SPARK Healthy Sleep for Insomnia

(SPARK Trial)

Overseen By Kyle S Minor, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Psychotic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

115 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist college students who struggle with sleep and experience symptoms like hearing voices or feeling overly suspicious. It tests whether a 30-minute digital session, delivered through a smartphone app called SPARK Healthy Sleep, can improve sleep, reduce mental health stigma, and enhance overall well-being. The trial involves students from Indiana University-Indianapolis who frequently experience sleep problems and score high on measures of psychotic-like experiences. Participants will receive the session either immediately or after a three-week wait. The goal is to determine if this approach is helpful and acceptable to students, potentially supporting mental health and preventing more serious issues. As an unphased trial, this study offers students a unique opportunity to contribute to innovative mental health solutions that could benefit themselves and others.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a digital intervention for sleep and mental health, so it's best to check with the study team for specific guidance.

What prior data suggests that this digital intervention is safe for college students?

Research shows that digital mental health tools, like SPARK Healthy Sleep, are generally safe and easy to use. This tool employs cognitive behavioral therapy techniques to improve sleep, a method known for its safety and effectiveness. Reports of serious side effects from similar digital sleep tools are absent, and they are often considered a gentle way to address sleep problems.

The program, delivered through a smartphone app, takes about 30 minutes, offering a low-risk option for users. Since the trial is in the "Not Applicable" phase, it primarily tests the tool's practicality and initial effectiveness, rather than new drug safety. This indicates a strong expectation of safety for participants. Overall, this approach appears safe for college students seeking to improve their sleep and reduce mental health stigma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SPARK Healthy Sleep for insomnia because it offers a fresh approach to tackling sleep issues. Unlike traditional methods like medication or cognitive behavioral therapy, SPARK Healthy Sleep provides a unique intervention immediately at baseline, which might help people experience benefits sooner. Additionally, it offers an innovative, non-pharmaceutical option that could be particularly appealing for those looking to avoid medication side effects. This approach not only aims to improve sleep quality but also does so in a potentially more accessible way for participants.

What evidence suggests that the SPARK Healthy Sleep intervention is effective for improving sleep and mental health in college students?

Initial findings suggest that online cognitive behavioral therapy (CBT) for insomnia can be as effective as in-person sessions with a therapist. This therapy improves sleep by teaching better sleep habits and managing disruptive thoughts. In this trial, participants in the experimental group will receive the SPARK Healthy Sleep intervention immediately, while the control group will receive it after a 3-week delay. Research has shown that digital programs like SPARK Healthy Sleep may also reduce mental health stigma and improve overall well-being in similar groups. By addressing both sleep problems and stigma, this approach aims to support students' mental health. Overall, evidence indicates that digital CBT could be a promising tool for improving sleep and mental health in college students at risk for psychosis. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

The SPARK Healthy Sleep trial is for college students at Indiana University-Indianapolis, aged 18 or older, who speak English fluently and are experiencing poor sleep quality alongside psychotic-like experiences. They must score high on specific questionnaires assessing risk for psychosis and sleep issues to participate.

Inclusion Criteria

Prodromal Questionnaire-Brief endorsement score ≥7

Current college enrollment

English fluency

Exclusion Criteria

Previous psychotic disorder diagnosis

I am unable to understand or sign the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Online consent and questionnaires

Baseline Assessment

Comprehensive battery including sleep quality, stigma measures, affect, paranoid ideation, social functioning, depression, emotion regulation, and cognitive testing

1 week

Online assessment

Intervention

Participants receive the SPARK-Healthy Sleep digital intervention via a smartphone app

30 minutes

Self-administered via smartphone app

Follow-up Assessment

Repeat of baseline measures to assess intervention impact

2 weeks

Online assessment

Qualitative Interviews

Semi-structured interviews with selected participants to gather feedback on user experience

1 week

Audio recorded interviews

What Are the Treatments Tested in This Trial?

Interventions

• SPARK Healthy Sleep

Trial Overview This study tests a digital intervention called SPARK Healthy Sleep aimed at improving sleep and reducing mental health stigma in students at risk for psychosis. It's delivered via an app with educational content, help-seeking strategies, and cognitive behavioral therapy techniques for insomnia.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 1 Intervention

Receives SPARK-Healthy Sleep intervention immediately at baseline

Group II: Control Group Active Control 1 Intervention

Wait-list control that receives the intervention after a 3-week delay (after the study's primary endpoint)

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

American Psychological Foundation

Collaborator

Trials

20

Recruited

2,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07119268

Study Details | NCT07119268 | SPARK Healthy Sleep The study evaluates feasibility, acceptability, and preliminary effectiveness of a smartphone-delivered intervention combining stigma reduction and cognitive ...

2. app.trialscreen.org app.trialscreen.org/trials/early-phase-1-spark-healthy-sleep-trial-nct07119268

SPARK Healthy Sleep Participants may experience improved sleep quality, reduced mental health stigma, and better overall mental health. Those in the control group will still ...

3. formative.jmir.org formative.jmir.org/2024/1/e51322/PDF

Randomized Controlled Feasibility Study For example, data suggests that the effects of digitalized CBT programs for insomnia are similar to those for face-to-face programs, indicating ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12592813/

Effectiveness of current digital cognitive behavioural therapy ... These results suggest that digital cognitive behavioural therapy for insomnia interventions are effective in improving adolescent's perceptions of their ...

5. spark-sf.s3.amazonaws.com spark-sf.s3.amazonaws.com/webinar/beth-malow-sleep-and-autism-slides.pdf

Sleep and Autism: Helping Families Get the Rest they Need ✓ Parents of 30 children with ASD and insomnia received sleep education (60 ... Melatonin (CR) + behavioral therapy most effective (Cortesi, J Sleep Res, 2012).

6. reporter.nih.gov reporter.nih.gov/search/cRAkbiNwa0SmxW23FsTB3A/project-details/11081731

RePORT RePORTER - National Institutes of Health (NIH) | Sleep is one such risk factor: more than 50% of peri-adolescents experience unhealthy sleep patterns, and sleep problems during peri-adolescence prospectively ...

7. bighealth.com bighealth.com/

Big Health: Mental Health Solutions Patients see significant improvement in sleep and insomnia, worry and anxiety, and low mood ... health treatments that deliver better outcomes for members and ...

8. withpower.com withpower.com/clinical-trials/for-insomnia?page=2

Top Insomnia Clinical Trials | Power Power is an online platform that helps thousands of Insomnia patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ...

9. hcplive.com hcplive.com/view/sleep-interventions-reduce-psychosis-risk-high-risk-young-adults

Sleep Interventions May Help Reduce Psychosis Risk in ... The outcomes suggest the targeted intervention may be an effective treatment for sleep issues among young mental health patients at the greatest ...