A Single-Session Online Insomnia Intervention

NCT04988464 | Completed

• 1 other identifier: #20-555
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

insomnia; suicide prevention; intervention; college students

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• Suicide Ideation

  Change from baseline Depression Symptom Inventory-Suicide Subscale at one week and one month

• Depression

  Change from baseline Depression Anxiety Stress Scale - Depression subscale at one week and one month

• Anxiety

  Change from baseline Depression Anxiety Stress Scale - Anxiety 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

Other Outcomes (7)

• Acceptability

  Immediate post-intervention

• Participant Satisfaction

  Change from immediately post-intervention satisfaction to one-month

• Sleep Knowledge

  During the intervention, immediately after baseline

Study Arms (2)

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.

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.

Behavioral: Building Healthy Habits

Interventions

Sleep Scholar BEHAVIORAL

A single-session, internet-based insomnia intervention for college students

Sleep Scholar

Building Healthy Habits BEHAVIORAL

A single-session, self-guided, internet-based intervention focused on healthy eating and exercise

Building Healthy Habits

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least subclinical insomnia
• Auburn University undergraduate students

You may not qualify if:

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

Sponsors & Collaborators

• Auburn University: lead
• Military Suicide Research Consortium: collaborator

Study Sites (1)

Auburn University

Auburn, Alabama, 36832, United States

Location

Related Publications (37)

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Suicide Prevention

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: August 3, 2021
• Study Start: January 18, 2021
• Primary Completion: December 3, 2021
• Study Completion: December 22, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

US (1)