NCT07119268 · Indiana University
SPARK Healthy Sleep
(SPARK)
What this study is about
SPARK-Healthy Sleep is a digital mental health intervention designed to help college students who may be at risk for psychosis and experience sleep problems. About 1 in 4 college students report psychotic-like experiences (such as hearing voices or feeling paranoid), and these students often have poor sleep quality, which can worsen their mental health symptoms.
View original scientific description
SPARK-Healthy Sleep is a digital mental health intervention designed to help college students who may be at risk for psychosis and experience sleep problems. About 1 in 4 college students report psychotic-like experiences (such as hearing voices or feeling paranoid), and these students often have poor sleep quality, which can worsen their mental health symptoms. This study tests whether a single-session digital intervention can improve sleep and reduce mental health stigma in at-risk college students. The intervention is delivered through a smartphone app and takes about 30 minutes to complete. It includes educational content about mental health being on a continuum (not just "normal" vs "abnormal"), strategies to reduce stigma around seeking help, and evidence-based sleep improvement techniques based on cognitive behavioral therapy for insomnia. The study will recruit 115 college students from Indiana University-Indianapolis who score high on measures of psychotic-like experiences and poor sleep quality. Half will receive the intervention immediately (experimental group), while the other half will wait three weeks before receiving it (control group). All participants will complete questionnaires about sleep, mental health symptoms, social functioning, and stigma at the beginning of the study and after two weeks. The main goals are to determine if the intervention is feasible and acceptable to students, and whether it shows preliminary effectiveness in improving sleep quality, reducing stigma, and improving overall mental health outcomes. A subset of participants will also complete interviews about their experience using the intervention. This research addresses important barriers to mental health care for college students, including stigma and limited access to services. If successful, this digital approach could provide a scalable way to help at-risk students improve their mental health and potentially prevent more serious problems from developing.
Interventions
DEVICE
SPARK Healthy Sleep
SPARK-Healthy Sleep is a single-session digital intervention delivered via smartphone that combines stigma reduction with evidence-based sleep improvement strategies.
Primary outcome measures
Intervention Completion Rates
Time frame: Week 2
Usage data will be collected to evaluate the number of participants that complete the full intervention.
System Usability Scores
Time frame: Week 2
The System Usability Scale (SUS) is a standardized, 10-item questionnaire that evaluates the subjective usability of a product or software. Participants are asked to rate each item on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The SUS score can range from 0 - 100, with higher scores indicating excellent usability.
Intervention Appropriateness Ratings
Time frame: Week 2
Participants will be asked to rate the appropriateness of the intervention on a 4-item questionnaire. Participants are asked to rate each item on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Scores can range from 4 - 20, with higher scores indicate greater appropriateness.
Prompt Completion Rates
Time frame: Week 2
Usage data will be collected to evaluate the number of participants that complete the intervention prompts over the 2 week intervention period
Time Spent on Modules
Time frame: Week 2
Usage data will be collected to evaluate the total amount of time spent on modules over the 2 week intervention period
Interaction Frequency
Time frame: Week 2
Usage data will be collected to evaluate the number of times participants engage with intervention over the 2 week intervention period
Change in Sleep Quality (PSQI)
Time frame: Baseline, Week 2
The PSQI assesses sleep quality and disturbances on a scale from 0 (no difficulty) to 3 (severe difficulty). Component scores are summed for a total score between 0 - 21. A score of 0-5 indicates excellent to good sleep quality. A score of \>5 indicates poor sleep quality.
Change in Internalized Stigma (ISMI)
Time frame: Baseline, Week 2
The ISMI measures how individuals perceive and internalize social stereotypes about mental illness. Each statement is rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). Statement scores are summed and then divided by the number of answered items. Total scores range from 1.00 - 4.00 with higher scores indicating severe internalized stigma.
Change in Treatment Seeking Stigma
Time frame: Baseline, Week 2
The Endorsed Anticipated Stigma Inventory - Treatment Seeking scale measures beliefs about seeking treatment for mental health. Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores may range from 8 - 40 with higher scores indicate greater reluctance to seek treatment.
Change in Sleep Duration
Time frame: Baseline, Week 2
Daily sleep data will be collected from participants via a study-provided Fitbit. Sleep duration will be calculated from recorded sleep start and end times.
Change in Sleep Score
Time frame: Baseline, Week 2
Daily sleep data will be collected from participants via a study-provided Fitbit. Sleep score is automatically calculated by the Fitbit device on a scale of 0 to 100, with higher scores indicating longer, higher quality sleep.
Change in Sleep Stages
Time frame: Baseline, Week 2
Daily sleep data will be collected from participants via a study-provided Fitbit. Average time spent in various sleep stages (awake, REM, light, deep) will be evaluated.
Change in Daily Readiness Score
Time frame: Baseline, Week 2
Daily sleep data will be collected from participants via a study-provided Fitbit. Daily Readiness Score is automatically calculated by the Fitbit device on a scale of 1 to 100, with higher scores indicating that the body is well-rested and more prepared for an intense or rigorous training session.
Change in Resting Heart Rate During Sleep
Time frame: Baseline, Week 2
Daily sleep data will be collected from participants via a study-provided Fitbit. Higher resting heart rate scores during sleep often indicate worse sleep quality.
Change in Heart Rate Variability During Sleep
Time frame: Baseline, Week 2
Daily sleep data will be collected from participants via a study-provided Fitbit. Higher heart rate variability during sleep generally indicates higher sleep quality.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥18 years
- Current college enrollment
- English fluency
- Prodromal Questionnaire-Brief endorsement score ≥7
- Pittsburgh Sleep Quality Index score \>5
- Pass validity screening questions
Exclusion criteria
- Previous psychotic disorder diagnosis
- Unable to provide informed consent
Where
- Indianapolis, Indiana
Collaborators
American Psychological Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations