A Single-Session Online Insomnia Intervention (SSIT)

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Sleep Scholar; Behavioral: Building Healthy Habits

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Auburn, Alabama, United States, 36832
      • Auburn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least subclinical insomnia
• Auburn University undergraduate students

Exclusion Criteria:

• Under age 18
• Engagement in shift work
• Untreated restless leg syndrome
• Untreated sleep apnea
• Untreated chronic pain
• Current engagement in insomnia treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Scholar; 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.	Behavioral: Sleep Scholar; A single-session, internet-based insomnia intervention for college students
Placebo Comparator: Building Healthy Habits; 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.	Behavioral: Building Healthy Habits; A single-session, self-guided, internet-based intervention focused on healthy eating and exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia	Insomnia Severity Index; range: 0-28; higher score is greater insomnia severity	Change from baseline Insomnia Severity Index at one week and one month
Sleep Latency	The Consensus Sleep Diary; seven daily sleep diaries	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	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	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	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	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	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	Change from baseline Dysfunctional Beliefs and Attitudes about Sleep Scale at one week and one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicide Ideation	Depression Symptom Inventory-Suicide Subscale	Change from baseline Depression Symptom Inventory-Suicide Subscale at one week and one month
Depression	The Depression Anxiety Stress Scale - Depression subscale	Change from baseline Depression Anxiety Stress Scale - Depression subscale at one week and one month
Anxiety	The Depression Anxiety Stress Scale - Anxiety subscale	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	Change from baseline Posttraumatic Stress Disorder Checklist for DSM-5 at one week and one month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	The Insomnia Treatment Acceptability Scale-Behavioral Subscale	Immediate post-intervention
Participant Satisfaction	Client Satisfaction Questionnaire-8	Change from immediately post-intervention satisfaction to one-month
Sleep Knowledge	Sleep Scholar Quizzes	During the intervention, immediately after baseline
Average Nap Duration	The Consensus Sleep Diary; seven daily sleep diaries	Change from average one week Nap Duration at two weeks, three weeks, and four weeks
Average Variance in Wake-Up Time	The Consensus Sleep Diary; seven daily sleep diaries	Change from average one week Variance in Wake-Up Time at two weeks, three weeks, and four weeks
Average Variance in Time in Bed	The Consensus Sleep Diary; seven daily sleep diaries	Change from average one week Variance in Time in Bed at two weeks, three weeks, and four weeks
Average Time from Bedtime to Trying to Sleep and From Wake Time to Rise Time	The Consensus Sleep Diary; seven daily sleep diaries	Change from average one week Time from Bedtime to Trying to Sleep and From Wake Time to Rise Time at two weeks, three weeks, and four weeks

Collaborators and Investigators

• Sponsor: Auburn University
• Collaborators: Military Suicide Research Consortium

Publications and helpful links

General Publications

• Ellis 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.
• Thorndike 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.
• Edinger JD, Wohlgemuth WK, Radtke RA, Coffman CJ, Carney CE. Dose-response effects of cognitive-behavioral insomnia therapy: a randomized clinical trial. Sleep. 2007 Feb;30(2):203-12. doi: 10.1093/sleep/30.2.203.
• Christensen 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. Erratum In: Lancet Psychiatry. 2016 Apr;3(4):320.
• Hertenstein E, Feige B, Gmeiner T, Kienzler C, Spiegelhalder K, Johann A, Jansson-Frojmark M, Palagini L, Rucker G, Riemann D, Baglioni C. Insomnia as a predictor of mental disorders: A systematic review and meta-analysis. Sleep Med Rev. 2019 Feb;43:96-105. doi: 10.1016/j.smrv.2018.10.006. Epub 2018 Nov 16.
• Blanco C, Okuda M, Wright C, Hasin DS, Grant BF, Liu SM, Olfson M. Mental health of college students and their non-college-attending peers: results from the National Epidemiologic Study on Alcohol and Related Conditions. Arch Gen Psychiatry. 2008 Dec;65(12):1429-37. doi: 10.1001/archpsyc.65.12.1429.
• 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.
• Liu 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.
• Batterham 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.
• Downs 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.
• Stinson 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.
• Taylor 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.
• Substance 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.
• Pigeon 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.
• Hurst 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.
• Sexton-Radek K, Hartley A. College residential sleep environment. Psychol Rep. 2013 Dec;113(3):903-7. doi: 10.2466/06.10.PR0.113x27z2.
• Gradisar M, Wolfson AR, Harvey AG, Hale L, Rosenberg R, Czeisler CA. The sleep and technology use of Americans: findings from the National Sleep Foundation's 2011 Sleep in America poll. J Clin Sleep Med. 2013 Dec 15;9(12):1291-9. doi: 10.5664/jcsm.3272.
• Adams, S. K., Williford, D. N., Vaccaro, A., Kisler, T. S., Francis, A., & Newman, B. (2017). The young and the restless: Socializing trumps sleep, fear of missing out, and technological distractions in first-year college students. International Journal of Adolescence and Youth, 22(3), 337-348. https://doi.org/10.1080/02673843.2016.1181557
• Forquer LM, Camden AE, Gabriau KM, Johnson CM. Sleep patterns of college students at a public university. J Am Coll Health. 2008 Mar-Apr;56(5):563-5. doi: 10.3200/JACH.56.5.563-565.
• Roepke SE, Duffy JF. Differential impact of chronotype on weekday and weekend sleep timing and duration. Nat Sci Sleep. 2010 Sep 1;2010(2):213-220. doi: 10.2147/NSS.S12572.
• Sivertsen B, Pallesen S, Friborg O, Nilsen KB, Bakke OK, Goll JB, Hopstock LA. Sleep patterns and insomnia in a large population-based study of middle-aged and older adults: The Tromso study 2015-2016. J Sleep Res. 2021 Feb;30(1):e13095. doi: 10.1111/jsr.13095. Epub 2020 May 29.
• Sivertsen B, Vedaa O, Harvey AG, Glozier N, Pallesen S, Aaro LE, Lonning KJ, Hysing M. Sleep patterns and insomnia in young adults: A national survey of Norwegian university students. J Sleep Res. 2019 Apr;28(2):e12790. doi: 10.1111/jsr.12790. Epub 2018 Dec 4.
• Trockel M, Karlin BE, Taylor CB, Brown GK, Manber R. Effects of cognitive behavioral therapy for insomnia on suicidal ideation in veterans. Sleep. 2015 Feb 1;38(2):259-65. doi: 10.5665/sleep.4410.
• Pigeon WR, Pinquart M, Conner K. Meta-analysis of sleep disturbance and suicidal thoughts and behaviors. J Clin Psychiatry. 2012 Sep;73(9):e1160-7. doi: 10.4088/JCP.11r07586.
• Pigeon WR, Campbell CE, Possemato K, Ouimette P. Longitudinal relationships of insomnia, nightmares, and PTSD severity in recent combat veterans. J Psychosom Res. 2013 Dec;75(6):546-50. doi: 10.1016/j.jpsychores.2013.09.004. Epub 2013 Oct 2.
• Smyth JM, Hockemeyer JR, Heron KE, Wonderlich SA, Pennebaker JW. Prevalence, type, disclosure, and severity of adverse life events in college students. J Am Coll Health. 2008 Jul-Aug;57(1):69-76. doi: 10.3200/JACH.57.1.69-76.
• Geiger-Brown JM, Rogers VE, Liu W, Ludeman EM, Downton KD, Diaz-Abad M. Cognitive behavioral therapy in persons with comorbid insomnia: A meta-analysis. Sleep Med Rev. 2015 Oct;23:54-67. doi: 10.1016/j.smrv.2014.11.007. Epub 2014 Nov 29.
• Seyffert M, Lagisetty P, Landgraf J, Chopra V, Pfeiffer PN, Conte ML, Rogers MA. Internet-Delivered Cognitive Behavioral Therapy to Treat Insomnia: A Systematic Review and Meta-Analysis. PLoS One. 2016 Feb 11;11(2):e0149139. doi: 10.1371/journal.pone.0149139. eCollection 2016.
• Ye YY, Chen NK, Chen J, Liu J, Lin L, Liu YZ, Lang Y, Li XJ, Yang XJ, Jiang XJ. Internet-based cognitive-behavioural therapy for insomnia (ICBT-i): a meta-analysis of randomised controlled trials. BMJ Open. 2016 Nov 30;6(11):e010707. doi: 10.1136/bmjopen-2015-010707.
• Ye YY, Zhang YF, Chen J, Liu J, Li XJ, Liu YZ, Lang Y, Lin L, Yang XJ, Jiang XJ. Internet-Based Cognitive Behavioral Therapy for Insomnia (ICBT-i) Improves Comorbid Anxiety and Depression-A Meta-Analysis of Randomized Controlled Trials. PLoS One. 2015 Nov 18;10(11):e0142258. doi: 10.1371/journal.pone.0142258. eCollection 2015.
• Edinger JD, Arnedt JT, Bertisch SM, Carney CE, Harrington JJ, Lichstein KL, Sateia MJ, Troxel WM, Zhou ES, Kazmi U, Heald JL, Martin JL. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Feb 1;17(2):255-262. doi: 10.5664/jcsm.8986.
• Bootzin, Richard R., & Perlis, M. L. (2011). Stimulus control therapy. In M. Perlis, M. S. Aloia, & B. Khun (Eds.), Behavioral Treatments for Sleep Disorders (pp. 21-30). Elsevier.
• Bootzin, Richard R. (1972). Stimulus control treatment for insomnia. Proceedings of the American Psychological Association, 7, 395-396.
• Spielman, A. J., Yang, C.-M., & Glovinsky, P. B. (2016). Insomnia: Sleep Restriction Therapy. In M. Sateia & D. Buysse (Eds.), Insomnia: Diagnosis and Treatment (pp. 277-289).
• Oinas-Kukkonen, H., & Harjumaa, M. (2009). Persuasive Systems Design: Key Issues, Process Model, and System Features. Communications of the Association for Information Systems, 24. https://doi.org/10.17705/1CAIS.02428

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Actual): December 3, 2021
• Study Completion (Actual): December 22, 2021

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 23, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: insomnia; intervention; college students; suicide prevention
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: #20-555

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No