Recruiting

SPARK-Healthy Sleep

Sponsor:

Indiana University

Code:

NCT07119268

Conditions

Schizophrenia and Related Disorders

Sleep Disturbance

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

SPARK Healthy Sleep

Study Details

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

Study ID

NCT07119268

Start date

Oct 24, 2025

Status verified date

Jun, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

115 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Group

Receives SPARK-Healthy Sleep intervention immediately at baseline

no intervention: Control Group

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

Interventions

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 measure

  • Intervention Completion Rates [ Time Frame: Week 2 ]
  • System Usability Scores [ Time Frame: Week 2 ]
  • Intervention Appropriateness Ratings [ Time Frame: Week 2 ]
  • Prompt Completion Rates [ Time Frame: Week 2 ]
  • Time Spent on Modules [ Time Frame: Week 2 ]
  • Interaction Frequency [ Time Frame: Week 2 ]
  • Change in Sleep Quality (PSQI) [ Time Frame: Baseline, Week 2 ]
  • Change in Internalized Stigma (ISMI) [ Time Frame: Baseline, Week 2 ]
  • Change in Treatment Seeking Stigma [ Time Frame: Baseline, Week 2 ]
  • Change in Sleep Duration [ Time Frame: Baseline, Week 2 ]
  • Change in Sleep Score [ Time Frame: Baseline, Week 2 ]
  • Change in Sleep Stages [ Time Frame: Baseline, Week 2 ]
  • Change in Daily Readiness Score [ Time Frame: Baseline, Week 2 ]
  • Change in Resting Heart Rate During Sleep [ Time Frame: Baseline, Week 2 ]
  • Change in Heart Rate Variability During Sleep [ Time Frame: Baseline, Week 2 ]

Central Contacts and Locations

Central contacts

Locations

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

More Information

Sponsor

Indiana University

Last update posted

Jul 7, 2026

Last verified

Jun, 2026

Keywords

  • College Students
  • Sleep Disturbances
  • Psychosis-Spectrum Disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-07-07.