Recruiting
Phase 1

CBT-I

Sponsor:

University of Kansas Medical Center

Code:

NCT07774039

Conditions

Hematopoietic Stem Cell Transplant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive behavioral therapy for insomnia (CBT-I)

Study Details

Brief summary:

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.

Conditions

Hematopoietic Stem Cell Transplant

Study ID

NCT07774039

Start date

Sep 16, 2026

Status verified date

Sep, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive behavioral therapy for insomnia (CBT-I)

no intervention: Treatment As Usual (TAU)

Interventions

Cognitive behavioral therapy for insomnia (CBT-I)

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.

Primary outcome measure

  • Recruitment [ Time Frame: 1 year ]
  • Retention [ Time Frame: 1 year ]
  • Attendance [ Time Frame: pre-hematopoietic stem cell transplant (HSCT) reassessment ]

Central Contacts and Locations

Central contacts

Catherine Siengsukon, PT, PHD

913-588-6913csiengsukon@kumc.edu

Jade Robichaud

jrobichaud@kumc.edu

Locations

University of Kansas Medical Center- Sleep, Health and Wellness Laboratory

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Jade Robichaud

jrobichaud@kumc.edu

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Sep 28, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.