Early Cognitive Behavioral Therapy for Insomnia (CBT-I) in People Planning to Under Hematopoietic Stem Cell Transplant (HSCT)
14 de agosto de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Catherine Siengsukon, PT, PHD
- Número de teléfono: 913-588-6913
- Correo electrónico: csiengsukon@kumc.edu
Copia de seguridad de contactos de estudio
- Nombre: Jade Robichaud
- Correo electrónico: jrobichaud@kumc.edu
Ubicaciones de estudio
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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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Contacto:
- Jade Robichaud
- Correo electrónico: jrobichaud@kumc.edu
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Terapia cognitivo-conductual para el insomnio (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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Sin intervención: Treatment As Usual (TAU)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recruitment
Periodo de tiempo: 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
Periodo de tiempo: 1 year
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number of participants who complete the study
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1 year
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Attendance
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adherence
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
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Intervention Appropriateness Measure (IAM)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sleep Self-Efficacy Scale (SESS)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
8 de septiembre de 2026
Finalización primaria (Estimado)
30 de junio de 2027
Finalización del estudio (Estimado)
30 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
11 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de agosto de 2026
Publicado por primera vez (Actual)
19 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00162729
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .