) as standalone interventions to reduce both symptoms of co-occurring insomnia and depression for breast cancer survivors; and 2) as components in adaptive behavioral treatment strategies that optimally sequence them for survivors who need additional support, resulting in a multifaceted supportive approach that is low cost, easily accessible, and highly efficient.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
747
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。
研究連絡先
- 名前：Philip Chow, PhD
- 電話番号：434-924-8082
- メール：pic2u@virginia.edu
研究場所
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Virginia
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Charlottesville、Virginia、アメリカ、22903
- University of Virginia
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コンタクト：
- Philip Chow, PhD
- 電話番号：434-924-8082
- メール：pic2u@virginia.edu
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コンタクト：
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主任研究者：
- Philip Chow, PhD
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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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- (1) age ≥18 years
- (2) Diagnosed with stage 0-3 breast cancer
- (3) Primary treatment for cancer (i.e., chemotherapy, immunotherapy, radiation, and surgical procedures intended to remove malignant tissue) finished between 3 months to 5 years from enrollment, with the exception of adjuvant hormonal, endocrine, and immunotherapy
- (4) elevated insomnia severity as measured by the Insomnia Severity Index (ISI) score ≥ 10, and elevated symptoms of depression as measured by the Patient Health Questionnaire-8 (PHQ-8) score ≥ 10
- (5) meets DSM 5 criteria for insomnia and depression.
Exclusion Criteria:
- (1) Current behavioral or psychological treatment for insomnia or depression
- (2) a change in medication for insomnia or depression within the past 4 weeks
- (3) irregular sleep schedules or shift work (i.e., usual bedtimes outside 8:00 p.m.-2:00 a.m. or arising time outside 4:00 a.m.-10:00 a.m.)
- (4) mental health condition deemed to interfere with study procedures or put the participant at undue risk based on self-reported history of psychosis or bipolar disorder, or active suicidal ideation that necessitates more intense care (as indicated from the Pitt-Optimum Suicide Management Protocol)
- (5) other self-reported untreated sleep disorders (i.e., obstructive sleep apnea, restless legs syndrome)
- (6) no reliable internet access (e.g., home broadband, public network, personal data plan) by smartphone
- (7) cannot read and speak English
- (8) does not reside within the US.
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：階乗代入
- 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 |
|---|---|
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実験的：Digital Insomnia Program First
Participants assigned to receive the digital insomnia program first will use it for 9 weeks.
Based on their response after 9 weeks, some will be re-randomized to receive an additional intervention (digital mental health program) or not.
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A self-guided, fully automated, interactive, and tailored internet-based program modeled on the primary tenants of face-to-face CBT-I (sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, relapse prevention).
It is fully accessible as a web-based application via smartphones, computers, and tablets.
Content is metered out over time through six "Cores".
Each Core acts as a digital analog for the typical weekly sessions of face-to-face CBT for insomnia, following the same general structure: (1) Core objectives - what will be learned and why this information is important, (2) review of previous week's homework and sleep diary data, (3) new intervention material, (4) assignment of homework - treatment strategies for the coming week, and (5) a summary of the Core's main points.
Users obtain access to a new Core based on a time- and event-based schedule (i.e., time since previous Core, completion of sleep diaries).
A self-guided, fully automated app designed for brief, frequent check-ins to promote skill acquisition.
Exercises in the app are assigned for 1 week each, and each exercise focuses on a specific mental health target (e.g., cognitive restructuring, savoring positive experiences, increasing knowledge of mental health).
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実験的：Digital Mental Health Program First
Participants assigned to receive the digital mental health program first will use it for 9 weeks.
Based on their response after 9 weeks, some will be re-randomized to receive an additional intervention (digital insomnia program) or not.
|
A self-guided, fully automated, interactive, and tailored internet-based program modeled on the primary tenants of face-to-face CBT-I (sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, relapse prevention).
It is fully accessible as a web-based application via smartphones, computers, and tablets.
Content is metered out over time through six "Cores".
Each Core acts as a digital analog for the typical weekly sessions of face-to-face CBT for insomnia, following the same general structure: (1) Core objectives - what will be learned and why this information is important, (2) review of previous week's homework and sleep diary data, (3) new intervention material, (4) assignment of homework - treatment strategies for the coming week, and (5) a summary of the Core's main points.
Users obtain access to a new Core based on a time- and event-based schedule (i.e., time since previous Core, completion of sleep diaries).
A self-guided, fully automated app designed for brief, frequent check-ins to promote skill acquisition.
Exercises in the app are assigned for 1 week each, and each exercise focuses on a specific mental health target (e.g., cognitive restructuring, savoring positive experiences, increasing knowledge of mental health).
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アクティブコンパレータ：Psychoeducation Only
Participants assigned to this arm will only receive the psychoeducation program for 9 weeks.
They will not be eligible to be re-randomized to receive additional program.
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An internet delivered program that includes modules containing general health information that is not specific to mental health or insomnia.
Modules contain information on the topics such as exercise and heart health,.
Content is primarily text-based and contains public domain health information; that is, content that is sourced primarily from US government health websites and is non-proprietary.
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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 |
|---|---|---|
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Patient Health-Questionnaire-8 (PHQ-8)
時間枠：Baseline
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8 item measure to evaluate severity of depression symptoms.
Each item is evaluated on a scale from 0-3.
Scores range from 0-24, with higher scores indicating greater severity of symptoms of depression.
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Baseline
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Patient Health Questionnaire-8 (PHQ-8)
時間枠：Post 18-weeks
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8 item measure to evaluate severity of depression symptoms.
Each item is evaluated on a scale from 0-3.
Scores range from 0-24, with higher scores indicating greater severity of symptoms of depression.
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Post 18-weeks
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Insomnia Severity Index (ISI)
時間枠：Baseline
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7 item measure to evaluate severity of insomnia symptoms.
Each item is evaluated on a scale from 0-4.
Scores range from 0-28, with higher scores indicating greater severity of insomnia symptoms.
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Baseline
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Insomnia Severity Index (ISI)
時間枠：Post 18-weeks
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7 item measure to evaluate severity of insomnia symptoms.
Each item is evaluated on a scale from 0-4.
Scores range from 0-28, with higher scores indicating greater severity of insomnia symptoms.
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Post 18-weeks
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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。
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 (推定)
2026年9月30日
一次修了 (推定)
2029年8月1日
研究の完了 (推定)
2029年8月30日
試験登録日
最初に提出
2026年7月17日
QC基準を満たした最初の提出物
2026年7月17日
最初の投稿 (実際)
2026年7月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月24日
QC基準を満たした最後の更新が送信されました
2026年7月22日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 7466
- R01CA295673 (米国 NIH グラント/契約)
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?
未定
IPD プランの説明
Contingent on the approval of the University of Virginia
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
いいえ
米国FDA規制機器製品の研究
いいえ
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。