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.
≥18 years old
≥10 on Insomnia Severity Index
Primary HSCT physician approval
English speaking
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
Parallel
Cognitive behavioral therapy for insomnia (CBT-I)
BehavioralThe 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.
Recruitment
number of people enrolled out of the number of people eligible
Retention
number of participants who complete the study
Attendance
number of cognitive behavioral therapy for insomnia (CBT-I) sessions attended
Adherence
% days/week performed stimulus control or counter control if unable to sleep within 20 minutes and % nights/week conducted wind-down routine
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.
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.
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.
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.
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.
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.
Dysfunctional Beliefs About Sleep (DBAS)
This assessment is a 10 item Likert-scale self-report questionnaire. Higher scores indicate more dysfunctional beliefs.
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