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NCT Number: NCT07774039

Early Cognitive Behavioral Therapy for Insomnia (CBT-I) in People Planning to Under 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.

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Key information

Conditions

Hematopoietic Stem Cell Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Kansas City, Kansas, 66160, United States

Location contact

Jade Robichaud

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Recruitment

    Time frame: 1 year

    number of people enrolled out of the number of people eligible

  2. Retention

    Time frame: 1 year

    number of participants who complete the study

  3. Attendance

    Time frame: pre-hematopoietic stem cell transplant (HSCT) reassessment

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

Secondary outcomes

  1. Adherence

    Time frame: pre-HSCT reassessment

    % days/week performed stimulus control or counter control if unable to sleep within 20 minutes and % nights/week conducted wind-down routine

  2. Acceptability of Intervention Measure (AIM)

    Time frame: pre-HSCT reassessment

    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.

  3. Feasibility of Intervention Measure (FIM)

    Time frame: pre-HSCT reassessment

    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.

  4. Intervention Appropriateness Measure (IAM)

    Time frame: pre-HSCT reassessment

    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.

  5. Insomnia Severity Index (ISI)

    Time frame: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment

    The ISI consists of 7 items with score ranging from 0-28. A higher score indicates higher insomnia severity

  6. PROMIS Sleep-Related Impairment Short Form 8a

    Time frame: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment

    Consists of 8 items, which are summed and converted to a T-score. A higher scores indicates greater sleep-related impairment.

  7. Actigraph total sleep time

    Time frame: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment

    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.

  8. Actigraph sleep efficiency

    Time frame: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment

    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.

  9. Actigraph wake after sleep onset

    Time frame: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment

    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.

  10. The PROMIS 29+2

    Time frame: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment

    31-item self-report measure. Scores are reported as standardized PROMIS T-scores, with higher scores indicating more of the domain being assessed.

Other outcomes

  1. Sleep Self-Efficacy Scale (SESS)

    Time frame: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment

    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.

  2. PROMIS Cognitive Function 8-item short form

    Time frame: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment

    8 items, each scored from 1-5. The raw score is converted to a t-score, with higher scores indicating better perceived cognitive function.

  3. Positive Affect and Negative Affect Schedule (PANAS)

    Time frame: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment

    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.

  4. Dysfunctional Beliefs About Sleep (DBAS)

    Time frame: Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment

    This assessment is a 10 item Likert-scale self-report questionnaire. Higher scores indicate more dysfunctional beliefs.

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Siengsukon, PT, PHD

CONTACT

[email protected]

913-588-6913

Jade Robichaud

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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