This study is a longitudinal clinical trial designed to assess the feasibility of sleep intervention (Cognitive Behavioral Therapy for Insomnia (CBT-I)) in individuals with insomnia following bariatric surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
CBT-I has a specific protocol with behavioral targets that differ significantly from standard CBT. This approach focuses on implementing sleep restriction and stimulus control interventions which are fully deployed during the first session. 5 CBT-I sessions will be delivered over the course of 8 weeks. Key recommendations include: 1) reduce time in bed; 2) get up at the same time every day; 3) do not go to bed unless sleepy; 4) do not stay in bed awake for more than 15 minutes; and 5) avoid napping. Participants are also taught relaxation strategies and cognitive therapy addresses arousal and catastrophizing.
Stony Brook University
Stony Brook, New York, United States
RECRUITINGRecruitment Rate
Number of participants screened into the study per month will help measure feasibility.
Time frame: Follow Up (week 15)
Completion of Study Measures
The average percentage of study measures (self-report questionnaires, daily diaries and CBT-I sessions) that are completed across participants will help determine feasibility.
Time frame: Follow Up (week 15)
ActiGraph Use
The average percentage of days spent wearing the medical-grade Fitbit-like-device that collects sleep and physical activity data to help assess feasibility.
Time frame: Follow Up (week 15)
Actigraph Compliance
The average percentage of hours of wear per day of the medical-grade Fitbit-like-device that collects sleep and physical activity data to help assess feasibility.
Time frame: Follow Up (week 15)
Treatment Acceptability
Treatment Acceptability Questionnaire will measure acceptability with patient-reported treatment satisfaction, and open-ended questions about satisfaction with both CBT-I and telemedicine (e.g., "What did you think about treating sleep as part of your Bariatric care?"; "How did you feel about getting treatment without being face-to-face?"; "What could we do to improve your treatment experience?").
Time frame: Follow Up (week 15)
Change in sleep onset latency
Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.
Time frame: Follow-up (week 15)
Change in wake after sleep onset (WASO)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.
Time frame: Follow-up (week 15)
Change in total sleep time (TST)
Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.
Time frame: Follow-up (week 15)
Change in sleep efficiency
This will be measured by actigraph data and data from participant daily sleep logs.
Time frame: Follow-up (week 15)
Change in Insomnia Severity
The Insomnia Severity Index will be used to assess insomnia symptoms. The total score ranges from 0 to 63, with higher scores indicating more severe insomnia symptoms.
Time frame: Visit 1 (Week 3), Visit 5 (Week 11), Follow up (Week 15)
% Excess Weight Loss
Measured weight data will be extracted from electronic medical records. The following formula will be used to calculate % excess weight loss. %EWL = \[(Initial Weight) - (Post Intervention Weight)\] / \[(Initial Weight) - (Ideal Weight)\]. Ideal weight will be extracted from the EMR.
Time frame: Baseline (week 1), Follow-up (week 15)
Change in BMI
BMI will be extracted from electronic medical records and the formula: ΔBMI = (Initial BMI) - (BMI at week 15) will be used to calculate change in BMI.
Time frame: Baseline (week 1), Follow-up (week 15)
% Total Weight Loss
Weight data will be extracted from the electronic medical record. %TWL will be calculated using the following formula: % TWL= \[(Initial Weight) - (Post intervention Weight)\] / \[(Initial Weight)\]× 100
Time frame: Baseline (week 1), Follow-up (week 15)