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

NCT07774039 | Recruiting Phase 1

• 1 other identifier: STUDY00162729
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematopoietic Stem Cell Transplant

Outcome Measures

Primary Outcomes (3)

• Recruitment

  number of people enrolled out of the number of people eligible

  1 year

• Retention

  number of participants who complete the study

  1 year

• Attendance

  number of cognitive behavioral therapy for insomnia (CBT-I) sessions attended

  pre-hematopoietic stem cell transplant (HSCT) reassessment

Secondary Outcomes (10)

• Adherence

  pre-HSCT reassessment

• Acceptability of Intervention Measure (AIM)

  pre-HSCT reassessment

• Feasibility of Intervention Measure (FIM)

  pre-HSCT reassessment

• Intervention Appropriateness Measure (IAM)

  pre-HSCT reassessment

• Insomnia Severity Index (ISI)

  Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment

Other Outcomes (4)

• Sleep Self-Efficacy Scale (SESS)

  Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment

• PROMIS Cognitive Function 8-item short form

  Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment

• Positive Affect and Negative Affect Schedule (PANAS)

  Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment

Study Arms (2)

Cognitive behavioral therapy for insomnia (CBT-I)

EXPERIMENTAL

Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)

Treatment As Usual (TAU)

NO INTERVENTION

Interventions

Cognitive behavioral therapy for insomnia (CBT-I) BEHAVIORAL

The CBT-I program is a 1x/week, 6-week one-one-one program via video conferencing with trained research personnel. The program is based on standard CBT-I manuals.

Cognitive behavioral therapy for insomnia (CBT-I)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• ≥10 on Insomnia Severity Index
• Primary HSCT physician approval
• English speaking

You may not qualify if:

• 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
• If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking \< 3 months or dose has changed in past 3 months
• T-score ≥70 on PROMIS 29+2 Anxiety or PROMIS 29+2 Depression domains indicating moderate/severe anxiety or depression
• Current or history (up to 2 years) of substance use disorder involving drugs or alcohol as defined by DSM-5-TR criteria
• History of other nervous system disorder such as stroke or Parkinson's disease
• Severe mental illness such as schizophrenia or bipolar disorder
• Severe neurological or sensory impairments that would interfere significantly with testing
• History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am
• Currently receiving a behavioral sleep health intervention or other behavioral health interventions that may impact sleep (such as exercise, mindfulness, CBT)

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center- Sleep, Health and Wellness Laboratory

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Catherine Siengsukon, PT, PHD

CONTACT

913-588-6913; csiengsukon@kumc.edu

Jade Robichaud

CONTACT

jrobichaud@kumc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 19, 2026
• Study Start: September 16, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)