Cognitive Behavioral Therapy for Insomnia Before Bone Marrow Transplant
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults who are planning to have a bone marrow (stem cell) transplant and currently have trouble sleeping, as shown by an insomnia score of 10 or higher. Participants must be able to take part in telehealth sessions before their transplant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive six sessions of telehealth-delivered CBT-I completed prior to transplant
Pre-HSCT Reassessment
Reassessments occur post-intervention approximately 1-2 weeks before HSCT
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
Trial Overview
The study compares early cognitive behavioral therapy for insomnia (CBT-I), delivered through six online sessions before the transplant, with usual care. Participants are randomly assigned to either group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Kansas Medical Center
Lead Sponsor
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