DMHI for At-Risk College Students

Not Applicable

• Conditions: Prodromal Symptoms; Psychosis
• Interventions: Behavioral: SPARK Coping

• Registration Number: NCT06608498
• Lead Sponsor: University of Washington

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-19
• Study First Posted: 2024-09-23
• Study Start: 2024-10-04
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-01-15
• Study Completion: 2025-01-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention (SPARK Coping)	SPARK Coping	Participants will be given a link to SPARK Coping immediately following their baseline assessments are complete.

Primary Outcome Measures

Name	Time	Method
Change in coping self-efficacy	Baseline, 2 weeks	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.
Change in internalized stigma	Baseline, 2 weeks	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.
Change in attitudes toward treatment	Baseline, 2 weeks	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.
Change in positive psychosis symptom frequency and distress	Baseline, 2 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Change in recovery	Baseline, 2 weeks	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).
Change in general psychopathology / distress	Baseline, 2 weeks	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.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States