30 Participants NeededMy employer runs this trial

Cognitive Behavioral Therapy for Insomnia Before Bone Marrow Transplant

CS
JR
Overseen ByJade Robichaud
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

Score of 10 or higher on Insomnia Severity Index
Primary HSCT physician approval
English speaking
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Exclusion Criteria

T-score of 70 or higher on PROMIS 29+2 Anxiety or Depression domains indicating moderate/severe anxiety or depression
Severe neurological or sensory impairments interfering significantly with testing
History within 5 years or current overnight shift work including hours of midnight to 4am
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six sessions of telehealth-delivered CBT-I completed prior to transplant

6 weeks
6 sessions (virtual)

Pre-HSCT Reassessment

Reassessments occur post-intervention approximately 1-2 weeks before HSCT

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
1 month and 3 months post-HSCT reassessments

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

Group I: Cognitive behavioral therapy for insomnia (CBT-I)Experimental Treatment1 Intervention
Group II: Treatment As Usual (TAU)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials
527
Recruited
181,000+