Early Cognitive Behavioral Therapy for Insomnia Before Stem Cell Transplant
Official title: 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)
Run by University of Kansas Medical Center · NCT07774039 · Data updated 2026-11-12
This trial tests whether starting six telehealth CBT-I sessions before hematopoietic stem cell transplant can help adults with insomnia feel better and have less fatigue.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Status | Recruiting |
| Started | September 16, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT07774039 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older planning HSCT with ISI ≥ 10 and English-speaking, who have physician approval and no major sleep, neurological, or psychiatric exclusions that would interfere with CBT-I.
✕Probably not a fit
Patients with untreated sleep disorders that are not addressed by CBT-I or with conditions that substantially limit engagement in telehealth therapy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 randomized, controlled trial to assess feasibility and acceptability of early CBT-I in adults planning HSCT who have insomnia symptoms. Participants are randomized to receive six telehealth CBT-I sessions before transplant or treatment as usual, with follow-up assessments about 1–2 weeks before transplant and at 1 and 3 months after HSCT. The study aims to see if this approach can reduce insomnia and fatigue and improve health-related quality of life. Enrollment targets 30 participants with an Insomnia Severity Index score of 10 or higher, and all must meet eligibility criteria including language, medical clearance, and absence of major sleep or psychiatric conditions that would preclude CBT-I. Outcomes will inform feasibility and preliminary signals of effect to guide future studies.
Why it matters
Potential benefit: If successful, patients could experience less insomnia and fatigue and a better quality of life around the time of HSCT.
How similar studies have gone: Prior studies of CBT-I in cancer care have shown feasibility and potential sleep benefits, but this pre-transplant, telehealth, early-intervention approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
Kansas City, Kansas, United States Recruiting
Study contacts
- Study coordinator: Catherine Siengsukon, PT, PHD
- Email: csiengsukon@kumc.edu
- Phone: 913-588-6913
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.