SPARK Healthy Sleep

NCT07119268 | Recruiting FDA Device

• 1 other identifier: SPARK Healthy Sleep
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia and Related Disorders; Sleep Disturbance

Keywords

College Students; Sleep Disturbances; Psychosis-Spectrum Disorders

Outcome Measures

Primary Outcomes (6)

• Intervention Completion Rates

  2 weeks

• System Usability Scores

  2 weeks

• Intervention Appropriateness Ratings

  2 weeks

• Prompt Completion Rates

  2 weeks

• Time Spent on Modules

  Total amount of time spent on modules over two weeks

  2 weeks

• Interaction Frequency

  Number of times engaging with intervention

  2 weeks

Secondary Outcomes (6)

• Pittsburgh Sleep Quality Index

  2 weeks

• Internalized Stigma Mental Health Inventory

  2 weeks

• The Community Assessment of Psychic Experiences (CAPE)

  2 weeks

• Positive and Negative Affect Schedule

  2 weeks

• Social Functioning Scale

  2 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Receives SPARK-Healthy Sleep intervention immediately at baseline

Device: SPARK Healthy Sleep

Control Group

NO INTERVENTION

Wait-list control that receives the intervention after a 3-week delay (after the study's primary endpoint)

Interventions

SPARK Healthy Sleep DEVICE

SPARK-Healthy Sleep is a single-session digital intervention delivered via smartphone that combines stigma reduction with evidence-based sleep improvement strategies.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Current college enrollment
• English fluency
• Prodromal Questionnaire-Brief endorsement score ≥7
• Pittsburgh Sleep Quality Index score \>5
• Pass validity screening questions

You may not qualify if:

• Previous psychotic disorder diagnosis
• Unable to provide informed consent

Sponsors & Collaborators

• Indiana University: lead
• American Psychological Foundation: collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Parasomnias

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Kyle S Minor, PhD

CONTACT

317-274-2933; ksminor@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants are randomized 1:1 into two groups that run simultaneously (in parallel) Experimental Group: Receives SPARK-Healthy Sleep intervention immediately at baseline Control Group: Wait-list control that receives the intervention after a 3-week delay (after the study's primary endpoint)

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 13, 2025
• Study Start: October 24, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-08

Locations

US (1)