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Taking people in United StatesPhase 1

Early sleep therapy for adults with insomnia before a stem cell transplant

Tests talk therapy for insomnia in adults planning a stem cell transplant.

Key facts

Who runs it
University of Kansas Medical Center
Where
Kansas City, United StatesSee the site
Trial code
Registry title
Early Cognitive Behavioral Therapy for Insomnia (CBT-I) in People Planning to Under Hematopoietic Stem Cell Transplant (HSCT)
Status
Recruiting
Phase
Phase 1
People taking part
30 people, planned
Started
16 Sept 2026
Expected to end
30 Jun 2027
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Cognitive behavioral therapy for insomnia (CBT-I)
Record updated
28 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with insomnia symptoms who are planning to have a hematopoietic stem cell transplant (HSCT). It tests six online sessions of talk therapy for insomnia (CBT-I) before transplant.

Age
18 years or older
Sex
All sexes can join
Disease stage
Planning to undergo HSCT, with a score of 10 or more on the Insomnia Severity Index. The main HSCT doctor must approve taking part. Must speak English.
Earlier treatment
People taking benzodiazepines, non-benzodiazepines, or melatonin for insomnia can join only if taken for 3 months or more with no dose change in the past 3 months. People now in a behavioral sleep program or other behavioral programs that may affect sleep (such as exercise, mindfulness, CBT) cannot join.

Main reasons for not taking part

  • Known untreated sleep disorder, such as sleep apnea or restless legs syndrome, or high risk of these on screening tests (more than 3 on STOP BANG)
  • Moderate or severe anxiety or depression (T-score 70 or more on PROMIS 29+2)
  • Drug or alcohol use disorder now or in the past 2 years
  • Stroke, Parkinson's disease, other nervous system disorder, or severe mental illness such as schizophrenia or bipolar disorder
  • Overnight shift work covering midnight-4am now or within the past 5 years

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • ≥18 years old
  • ≥10 on Insomnia Severity Index
  • Primary HSCT physician approval
  • English speaking

Who cannot take part

  • Currently receiving a behavioral sleep health intervention or other behavioral health interventions that may impact sleep (such as exercise, mindfulness, CBT)
  • Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)
  • Increased risk of Restless legs syndrome as determined by RLS-Diagnosis Index
  • Parasomnia as determined by the Sleep Disorders-Revised
  • 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
  • History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am
  • >3 on STOP BANG indicating increased risk of sleep apnea
  • 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
  • Severe neurological or sensory impairments that would interfere significantly with testing

Where in United States

  • University of Kansas Medical Center- Sleep, Health and Wellness LaboratoryKansas City, United StatesContact: Jade RobichaudTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Cognitive behavioral therapy for insomnia (CBT-I)Treatment being tested
  • Treatment As Usual (TAU)No study treatment, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
Early sleep therapy for adults with insomnia before a stem cell transplantGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
28 September 2026