M-Health Administered Sleep Treatment to Enhance Recovery in Bariatric Populations (MASTER)

Insomnia Clinical Trial

— MASTER  

Official title:

M-Health Administered Sleep Treatment to Enhance Recovery in Bariatric Populations (MASTER)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04619771
• Other study ID #: IRB2020-00283
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: February 2022

Study information

• Verified date: March 2021
• Source: Stony Brook University
• Contact: Genna F Popovich Hymowitz, Ph.D.
• Phone: 631-632-8657
• Email: genna.hymowitz[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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).

Related Conditions & MeSH terms

• Insomnia
• Morbid Obesity
• Obesity, Morbid
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive 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.

Locations

Country	Name	City	State
United States	Stony Brook University	Stony Brook	New York

Sponsors (3)

Lead Sponsor	Collaborator
Stony Brook University	Dartmouth-Hitchcock Medical Center, Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	Number of participants screened into the study per month will help measure feasibility.	Follow Up (week 15)
Primary	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.	Follow Up (week 15)
Primary	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.	Follow Up (week 15)
Primary	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.	Follow Up (week 15)
Secondary	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?").	Follow Up (week 15)
Secondary	Change in sleep onset latency	Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.	Follow-up (week 15)
Secondary	Change in wake after sleep onset (WASO)	Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.	Follow-up (week 15)
Secondary	Change in total sleep time (TST)	Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.	Follow-up (week 15)
Secondary	Change in sleep efficiency	This will be measured by actigraph data and data from participant daily sleep logs.	Follow-up (week 15)
Secondary	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.	Visit 1 (Week 3), Visit 5 (Week 11), Follow up (Week 15)
Secondary	% 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.	Baseline (week 1), Follow-up (week 15)
Secondary	Change in BMI	BMI will be extracted from electronic medical records and the formula: ?BMI = (Initial BMI) - (BMI at week 15) will be used to calculate change in BMI.	Baseline (week 1), Follow-up (week 15)
Secondary	% 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	Baseline (week 1), Follow-up (week 15)