RECRUITING Phase 1 ClinicalTrials.gov

Early Cognitive Behavioral Therapy for Insomnia (CBT-I) in People Planning to Under Hematopoietic Stem Cell Transplant (HSCT)

Sponsor: University of Kansas Medical Center • ClinicalTrials.gov ID: NCT07774039

Registry updated: 2026-09-28

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Description

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.

Interventions

Cognitive behavioral therapy for insomnia (CBT-I) (Behavioral)
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.

Eligibility criteria

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)

Conditions

Hematopoietic Stem Cell Transplant

Locations

University of Kansas Medical Center- Sleep, Health and Wellness Laboratory — Kansas City, Kansas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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