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

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT07774039
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Hematopoietic Stem Cell Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Aug 19, 2026
Start date
Sep 8, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cognitive behavioral therapy for insomnia (CBT-I)
  • No Intervention: Treatment As Usual (TAU)

Primary Outcome Measure

Recruitment [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Medical Center- Sleep, Health and Wellness LaboratoryKansas CityKansas66160
Jade Robichaud
[email protected]

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

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