SPARK Healthy Sleep for Insomnia
(SPARK Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assist college students who struggle with sleep and experience symptoms like hearing voices or feeling overly suspicious. It tests whether a 30-minute digital session, delivered through a smartphone app called SPARK Healthy Sleep, can improve sleep, reduce mental health stigma, and enhance overall well-being. The trial involves students from Indiana University-Indianapolis who frequently experience sleep problems and score high on measures of psychotic-like experiences. Participants will receive the session either immediately or after a three-week wait. The goal is to determine if this approach is helpful and acceptable to students, potentially supporting mental health and preventing more serious issues. As an unphased trial, this study offers students a unique opportunity to contribute to innovative mental health solutions that could benefit themselves and others.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on a digital intervention for sleep and mental health, so it's best to check with the study team for specific guidance.
What prior data suggests that this digital intervention is safe for college students?
Research shows that digital mental health tools, like SPARK Healthy Sleep, are generally safe and easy to use. This tool employs cognitive behavioral therapy techniques to improve sleep, a method known for its safety and effectiveness. Reports of serious side effects from similar digital sleep tools are absent, and they are often considered a gentle way to address sleep problems.
The program, delivered through a smartphone app, takes about 30 minutes, offering a low-risk option for users. Since the trial is in the "Not Applicable" phase, it primarily tests the tool's practicality and initial effectiveness, rather than new drug safety. This indicates a strong expectation of safety for participants. Overall, this approach appears safe for college students seeking to improve their sleep and reduce mental health stigma.12345Why are researchers excited about this trial?
Researchers are excited about SPARK Healthy Sleep for insomnia because it offers a fresh approach to tackling sleep issues. Unlike traditional methods like medication or cognitive behavioral therapy, SPARK Healthy Sleep provides a unique intervention immediately at baseline, which might help people experience benefits sooner. Additionally, it offers an innovative, non-pharmaceutical option that could be particularly appealing for those looking to avoid medication side effects. This approach not only aims to improve sleep quality but also does so in a potentially more accessible way for participants.
What evidence suggests that the SPARK Healthy Sleep intervention is effective for improving sleep and mental health in college students?
Initial findings suggest that online cognitive behavioral therapy (CBT) for insomnia can be as effective as in-person sessions with a therapist. This therapy improves sleep by teaching better sleep habits and managing disruptive thoughts. In this trial, participants in the experimental group will receive the SPARK Healthy Sleep intervention immediately, while the control group will receive it after a 3-week delay. Research has shown that digital programs like SPARK Healthy Sleep may also reduce mental health stigma and improve overall well-being in similar groups. By addressing both sleep problems and stigma, this approach aims to support students' mental health. Overall, evidence indicates that digital CBT could be a promising tool for improving sleep and mental health in college students at risk for psychosis.16789
Are You a Good Fit for This Trial?
The SPARK Healthy Sleep trial is for college students at Indiana University-Indianapolis, aged 18 or older, who speak English fluently and are experiencing poor sleep quality alongside psychotic-like experiences. They must score high on specific questionnaires assessing risk for psychosis and sleep issues to participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Comprehensive battery including sleep quality, stigma measures, affect, paranoid ideation, social functioning, depression, emotion regulation, and cognitive testing
Intervention
Participants receive the SPARK-Healthy Sleep digital intervention via a smartphone app
Follow-up Assessment
Repeat of baseline measures to assess intervention impact
Qualitative Interviews
Semi-structured interviews with selected participants to gather feedback on user experience
What Are the Treatments Tested in This Trial?
Interventions
- SPARK Healthy Sleep
Trial Overview
This study tests a digital intervention called SPARK Healthy Sleep aimed at improving sleep and reducing mental health stigma in students at risk for psychosis. It's delivered via an app with educational content, help-seeking strategies, and cognitive behavioral therapy techniques for insomnia.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Receives SPARK-Healthy Sleep intervention immediately at baseline
Wait-list control that receives the intervention after a 3-week delay (after the study's primary endpoint)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
American Psychological Foundation
Collaborator
Citations
Study Details | NCT07119268 | SPARK Healthy Sleep
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