Early Cognitive Behavioral Therapy for Insomnia (CBT-I) in People Planning to Under Hematopoietic Stem Cell Transplant (HSCT)
2026년 8월 14일 업데이트: University of Kansas Medical Center
Feasibility, Acceptability, and Preliminary Treatment Efficacy of Early Cognitive Behavioral Therapy for Insomnia (CBT-I) to Mitigate Insomnia Symptoms and Fatigue and Improve Health-related Quality of Life in Individuals Planning to Undergo Hematopoietic Stem Cell Transplant (HSCT)
This proposed study is a prospective, randomized, controlled Phase 1 clinical trial to determine feasibility, acceptability (Aim 1) and preliminary effect (Aim 2) to mitigate insomnia symptoms and fatigue and improve health-related quality of life in patients who are planning to undergo HSCT.
The investigators plan to enroll n=30 with insomnia symptoms (Insomnia Severity Index ≥10) who will be randomized into one of two groups: 1.
A group that starts CBT-I after the initial evaluation visit with the HSCT care team (Early CBT-I), or 2. Treatment as usual (TAU).
Participants in the CBT-I group will receive six sessions of telehealth-delivered CBT-I that is completed prior to transplant.
Reassessments will occur post-intervention (~1-2 weeks before HSCT) and 1- and 3-months post-HSCT.
연구 개요
연구 유형
중재적
등록 (추정된)
30
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Catherine Siengsukon, PT, PHD
- 전화번호: 913-588-6913
- 이메일: csiengsukon@kumc.edu
연구 연락처 백업
- 이름: Jade Robichaud
- 이메일: jrobichaud@kumc.edu
연구 장소
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Kansas
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Kansas City, Kansas, 미국, 66160
- University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
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연락하다:
- Jade Robichaud
- 이메일: jrobichaud@kumc.edu
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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
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- ≥18 years old
- ≥10 on Insomnia Severity Index
- Primary HSCT physician approval
- English speaking
Exclusion Criteria:
- Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)
- >3 on STOP BANG indicating increased risk of sleep apnea
- Increased risk of Restless legs syndrome as determined by RLS-Diagnosis Index
- Parasomnia as determined by the Sleep Disorders-Revised
- If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking < 3 months or dose has changed in past 3 months
- T-score ≥70 on PROMIS 29+2 Anxiety or PROMIS 29+2 Depression domains indicating moderate/severe anxiety or depression
- Current or history (up to 2 years) of substance use disorder involving drugs or alcohol as defined by DSM-5-TR criteria
- History of other nervous system disorder such as stroke or Parkinson's disease
- Severe mental illness such as schizophrenia or bipolar disorder
- Severe neurological or sensory impairments that would interfere significantly with testing
- History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am
- Currently receiving a behavioral sleep health intervention or other behavioral health interventions that may impact sleep (such as exercise, mindfulness, CBT)
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: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 불면증에 대한 인지행동치료(CBT-I)
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The CBT-I program is a 1x/week, 6-week one-one-one program via video conferencing with trained research personnel.
The program is based on standard CBT-I manuals.
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간섭 없음: Treatment As Usual (TAU)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment
기간: 1 year
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number of people enrolled out of the number of people eligible
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1 year
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Retention
기간: 1 year
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number of participants who complete the study
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1 year
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Attendance
기간: pre-hematopoietic stem cell transplant (HSCT) reassessment
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number of cognitive behavioral therapy for insomnia (CBT-I) sessions attended
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pre-hematopoietic stem cell transplant (HSCT) reassessment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adherence
기간: pre-HSCT reassessment
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% days/week performed stimulus control or counter control if unable to sleep within 20 minutes and % nights/week conducted wind-down routine
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pre-HSCT reassessment
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Acceptability of Intervention Measure (AIM)
기간: pre-HSCT reassessment
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The AIM is a 4-item questionnaire with responses from 1 = completely disagree to 5 = completely agree.
A mean is calculated, and higher score indicates greater acceptability.
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pre-HSCT reassessment
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Feasibility of Intervention Measure (FIM)
기간: pre-HSCT reassessment
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The FIM is a 4-item questionnaire with responses from 1 = completely disagree to 5 = completely agree.
A mean is calculated, and higher score indicates greater feasibility.
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pre-HSCT reassessment
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Intervention Appropriateness Measure (IAM)
기간: pre-HSCT reassessment
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The IAM is a 4-item questionnaire with responses from 1 = completely disagree to 5 = completely agree.
A mean is calculated, and higher score indicates greater appropriateness.
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pre-HSCT reassessment
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Insomnia Severity Index (ISI)
기간: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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The ISI consists of 7 items with score ranging from 0-28.
A higher score indicates higher insomnia severity
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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PROMIS Sleep-Related Impairment Short Form 8a
기간: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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Consists of 8 items, which are summed and converted to a T-score.
A higher scores indicates greater sleep-related impairment.
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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Actigraph total sleep time
기간: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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Participants will wear an actigraph on their non-dominant wrist for 7 nights.
Total sleep time will be determined using ActiLife software from time to fall asleep to time to wake up and will be reported in minutes.
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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Actigraph sleep efficiency
기간: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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Participants will wear an actigraph on their non-dominant wrist for 7 nights.
Sleep efficiency will be determined using ActiLife software and calculated as total sleep time divided by time in bed X 100 and will be reported in percent.
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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Actigraph wake after sleep onset
기간: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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Participants will wear an actigraph on their non-dominant wrist for 7 nights.
Wake after sleep onset will be determined using ActiLife software and calculated number of minutes determine be awake during the sleep period and will be reported in percent.
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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The PROMIS 29+2
기간: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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31-item self-report measure.
Scores are reported as standardized PROMIS T-scores, with higher scores indicating more of the domain being assessed.
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sleep Self-Efficacy Scale (SESS)
기간: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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SESS is a 9-item self-report questionnaire used to measure sleep self-efficacy.
The respondents indicate confidence in ability to accomplish 9 sleep behaviors on a 5-point Likert scale with 1 = "not confident" at all to 5 = "very confident".
The score ranges from 0 to 45 with a higher score indicating greater sleep self-efficacy.
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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PROMIS Cognitive Function 8-item short form
기간: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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8 items, each scored from 1-5.
The raw score is converted to a t-score, with higher scores indicating better perceived cognitive function.
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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Positive Affect and Negative Affect Schedule (PANAS)
기간: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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The PANAS is a 20-item self-report questionnaire used to measure positive and negative emotions.
There are two subscales (Positive Affect and Negative Affect) with 10 items each.
The respondent scores how applicable a list of emotions are on a 5-point Likert scale with 1 = "Very slightly or not at all" to 5 = "Extremely".
A higher score on the Positive Affect subscale indicates greater intensity of positive emotions, and a high score on Negative Affect indicates greater intensity of negative emotions.
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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Dysfunctional Beliefs About Sleep (DBAS)
기간: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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This assessment is a 10 item Likert-scale self-report questionnaire.
Higher scores indicate more dysfunctional beliefs.
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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)
2026년 9월 8일
기본 완료 (추정된)
2027년 6월 30일
연구 완료 (추정된)
2027년 6월 30일
연구 등록 날짜
최초 제출
2026년 8월 11일
QC 기준을 충족하는 최초 제출
2026년 8월 14일
처음 게시됨 (실제)
2026년 8월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 14일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00162729
개별 참가자 데이터(IPD) 계획
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아니요
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