RecruitingNANCT07119268

SPARK-Healthy Sleep: A Digital Health Intervention to Promote Behavioral, Emotional, and Cognitive Changes

Sponsor: Indiana University

Trial Details

Condition	Schizophrenia and Related Disorders, Sleep Disturbance
Intervention	SPARK Healthy Sleep
Phase	NA
Status	Recruiting
Participants	115
Est. Completion	31 Oct 2026
Last Updated	7 July 2026

Primary Outcome

Intervention Completion Rates; System Usability Scores; Intervention Appropriateness Ratings; Prompt Completion Rates; Time Spent on Modules; Interaction Frequency; Change in Sleep Quality (PSQI); Change in Internalized Stigma (ISMI); Change in Treatment Seeking Stigma; Change in Sleep Duration; Change in Sleep Score; Change in Sleep Stages; Change in Daily Readiness Score; Change in Resting Heart Rate During Sleep; Change in Heart Rate Variability During Sleep

Eligibility Criteria

Inclusion 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

Trial Sites

Countries

United States

View Registry Entry

Related Analysis

SPARK-Healthy Sleep Trial: Single-Session Digital CBT-I App Targets Sleep and Psychosis Risk in College Students — Key Details for Clinicians

A new US feasibility trial is testing whether a 30-minute smartphone app combining CBT-I techniques and stigma psychoeducation can improve sleep and reduce help-seeking barriers in college students at risk for psychosis. The SPARK-Healthy Sleep study (NCT07119268) is enrolling 115 students with elevated prodromal questionnaire scores and poor sleep quality at Indiana University-Indianapolis. Australian early psychosis clinicians and digital health researchers should monitor this trial as a potential model for scalable secondary prevention.

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