Early Cognitive Behavioral Therapy for Insomnia (CBT-I) in People Planning to Under Hematopoietic Stem Cell Transplant (HSCT) (NCT07774039)
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-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Kansas Medical Center- Sleep, Health and Wellness Laboratory — Kansas City, Kansas
Age range: 18 Years
🧪 Interventions in This Study
- Cognitive behavioral therapy for insomnia (CBT-I) (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of Kansas Medical Center- Sleep, Health and Wellness Laboratory — Kansas City, Kansas
📞 Contact the Study Coordinator
Phone: (913) 588-6913
Email: csiengsukon@kumc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hematopoietic Stem Cell Transplant
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- Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors — Tampa, Florida
- Prehabilitation Program to Improve Cardiac Reserve in High-Risk Patients Undergoing Hematopoietic Stem Cell Transplantation — Ann Arbor, Michigan
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Explore by condition: All Hematopoietic Stem Cell Transplant clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.