Clinical trial NCT04988464: A Single-Session Online Insomnia Intervention
Official title: A Randomized Controlled Trial of Sleep Scholar: A Single-Session, Internet-Based Insomnia Intervention for College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: insomnia
suicide prevention
intervention
college students
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: Military Suicide Research Consortium
First posted: 2021-08-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia
timeFrame: Change from baseline Insomnia Severity Index at one week and one month
measure: Sleep Latency
timeFrame: Change from average baseline Sleep Latency at one week, two weeks, three weeks, and four weeks
measure: Number Of Nocturnal Awakenings
timeFrame: Change from average baseline Number Of Nocturnal Awakenings at one week, two weeks, three weeks, and four weeks
measure: Duration Of Awakenings After Sleep Onset
timeFrame: Change from average baseline Duration Of Awakenings After Sleep Onset at one week, two weeks, three weeks, and four weeks
measure: Duration Of Early Morning Awakenings
timeFrame: Change from average baseline Duration Of Early Morning Awakenings at one week, two weeks, three weeks, and four weeks
measure: Sleep Efficiency
timeFrame: Change from average baseline Sleep Efficiency Index at one week, two weeks, three weeks, and four weeks
measure: Sleep Quality
timeFrame: Change from baseline Pittsburgh Sleep Quality Index at one week and one month
measure: Beliefs and Attitudes About Sleep
timeFrame: Change from baseline Dysfunctional Beliefs and Attitudes about Sleep Scale at one week and one month
Secondary outcomes:
measure: Suicide Ideation
timeFrame: Change from baseline Depression Symptom Inventory-Suicide Subscale at one week and one month
measure: Depression
timeFrame: Change from baseline Depression Anxiety Stress Scale - Depression subscale at one week and one month
measure: Anxiety
timeFrame: Change from baseline Depression Anxiety Stress Scale - Anxiety subscale at one week and one month
measure: Posttraumatic Stress
timeFrame: Change from baseline Posttraumatic Stress Disorder Checklist for DSM-5 at one week and one month
Other outcomes:
measure: Acceptability
timeFrame: Immediate post-intervention
measure: Participant Satisfaction
timeFrame: Change from immediately post-intervention satisfaction to one-month
measure: Sleep Knowledge
timeFrame: During the intervention, immediately after baseline
measure: Average Nap Duration
timeFrame: Change from average one week Nap Duration at two weeks, three weeks, and four weeks
measure: Average Variance in Wake-Up Time
timeFrame: Change from average one week Variance in Wake-Up Time at two weeks, three weeks, and four weeks
measure: Average Variance in Time in Bed
timeFrame: Change from average one week Variance in Time in Bed at two weeks, three weeks, and four weeks
measure: Average Time from Bedtime to Trying to Sleep and From Wake Time to Rise Time
timeFrame: 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
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
Study officials:
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