SleepNCT02665247
Impact of Sleep Workshops in College Students
A study testing C-SIP and Dream discussion in people with Sleep and Insomnia, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Insomnia, Sleep Deprivation
- What is being tested?
- C-SIP and Dream discussion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2016to 24 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Currently enrolled in classes at the NYU Washington Square campus
Who cannot join
- Students previously enrolled in the "While You Were Sleeping" course at NYU
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sleep, Insomnia, Sleep Deprivation
- Being tested
- C-SIP, Dream discussion
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-SIPBehavioural
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.
Dream discussionOther
Participants assigned to the control group will attend sessions in which information on sleep is presented in the form of dream discussions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Dream discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Center for Epidemiologic Studies Depression Scale (CESD) score from baseline
Measured: 13 weeks
Change in Epworth Sleepiness Scale (ESS) score from baseline
Measured: 13 weeks
Change in Fatigue Severity Scale (FSS) score from baseline
Measured: 13 weeks
Change in Health Behaviors Survey (HBS) score from baseline
Measured: 13 weeks
Change in Morningness-Eveningness Questionnaire (MEQ-SA) from baseline
Measured: 13 weeks
Change in Perceived Stress Scale (PSS) score from baseline
Measured: 13 weeks
Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline
Measured: 13 weeks
Change in Sleep Hygiene Index (SHI) score from baseline
Measured: 13 weeks
Change in State Trait Anxiety Inventory for Adults (Y-6 item) (STAI-Y6) score from baseline
Measured: 13 weeks
Change in Sleep Student Behavior Survey (SSBS) score from baseline
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study start24 Oct 2016
- Primary completion24 Nov 2019
- Study completion24 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jess Shatkin, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665247
- Sponsor's protocol ID
- 15-00847
- Status last verified
- Jul 2022
- First submitted
- 22 Jan 2016
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sleep Workshops in College Students
- ClinicalTrials.gov ID
- NCT02665247
- Acronym / sponsor ID
- 15-00847
- Conditions
- Sleep, Insomnia, Sleep Deprivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 24 Oct 2016 (actual)
- Primary completion
- 24 Nov 2019 (actual)
- Study completion
- 24 Nov 2019 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-SIP | Experimental | Behavioral: C-SIPParticipants 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. |
| Control Session | Other | Other: Dream discussionParticipants assigned to the control group will attend sessions in which information on sleep is presented in the form of dream discussions. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Currently enrolled in classes at the NYU Washington Square campus
Key exclusion criteria (1 listed)
- Students previously enrolled in the "While You Were Sleeping" course at NYU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-SIPIn 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. | Behavioural | C-SIP |
| Dream discussionParticipants assigned to the control group will attend sessions in which information on sleep is presented in the form of dream discussions. | Other | Control Session |
Primary outcome
Change in Center for Epidemiologic Studies Depression Scale (CESD) score from baseline
Time frame: 13 weeks
Change in Epworth Sleepiness Scale (ESS) score from baseline
Time frame: 13 weeks
Change in Fatigue Severity Scale (FSS) score from baseline
Time frame: 13 weeks
Change in Health Behaviors Survey (HBS) score from baseline
Time frame: 13 weeks
Change in Morningness-Eveningness Questionnaire (MEQ-SA) from baseline
Time frame: 13 weeks
Change in Perceived Stress Scale (PSS) score from baseline
Time frame: 13 weeks
Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline
Time frame: 13 weeks
Change in Sleep Hygiene Index (SHI) score from baseline
Time frame: 13 weeks
Change in State Trait Anxiety Inventory for Adults (Y-6 item) (STAI-Y6) score from baseline
Time frame: 13 weeks
Change in Sleep Student Behavior Survey (SSBS) score from baseline
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jess Shatkin principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-SIP and Dream discussion in people with Sleep and Insomnia, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Center for Epidemiologic Studies Depression Scale (CESD) score from baseline (time frame: 13 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.