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

Feasibility, Acceptability, and Preliminary Treatment Efficacy of Early Cognitive Behavioral Therapy for Insomnia (CBT-I) to Mitigate Insomnia Symptoms and Fatigue and Improve Health-related Quality of Life in Individuals Planning to Undergo Hematopoietic Stem Cell Transplant (HSCT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hematopoietic Stem Cell Transplant
• Intervention / Treatment: Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Catherine Siengsukon, PT, PHD; Phone Number: 913-588-6913; Email: csiengsukon@kumc.edu
• Study Contact Backup: Name: Jade Robichaud; Email: jrobichaud@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
      • Contact: Jade Robichaud; Email: jrobichaud@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive behavioral therapy for insomnia (CBT-I)	Behavioral: Cognitive behavioral therapy for insomnia (CBT-I); 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.
No Intervention: Treatment As Usual (TAU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	% days/week performed stimulus control or counter control if unable to sleep within 20 minutes and % nights/week conducted wind-down routine	pre-HSCT reassessment
Acceptability of Intervention Measure (AIM)	The AIM is a 4-item questionnaire with responses from 1 = completely disagree to 5 = completely agree. A mean is calculated, and higher score indicates greater acceptability.	pre-HSCT reassessment
Feasibility of Intervention Measure (FIM)	The FIM is a 4-item questionnaire with responses from 1 = completely disagree to 5 = completely agree. A mean is calculated, and higher score indicates greater feasibility.	pre-HSCT reassessment
Intervention Appropriateness Measure (IAM)	The IAM is a 4-item questionnaire with responses from 1 = completely disagree to 5 = completely agree. A mean is calculated, and higher score indicates greater appropriateness.	pre-HSCT reassessment
Insomnia Severity Index (ISI)	The ISI consists of 7 items with score ranging from 0-28. A higher score indicates higher insomnia severity	Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
PROMIS Sleep-Related Impairment Short Form 8a	Consists of 8 items, which are summed and converted to a T-score. A higher scores indicates greater sleep-related impairment.	Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
Actigraph total sleep time	Participants will wear an actigraph on their non-dominant wrist for 7 nights. Total sleep time will be determined using ActiLife software from time to fall asleep to time to wake up and will be reported in minutes.	Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
Actigraph sleep efficiency	Participants will wear an actigraph on their non-dominant wrist for 7 nights. Sleep efficiency will be determined using ActiLife software and calculated as total sleep time divided by time in bed X 100 and will be reported in percent.	Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
Actigraph wake after sleep onset	Participants will wear an actigraph on their non-dominant wrist for 7 nights. Wake after sleep onset will be determined using ActiLife software and calculated number of minutes determine be awake during the sleep period and will be reported in percent.	Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
The PROMIS 29+2	31-item self-report measure. Scores are reported as standardized PROMIS T-scores, with higher scores indicating more of the domain being assessed.	Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Self-Efficacy Scale (SESS)	SESS is a 9-item self-report questionnaire used to measure sleep self-efficacy. The respondents indicate confidence in ability to accomplish 9 sleep behaviors on a 5-point Likert scale with 1 = "not confident" at all to 5 = "very confident". The score ranges from 0 to 45 with a higher score indicating greater sleep self-efficacy.	Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
PROMIS Cognitive Function 8-item short form	8 items, each scored from 1-5. The raw score is converted to a t-score, with higher scores indicating better perceived cognitive function.	Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
Positive Affect and Negative Affect Schedule (PANAS)	The PANAS is a 20-item self-report questionnaire used to measure positive and negative emotions. There are two subscales (Positive Affect and Negative Affect) with 10 items each. The respondent scores how applicable a list of emotions are on a 5-point Likert scale with 1 = "Very slightly or not at all" to 5 = "Extremely". A higher score on the Positive Affect subscale indicates greater intensity of positive emotions, and a high score on Negative Affect indicates greater intensity of negative emotions.	Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
Dysfunctional Beliefs About Sleep (DBAS)	This assessment is a 10 item Likert-scale self-report questionnaire. Higher scores indicate more dysfunctional beliefs.	Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): September 8, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: August 11, 2026
• First Submitted That Met QC Criteria: August 14, 2026
• First Posted (Actual): August 19, 2026

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 14, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: STUDY00162729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No