SPARK Healthy Sleep
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIndiana University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥18 years
Current college enrollment
English fluency
Prodromal Questionnaire-Brief endorsement score ≥7
Disqualifiers
Previous psychotic disorder diagnosis
Unable to provide informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
SPARK Healthy Sleep
DeviceSPARK-Healthy Sleep is a single-session digital intervention delivered via smartphone that combines stigma reduction with evidence-based sleep improvement strategies.
Treatment groups
115 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Intervention Completion Rates
Usage data will be collected to evaluate the number of participants that complete the full intervention.
Time frame
Week 22
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.
Time frame
Week 23
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.
Time frame
Week 24
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
Time frame
Week 2Secondary outcomes
1
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.
Time frame
Baseline, Week 22
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.
Time frame
Baseline, Week 23
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).
Time frame
Baseline, Week 24
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.
Time frame
Baseline, Week 2Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
American Psychological Foundation
Collaborator
Source ClinicalTrials.gov