Schizophrenia and Related DisordersSPARKNCT07119268
SPARK Healthy Sleep
A study testing SPARK Healthy Sleep in people with Schizophrenia and Related Disorders and Sleep Disturbance, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia and Related Disorders, Sleep Disturbance
- What is being tested?
- SPARK Healthy Sleep
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Current college enrollment
- English fluency
- Prodromal Questionnaire-Brief endorsement score ≥7
- Pittsburgh Sleep Quality Index score >5
- Pass validity screening questions
Who cannot join
- Previous psychotic disorder diagnosis
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Kyle Minor, PhD, (317) 274-2933, ksminor@iu.edu
About this study
Official title: SPARK-Healthy Sleep: A Digital Health Intervention to Promote Behavioral, Emotional, and Cognitive Changes
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.
Read more
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.
Read the 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.
- Being tested
- SPARK Healthy Sleep
- Keywords
- College Students, Sleep Disturbances, Psychosis-Spectrum Disorders
- Medical subject headings
- Schizophrenia, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARK Healthy SleepDevice
SPARK-Healthy Sleep is a single-session digital intervention delivered via smartphone that combines stigma reduction with evidence-based sleep improvement strategies.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Receives SPARK-Healthy Sleep intervention immediately at baseline Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Completion Rates
Usage data will be collected to evaluate the number of participants that complete the full intervention.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 2
Secondary outcomes (10)
Change in Paranoia (CAPE-P42)
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.
Measured: Baseline, Week 2
Change in Negative Affect (PANAS)
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.
Measured: Baseline, Week 2
Change in Social Functioning (SSI-Brief)
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).
Measured: Baseline, Week 2
Change in Depression (BDI-II)
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.
Measured: Baseline, Week 2
Change in Emotion Regulation
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.
Measured: Baseline, Week 2
Change in Cognition - Coding
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.
Measured: Baseline, Week 2
Change in Cognition - Verbal Fluency
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.
Measured: Baseline, Week 2
Change in Sleep Self-Efficacy
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.
Measured: Baseline, Week 2
Change in Insomnia Severity
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.
Measured: Baseline, Week 2
Change in Sleep Beliefs (DBAS)
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).
Measured: Baseline, Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start24 Oct 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Foundation
- Responsible party
- Principal investigator, Kyle S. Minor, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119268
- Sponsor's protocol ID
- SPARK Healthy Sleep
- Acronym
- SPARK
- Status last verified
- Jun 2026
- First submitted
- 31 Jul 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPARK-Healthy Sleep: A Digital Health Intervention to Promote Behavioral, Emotional, and Cognitive Changes
- ClinicalTrials.gov ID
- NCT07119268
- Acronym / sponsor ID
- SPARK / SPARK Healthy Sleep
- Keywords
- College Students, Sleep Disturbances, Psychosis-Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- American Psychological Foundation
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: SPARK Healthy SleepReceives SPARK-Healthy Sleep intervention immediately at baseline |
| Control Group | No intervention | –Wait-list control that receives the intervention after a 3-week delay (after the study's primary endpoint) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Current college enrollment
- English fluency
- Prodromal Questionnaire-Brief endorsement score ≥7
- Pittsburgh Sleep Quality Index score >5
Key exclusion criteria (2 listed)
- Previous psychotic disorder diagnosis
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPARK Healthy SleepSPARK-Healthy Sleep is a single-session digital intervention delivered via smartphone that combines stigma reduction with evidence-based sleep improvement strategies. | Device | Experimental Group |
Primary outcome
Intervention Completion Rates
Time frame: Week 2
Usage data will be collected to evaluate the number of participants that complete the full intervention.
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.
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.
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPARK Healthy Sleep in people with Schizophrenia and Related Disorders and Sleep Disturbance, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyle S Minor, PhD (317-274-2933, ksminor@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Completion Rates (time frame: Week 2). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.