Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Psychological Foundation | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Receives 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Completion Rates | Usage data will be collected to evaluate the number of participants that complete the full intervention. | 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. | 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. | 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 | 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 | 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 | Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyle S Minor, PhD | Contact | 317-274-2933 | ksminor@iu.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Recruiting | Indianapolis | Indiana | 46202 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, Week 2 |
| 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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). | Baseline, Week 2 |