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Impact of Sleep Workshops in College Students

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ClinicalTrials.gov Identifier: NCT02665247
Recruitment Status : Completed
First Posted : January 27, 2016
Last Update Posted : July 7, 2022
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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Brief Summary:
The purpose of this pilot study is to assess the impact of sleep workshops on sleep, mood, anxiety and well-being measures in a sample of college students. College students have a high prevalence of sleep problems including poor sleep hygiene, volitional sleep deprivation, and insomnia. Sleep disorders in college students negatively affect mood, social functioning, physical safety, and academic performance. Rarely recognized by the students themselves, these conditions are therefore often untreated. Participants in this study will be randomly assigned to receive the College Sleep Improvement Plan (C-SIP) or a control session. Participants will be asked to track their sleep as well as complete questionnaires; a subset of participants will be asked to wear an activity monitor.

Condition or disease Intervention/treatment Phase
Sleep Insomnia Sleep Deprivation Behavioral: C-SIP Other: Dream discussion Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Sleep Workshops in College Students
Actual Study Start Date : October 24, 2016
Actual Primary Completion Date : November 24, 2019
Actual Study Completion Date : November 24, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: C-SIP
Participants assigned to the C-SIP group will attend sessions where information about sleep is presented. In session I, information about sleep and the effects of lack of sleep will be presented. Participants will also be presented with advice and tips on how to improve sleep. Session II will focus on assisting participants overcome any barriers they faced in applying the advice they received in session I; participants will also receive additional information on sleep and sleep-related techniques.
 Behavioral: C-SIP
In session I, information about sleep and the effects of lack of sleep will be presented. Participants will also be presented with advice and tips on how to improve sleep. Session II will focus on assisting participants overcome any barriers they faced in applying the advice they received in session I; participants will also receive additional information on sleep and sleep-related techniques.
Control Session
Participants assigned to the control group will attend sessions in which information on sleep is presented in the form of dream discussions.
 Other: Dream discussion
Participants assigned to the control group will attend sessions in which information on sleep is presented in the form of dream discussions.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Center for Epidemiologic Studies Depression Scale (CESD) score from baseline [ Time Frame: 13 weeks ]
  2. Change in Epworth Sleepiness Scale (ESS) score from baseline [ Time Frame: 13 weeks ]
  3. Change in Fatigue Severity Scale (FSS) score from baseline [ Time Frame: 13 weeks ]
  4. Change in Health Behaviors Survey (HBS) score from baseline [ Time Frame: 13 weeks ]
  5. Change in Morningness-Eveningness Questionnaire (MEQ-SA) from baseline [ Time Frame: 13 weeks ]
  6. Change in Perceived Stress Scale (PSS) score from baseline [ Time Frame: 13 weeks ]
  7. Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline [ Time Frame: 13 weeks ]
  8. Change in Sleep Hygiene Index (SHI) score from baseline [ Time Frame: 13 weeks ]
  9. Change in State Trait Anxiety Inventory for Adults (Y-6 item) (STAI-Y6) score from baseline [ Time Frame: 13 weeks ]
  10. Change in Sleep Student Behavior Survey (SSBS) score from baseline [ Time Frame: 13 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Currently enrolled in classes at the NYU Washington Square campus

Exclusion Criteria:

  • Students previously enrolled in the "While You Were Sleeping" course at NYU
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): NCT02665247


Locations
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United States, New York
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Jess Shatkin NYU Langone Medical Center
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02665247    
Other Study ID Numbers: 15-00847
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: July 7, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Deprivation
Dyssomnias
Sleep Wake Disorders
 Nervous System Diseases
Neurologic Manifestations
Mental Disorders