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CompletedNCT06608498Updated Dec 17, 2025

DMHI for At-Risk College Students

An interventional study of SPARK Coping in Prodromal Symptoms and Psychosis, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2025-12-17.

Sponsored by University of Washington · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn if a single-session digital intervention (SPARK Coping) is acceptable, usable, and demonstrates a preliminary signal of efficacy in reducing symptom-related distress and increasing positive treatment-seeking attitudes among college students reporting subthreshold symptoms associated with risk for psychosis. Research questions inclue:

  • Does SPARK Coping reduce symptom-related distress and increase positive treatment seeking attitudes (primary outcomes) relative to a waitlist control condition?
  • Does SPARK Coping increase adaptive coping and reduce internalized stigma (primary targets) relative to a waitlist control condition?

Researchers will compare provision of SPARK Coping to a waitlist control condition and collect data from participants on each of the variables described above. Participants will:

  • Complete questionnaires and surveys remotely at the start of the study and two weeks later
  • Be offered access to the SPARK Coping intervention either after completion of their baseline assessment (intervention arm) or after two weeks (waitlist control arm).
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Conditions studied

  • Prodromal Symptoms
  • Psychosis

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Keywords

  • College student mental health
03

In context

Psychotic Disorders

1,626 studies on the registry are indexed under Psychotic Disorders; 293 are open to participants now.

This study's enrollment of 50 is below the median of 70 across 1,333 interventional studies indexed under Psychotic Disorders.

Browse Psychotic Disorders studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 at the University of Washington.

Exclusion criteria

Exclusion Criteria:

  • Inconsistent or implausible reporting of symptoms at screening as determined by empirically-determined methods for detecting malingering or inconsistency
  • Failure to demonstrate understanding of study details in comprehension screening
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Intervention (SPARK Coping)

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

    Behavioral: SPARK Coping

  • No intervention
    Waitlist Control

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

Interventions

  • BehavioralSPARK Coping

    SPARK Coping is a single-session intervention providing psychoeducation and structured practices related to stigma reduction, cognitive restructuring, behavioral activation, and effective coping. It is a self-guided website powered by research data capture software.

06

What researchers measure

Primary outcomes

  1. Change in coping self-efficacy

    Caregiver coping self-efficacy will be assessed with the Coping Self-Efficacy Scale, a 26-item self-report questionnaire measuring the perceived ability of coping with various life challenges. Responses are rated on a 0 to 10 scale, and scores range from 0 to 260, with higher scores denoting a greater sense of self-efficacy in coping.

    Time frame: Baseline, 2 weeks

  2. Change in internalized stigma

    Internalized stigma will be assessed with the Internalized Stigma of Mental Health Inventory, Brief (ISMI-9). The ISMI-9 is a nine-item self-report short form, where each item is rated on a four-point Likert scale (1 = Strongly disagree, 4 = Strongly agree), and higher scores indicate more severe internalization of mental illness stigma.

    Time frame: Baseline, 2 weeks

  3. Change in attitudes toward treatment

    Help-Seeking Attitudes will be measured using the treatment and treatment-seeking subscales of the Endorsed and Anticipated Stigma Inventory (EASI). The full EASI is a 40-item self-reported questionnaire with subscales measuring beliefs about mental illness, beliefs about mental health treatment, beliefs about mental health treatment seeking, concerns about stigma from loved ones, and concerns about stigma from the workplace. The subscales are scored by summing the ratings from the eight individual items in each subscale (5-point scale with 1 = Strongly disagree, 5 = Strongly agree), with lower scores indicating less stigma, and more positive attitudes towards treatment and treatment-seeking. We will assess attitudes toward treatment and treatment-seeking by administering those two subscales. Total scores combining these two scales range from 16 to 80.

    Time frame: Baseline, 2 weeks

  4. Change in positive psychosis symptom frequency and distress

    Distress related to positive psychosis symptoms will be assessed with the CAPE-P15, a 15-item measure of positive symptoms of psychosis and psychosis risk as well as distress associated with such experiences. These 15 items are rated both on frequency (1 = Never to 4 = Nearly always) and distress (1 = Not distressed to 4 = Very distressed).

    Time frame: Baseline, 2 weeks

Secondary outcomes

  1. Change in recovery

    Recovery will be assessed using the Choice of Outcome in CBT for Psychoses, Short Form (CHOICE-SF). The CHOICE-SF is an 11-item self-report form developed to assess recovery-related goals for therapy. Participants rate themselves in different therapy-focused areas such as "self-confidence" or "ways of dealing with everyday stress" on a scale (0 = Worst, 10 = Best).

    Time frame: Baseline, 2 weeks

  2. Change in general psychopathology / distress

    General psychopathology / distress will be assessed with General Health Questionnaire (GHQ), a 12-item questionnaire assessing general psychological morbidity. Respondents indicate agreement on a four-point scale (0 = Not at all; 3 = More than usual) and total scores ranging from 0 to 36 with higher scores indicating more severe psychological morbidity.

    Time frame: Baseline, 2 weeks

07

Study locations

1 site
  • University of Washington
    Seattle, Washington 98195, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06608498
Lead sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Benjamin Buck (Assistant Professor; Department of Psychiatry and Behavioral Sciences, University of Washington) — Principal investigator
First posted
Sep 23, 2024
Start date
Oct 4, 2024
Primary completion
Jan 6, 2025
Completion
Jan 6, 2025
Last update
Dec 17, 2025

Study contacts

Ben Buck, PhD
principal investigator · University of Washington

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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