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DMHI for At-Risk College Students

NCT ID: NCT06608498

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-04

Study Completion Date

2025-01-06

Brief Summary

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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

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Conditions

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Prodromal Symptoms Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention (SPARK Coping)

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

Group Type ACTIVE_COMPARATOR

SPARK Coping

Intervention Type 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.

Waitlist Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Benjamin Buck

Assistant Professor; Department of Psychiatry and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ben Buck, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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P50MH115837

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00019663

Identifier Type: -

Identifier Source: org_study_id