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NCT Number: NCT07119268

SPARK Healthy Sleep

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Kyle Minor, PhD

CONTACT

[email protected]

(317) 274-2933

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Intervention Completion Rates

    Time frame: Week 2

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

  2. System Usability Scores

    Time frame: Week 2

    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.

  3. Intervention Appropriateness Ratings

    Time frame: Week 2

    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.

  4. Prompt Completion Rates

    Time frame: Week 2

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

  5. Time Spent on Modules

    Time frame: Week 2

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

  6. Interaction Frequency

    Time frame: Week 2

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

  7. Change in Sleep Quality (PSQI)

    Time frame: Baseline, Week 2

    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.

  8. Change in Internalized Stigma (ISMI)

    Time frame: Baseline, Week 2

    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.

  9. Change in Treatment Seeking Stigma

    Time frame: Baseline, Week 2

    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.

  10. Change in Sleep Duration

    Time frame: Baseline, Week 2

    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.

  11. Change in Sleep Score

    Time frame: Baseline, Week 2

    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.

  12. Change in Sleep Stages

    Time frame: Baseline, Week 2

    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.

  13. Change in Daily Readiness Score

    Time frame: Baseline, Week 2

    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.

  14. Change in Resting Heart Rate During Sleep

    Time frame: Baseline, Week 2

    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.

  15. Change in Heart Rate Variability During Sleep

    Time frame: Baseline, Week 2

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

Secondary outcomes

  1. Change in Paranoia (CAPE-P42)

    Time frame: Baseline, Week 2

    The Community Assessment of Psychic Experiences (CAPE-P42) measures the frequency and distress levels of experiences in the general population. Frequency of experience is rated on a 4-point Likert scale from 1 (never) to 4 (nearly always) and associated distress of those experiences that have occurred is rated on a 4-point Likert scale from 1 (not distressed) to 4 (very distressed). Total scores range from 42 to 168, with higher scores indicating more frequent and more distressing experiences.

  2. Change in Negative Affect (PANAS)

    Time frame: Baseline, Week 2

    The Positive and Negative Affect Schedule (PANAS) measures an individual's emotional state. Each item is rated on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). The Negative Affect Score can range from 10-50, which higher scores indicating higher levels of distress and negative emotional states.

  3. Change in Social Functioning (SSI-Brief)

    Time frame: Baseline, Week 2

    The SSI-Brief assesses self-reported verbal and non-verbal communication across 6 subscales. Each statement is rated on a 5-point Likert scale from 1 (not at all like me) to 5 (exactly like me). Scores can range from 30 - 150, with higher scores indicating better social skills/social competence (such as greater social and emotional communication skill).

  4. Change in Depression (BDI-II)

    Time frame: Baseline, Week 2

    The Beck Depression Inventory-II assesses severity of depression. Each item presents four statements graded in severity from 0 to 3. Total scores range from 0 to 63, with higher scores indicating greater symptom severity.

  5. Change in Emotion Regulation

    Time frame: Baseline, Week 2

    The Emotion Regulation Questionnaire (ERQ) measures how individuals manage and control their emotions across 2 subscales (cognitive reappraisal - how often situations are reinterpreted to change their emotional impact, and expressive suppression - how often emotional expressions are hidden or held back). Each item is rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Each subscale is summed and divided by the number of items, for a total score between 1 and 7. Higher scores indicate a more frequent, habitual use of that emotional regulation strategy.

  6. Change in Cognition - Coding

    Time frame: Baseline, Week 2

    The Brief Assessment of Cognition in Schizophrenia (BACS) Symbol Coding task is a measure of processing speed. Participants use a reference key to match symbols with numbers and complete as many correct responses as possible within the allotted time (90 seconds). There is no fixed maximum score, as the score reflects the total number of correct responses produced within the testing period. Higher scores indicate faster cognitive processing.

  7. Change in Cognition - Verbal Fluency

    Time frame: Baseline, Week 2

    Verbal fluency measures executive functioning by asking participants to generate words under specific rules (for example, words that start with the same letter, or words within a specific category such as animals or fruits). Participants will be asked to name as many words as possible within 60 seconds. The total number of unique, valid words is scored. Lower scores may indicate cognitive impairment.

  8. Change in Sleep Self-Efficacy

    Time frame: Baseline, Week 2

    The Sleep Self-Efficacy Scale measures confidence in an individual's ability to manage sleep-related behaviors, fall asleep and cope with poor sleep. Each item is rated on a 5-point Likert scale from 1 (not confident at all) to 5 (very confident). Total scores range from 9 to 45 with higher scores indicating higher confidence.

  9. Change in Insomnia Severity

    Time frame: Baseline, Week 2

    The Insomnia Severity Index screens for insomnia by asking respondents to rate the nature and symptoms of their sleep problems. Each item is rated on a 5-point Likert scale from 0 (none) to 4 (very severe). Total scores range from 0 to 28 with higher scores indicating a more severe insomnia problem.

  10. Change in Sleep Beliefs (DBAS)

    Time frame: Baseline, Week 2

    The Dysfunctional Beliefs and Attitudes About Sleep (DBAS) evaluates expectations and attitudes regarding the causes, consequences, and potential treatments for sleep issues. Each item is rated on a 10 point Likert scale from 0 (strongly disagree) to 10 (strongly agree). Total scores range from 0 to 10 with scores calculated as a mean of the 16 items. Higher scores indicating more dysfunctional beliefs and attitudes about sleep (worse outcome), and lower scores indicating more adaptive and realistic beliefs about sleep (better outcome).

Study contacts

Contact information is provided by the study sponsor or research team.

Kyle S Minor, PhD

CONTACT

[email protected]

317-274-2933

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • American Psychological Foundation

Registry information

Official study title

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

Acronym: SPARK

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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