InsomniaSSITNCT04988464
A Single-Session Online Insomnia Intervention
A study testing Sleep Scholar and Building Healthy Habits in people with Insomnia, run by Auburn University at 1 site in United States.
Trial summary
Cognitive-Behavioral Therapy for Insomnia (CBT-I) is a promising suicide intervention for college students because insomnia is robust risk factor for suicide ideation and CBT-I reduces suicide ideation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Sleep Scholar and Building Healthy Habits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2021to 22 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least subclinical insomnia
- Auburn University undergraduate students
Who cannot join
- Under age 18
- Engagement in shift work
- Untreated restless leg syndrome
- Untreated sleep apnea
- Untreated chronic pain
- Current engagement in insomnia treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Sleep Scholar: A Single-Session, Internet-Based Insomnia Intervention for College Students
Cognitive-Behavioral Therapy for Insomnia (CBT-I) is a promising suicide intervention for college students because insomnia is robust risk factor for suicide ideation and CBT-I reduces suicide ideation. Moreover, CBT-I can be self-guided and internet-based, brief, and relatively lower in stigma compared to treatment specifically targeting suicide ideation. However, self-guided, internet-based CBT-I is not brief, and brief CBT-I is neither self-guided nor internet-based. In addition, CBT-I is not usually designed to address the unique experiences of college students. Therefore, this study is a randomized-controlled trial examining the efficacy of Sleep Scholar, a single-session, internet-based insomnia intervention tailored to the needs of college students. The investigators hypothesize that Sleep Scholar will improve insomnia, sleep diary variables (e.g., sleep latency), sleep quality, dysfunctional beliefs about sleep, suicide ideation, depressive, anxiety, and PTSD symptoms over time and compared to a control condition (Building Healthy Habits). The investigators will recruit college students with at least subclinical insomnia symptoms. Participants will complete seven daily pre-treatment sleep diaries and a pre-treatment assessment then be randomized to either Sleep Scholar or Building Healthy Habits, the control single-session, internet-based health intervention condition. After the intervention, participants will complete a post-treatment assessment of acceptability and satisfaction, implement the intervention's strategies, and complete daily sleep diaries for the following four weeks. In addition, participants will complete a one-week and one-month follow-up. If found to be efficacious, Sleep Scholar has the potential to be widely disseminated to college students with insomnia symptoms.
Read the detailed description
In 2019, college-aged adults in the United States (18-25-year-olds) had the highest rate of past-year suicide ideation (11.8%) compared to any other age group. In addition, the rate of suicide ideation among college-aged adults in the United States has been rising in recent years, especially during the COVID-19 pandemic. Despite the need for mental health treatment among college students, only approximately half of college students experiencing suicide ideation received treatment in the past year, reporting limited access to mental health treatment due to time constraints, financial costs, stigma, concerns about privacy, and an inconvenient location of treatment facilities. Insomnia treatment is a particularly promising target for suicide prevention efforts among college students because insomnia is fairly common, insomnia is a robust risk factor for suicide ideation, and insomnia treatments improve suicide ideation. Moreover, insomnia treatments can be self-guided and internet-based, brief, and relatively lower in stigma compared to treatment specifically targeting suicide ideation. However, current self-guided, internet-based insomnia treatments require a time-intensive process, and current brief insomnia treatments require a trained professional. In addition, previous randomized controlled trials that examined the efficacy of insomnia treatment have recruited samples that are mostly older than college-aged adults and the interventions were not developed with the unique sleep needs of college students in mind. As such, the generalizability of insomnia treatments to college students is unknown. Therefore, the current study aims to examine the efficacy of Sleep Scholar, a single-session, internet-based insomnia intervention tailored to the needs of college students with at least subclinical insomnia symptoms and a lifetime history of suicide ideation.
Insomnia
Approximately 10% of college students meet criteria for insomnia disorder, and approximately one-third of college students have subclinical insomnia symptoms. College students experience a variety of stressors, including transitioning to a new environment, interpersonal difficulties (e.g., family and romantic partners), and increased academic responsibilities. These stressful life events may increase their risk for developing insomnia symptoms through poor sleep hygiene. For example, college students commonly report experiencing noise from roommates and neighbors in the hallway when attempting to sleep and an uncomfortable bedroom temperature as they may not be able to control their dorm room's temperature or may have a difference temperature preference from their roommate. In addition, college-aged adults are significantly more likely to use electronic devices (e.g., cell phone, laptop, video games) before attempting to sleep compared to middle-aged and older adults. College-aged adults are also more like to engage in binge drinking and misuse of stimulant medication compared to middle-aged or older adults. Furthermore, compared with middle-aged and older adults, college students report a greater discrepancy between their weekday and weekend sleep patterns, possibly due to staying up late to socialize with friends. This may be why college students with insomnia spend a greater amount of time in bed and have greater variability in their sleep-wake schedule compared to adults with insomnia that are older.
Insomnia and Mental Health Conditions
Insomnia symptoms are a transdiagnostic factor for other common mental health conditions. Among individuals with insomnia disorder, almost one-third (32%) report suicide ideation. Two meta-analyses showed that insomnia had a positive relationship with suicide ideation. This relationship held across cross-sectional and longitudinal designs, various populations, and while controlling for covariates (e.g., depression and anxiety). In addition, two longitudinal studies included in the meta-anylses showed that the relationship between insomnia and suicide ideation is unidirectional, where insomnia predicted subsequent suicide ideation, but the reverse was not true. Last, in both meta-analyses, insomnia had the strongest and most consistent relationship with suicide ideation compared to the other sleep disturbances. Similarly, approximately 7 to 12% of college students experience depressive, anxiety, and post-traumatic stress disorder (PTSD) symptoms. A meta-analysis of longitudinal studies demonstrated that insomnia symptoms were a positive predictor of depressive and anxiety symptoms, and, a longitudinal study showed that insomnia symptoms were a positive predictor of PTSD symptoms.
Insomnia Interventions
Cognitive-behavioral therapy for insomnia (CBT-I) is a non-pharmacological, evidence-based treatment shown to improve quality and quantity of sleep. Beyond insomnia symptoms, CBT-I improves suicide ideation, depression, anxiety, and PTSD symptoms. There have been several adaptations of traditional CBT-I, including self-guided, internet-based CBT-I and brief, face-to-face CBT-I. Regarding brief, face-to-face CBT-I, when determining the optimal dose of CBT-I, results showed only the one- and four-session conditions significantly improved insomnia symptoms compared to a waitlist control condition. In addition, the single session of CBT-I produced greater positive changes in sleep diary total wake time and sleep efficiency (i.e., proportion of the time in bed that one is sleep) compared to four sessions of CBT-I. Despite the promising evidence that self-guided, internet-based and brief, face-to-face CBT-I interventions reduce suicide ideation and other mental health conditions, self-guided, internet-based CBT-I interventions require a time-intensive process, typically taking several weeks to complete treatment. In addition, there are relatively few single-session CBT-I interventions, and existing single-session CBT-I interventions are not self-guided or internet-based, requiring financial resources and a specific time or location to complete the intervention with a trained professional. Moreover, previous randomized controlled trials that examined the efficacy of insomnia treatment have recruited samples that are mostly older than college-aged adults and the interventions were not developed with the unique sleep needs of college students in mind.
Pilot of Sleep Scholar
Sleep Scholar is a single-session, self-guided, internet-based CBT-I intervention targeted specifically for college students. As such, it has the combined accessibility benefits of both self-guided, internet-based and brief CBT-I interventions. It is accessed through a web browser and completed in approximately 30 minutes without the direct aid of a research assistant or therapist. Sleep Scholar includes three text-based modules based of Psychoeducation, Stimulus Control, and Sleep Quality Enhancement. These modules contain strategies to help college students decrease their excessive time in bed and develop a consistent sleep-wake pattern, including a specific time in bed recommendation. In addition, Sleep Scholar provides vignettes of college students in real-life situations addressing environmental factors, electronic devices before bed, and substance use to improve their insomnia symptoms.
Based on the results of Crosby and Witte's pilot study, several modifications were made to Sleep Scholar based on the Persuasive Systems Design Model of internet-based interventions. Changes were made to support implementation of Sleep Scholar's strategies (e.g., reduced psychological jargon; provided daily sleep diaries while implementing treatment strategies and automatically calculated time in bed adjustments), increase adherence (e.g., access to a website with potential barriers and solutions; during the intervention, asked participants to consider how they will implement difficult goals), and reduce attrition (e.g., sent reminders with loss-framed messages if actions aren't completed by a specific deadline). In addition, reminders were scheduled based on the sleep patterns of participants in the pilot study.
Method
Participants
All study procedures have been approved by the Auburn University Institutional Review Board. Undergraduate students will be recruited from Auburn University using the SONA Human Subject Pool Software and public advertisements. Potential participants will complete an eligibility screener with the inclusion criteria of at least subclinical insomnia (i.e., score ≥8 on the Insomnia Severity Index).
Procedures
Eligible participants will complete an informed consent session with a research assistant via a secure Zoom link. After the consent session, participants will receive text message reminders each morning to complete seven daily sleep diaries. Once participants complete at least five daily sleep diaries, they will be administered a pre-treatment assessment and be randomized in a 1:1 manner into either Sleep Scholar, a single-session, self-guided, internet-based insomnia intervention, or Building Healthy Habits, a single-session, self-guided, internet-based control intervention focused on healthy eating and exercise. Immediately after completing each intervention, participants will complete a post-treatment assessment.
The day after completing the intervention, participants will receive an email that summarizes the key strategies of the intervention and begin receiving daily text message reminders each morning to complete daily sleep diaries for four weeks (28 days). At the end of each week of sleep diaries, sleep diary data will automatically be averaged, and all participants will be provided individualized feedback on their sleep diary variables (e.g., average bedtime and sleep efficiency). However, only participants assigned to Sleep Scholar will be presented their time in bed window recommendation for the next week. In addition, one week and one month after the intervention, all participants will complete a follow-up assessment. In total, participants will complete daily sleep diaries for five weeks (35 days) and survey assessments pre-treatment, post-treatment, one-week post-treatment, and one-month post-treatment.
Hypothesis and Data Analytic Strategy
I hypothesize that Sleep Scholar will improve insomnia, sleep diary variables (e.g., sleep latency), sleep quality, dysfunctional beliefs about sleep, suicide ideation, depressive, anxiety, and PTSD symptoms over time and compared to Building Healthy Habits. All analyses will be based on intention-to-treat. Missing data will be handled with multiple imputation, and all analyses will be conducted with IBM SPSS Statistics (Version 26). The primary outcomes of the intervention's effect on the sleep-related symptoms and secondary outcomes of mental health symptoms will be examined using a 2 x 3 mixed-model repeated measures ANOVA; and sleep diary variables will be examined with a 2 x 5 mixed-model repeated measures ANOVA. ANOVA factors will be condition (i.e., Sleep Scholar and Building Healthy Habits), time (i.e., pre-treatment, one-week follow-up, and one-month follow-up; or weekly averages from the five weeks of daily sleep diaries), and the condition-by-time interaction.
- Conditions
- Insomnia
- Being tested
- Sleep Scholar, Building Healthy Habits
- Keywords
- insomnia, suicide prevention, intervention, college students
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep ScholarBehavioural
A single-session, internet-based insomnia intervention for college students
Building Healthy HabitsBehavioural
A single-session, self-guided, internet-based intervention focused on healthy eating and exercise
| Study group | Role | What they receive |
|---|---|---|
| Sleep Scholar | Experimental | Sleep Scholar is a fully automated, single-session, self-guided, internet-based CBT-I intervention that participants will read from a web browser on their electronic device. Sleep Scholar's content was adapted from Ellis and colleague's, Morin's, and Perlis and colleague's protocols for therapist-guided CBT-I interventions. Sleep Scholar will be completed in approximately 30 minutes and consists of three successive text-based modules: Sleep Education, Initiating Sleep, and Enhancing Sleep Quality. New content (e.g., vignettes and quizzes) was created to tailor the intervention to college students. For example, after each module, short multiple choice and/or true-false question will be administered to assess participants' understanding of Sleep Scholar's strategies. Participants will be automatically provided feedback on their responses to ensure their understanding of Sleep Scholar's strategies. Receives: Behavioral: Sleep Scholar |
| Building Healthy Habits | Placebo comparator | Building Healthy Habits will be used as the control condition. It combines two modules being utilized as the control condition in an ongoing randomized controlled trial. It is a single-session, self-guided, internet-based intervention that participants will read from a web browser on their electronic device. Building Healthy Habits was piloted by undergraduate research assistants to ensure that it was approximately the same duration as Sleep Scholar (i.e., 30 minutes). It consists of two successive text-based modules focused on healthy movement and healthy eating. Receives: Behavioral: Building Healthy Habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia
Insomnia Severity Index; range: 0-28; higher score is greater insomnia severity
Measured: Change from baseline Insomnia Severity Index at one week and one month
Sleep Latency
The Consensus Sleep Diary; seven daily sleep diaries
Measured: Change from average baseline Sleep Latency at one week, two weeks, three weeks, and four weeks
Number Of Nocturnal Awakenings
The Consensus Sleep Diary; seven daily sleep diaries
Measured: Change from average baseline Number Of Nocturnal Awakenings at one week, two weeks, three weeks, and four weeks
Duration Of Awakenings After Sleep Onset
The Consensus Sleep Diary; seven daily sleep diaries
Measured: Change from average baseline Duration Of Awakenings After Sleep Onset at one week, two weeks, three weeks, and four weeks
Duration Of Early Morning Awakenings
The Consensus Sleep Diary; seven daily sleep diaries
Measured: Change from average baseline Duration Of Early Morning Awakenings at one week, two weeks, three weeks, and four weeks
Sleep Efficiency
The Consensus Sleep Diary; seven daily sleep diaries; total sleep time divided by total time in bed
Measured: Change from average baseline Sleep Efficiency Index at one week, two weeks, three weeks, and four weeks
Sleep Quality
The Pittsburgh Sleep Quality Index; range: 0-30; higher score is poorer sleep quality
Measured: Change from baseline Pittsburgh Sleep Quality Index at one week and one month
Beliefs and Attitudes About Sleep
The Dysfunctional Beliefs and Attitudes about Sleep Scale; range: 0-10; higher score is greater dysfunctional beliefs and attitudes about sleep
Measured: Change from baseline Dysfunctional Beliefs and Attitudes about Sleep Scale at one week and one month
Secondary outcomes (4)
Suicide Ideation
Depression Symptom Inventory-Suicide Subscale
Measured: Change from baseline Depression Symptom Inventory-Suicide Subscale at one week and one month
Depression
The Depression Anxiety Stress Scale - Depression subscale
Measured: Change from baseline Depression Anxiety Stress Scale - Depression subscale at one week and one month
Anxiety
The Depression Anxiety Stress Scale - Anxiety subscale
Measured: Change from baseline Depression Anxiety Stress Scale - Anxiety subscale at one week and one month
Posttraumatic Stress
The Posttraumatic Stress Disorder Checklist for DSM-5
Measured: Change from baseline Posttraumatic Stress Disorder Checklist for DSM-5 at one week and one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start18 Jan 2021
- Primary completion3 Dec 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Model description
- Participants will complete at least five daily sleep diaries over one week, complete a pre-treatment survey assessment, be randomized in a 1:1 manner into either Sleep Scholar or Building Healthy Habits, complete a post-treatment survey assessment, then complete at least five daily sleep diaries each week for four weeks, and complete a survey assessment both one-week and one-month post-treatment. In total, participants will complete daily sleep diaries for five weeks (35 days) and survey assessments pre-treatment, post-treatment, one-week post-treatment, and one-month post-treatment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Collaborators
- Military Suicide Research Consortium
- Responsible party
- Principal investigator, Eric Crosby, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988464
- Sponsor's protocol ID
- #20-555
- Acronym
- SSIT
- Status last verified
- Mar 2022
- First submitted
- 8 Jul 2021
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zuromski KL, Cero I, Witte TK. Insomnia symptoms drive changes in suicide ideation: A latent difference score model of community adults over a brief interval. J Abnorm Psychol. 2017 Aug;126(6):739-749. doi: 10.1037/abn0000282. Epub 2017 May 29.
PubMed 28557509Liu RT, Steele SJ, Hamilton JL, Do QBP, Furbish K, Burke TA, Martinez AP, Gerlus N. Sleep and suicide: A systematic review and meta-analysis of longitudinal studies. Clin Psychol Rev. 2020 Nov;81:101895. doi: 10.1016/j.cpr.2020.101895. Epub 2020 Aug 8.
PubMed 32801085Batterham PJ, Christensen H, Mackinnon AJ, Gosling JA, Thorndike FP, Ritterband LM, Glozier N, Griffiths KM. Trajectories of change and long-term outcomes in a randomised controlled trial of internet-based insomnia treatment to prevent depression. BJPsych Open. 2017 Sep 25;3(5):228-235. doi: 10.1192/bjpo.bp.117.005231. eCollection 2017 Sep.
PubMed 28959453Christensen H, Batterham PJ, Gosling JA, Ritterband LM, Griffiths KM, Thorndike FP, Glozier N, O'Dea B, Hickie IB, Mackinnon AJ. Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): a randomised controlled trial. Lancet Psychiatry. 2016 Apr;3(4):333-41. doi: 10.1016/S2215-0366(15)00536-2. Epub 2016 Jan 28.
PubMed 26827250Thorndike FP, Saylor DK, Bailey ET, Gonder-Frederick L, Morin CM, Ritterband LM. Development and Perceived Utility and Impact of an Internet Intervention for Insomnia. E J Appl Psychol. 2008;4(2):32-42. doi: 10.7790/ejap.v4i2.133.
PubMed 20953264Ellis JG, Cushing T, Germain A. Treating Acute Insomnia: A Randomized Controlled Trial of a "Single-Shot" of Cognitive Behavioral Therapy for Insomnia. Sleep. 2015 Jun 1;38(6):971-8. doi: 10.5665/sleep.4752.
PubMed 25515106Downs MF, Eisenberg D. Help seeking and treatment use among suicidal college students. J Am Coll Health. 2012;60(2):104-14. doi: 10.1080/07448481.2011.619611.
PubMed 22316407Stinson K, Tang NK, Harvey AG. Barriers to treatment seeking in primary insomnia in the United Kingdom: a cross-sectional perspective. Sleep. 2006 Dec;29(12):1643-6. doi: 10.1093/sleep/29.12.1643.
PubMed 17252896Taylor DJ, Bramoweth AD, Grieser EA, Tatum JI, Roane BM. Epidemiology of insomnia in college students: relationship with mental health, quality of life, and substance use difficulties. Behav Ther. 2013 Sep;44(3):339-48. doi: 10.1016/j.beth.2012.12.001. Epub 2012 Dec 19.
PubMed 23768662Substance Abuse and Mental Health Services Administration. (2020). Key substance use and mental health indicators in the United States: Results from the 2019 National Survey on Drug Use and Health (HHS Publication No. PEP20-07-01-001, NSDUH Series H-55). 114.
Substance Abuse and Mental Health Services Administration, Hedden, S. L., Kennet, J., Lipari, R., Medley, G., Tice, P., Copello, E. A. P., & Kroutil, L. A. (2015). Key Substance Use and Mental Health Indicators in the United States: Results from the 2015 National Survey on Drug Use and Health. 74.
Pigeon WR, Funderburk JS, Cross W, Bishop TM, Crean HF. Brief CBT for insomnia delivered in primary care to patients endorsing suicidal ideation: a proof-of-concept randomized clinical trial. Transl Behav Med. 2019 Nov 25;9(6):1169-1177. doi: 10.1093/tbm/ibz108.
PubMed 31271210Pigeon WR, Funderburk J, Bishop TM, Crean HF. Brief cognitive behavioral therapy for insomnia delivered to depressed veterans receiving primary care services: A pilot study. J Affect Disord. 2017 Aug 1;217:105-111. doi: 10.1016/j.jad.2017.04.003. Epub 2017 Apr 6.
PubMed 28395207Hurst CS, Baranik LE, Daniel F. College student stressors: a review of the qualitative research. Stress Health. 2013 Oct;29(4):275-85. doi: 10.1002/smi.2465. Epub 2012 Oct 1.
PubMed 23023893Sexton-Radek K, Hartley A. College residential sleep environment. Psychol Rep. 2013 Dec;113(3):903-7. doi: 10.2466/06.10.PR0.113x27z2.
PubMed 24693819
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Sleep Scholar: A Single-Session, Internet-Based Insomnia Intervention for College Students
- ClinicalTrials.gov ID
- NCT04988464
- Acronym / sponsor ID
- SSIT / #20-555
- Conditions
- Insomnia
- Keywords
- insomnia, suicide prevention, intervention, college students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Collaborators
- Military Suicide Research Consortium
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 3 Aug 2021 (actual)
- 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.
Cognitive-Behavioral Therapy for Insomnia (CBT-I) is a promising suicide intervention for college students because insomnia is robust risk factor for suicide ideation and CBT-I reduces suicide ideation. Moreover, CBT-I can be self-guided and internet-based, brief, and relatively lower in stigma compared to treatment specifically targeting suicide ideation. However, self-guided, internet-based CBT-I is not brief, and brief CBT-I is neither self-guided nor internet-based. In addition, CBT-I is not usually designed to address the unique experiences of college students. Therefore, this study is a randomized-controlled trial examining the efficacy of Sleep Scholar, a single-session, internet-based insomnia intervention tailored to the needs of college students. The investigators hypothesize that Sleep Scholar will improve insomnia, sleep diary variables (e.g., sleep latency), sleep quality, dysfunctional beliefs about sleep, suicide ideation, depressive, anxiety, and PTSD symptoms over time and compared to a control condition (Building Healthy Habits). The investigators will recruit college students with at least subclinical insomnia symptoms. Participants will complete seven daily pre-treatment sleep diaries and a pre-treatment assessment then be randomized to either Sleep Scholar or Building Healthy Habits, the control single-session, internet-based health intervention condition. After the intervention, participants will complete a post-treatment assessment of acceptability and satisfaction, implement the intervention's strategies, and complete daily sleep diaries for the following four weeks. In addition, participants will complete a one-week and one-month follow-up. If found to be efficacious, Sleep Scholar has the potential to be widely disseminated to college students with insomnia symptoms.
Detailed description
In 2019, college-aged adults in the United States (18-25-year-olds) had the highest rate of past-year suicide ideation (11.8%) compared to any other age group. In addition, the rate of suicide ideation among college-aged adults in the United States has been rising in recent years, especially during the COVID-19 pandemic. Despite the need for mental health treatment among college students, only approximately half of college students experiencing suicide ideation received treatment in the past year, reporting limited access to mental health treatment due to time constraints, financial costs, stigma, concerns about privacy, and an inconvenient location of treatment facilities. Insomnia treatment is a particularly promising target for suicide prevention efforts among college students because insomnia is fairly common, insomnia is a robust risk factor for suicide ideation, and insomnia treatments improve suicide ideation. Moreover, insomnia treatments can be self-guided and internet-based, brief, and relatively lower in stigma compared to treatment specifically targeting suicide ideation. However, current self-guided, internet-based insomnia treatments require a time-intensive process, and current brief insomnia treatments require a trained professional. In addition, previous randomized controlled trials that examined the efficacy of insomnia treatment have recruited samples that are mostly older than college-aged adults and the interventions were not developed with the unique sleep needs of college students in mind. As such, the generalizability of insomnia treatments to college students is unknown. Therefore, the current study aims to examine the efficacy of Sleep Scholar, a single-session, internet-based insomnia intervention tailored to the needs of college students with at least subclinical insomnia symptoms and a lifetime history of suicide ideation.
Insomnia
Approximately 10% of college students meet criteria for insomnia disorder, and approximately one-third of college students have subclinical insomnia symptoms. College students experience a variety of stressors, including transitioning to a new environment, interpersonal difficulties (e.g., family and romantic partners), and increased academic responsibilities. These stressful life events may increase their risk for developing insomnia symptoms through poor sleep hygiene. For example, college students commonly report experiencing noise from roommates and neighbors in the hallway when attempting to sleep and an uncomfortable bedroom temperature as they may not be able to control their dorm room's temperature or may have a difference temperature preference from their roommate. In addition, college-aged adults are significantly more likely to use electronic devices (e.g., cell phone, laptop, video games) before attempting to sleep compared to middle-aged and older adults. College-aged adults are also more like to engage in binge drinking and misuse of stimulant medication compared to middle-aged or older adults. Furthermore, compared with middle-aged and older adults, college students report a greater discrepancy between their weekday and weekend sleep patterns, possibly due to staying up late to socialize with friends. This may be why college students with insomnia spend a greater amount of time in bed and have greater variability in their sleep-wake schedule compared to adults with insomnia that are older.
Insomnia and Mental Health Conditions
Insomnia symptoms are a transdiagnostic factor for other common mental health conditions. Among individuals with insomnia disorder, almost one-third (32%) report suicide ideation. Two meta-analyses showed that insomnia had a positive relationship with suicide ideation. This relationship held across cross-sectional and longitudinal designs, various populations, and while controlling for covariates (e.g., depression and anxiety). In addition, two longitudinal studies included in the meta-anylses showed that the relationship between insomnia and suicide ideation is unidirectional, where insomnia predicted subsequent suicide ideation, but the reverse was not true. Last, in both meta-analyses, insomnia had the strongest and most consistent relationship with suicide ideation compared to the other sleep disturbances. Similarly, approximately 7 to 12% of college students experience depressive, anxiety, and post-traumatic stress disorder (PTSD) symptoms. A meta-analysis of longitudinal studies demonstrated that insomnia symptoms were a positive predictor of depressive and anxiety symptoms, and, a longitudinal study showed that insomnia symptoms were a positive predictor of PTSD symptoms.
Insomnia Interventions
Cognitive-behavioral therapy for insomnia (CBT-I) is a non-pharmacological, evidence-based treatment shown to improve quality and quantity of sleep. Beyond insomnia symptoms, CBT-I improves suicide ideation, depression, anxiety, and PTSD symptoms. There have been several adaptations of traditional CBT-I, including self-guided, internet-based CBT-I and brief, face-to-face CBT-I. Regarding brief, face-to-face CBT-I, when determining the optimal dose of CBT-I, results showed only the one- and four-session conditions significantly improved insomnia symptoms compared to a waitlist control condition. In addition, the single session of CBT-I produced greater positive changes in sleep diary total wake time and sleep efficiency (i.e., proportion of the time in bed that one is sleep) compared to four sessions of CBT-I. Despite the promising evidence that self-guided, internet-based and brief, face-to-face CBT-I interventions reduce suicide ideation and other mental health conditions, self-guided, internet-based CBT-I interventions require a time-intensive process, typically taking several weeks to complete treatment. In addition, there are relatively few single-session CBT-I interventions, and existing single-session CBT-I interventions are not self-guided or internet-based, requiring financial resources and a specific time or location to complete the intervention with a trained professional. Moreover, previous randomized controlled trials that examined the efficacy of insomnia treatment have recruited samples that are mostly older than college-aged adults and the interventions were not developed with the unique sleep needs of college students in mind.
Pilot of Sleep Scholar
Sleep Scholar is a single-session, self-guided, internet-based CBT-I intervention targeted specifically for college students. As such, it has the combined accessibility benefits of both self-guided, internet-based and brief CBT-I interventions. It is accessed through a web browser and completed in approximately 30 minutes without the direct aid of a research assistant or therapist. Sleep Scholar includes three text-based modules based of Psychoeducation, Stimulus Control, and Sleep Quality Enhancement. These modules contain strategies to help college students decrease their excessive time in bed and develop a consistent sleep-wake pattern, including a specific time in bed recommendation. In addition, Sleep Scholar provides vignettes of college students in real-life situations addressing environmental factors, electronic devices before bed, and substance use to improve their insomnia symptoms.
Based on the results of Crosby and Witte's pilot study, several modifications were made to Sleep Scholar based on the Persuasive Systems Design Model of internet-based interventions. Changes were made to support implementation of Sleep Scholar's strategies (e.g., reduced psychological jargon; provided daily sleep diaries while implementing treatment strategies and automatically calculated time in bed adjustments), increase adherence (e.g., access to a website with potential barriers and solutions; during the intervention, asked participants to consider how they will implement difficult goals), and reduce attrition (e.g., sent reminders with loss-framed messages if actions aren't completed by a specific deadline). In addition, reminders were scheduled based on the sleep patterns of participants in the pilot study.
Method
Participants
All study procedures have been approved by the Auburn University Institutional Review Board. Undergraduate students will be recruited from Auburn University using the SONA Human Subject Pool Software and public advertisements. Potential participants will complete an eligibility screener with the inclusion criteria of at least subclinical insomnia (i.e., score ≥8 on the Insomnia Severity Index).
Procedures
Eligible participants will complete an informed consent session with a research assistant via a secure Zoom link. After the consent session, participants will receive text message reminders each morning to complete seven daily sleep diaries. Once participants complete at least five daily sleep diaries, they will be administered a pre-treatment assessment and be randomized in a 1:1 manner into either Sleep Scholar, a single-session, self-guided, internet-based insomnia intervention, or Building Healthy Habits, a single-session, self-guided, internet-based control intervention focused on healthy eating and exercise. Immediately after completing each intervention, participants will complete a post-treatment assessment.
The day after completing the intervention, participants will receive an email that summarizes the key strategies of the intervention and begin receiving daily text message reminders each morning to complete daily sleep diaries for four weeks (28 days). At the end of each week of sleep diaries, sleep diary data will automatically be averaged, and all participants will be provided individualized feedback on their sleep diary variables (e.g., average bedtime and sleep efficiency). However, only participants assigned to Sleep Scholar will be presented their time in bed window recommendation for the next week. In addition, one week and one month after the intervention, all participants will complete a follow-up assessment. In total, participants will complete daily sleep diaries for five weeks (35 days) and survey assessments pre-treatment, post-treatment, one-week post-treatment, and one-month post-treatment.
Hypothesis and Data Analytic Strategy
I hypothesize that Sleep Scholar will improve insomnia, sleep diary variables (e.g., sleep latency), sleep quality, dysfunctional beliefs about sleep, suicide ideation, depressive, anxiety, and PTSD symptoms over time and compared to Building Healthy Habits. All analyses will be based on intention-to-treat. Missing data will be handled with multiple imputation, and all analyses will be conducted with IBM SPSS Statistics (Version 26). The primary outcomes of the intervention's effect on the sleep-related symptoms and secondary outcomes of mental health symptoms will be examined using a 2 x 3 mixed-model repeated measures ANOVA; and sleep diary variables will be examined with a 2 x 5 mixed-model repeated measures ANOVA. ANOVA factors will be condition (i.e., Sleep Scholar and Building Healthy Habits), time (i.e., pre-treatment, one-week follow-up, and one-month follow-up; or weekly averages from the five weeks of daily sleep diaries), and the condition-by-time interaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will complete at least five daily sleep diaries over one week, complete a pre-treatment survey assessment, be randomized in a 1:1 manner into either Sleep Scholar or Building Healthy Habits, complete a post-treatment survey assessment, then complete at least five daily sleep diaries each week for four weeks, and complete a survey assessment both one-week and one-month post-treatment. In total, participants will complete daily sleep diaries for five weeks (35 days) and survey assessments pre-treatment, post-treatment, one-week post-treatment, and one-month post-treatment.
| Arm | Type | Receives |
|---|---|---|
| Sleep Scholar | Experimental | Behavioral: Sleep ScholarSleep Scholar is a fully automated, single-session, self-guided, internet-based CBT-I intervention that participants will read from a web browser on their electronic device. Sleep Scholar's content was adapted from Ellis and colleague's, Morin's, and Perlis and colleague's protocols for therapist-guided CBT-I interventions. Sleep Scholar will be completed in approximately 30 minutes and consists of three successive text-based modules: Sleep Education, Initiating Sleep, and Enhancing Sleep Quality. New content (e.g., vignettes and quizzes) was created to tailor the intervention to college students. For example, after each module, short multiple choice and/or true-false question will be administered to assess participants' understanding of Sleep Scholar's strategies. Participants will be automatically provided feedback on their responses to ensure their understanding of Sleep Scholar's strategies. |
| Building Healthy Habits | Placebo comparator | Behavioral: Building Healthy HabitsBuilding Healthy Habits will be used as the control condition. It combines two modules being utilized as the control condition in an ongoing randomized controlled trial. It is a single-session, self-guided, internet-based intervention that participants will read from a web browser on their electronic device. Building Healthy Habits was piloted by undergraduate research assistants to ensure that it was approximately the same duration as Sleep Scholar (i.e., 30 minutes). It consists of two successive text-based modules focused on healthy movement and healthy eating. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least subclinical insomnia
- Auburn University undergraduate students
Key exclusion criteria (6 listed)
- Under age 18
- Engagement in shift work
- Untreated restless leg syndrome
- Untreated sleep apnea
- Untreated chronic pain
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 |
|---|---|---|
| Sleep ScholarA single-session, internet-based insomnia intervention for college students | Behavioural | Sleep Scholar |
| Building Healthy HabitsA single-session, self-guided, internet-based intervention focused on healthy eating and exercise | Behavioural | Building Healthy Habits |
Primary outcome
Insomnia
Time frame: Change from baseline Insomnia Severity Index at one week and one month
Insomnia Severity Index; range: 0-28; higher score is greater insomnia severity
Sleep Latency
Time frame: Change from average baseline Sleep Latency at one week, two weeks, three weeks, and four weeks
The Consensus Sleep Diary; seven daily sleep diaries
Number Of Nocturnal Awakenings
Time frame: Change from average baseline Number Of Nocturnal Awakenings at one week, two weeks, three weeks, and four weeks
The Consensus Sleep Diary; seven daily sleep diaries
Duration Of Awakenings After Sleep Onset
Time frame: Change from average baseline Duration Of Awakenings After Sleep Onset at one week, two weeks, three weeks, and four weeks
The Consensus Sleep Diary; seven daily sleep diaries
Duration Of Early Morning Awakenings
Time frame: Change from average baseline Duration Of Early Morning Awakenings at one week, two weeks, three weeks, and four weeks
The Consensus Sleep Diary; seven daily sleep diaries
Sleep Efficiency
Time frame: Change from average baseline Sleep Efficiency Index at one week, two weeks, three weeks, and four weeks
The Consensus Sleep Diary; seven daily sleep diaries; total sleep time divided by total time in bed
Sleep Quality
Time frame: Change from baseline Pittsburgh Sleep Quality Index at one week and one month
The Pittsburgh Sleep Quality Index; range: 0-30; higher score is poorer sleep quality
Beliefs and Attitudes About Sleep
Time frame: Change from baseline Dysfunctional Beliefs and Attitudes about Sleep Scale at one week and one month
The Dysfunctional Beliefs and Attitudes about Sleep Scale; range: 0-10; higher score is greater dysfunctional beliefs and attitudes about sleep
4 secondary outcomes
Suicide Ideation
Time frame: Change from baseline Depression Symptom Inventory-Suicide Subscale at one week and one month
Depression
Time frame: Change from baseline Depression Anxiety Stress Scale - Depression subscale at one week and one month
Anxiety
Time frame: Change from baseline Depression Anxiety Stress Scale - Anxiety subscale at one week and one month
Posttraumatic Stress
Time frame: Change from baseline Posttraumatic Stress Disorder Checklist for DSM-5 at one week and one month
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 15 Mar 2022.
- Background: PubMed 28557509Zuromski KL, Cero I, Witte TK. Insomnia symptoms drive changes in suicide ideation: A latent difference score model of community adults over a brief interval. J Abnorm Psychol. 2017 Aug;126(6):739-749. doi: 10.1037/abn0000282. Epub 2017 May 29.
- Background: PubMed 32801085Liu RT, Steele SJ, Hamilton JL, Do QBP, Furbish K, Burke TA, Martinez AP, Gerlus N. Sleep and suicide: A systematic review and meta-analysis of longitudinal studies. Clin Psychol Rev. 2020 Nov;81:101895. doi: 10.1016/j.cpr.2020.101895. Epub 2020 Aug 8.
- Background: PubMed 28959453Batterham PJ, Christensen H, Mackinnon AJ, Gosling JA, Thorndike FP, Ritterband LM, Glozier N, Griffiths KM. Trajectories of change and long-term outcomes in a randomised controlled trial of internet-based insomnia treatment to prevent depression. BJPsych Open. 2017 Sep 25;3(5):228-235. doi: 10.1192/bjpo.bp.117.005231. eCollection 2017 Sep.
- Background: PubMed 26827250Christensen H, Batterham PJ, Gosling JA, Ritterband LM, Griffiths KM, Thorndike FP, Glozier N, O'Dea B, Hickie IB, Mackinnon AJ. Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): a randomised controlled trial. Lancet Psychiatry. 2016 Apr;3(4):333-41. doi: 10.1016/S2215-0366(15)00536-2. Epub 2016 Jan 28.
- Background: PubMed 20953264Thorndike FP, Saylor DK, Bailey ET, Gonder-Frederick L, Morin CM, Ritterband LM. Development and Perceived Utility and Impact of an Internet Intervention for Insomnia. E J Appl Psychol. 2008;4(2):32-42. doi: 10.7790/ejap.v4i2.133.
- Background: PubMed 25515106Ellis JG, Cushing T, Germain A. Treating Acute Insomnia: A Randomized Controlled Trial of a "Single-Shot" of Cognitive Behavioral Therapy for Insomnia. Sleep. 2015 Jun 1;38(6):971-8. doi: 10.5665/sleep.4752.
- Background: PubMed 22316407Downs MF, Eisenberg D. Help seeking and treatment use among suicidal college students. J Am Coll Health. 2012;60(2):104-14. doi: 10.1080/07448481.2011.619611.
- Background: PubMed 17252896Stinson K, Tang NK, Harvey AG. Barriers to treatment seeking in primary insomnia in the United Kingdom: a cross-sectional perspective. Sleep. 2006 Dec;29(12):1643-6. doi: 10.1093/sleep/29.12.1643.
- Background: PubMed 23768662Taylor DJ, Bramoweth AD, Grieser EA, Tatum JI, Roane BM. Epidemiology of insomnia in college students: relationship with mental health, quality of life, and substance use difficulties. Behav Ther. 2013 Sep;44(3):339-48. doi: 10.1016/j.beth.2012.12.001. Epub 2012 Dec 19.
- BackgroundSubstance Abuse and Mental Health Services Administration. (2020). Key substance use and mental health indicators in the United States: Results from the 2019 National Survey on Drug Use and Health (HHS Publication No. PEP20-07-01-001, NSDUH Series H-55). 114.
- BackgroundSubstance Abuse and Mental Health Services Administration, Hedden, S. L., Kennet, J., Lipari, R., Medley, G., Tice, P., Copello, E. A. P., & Kroutil, L. A. (2015). Key Substance Use and Mental Health Indicators in the United States: Results from the 2015 National Survey on Drug Use and Health. 74.
- Background: PubMed 31271210Pigeon WR, Funderburk JS, Cross W, Bishop TM, Crean HF. Brief CBT for insomnia delivered in primary care to patients endorsing suicidal ideation: a proof-of-concept randomized clinical trial. Transl Behav Med. 2019 Nov 25;9(6):1169-1177. doi: 10.1093/tbm/ibz108.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Scholar and Building Healthy Habits in people with Insomnia, run by Auburn University 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 2 inclusion and 6 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 15 Mar 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. Some participants in this study may receive a placebo. 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?
Insomnia (time frame: Change from baseline Insomnia Severity Index at one week and one month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04988464, which also lists 37 linked publications.
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 15 Mar 2022; AzTrials last refreshed its copy on 27 Oct 2026.