Clinical trial NCT05905601: MHealth for Psychosis Help-seeking
Official title: User-centered Design of a Mobile Health Intervention to Promote Help-seeking and Reduce Duration of Untreated Illness Among Young Adults with Early Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Keywords: Early psychosis
Psychosis risk
Duration of untreated psychosis
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-06-15
Enrollment: 60
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 proposed study research project aims to develop and test a mobile health intervention designed to improve the wellness of young people at risk for psychosis and facilitate users' engagement with treatment and thus reduce duration of untreated psychosis. This clinical trial will involve a remote pilot randomized controlled trial that will examine (1) the feasibility of the proposed research approach, (2) the acceptability and usability of the NORTH intervention as well as (3) the specific additive value of help-seeking support in the context of self-guided mHealth for early psychosis. The full intervention, which includes psychoeducational lessons, Cognitive-Behavior Therapy-based practices, a symptom tracking feature, and help-seeking resources will be compared to a "Lite" version that will include the lessons, practices, and tracking but exclude the help-seeking resources.


Eligibility criteria: Inclusion Criteria:

* Elevated risk for psychosis that warrants further evaluation (a distress score \>= 20 on the Prodromal Questionnaire, Brief \[PQ-B\], per Savill et al., 2018; 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) and confirmation of symptoms consistent with online data collection checks (per Moritz et al., 2013)
* Age 18-30 years old
* Lives in the United States
* Under five years since participant's first psychotic episode or awareness of symptom onset
* Owns an iPhone
* Unengaged in specialty mental health treatment, in which the participant has not done either of the following in the previous three months: (1) taken a prescribed antipsychotic medication, (2) attended regular (i.e. more than one session of) psychotherapy.

Exclusion Criteria:

* Failed to demonstrate understanding of study details in comprehension screening process.
* Engaged in specialty mental health treatment in the previous three months, defined as the following: (1) taken a prescribed antipsychotic medication, OR (2) attended regular (i.e. more than one session of) psychotherapy.
* Unengaged in treatment, but only as a result of having completed or "graduated" from a specialty mental health program.

Primary outcomes:
measure: Change in treatment seeking steps
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in treatment-seeking attitudes
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in internalized stigma
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in perceived stress
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in resilience / coping
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Change in symptoms
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in recovery
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in functioning
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Intervention acceptability / usability
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Benjamin Buck, PhD
role: PRINCIPAL_INVESTIGATOR
References: