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Clinical Trials/NCT04988464
NCT04988464CompletedNot Applicable

A Randomized Controlled Trial of Sleep Scholar: A Single-Session, Internet-Based Insomnia Intervention for College Students

Auburn University2 sites in 1 country64 target enrollmentStarted: January 18, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
64
Locations
2
Primary Endpoint
Number Of Nocturnal Awakenings

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

  • Suicide Ideation(Change from baseline Depression Symptom Inventory-Suicide Subscale at one week and one month)
  • Anxiety(Change from baseline Depression Anxiety Stress Scale - Anxiety subscale at one week and one month)
  • Depression(Change from baseline Depression Anxiety Stress Scale - Depression subscale at one week and one month)
  • Posttraumatic Stress(Change from baseline Posttraumatic Stress Disorder Checklist for DSM-5 at one week and one month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eric Crosby

Principal Investigator

Auburn University

Study Sites (2)

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