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

Phase 1Not Yet RecruitingNCT07774039

University of Kansas Medical Center30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hematopoietic Stem Cell Transplant

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Recruitment

number of people enrolled out of the number of people eligible

Time frame: 1 year

Retention

number of participants who complete the study

Time frame: 1 year

Attendance

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

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

Secondary Outcomes

Adherence

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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