Evaluating the Impact of Digital Behavioral Interventions to Address Insomnia and Depression in Breast Cancer Survivors Using an Adaptive Design
2026년 7월 22일 업데이트: 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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
747
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Philip Chow, PhD
- 전화번호: 434-924-8082
- 이메일: pic2u@virginia.edu
연구 장소
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Virginia
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Charlottesville, Virginia, 미국, 22903
- University of Virginia
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연락하다:
- Philip Chow, PhD
- 전화번호: 434-924-8082
- 이메일: pic2u@virginia.edu
-
연락하다:
- 이메일: pic2u@virginia.edu
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수석 연구원:
- Philip Chow, PhD
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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
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
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: 요인 할당
- 마스킹: 하나의
팔의 수
3
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient Health-Questionnaire-8 (PHQ-8)
기간: 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)
기간: 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)
기간: 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)
기간: Post 18-weeks
|
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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
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 (추정된)
연구 시작
2026년 9월 30일
기본 완료 (추정된)
기본 완료
2029년 8월 1일
연구 완료 (추정된)
연구 완료
2029년 8월 30일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 17일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 17일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 24일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 22일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 7466
- R01CA295673 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
IPD 계획 설명
Contingent on the approval of the University of Virginia
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .