Early Cognitive Behavioral Therapy for Insomnia (CBT-I) in People Planning to Under Hematopoietic Stem Cell Transplant (HSCT)
14 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
30
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Catherine Siengsukon, PT, PHD
- Número de telefone: 913-588-6913
- E-mail: csiengsukon@kumc.edu
Estude backup de contato
- Nome: Jade Robichaud
- E-mail: jrobichaud@kumc.edu
Locais de estudo
-
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160
- University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
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Contato:
- Jade Robichaud
- E-mail: jrobichaud@kumc.edu
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Terapia cognitivo-comportamental para insônia (TCC-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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Sem intervenção: Treatment As Usual (TAU)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Recruitment
Prazo: 1 year
|
number of people enrolled out of the number of people eligible
|
1 year
|
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Retention
Prazo: 1 year
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number of participants who complete the study
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1 year
|
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Attendance
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adherence
Prazo: pre-HSCT reassessment
|
% 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)
Prazo: pre-HSCT reassessment
|
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.
|
pre-HSCT reassessment
|
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Feasibility of Intervention Measure (FIM)
Prazo: pre-HSCT reassessment
|
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.
|
pre-HSCT reassessment
|
|
Intervention Appropriateness Measure (IAM)
Prazo: pre-HSCT reassessment
|
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.
|
pre-HSCT reassessment
|
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Insomnia Severity Index (ISI)
Prazo: 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
Prazo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
Consists of 8 items, which are summed and converted to a T-score.
A higher scores indicates greater sleep-related impairment.
|
Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
|
Actigraph total sleep time
Prazo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
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
|
|
Actigraph sleep efficiency
Prazo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
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
Prazo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
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.
|
Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
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The PROMIS 29+2
Prazo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sleep Self-Efficacy Scale (SESS)
Prazo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
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
Prazo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
8 items, each scored from 1-5.
The raw score is converted to a t-score, with higher scores indicating better perceived cognitive function.
|
Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
|
Positive Affect and Negative Affect Schedule (PANAS)
Prazo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
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.
|
Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
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Dysfunctional Beliefs About Sleep (DBAS)
Prazo: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
This assessment is a 10 item Likert-scale self-report questionnaire.
Higher scores indicate more dysfunctional beliefs.
|
Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
8 de setembro de 2026
Conclusão Primária (Estimado)
30 de junho de 2027
Conclusão do estudo (Estimado)
30 de junho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
11 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de agosto de 2026
Primeira postagem (Real)
19 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00162729
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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