NCT02665247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

October 24, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2019

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

3.1 years

First QC Date

January 22, 2016

Last Update Submit

July 5, 2022

Conditions

SleepInsomniaSleep Deprivation

Outcome Measures

Primary Outcomes (10)

  • Change in Center for Epidemiologic Studies Depression Scale (CESD) score from baseline

    13 weeks

  • Change in Epworth Sleepiness Scale (ESS) score from baseline

    13 weeks

  • Change in Fatigue Severity Scale (FSS) score from baseline

    13 weeks

  • Change in Health Behaviors Survey (HBS) score from baseline

    13 weeks

  • Change in Morningness-Eveningness Questionnaire (MEQ-SA) from baseline

    13 weeks

  • Change in Perceived Stress Scale (PSS) score from baseline

    13 weeks

  • Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline

    13 weeks

  • Change in Sleep Hygiene Index (SHI) score from baseline

    13 weeks

  • Change in State Trait Anxiety Inventory for Adults (Y-6 item) (STAI-Y6) score from baseline

    13 weeks

  • Change in Sleep Student Behavior Survey (SSBS) score from baseline

    13 weeks

Study Arms (2)

C-SIP

EXPERIMENTAL

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

Control Session

OTHER

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

Interventions

C-SIPBEHAVIORAL

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.

C-SIP
Dream discussionOTHER

Participants assigned to the control group will attend sessions in which information on sleep is presented in the form of dream discussions.

Control Session

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Currently enrolled in classes at the NYU Washington Square campus

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleep Deprivation

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jess Shatkin

    NYU Langone Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2016

First Posted

January 27, 2016

Study Start

October 24, 2016

Primary Completion

November 24, 2019

Study Completion

November 24, 2019

Last Updated

July 7, 2022

Record last verified: 2022-07

Locations

US(1)