DMHI for At-Risk College Students

User-Centered Design of a Single-Module Digital Mental Health Intervention for College Students at Risk for Psychosis

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).

Study Overview

• Status: Completed
• Conditions: Psychosis; Prodromal Symptoms
• Intervention / Treatment: Behavioral: SPARK Coping

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention (SPARK Coping); Participants will be given a link to SPARK Coping immediately following their baseline assessments are complete.	Behavioral: SPARK 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.
No Intervention: Waitlist Control; Participants will wait until their follow-up assessment to be given access to the SPARK Coping intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 2 weeks
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.	Baseline, 2 weeks
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.	Baseline, 2 weeks
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).	Baseline, 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, 2 weeks
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.	Baseline, 2 weeks

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Ben Buck, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2024
• Primary Completion (Actual): January 6, 2025
• Study Completion (Actual): January 6, 2025

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: College student mental health
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Psychotic Disorders; Prodromal Symptoms
• Other Study ID Numbers: STUDY00019663; P50MH115837 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No