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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center

About 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.

Eligibility criteria

Qualifiers

≥18 years old

≥10 on Insomnia Severity Index

Primary HSCT physician approval

English speaking

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Cognitive behavioral therapy for insomnia (CBT-I)

Treatment groups

30 Participants
are divided into 2 treatment groups