SPARK Healthy Sleep

Официальное название

SPARK-Healthy Sleep: A Digital Health Intervention to Promote Behavioral, Emotional, and Cognitive Changes

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство SPARK Healthy Sleep
  SPARK-Healthy Sleep is a single-session digital intervention delivered via smartphone that combines stigma reduction with evidence-based sleep improvement strategies.

Первичные конечные точки

• Intervention Completion Rates [Срок оценки: Week 2]
• System Usability Scores [Срок оценки: Week 2]
• Intervention Appropriateness Ratings [Срок оценки: Week 2]
• Prompt Completion Rates [Срок оценки: Week 2]
• Time Spent on Modules [Срок оценки: Week 2]
• Interaction Frequency [Срок оценки: Week 2]
• Change in Sleep Quality (PSQI) [Срок оценки: Baseline, Week 2]
• Change in Internalized Stigma (ISMI) [Срок оценки: Baseline, Week 2]
• Change in Treatment Seeking Stigma [Срок оценки: Baseline, Week 2]
• Change in Sleep Duration [Срок оценки: Baseline, Week 2]

Вторичные конечные точки (10)

• Change in Paranoia (CAPE-P42) [Срок оценки: Baseline, Week 2]
• Change in Negative Affect (PANAS) [Срок оценки: Baseline, Week 2]
• Change in Social Functioning (SSI-Brief) [Срок оценки: Baseline, Week 2]
• Change in Depression (BDI-II) [Срок оценки: Baseline, Week 2]
• Change in Emotion Regulation [Срок оценки: Baseline, Week 2]
• Change in Cognition - Coding [Срок оценки: Baseline, Week 2]
• Change in Cognition - Verbal Fluency [Срок оценки: Baseline, Week 2]
• Change in Sleep Self-Efficacy [Срок оценки: Baseline, Week 2]
• Change in Insomnia Severity [Срок оценки: Baseline, Week 2]
• Change in Sleep Beliefs (DBAS) [Срок оценки: Baseline, Week 2]

Критерии участия

Критерии включения

• Age ≥18 years
• Current college enrollment
• English fluency
• Prodromal Questionnaire-Brief endorsement score ≥7
• Pittsburgh Sleep Quality Index score >5
• Pass validity screening questions

Критерии исключения

• Previous psychotic disorder diagnosis
• Unable to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Indiana University — Indianapolis

Идентификаторы

NCT: NCT07119268 · SPARK Healthy Sleep

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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