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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02665247
Other study ID # 15-00847
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 24, 2016
Est. completion date November 24, 2019

Study information

Verified date July 2022
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date November 24, 2019
Est. primary completion date November 24, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States NYU School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Center for Epidemiologic Studies Depression Scale (CESD) score from baseline 13 weeks
Primary Change in Epworth Sleepiness Scale (ESS) score from baseline 13 weeks
Primary Change in Fatigue Severity Scale (FSS) score from baseline 13 weeks
Primary Change in Health Behaviors Survey (HBS) score from baseline 13 weeks
Primary Change in Morningness-Eveningness Questionnaire (MEQ-SA) from baseline 13 weeks
Primary Change in Perceived Stress Scale (PSS) score from baseline 13 weeks
Primary Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline 13 weeks
Primary Change in Sleep Hygiene Index (SHI) score from baseline 13 weeks
Primary Change in State Trait Anxiety Inventory for Adults (Y-6 item) (STAI-Y6) score from baseline 13 weeks
Primary Change in Sleep Student Behavior Survey (SSBS) score from baseline 13 weeks
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