Back to resultsImpact of Sleep Workshops in College Students
Primary Purpose
Sleep, Insomnia, Sleep Deprivation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
C-SIP
Dream discussion
Sponsored by
About this trial
This is an interventional treatment trial for Sleep
Eligibility 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
Sites / Locations
- NYU School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
C-SIP
Control Session
Arm Description
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.
Participants assigned to the control group will attend sessions in which information on sleep is presented in the form of dream discussions.
Outcomes
Primary Outcome Measures
Change in Center for Epidemiologic Studies Depression Scale (CESD) score from baseline
Change in Epworth Sleepiness Scale (ESS) score from baseline
Change in Fatigue Severity Scale (FSS) score from baseline
Change in Health Behaviors Survey (HBS) score from baseline
Change in Morningness-Eveningness Questionnaire (MEQ-SA) from baseline
Change in Perceived Stress Scale (PSS) score from baseline
Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline
Change in Sleep Hygiene Index (SHI) score from baseline
Change in State Trait Anxiety Inventory for Adults (Y-6 item) (STAI-Y6) score from baseline
Change in Sleep Student Behavior Survey (SSBS) score from baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02665247
Brief Title
Impact of Sleep Workshops in College Students
Official Title
Impact of Sleep Workshops in College Students
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 24, 2016 (Actual)
Primary Completion Date
November 24, 2019 (Actual)
Study Completion Date
November 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Insomnia, Sleep Deprivation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C-SIP
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Session
Arm Type
Other
Arm Description
Participants assigned to the control group will attend sessions in which information on sleep is presented in the form of dream discussions.
Intervention Type
Behavioral
Intervention Name(s)
C-SIP
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dream discussion
Intervention Description
Participants assigned to the control group will attend sessions in which information on sleep is presented in the form of dream discussions.
Primary Outcome Measure Information:
Title
Change in Center for Epidemiologic Studies Depression Scale (CESD) score from baseline
Time Frame
13 weeks
Title
Change in Epworth Sleepiness Scale (ESS) score from baseline
Time Frame
13 weeks
Title
Change in Fatigue Severity Scale (FSS) score from baseline
Time Frame
13 weeks
Title
Change in Health Behaviors Survey (HBS) score from baseline
Time Frame
13 weeks
Title
Change in Morningness-Eveningness Questionnaire (MEQ-SA) from baseline
Time Frame
13 weeks
Title
Change in Perceived Stress Scale (PSS) score from baseline
Time Frame
13 weeks
Title
Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline
Time Frame
13 weeks
Title
Change in Sleep Hygiene Index (SHI) score from baseline
Time Frame
13 weeks
Title
Change in State Trait Anxiety Inventory for Adults (Y-6 item) (STAI-Y6) score from baseline
Time Frame
13 weeks
Title
Change in Sleep Student Behavior Survey (SSBS) score from baseline
Time Frame
13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jess Shatkin
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Impact of Sleep Workshops in College Students
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