SPARK Healthy Sleep
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SPARK Healthy Sleep.
- Who it may be relevant to
- Registry conditions: Schizophrenia and Related Disorders, Sleep Disturbance. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
SPARK-Healthy Sleep: A Digital Health Intervention to Promote Behavioral, Emotional, and Cognitive Changes
Overview
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.
Detailed description
Study Overview SPARK-Healthy Sleep is a randomized controlled pilot study testing a single-session digital mental health intervention for college students at risk for psychosis who experience sleep difficulties. The study evaluates feasibility, acceptability, and preliminary effectiveness of a smartphone-delivered intervention combining stigma reduction and cognitive behavioral therapy for insomnia (CBT-I) principles.
SPARK-Healthy Sleep is delivered via Qualtrics platform in approximately 30 minutes. The intervention consists of five modules:
Introduction: Welcome, safety information, single-session concept introduction Stigma Resistance: Mental health continuum education, stress-vulnerability model, interactive exercises Sleep Regulation: CBT-I principles, sleep hygiene education, cognitive restructuring, behavioral strategies Planning: Personalized sleep plan development, goal-setting exercises Recap: Summary, resource provision, follow-up instructions
The intervention incorporates videos, interactive text responses, and personalized feedback based on participant inputs.
Assessment Schedule
Screening Assessment:
Online consent process Demographics questionnaire Schizotypal Personality Questionnaire-Brief Updated Prodromal Questionnaire-Brief Pittsburgh Sleep Quality Index Additional measures: Academic satisfaction, life satisfaction, loneliness, digital mental health interest
At the Week 0 (Baseline) visit, a comprehensive battery including sleep quality, stigma measures, affect, paranoid ideation, social functioning, depression, emotion regulation, and cognitive testing is administered. Additionally, the experimental group will undergo the intervention installation and orientation.
At the Week 2, Follow-up Assessment, the baseline measures will be repeated and the experimental group will be asked to complete system usability and intervention acceptability measures. At this time, the control group will be provided with access to the intervention as a "post-study" opportunity.
Interventions
- Device 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 measures
- 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]
Secondary outcome measures (10)
- Change in Paranoia (CAPE-P42) [Time frame: Baseline, Week 2]
- Change in Negative Affect (PANAS) [Time frame: Baseline, Week 2]
- Change in Social Functioning (SSI-Brief) [Time frame: Baseline, Week 2]
- Change in Depression (BDI-II) [Time frame: Baseline, Week 2]
- Change in Emotion Regulation [Time frame: Baseline, Week 2]
- Change in Cognition - Coding [Time frame: Baseline, Week 2]
- Change in Cognition - Verbal Fluency [Time frame: Baseline, Week 2]
- Change in Sleep Self-Efficacy [Time frame: Baseline, Week 2]
- Change in Insomnia Severity [Time frame: Baseline, Week 2]
- Change in Sleep Beliefs (DBAS) [Time frame: Baseline, Week 2]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Indiana University — Indianapolis
Identifiers
NCT: NCT07119268 · SPARK Healthy Sleep