Insomnia, Morbid Obesity
Conditions
Keywords
Insomnia, Sleep, Bariatric Surgery, Morbid Obesity
Brief summary
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy for Insomnia
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.
Sponsors
Johns Hopkins University
Dartmouth-Hitchcock Medical Center
Stony Brook University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-64 * Fluency with English * Willingness to maintain an active telehealth platform account * Daily access to wireless internet connection or sufficient cell phone service for telemedicine * Undergone bariatric surgery (Roux-en-Y or vertical sleeve gastrectomy) within past 1-3 years * Must have experienced \<50% excess weight loss following surgery Clinically significant insomnia (i.e., ISI score \>11)
Exclusion criteria
* Patient underwent revision of initial weight loss procedure * PHQ-9 Depression score \> 15 * GAD-7 Anxiety score \> 15 * Current alcohol or substance abuse * Current narcotic use * Unstable major psychiatric condition * Restless leg syndrome * Sleep apnea with non-adherence to CPAP intervention (i.e., use of CPAP \<4 nights/week) * Other problems at investigator discretion * Vulnerable populations (e.g., adults unable to consent, ages \<18, pregnant women, and prisoners).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | Follow Up (week 15) | Number of participants screened into the study per month will help measure feasibility. |
| Completion of Study Measures | Follow Up (week 15) | The average percentage of study measures (self-report questionnaires, daily diaries and CBT-I sessions) that are completed across participants will help determine feasibility. |
| ActiGraph Use | Follow Up (week 15) | The average percentage of days spent wearing the medical-grade Fitbit-like-device that collects sleep and physical activity data to help assess feasibility. |
| Actigraph Compliance | Follow Up (week 15) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep efficiency | Follow-up (week 15) | This will be measured by actigraph data and data from participant daily sleep logs. |
| Change in Insomnia Severity | Visit 1 (Week 3), Visit 5 (Week 11), Follow up (Week 15) | 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. |
| Treatment Acceptability | Follow Up (week 15) | 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?). |
| Change in BMI | Baseline (week 1), Follow-up (week 15) | 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. |
| % Total Weight Loss | Baseline (week 1), Follow-up (week 15) | 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 |
| % Excess Weight Loss | Baseline (week 1), Follow-up (week 15) | 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. |
| Change in sleep onset latency | Follow-up (week 15) | Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer. |
| Change in wake after sleep onset (WASO) | Follow-up (week 15) | Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer. |
| Change in total sleep time (TST) | Follow-up (week 15) | Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer. |
Countries
United States
Contacts
Primary ContactGenna F Popovich Hymowitz, Ph.D.
Backup ContactMarshall Beauchamp, Ph.D.
Outcome results
None listed