| NCT ID | NCT07119268 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Schizophrenia and Related Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 115 participants |
| Start Date | 2025-10-24 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 115 participants in total. It began in 2025-10-24 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07119268 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Schizophrenia and Related Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07119268 currently recruiting?
Yes, NCT07119268 is actively recruiting participants. Contact the research team at ksminor@iu.edu for enrollment information.
Where is the NCT07119268 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT07119268 clinical trial?
NCT07119268 is sponsored by Indiana University. The trial plans to enroll 115 participants.
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