Hematopoietic Stem Cell Transplant
Conditions
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.
Interventions
BEHAVIORALCognitive 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.
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 1 year | number of people enrolled out of the number of people eligible |
| Retention | 1 year | number of participants who complete the study |
| Attendance | pre-hematopoietic stem cell transplant (HSCT) reassessment | number of cognitive behavioral therapy for insomnia (CBT-I) sessions attended |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | 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 |
| PROMIS Sleep-Related Impairment Short Form 8a | 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. |
| Actigraph total sleep time | 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. |
| Acceptability of Intervention Measure (AIM) | 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. |
| Actigraph wake after sleep onset | 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. |
| The PROMIS 29+2 | 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. |
| Adherence | 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 |
| Actigraph sleep efficiency | 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. |
| Feasibility of Intervention Measure (FIM) | 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. |
| Intervention Appropriateness Measure (IAM) | 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. |
Countries
United States
Contacts
CONTACTCatherine Siengsukon, PT, PHD
CONTACTJade Robichaud
Outcome results
None listed