SPARK-Healthy Sleep: A Digital Health Intervention to Promote Behavioral, Emotional, and Cognitive Changes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Intervention Completion Rates
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Current college enrollment
- •English fluency
- •Prodromal Questionnaire-Brief endorsement score ≥7
- •Pittsburgh Sleep Quality Index score >5
- •Pass validity screening questions
排除标准
- •Previous psychotic disorder diagnosis
- •Unable to provide informed consent
研究组 & 干预措施
Experimental Group
Receives SPARK-Healthy Sleep intervention immediately at baseline
干预措施: SPARK Healthy Sleep (Device)
Control Group
Wait-list control that receives the intervention after a 3-week delay (after the study's primary endpoint)
结局指标
主要结局
Intervention Completion Rates
时间窗: Week 2
Usage data will be collected to evaluate the number of participants that complete the full intervention.
System Usability Scores
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
Intervention Completion Rates
时间窗: 2 weeks
System Usability Scores
时间窗: 2 weeks
Intervention Appropriateness Ratings
时间窗: 2 weeks
Prompt Completion Rates
时间窗: 2 weeks
Time Spent on Modules
时间窗: 2 weeks
Total amount of time spent on modules over two weeks
Interaction Frequency
时间窗: 2 weeks
Number of times engaging with intervention
次要结局
- Change in Paranoia (CAPE-P42)(Baseline, Week 2)
- Change in Negative Affect (PANAS)(Baseline, Week 2)
- Change in Social Functioning (SSI-Brief)(Baseline, Week 2)
- Change in Depression (BDI-II)(Baseline, Week 2)
- Change in Emotion Regulation(Baseline, Week 2)
- Change in Cognition - Coding(Baseline, Week 2)
- Change in Cognition - Verbal Fluency(Baseline, Week 2)
- Change in Sleep Self-Efficacy(Baseline, Week 2)
- Change in Insomnia Severity(Baseline, Week 2)
- Change in Sleep Beliefs (DBAS)(Baseline, Week 2)
- Pittsburgh Sleep Quality Index(2 weeks)
- Internalized Stigma Mental Health Inventory(2 weeks)
- The Community Assessment of Psychic Experiences (CAPE)(2 weeks)
- Positive and Negative Affect Schedule(2 weeks)
- Social Functioning Scale(2 weeks)
- Beck Depression Inventory(2 weeks)
研究者
Kyle S. Minor
Associate Professor
Indiana University