search
Back to results

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

Primary Purpose

Insomnia, Morbid Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Sleep, Bariatric Surgery, Morbid Obesity

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Stony Brook UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive Behavioral Therapy for Insomnia

Arm Description

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.

Outcomes

Primary Outcome Measures

Recruitment Rate
Number of participants screened into the study per month will help measure feasibility.
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.
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.
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.

Secondary Outcome Measures

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?").
Change in sleep onset latency
Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.
Change in wake after sleep onset (WASO)
Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.
Change in total sleep time (TST)
Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.
Change in sleep efficiency
This will be measured by actigraph data and data from participant daily sleep logs.
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.
% 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.
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.
% 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

Full Information

First Posted
October 27, 2020
Last Updated
March 15, 2021
Sponsor
Stony Brook University
Collaborators
Johns Hopkins University, Dartmouth-Hitchcock Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04619771
Brief Title
M-Health Administered Sleep Treatment to Enhance Recovery in Bariatric Populations (MASTER)
Acronym
MASTER
Official Title
M-Health Administered Sleep Treatment to Enhance Recovery in Bariatric Populations (MASTER)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
Collaborators
Johns Hopkins University, Dartmouth-Hitchcock Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Morbid Obesity
Keywords
Insomnia, Sleep, Bariatric Surgery, Morbid Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy for Insomnia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia
Other Intervention Name(s)
CBT-I
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment Rate
Description
Number of participants screened into the study per month will help measure feasibility.
Time Frame
Follow Up (week 15)
Title
Completion of Study Measures
Description
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)
Title
ActiGraph Use
Description
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)
Title
Actigraph Compliance
Description
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)
Secondary Outcome Measure Information:
Title
Treatment Acceptability
Description
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)
Title
Change in sleep onset latency
Description
Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.
Time Frame
Follow-up (week 15)
Title
Change in wake after sleep onset (WASO)
Description
Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.
Time Frame
Follow-up (week 15)
Title
Change in total sleep time (TST)
Description
Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.
Time Frame
Follow-up (week 15)
Title
Change in sleep efficiency
Description
This will be measured by actigraph data and data from participant daily sleep logs.
Time Frame
Follow-up (week 15)
Title
Change in Insomnia Severity
Description
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)
Title
% Excess Weight Loss
Description
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)
Title
Change in BMI
Description
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)
Title
% Total Weight Loss
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Genna F Popovich Hymowitz, Ph.D.
Phone
631-632-8657
Email
genna.hymowitz@stonybrookmedicine.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Marshall Beauchamp, Ph.D.
Phone
631-632-8657
Email
marshall.beauchamp@stonybrookmedicine.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Genna F Popovich Hymowitz, Ph.D.
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Genna F P Hymowitz
Phone
631-632-8657
Email
genna.hymowitz@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Marshall P Beauchamp
Phone
16316328657
Email
marshall.beauchamp@stonybrook.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs