Clinical trial NCT06608498: DMHI for At-Risk College Students
Official title: User-Centered Design of a Single-Module Digital Mental Health Intervention for College Students At Risk for Psychosis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Prodromal Symptoms
Psychosis
Keywords: College student mental health
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-09-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Change in coping self-efficacy
timeFrame: Baseline, 2 weeks
measure: Change in internalized stigma
timeFrame: Baseline, 2 weeks
measure: Change in attitudes toward treatment
timeFrame: Baseline, 2 weeks
measure: Change in positive psychosis symptom frequency and distress
timeFrame: Baseline, 2 weeks
Secondary outcomes:
measure: Change in recovery
timeFrame: Baseline, 2 weeks
measure: Change in general psychopathology / distress
timeFrame: Baseline, 2 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Ben Buck, PhD
role: PRINCIPAL_INVESTIGATOR
References: