Recruiting

M-Health

Sponsor:

Stony Brook University

Code:

NCT04619771

Conditions

Insomnia

Morbid Obesity

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy for Insomnia

Study Details

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.

Conditions

Insomnia

Morbid Obesity

Study ID

NCT04619771

Start date

Jan 1, 2021

Status verified date

Mar, 2021

Completion date

Feb, 2022

Anticipated

Primary completion date

Nov, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Recruitment Rate [ Time Frame: Follow Up (week 15) ]
  • Completion of Study Measures [ Time Frame: Follow Up (week 15) ]
  • ActiGraph Use [ Time Frame: Follow Up (week 15) ]
  • Actigraph Compliance [ Time Frame: Follow Up (week 15) ]

Central Contacts and Locations

Central contacts

Genna F Popovich Hymowitz, Ph.D.

631-632-8657genna.hymowitz@stonybrookmedicine.edu

Marshall Beauchamp, Ph.D.

631-632-8657marshall.beauchamp@stonybrookmedicine.edu

Locations

Stony Brook University

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Genna F P Hymowitz

631-632-8657genna.hymowitz@stonybrookmedicine.edu

Marshall P Beauchamp

16316328657marshall.beauchamp@stonybrook.edu

More Information

Sponsor

Stony Brook University

Last update posted

Mar 17, 2021

Last verified

Mar, 2021

Keywords

  • Insomnia
  • Sleep
  • Bariatric Surgery
  • Morbid Obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2021-03-17.