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 (15)

• Intervention Completion Rates

  Usage data will be collected to evaluate the number of participants that complete the full intervention.

  Week 2

• System Usability Scores

  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.

  Week 2

• Intervention Appropriateness Ratings

  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.

  Week 2

• Prompt Completion Rates

  Usage data will be collected to evaluate the number of participants that complete the intervention prompts over the 2 week intervention period

  Week 2

• Time Spent on Modules

  Usage data will be collected to evaluate the total amount of time spent on modules over the 2 week intervention period

  Week 2

• Interaction Frequency

  Usage data will be collected to evaluate the number of times participants engage with intervention over the 2 week intervention period

  Week 2

• Change in Sleep Quality (PSQI)

  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.

  Baseline, Week 2

• Change in Internalized Stigma (ISMI)

  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.

  Baseline, Week 2

• Change in Treatment Seeking Stigma

  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.

  Baseline, Week 2

• Change in Sleep Duration

  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.

  Baseline, Week 2

• Change in Sleep Score

  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.

  Baseline, Week 2

• Change in Sleep Stages

  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.

  Baseline, Week 2

• Change in Daily Readiness Score

  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.

  Baseline, Week 2

• Change in Resting Heart Rate During Sleep

  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.

  Baseline, Week 2

• Change in Heart Rate Variability During Sleep

  Daily sleep data will be collected from participants via a study-provided Fitbit. Higher heart rate variability during sleep generally indicates higher sleep quality.

  Baseline, Week 2

Secondary Outcomes (10)

• Change in Paranoia (CAPE-P42)

  Baseline, Week 2

• Change in Negative Affect (PANAS)

  Baseline, Week 2

• Change in Social Functioning (SSI-Brief)

  Baseline, Week 2

• Change in Depression (BDI-II)

  Baseline, Week 2

• Change in Emotion Regulation

  Baseline, Week 2

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 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-06

Locations

US (1)