N/A
N=60
mHealth for Psychosis Help-seeking
Psychosis
Bottom Line
View on ClinicalTrials.gov: NCT05905601 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Change in Treatment Seeking Steps — 6.43; 10.08; 7.65; 9.58 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NORTH "Full" (Behavioral); NORTH "Lite" (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Treatment Seeking Steps |
6.43; 10.08; 7.65; 9.58; 8.17; 9.49 | — |
| PRIMARY Change in Treatment-related Attitudes/Beliefs (Treatment Beliefs) |
20.16; 18.47; 19.14; 19.13; 18.95; 17.78 | — |
| PRIMARY Change in Treatment-related Attitudes/Beliefs (Treatment Seeking Attitudes) |
22.47; 21.50; 22.17; 22.44; 21.55; 21.26 | — |
| PRIMARY Change in Internalized Stigma |
2.34; 2.35; 2.29; 2.22; 2.26; 2.24 | — |
| PRIMARY Change in Perceived Stress** |
87.14; 92.33; 82.97; 89.36; 79.66; 85.40 | — |
| PRIMARY Change in Resilience / Coping |
2.69; 2.63; 2.70; 2.82; 2.74; 2.92 | — |
| SECONDARY Change in Symptoms (Positive) |
3.44; 4.03; 3.42; 3.68; 3.18; 3.55 | — |
| SECONDARY Change in Symptoms (Negative) |
4.54; 4.85; 4.39; 4.38; 4.35; 4.43 | — |
| SECONDARY Change in Symptoms (Depressive) |
4.90; 5.32; 4.61; 4.61; 4.47; 4.75 | — |
| SECONDARY Change in Recovery |
4.88; 4.77; 5.06; 5.23; 5.25; 5.54 | — |
| SECONDARY Change in Functioning |
16.27; 17.85; 14.21; 14.65; 12.76; 14.31 | — |
| SECONDARY Intervention Acceptability / Usability |
2.71; 2.71 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05905601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.