SPARK Coping for Prodromal Symptoms

Overseen By Erica Whiting

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Inconsistent reporting, comprehension failure

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a one-time digital program called SPARK Coping can help college students experiencing early signs of psychosis feel less distressed and more open to seeking treatment. The study aims to determine if the program also enhances positive coping strategies and reduces self-stigma (negative beliefs about oneself). Participants will either use SPARK Coping immediately or two weeks later and complete surveys to share their experiences. This trial suits college students in the U.S. who feel at risk for psychosis and want to manage their symptoms better. As an unphased trial, it offers a unique opportunity for students to contribute to innovative mental health solutions.

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 seems focused on a digital intervention, so it's likely you can continue your current treatments, but you should confirm with the study team.

What prior data suggests that the SPARK Coping intervention is safe for college students?

Research has shown that SPARK Coping is a digital tool designed to reduce stress and encourage treatment-seeking behavior. It is user-friendly and involves no medication or physical procedures, which generally results in a low risk of side effects.

The trial's main goal is to assess the tool's ease of use and user satisfaction. The developers have prioritized safety in its design. Since this trial is in the "Not Applicable" phase, it focuses on the tool's effectiveness rather than safety issues typical of drug trials. Participants can therefore expect a safe and comfortable experience with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SPARK Coping because it offers a unique approach to managing prodromal symptoms, which are early signs of potential mental health disorders. Unlike traditional treatments that often involve medication or in-person therapy, SPARK Coping is delivered online, making it more accessible and convenient for participants. This digital intervention allows users to engage with coping strategies immediately after their initial assessments, potentially leading to earlier intervention and support. By utilizing an online platform, SPARK Coping aims to empower individuals with tools they can access anytime, fostering greater self-management and resilience.

What evidence suggests that SPARK Coping is effective for reducing symptom-related distress in college students?

Research has shown that early programs like SPARK Coping can benefit individuals at high risk of developing psychosis. Studies suggest these programs might prevent up to 12.4% of psychosis cases. In this trial, participants in the intervention arm will receive immediate access to SPARK Coping, designed to reduce distress from symptoms and encourage help-seeking behavior. It also aims to improve stress management and reduce mental health stigma. Although more information is needed specifically about SPARK Coping, similar programs have shown promise in helping those at risk feel better and seek treatment sooner. ^{1 6 7 8 9}

Who Is on the Research Team?

Ben Buck, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for U.S. college students who may be at risk for psychosis but aren't yet diagnosed with a mental illness. They should have specific scores on the Prodromal Questionnaire and Community Assessment of Psychic Experiences indicating potential risk.

Inclusion Criteria

Symptoms indicating risk for psychosis (a distress score >= 20 on the Prodromal Questionnaire, Brief [PQ-B], per Savill et al., 2018; Early Intervention in Psychiatry and a positive frequency average score >= 1.47 on the Community Assessment of Psychic Experiences (CAPE-P15), per Jaya et al., 2021 and Bukenaite et al., 2017)

Residence in the United States

Currently enrolled in a post-secondary college program.

Exclusion Criteria

Failure to demonstrate understanding of study details in comprehension screening

Inconsistent or implausible reporting of symptoms at screening as determined by empirically-determined methods for detecting malingering or inconsistency

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Remote assessment

Baseline Assessment

Participants complete questionnaires and surveys remotely at the start of the study

1 week

Remote assessment

Intervention

Participants in the intervention arm are given access to the SPARK Coping digital intervention

2 weeks

Remote access

Follow-up

Participants complete follow-up assessments to evaluate changes in symptoms and attitudes

2 weeks

Remote assessment

What Are the Treatments Tested in This Trial?

Interventions

• SPARK Coping

Trial Overview Researchers are testing SPARK Coping, a digital intervention aimed to reduce distress from symptoms related to psychosis risk and encourage positive attitudes towards seeking treatment, compared to a waitlist control group.

How Is the Trial Designed?

Group I: Intervention (SPARK Coping) Active Control 1 Intervention

Participants will be given a link to SPARK Coping immediately following their baseline assessments are complete.

Group II: Waitlist Control Active Control 1 Intervention

Participants will wait until their follow-up assessment to be given access to the SPARK Coping intervention.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. withpower.com withpower.com/trial/phase-mental-disorders-8-2024-a4942

SPARK Coping for Prodromal Symptoms This trial is for U.S. college students who may be at risk for psychosis but aren't yet diagnosed with a mental illness. They should have specific scores on the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12092282/

Preventing psychosis in people at clinical high risk A recent meta-umbrella systematic review showed that effective interventions in CHR-P could prevent up to 12.4% of all cases of psychosis [23].

3. researchgate.net researchgate.net/publication/51224034_Early_intervention_for_psychosis_Review

Early intervention for psychosis (Review) | Request PDF A previous Cochrane review evaluating interventions to improve outcomes for people with firstepisode psychosis found insufficient data to draw ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4266296/

Clinical and Functional Outcomes After 2 Years in the Early ... To test effectiveness of the Early Detection, Intervention, and Prevention of Psychosis Program in preventing the onset of severe psychosis ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/eip.13408

Sessions Abstracts - 2023 - Early Intervention in Psychiatry Many studies have explored prediction of long-term outcome within early psychosis (EP) patients. Indeed, identification of factors associated ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6196741/

Identifying and treating the prodromal phases of bipolar ... The goal of this paper is to review recent research on the identification and treatment of prodromal periods that precede bipolar and psychotic disorders.

7. formative.jmir.org formative.jmir.org/2022/5/e32740/

Pilot Testing in the Wild: Feasibility, Acceptability, Usage ... The objective of this pilot study is to assess the feasibility, acceptability, and clinical utility of a novel intervention for BD-II.

8. ppmi-info.org ppmi-info.org/sites/default/files/docs/P2P%20013_Master%20Protocol_AM1_v2.0_29Oct2024_Final_signed.pdf

Clinical Study Protocol Phase II-III Many of these prodromal participants are enriched for abnormal DAT SPECT imaging as a marker of presynaptic dopamine deficiency. Further, PPMI.

9. link.springer.com link.springer.com/article/10.1007/s00406-021-01355-8

Integrating trauma, self-disturbances, cognitive biases, and ... Our study suggests that combining trauma, cognitive biases, SD and personality traits such as ST and HA into one model can enhance our understanding of ...