DMHI for At-Risk College Students

NCT06608498 | Completed

• 2 other identifiers: STUDY00019663P50MH115837
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Prodromal Symptoms; Psychosis

Keywords

College student mental health

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Change in recovery

  Baseline, 2 weeks

• Change in general psychopathology / distress

  Baseline, 2 weeks

Study Arms (2)

Intervention (SPARK Coping)

ACTIVE COMPARATOR

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

Behavioral: SPARK Coping

Waitlist Control

NO INTERVENTION

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

Interventions

SPARK Coping BEHAVIORAL

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.

Intervention (SPARK Coping)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Prodromal Symptoms; Psychotic Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Ben Buck, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor; Department of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: October 4, 2024
• Primary Completion: January 6, 2025
• Study Completion: January 6, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)