Early Cognitive Behavioral Therapy for Insomnia (CBT-I) in People Planning to Under Hematopoietic Stem Cell Transplant (HSCT)
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: University of Kansas Medical Center
You may qualify if…
- ✓ ≥18 years old
- ✓ ≥10 on Insomnia Severity Index
- ✓ Primary HSCT physician approval
- ✓ English speaking
You may not qualify if…
- ✕ 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
Where it's recruiting
Kansas City
Source: ClinicalTrials.gov · NCT07774039 · last updated 2026-09-28