Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-30 @ 10:37 PM
Study NCT ID:
NCT07119268
Status:
RECRUITING
Last Update Posted:
2025-11-07
First Post:
2025-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SPARK Healthy Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Participants are randomized 1:1 into two groups that run simultaneously (in parallel)\n\nExperimental 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)"}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2025-08-06', 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intervention Completion Rates', 'timeFrame': '2 weeks'}, {'measure': 'System Usability Scores', 'timeFrame': '2 weeks'}, {'measure': 'Intervention Appropriateness Ratings', 'timeFrame': '2 weeks'}, {'measure': 'Prompt Completion Rates', 'timeFrame': '2 weeks'}, {'measure': 'Time Spent on Modules', 'timeFrame': '2 weeks', 'description': 'Total amount of time spent on modules over two weeks'}, {'measure': 'Interaction Frequency', 'timeFrame': '2 weeks', 'description': 'Number of times engaging with intervention'}], 'secondaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': '2 weeks', 'description': 'Sleep quality'}, {'measure': 'Internalized Stigma Mental Health Inventory', 'timeFrame': '2 weeks', 'description': 'Stigma'}, {'measure': 'The Community Assessment of Psychic Experiences (CAPE)', 'timeFrame': '2 weeks', 'description': 'Paranoia questionnaire (42 items)'}, {'measure': 'Positive and Negative Affect Schedule', 'timeFrame': '2 weeks', 'description': 'Affect'}, {'measure': 'Social Functioning Scale', 'timeFrame': '2 weeks', 'description': 'Social functioning'}, {'measure': 'Beck Depression Inventory', 'timeFrame': '2 weeks', 'description': 'Depression'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['College Students', 'Sleep Disturbances', 'Psychosis-Spectrum Disorders'], 'conditions': ['Schizophrenia and Related Disorders', 'Sleep Disturbance']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nThe 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.\n\nThe 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.\n\nThis 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.', 'detailedDescription': '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.\n\nStudy Design This is a pragmatic randomized controlled trial with a wait-list control design. Participants are randomized 1:1 to immediate intervention or 3-week delayed intervention, stratified by race, gender, and age. The study is unblinded given the nature of the digital intervention.\n\nParticipants and Recruitment Target enrollment: 115 college students from Indiana University-Indianapolis (aiming for 100 completers). Recruitment occurs through the SONA research participation system and mass emails to the student body.\n\nInclusion 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\n\nExclusion Criteria: Previous psychotic disorder diagnosis, Unable to provide informed consent\n\nIntervention Description\n\nSPARK-Healthy Sleep is delivered via Qualtrics platform in approximately 30 minutes. The intervention consists of five modules:\n\nIntroduction: 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\n\nThe intervention incorporates videos, interactive text responses, and personalized feedback based on participant inputs.\n\nAssessment Schedule\n\nScreening Assessment:\n\nOnline 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\n\nBaseline Assessment (Week 0):\n\nComprehensive battery including sleep quality, stigma measures, affect, paranoid ideation, social functioning, depression, emotion regulation, and cognitive testing Intervention installation and orientation for experimental group\n\nFollow-up Assessment (Week 2):\n\nRepeat of baseline measures System usability and intervention acceptability measures Intervention access provided to control group\n\nQualitative Interviews:\n\nSemi-structured interviews with 10 participants selected across engagement levels Audio recorded with permission Focus on user experience, barriers, and improvement suggestions\n\nPrimary Outcomes Feasibility: Intervention completion rates (target ≥80%), system usability scores Acceptability: Intervention appropriateness ratings, prompt completion rates Usage data: Time spent, modules completed, interaction frequency\n\nSecondary Outcomes Sleep quality (Pittsburgh Sleep Quality Index) Mental health stigma (Internalized Stigma Mental Health Inventory) Paranoid ideation (Community Assessment of Psychic Experiences) Negative affect (Positive and Negative Affect Schedule) Functional outcomes: Social functioning, depression, emotion regulation, executive functioning\n\nStatistical Analysis Plan Sample Size: Power analysis indicates n=50 per arm provides adequate power (0.80) to detect medium effects (α=0.05).\n\nPrimary Analysis: Descriptive statistics for feasibility and acceptability outcomes. Target thresholds: ≥80% completion rates and high usability/appropriateness ratings.\n\nSecondary Analysis: 2x2 mixed-effects ANOVA examining intervention effects over time (baseline, follow-up) and between conditions (immediate vs. delayed intervention). Within-group effect sizes calculated to quantify intervention impact. Bonferroni corrections applied for multiple comparisons.\n\nMissing Data: Multiple imputation for missing at random data. Intent-to-treat analysis with sensitivity analyses for different missingness patterns.\n\nQualitative Analysis: Thematic content analysis of interview transcripts to identify implementation barriers and improvement recommendations.\n\nData Management and Quality Assurance Data Collection: All data collected via password-protected Qualtrics surveys stored on secure IU research servers.\n\nQuality Control:\n\nRange checks in Qualtrics Double entry for critical variables Regular data backup verification Monthly data quality review by PI\n\nSafety Monitoring:\n\nAutomated flags for concerning responses on depression and psychosis measures 24-hour PI notification protocol Established referral pathways to campus counseling and first-episode psychosis services Resource information provided to all participants\n\nData Storage: De-identified data stored indefinitely on encrypted servers. Separate master list links participant IDs to identifying information, accessible only to PI and study team.\n\nThis pilot study will provide essential feasibility data and preliminary effect size estimates for future larger-scale randomized controlled trials examining longer-term outcomes and broader implementation across college campuses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Current college enrollment\n* English fluency\n* Prodromal Questionnaire-Brief endorsement score ≥7\n* Pittsburgh Sleep Quality Index score \\>5\n* Pass validity screening questions\n\nExclusion Criteria:\n\n* Previous psychotic disorder diagnosis\n* Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07119268', 'acronym': 'SPARK', 'briefTitle': 'SPARK Healthy Sleep', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'SPARK-Healthy Sleep: A Digital Health Intervention to Promote Behavioral, Emotional, and Cognitive Changes', 'orgStudyIdInfo': {'id': 'SPARK Healthy Sleep'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Receives SPARK-Healthy Sleep intervention immediately at baseline', 'interventionNames': ['Device: SPARK Healthy Sleep']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': "Wait-list control that receives the intervention after a 3-week delay (after the study's primary endpoint)"}], 'interventions': [{'name': 'SPARK Healthy Sleep', 'type': 'DEVICE', 'description': 'SPARK-Healthy Sleep is a single-session digital intervention delivered via smartphone that combines stigma reduction with evidence-based sleep improvement strategies.', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kyle Minor, PhD', 'role': 'CONTACT', 'email': 'ksminor@iu.edu', 'phone': '(317) 274-2933'}], 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'centralContacts': [{'name': 'Kyle S Minor, PhD', 'role': 'CONTACT', 'email': 'ksminor@iu.edu', 'phone': '317-274-2933'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Psychological Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kyle S. Minor', 'investigatorAffiliation': 'Indiana University'}}}}