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

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ClinicalTrials.gov Identifier: NCT04619771
Recruitment Status : Recruiting
First Posted : November 6, 2020
Last Update Posted : March 17, 2021
Sponsor:
Collaborators:
Johns Hopkins University
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Genna Popovich Hymowitz, Stony Brook University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Insomnia Morbid Obesity Behavioral: Cognitive Behavioral Therapy for Insomnia Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: M-Health Administered Sleep Treatment to Enhance Recovery in Bariatric Populations (MASTER)
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : February 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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. We will deliver 5 CBT-I sessions 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.
 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.
Other Name: CBT-I


Outcome Measures
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Primary Outcome Measures :
  1. Recruitment Rate [ Time Frame: Follow Up (week 15) ]
    Number of participants screened into the study per month will help measure feasibility.

  2. Completion of Study Measures [ Time Frame: 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.

  3. ActiGraph Use [ Time Frame: 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.

  4. Actigraph Compliance [ Time Frame: 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 Outcome Measures :
  1. Treatment Acceptability [ Time Frame: 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?").

  2. Change in sleep onset latency [ Time Frame: Follow-up (week 15) ]
    Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.

  3. Change in wake after sleep onset (WASO) [ Time Frame: Follow-up (week 15) ]
    Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.

  4. Change in total sleep time (TST) [ Time Frame: Follow-up (week 15) ]
    Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.

  5. Change in sleep efficiency [ Time Frame: Follow-up (week 15) ]
    This will be measured by actigraph data and data from participant daily sleep logs.

  6. Change in Insomnia Severity [ Time Frame: 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.

  7. % Excess Weight Loss [ Time Frame: 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.

  8. Change in BMI [ Time Frame: 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.

  9. % Total Weight Loss [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04619771


Contacts
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Contact: Genna F Popovich Hymowitz, Ph.D. 631-632-8657 genna.hymowitz@stonybrookmedicine.edu
Contact: Marshall Beauchamp, Ph.D. 631-632-8657 marshall.beauchamp@stonybrookmedicine.edu

Locations
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United States, New York
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794
Contact: Genna F P Hymowitz    631-632-8657    genna.hymowitz@stonybrookmedicine.edu   
Contact: Marshall P Beauchamp    16316328657    marshall.beauchamp@stonybrook.edu   
Sponsors and Collaborators
Stony Brook University
Johns Hopkins University
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Genna F Popovich Hymowitz, Ph.D. Stony Brook University
More Information
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Responsible Party: Genna Popovich Hymowitz, Clinical Assistant Professor, Stony Brook University
ClinicalTrials.gov Identifier: NCT04619771    
Other Study ID Numbers: IRB2020-00283
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Genna Popovich Hymowitz, Stony Brook University:
Insomnia
Sleep
Bariatric Surgery
Morbid Obesity
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders