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

University of Kansas Medical Center · 2026
ClinicalTrials.gov · Datasets · License: Public Domain · 2026
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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.
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