InsomniaMASTERNCT04619771
M-Health Administered Sleep Treatment to Enhance Recovery in Bariatric Populations (MASTER)
A study testing Cognitive Behavioral Therapy for Insomnia in people with Insomnia and Morbid Obesity, run by Stony Brook University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Insomnia, Morbid Obesity
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University
Stony Brook, New York, 11794
Genna F P Hymowitz, 631-632-8657, genna.hymowitz@stonybrookmedicine.edu
Marshall P Beauchamp, 16316328657, marshall.beauchamp@stonybrook.edu
About this study
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.
- Conditions
- Insomnia, Morbid Obesity
- Being tested
- Cognitive Behavioral Therapy for Insomnia
- Keywords
- Insomnia, Sleep, Bariatric Surgery, Morbid Obesity
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
Also called CBT-I
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number of participants screened into the study per month will help measure feasibility.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Follow Up (week 15)
Secondary outcomes (9)
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?").
Measured: Follow Up (week 15)
Change in sleep onset latency
Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.
Measured: Follow-up (week 15)
Change in wake after sleep onset (WASO)
Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.
Measured: Follow-up (week 15)
Change in total sleep time (TST)
Sleep parameters will be measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer.
Measured: Follow-up (week 15)
Change in sleep efficiency
This will be measured by actigraph data and data from participant daily sleep logs.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline (week 1), Follow-up (week 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Jan 2021
- Primary completionNov 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Dartmouth-Hitchcock Medical Center
- Responsible party
- Principal investigator, Genna Popovich Hymowitz, Stony Brook University
- Investigators
- Genna F Popovich Hymowitz, Ph.D., Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619771
- Sponsor's protocol ID
- IRB2020-00283
- Acronym
- MASTER
- Status last verified
- Mar 2021
- First submitted
- 27 Oct 2020
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- M-Health Administered Sleep Treatment to Enhance Recovery in Bariatric Populations (MASTER)
- ClinicalTrials.gov ID
- NCT04619771
- Acronym / sponsor ID
- MASTER / IRB2020-00283
- Conditions
- Insomnia, Morbid Obesity
- Keywords
- Insomnia, Sleep, Bariatric Surgery, Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Dartmouth-Hitchcock Medical Center
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Experimental | Behavioral: Cognitive Behavioral Therapy for InsomniaCBT-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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for InsomniaAlso: CBT-ICBT-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. | Behavioural | Cognitive Behavioral Therapy for Insomnia |
Primary outcome
Recruitment Rate
Time frame: Follow Up (week 15)
Number of participants screened into the study per month will help measure feasibility.
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.
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.
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.
9 secondary outcomes
Treatment Acceptability
Time frame: Follow Up (week 15)
Change in sleep onset latency
Time frame: Follow-up (week 15)
Change in wake after sleep onset (WASO)
Time frame: Follow-up (week 15)
Change in total sleep time (TST)
Time frame: Follow-up (week 15)
Change in sleep efficiency
Time frame: Follow-up (week 15)
Change in Insomnia Severity
Time frame: Visit 1 (Week 3), Visit 5 (Week 11), Follow up (Week 15)
% Excess Weight Loss
Time frame: Baseline (week 1), Follow-up (week 15)
Change in BMI
Time frame: Baseline (week 1), Follow-up (week 15)
% Total Weight Loss
Time frame: Baseline (week 1), Follow-up (week 15)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Genna F Popovich Hymowitz, Ph.D. principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia in people with Insomnia and Morbid Obesity, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Genna F Popovich Hymowitz, Ph.D. (631-632-8657, genna.hymowitz@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Follow Up (week 15)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.