User-centered Design of a Mobile Health Intervention to Promote Help-seeking and Reduce Duration of Untreated Illness Among Young Adults With Early Psychosis
Phase: NA
Conditions: Psychosis
Sponsor: University of Washington

STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN 
 
Title: mHealth for Psychosis Help-Seeking 
ClinicalTrials.gov Identifier: NCT05905601 
Principal Investigator: Benjamin Buck, Ph.D. 
Updated June 27, 2025 
 
 

OVERVIEW 
 
Study Objectives. A long duration of untreated illness is linked with poorer outcomes among youth 
experiencing early psychosis. While this population faces numerous barriers to in-person services 
(e.g. long travel distances, a lack of symptom recognition, stigmatizing attitudes toward help-seeking) 
most young people express interest in digital technologies to support their mental health. While 
multiple digital mental health interventions have demonstrated value in supporting self-management 
of individuals experiencing symptoms of psychosis, there is a need for new interventions designed for 
delivery to those who are not engaged with services but are seeking resources to learn more about 
their experiences online. The present study examines the acceptability, usability, and preliminary 
efficacy of the NORTH mHealth intervention, a mobile app designed to remotely and scalably provide  
support to young adults in need of evaluation or treatment for symptoms of early psychosis. This 
intervention, which was developed in a multi-phase user-centered design process, offers multimedia 
interactive content based on the principles of cognitive behavior therapy and motivational 
enhancement. Following an experimental therapeutics paradigm, this study examines two versions of 
the NORTH mHealth intervention: (1) NORTH “lite” – a version of NORTH that provides only self-
management components, and (2) NORTH “full” – a version of NORTH that offers components 
designed to increase treatment motivation, including interactive psychoeducational information about 
diagnoses, treatments, and the treatment-seeking process. This study aims to examine whether the 
promise of mHealth can be leveraged to improve treatment-seeking attitudes and actions among this 
at-risk population. 
 
Design. This is a parallel group randomized controlled trial design. Participants are randomized 1:1 to 
either NORTH “lite” or NORTH “full.” Randomization is stratified based on whether the individual had 
engaged in mental health treatment (per inclusion criterion i.e. either regular psychotherapy or 
antipsychotic medication) within the past year vs. longer than one year ago (or not at all). Primary 
outcome assessments are collected at (1) baseline, (2) 6 weeks after app installation, and (3) 12 
weeks after app installation. 
 
METHODS 
 
Participants. Participants are 60 treatment-unengaged young adults experiencing psychosis 
symptoms indicating need for evaluation and/or treatment who meet the following criteria: (1) age 18-
30, (2) living in the US, (3) owning an iPhone, (4) symptoms of psychosis as measured by both (4a) a 
score >= 20 on the Prodromal Questionnaire, Brief (PQB), (4b) a positive frequency average score >= 
1.47 on the Community Assessment of Psychic Experiences (CAPE-P15), and (4c) a score =< 8 on 
the Moritz CAPE lie scale designed for online data collection, (5) less than five years since a first 
episode of psychosis or awareness of symptom onset, and (6) unengaged in specialty mental health 
services in the previous three months as defined either (6a) having taken a prescribed antipsychotic 
medication, (6b) or having attended regular psychotherapy. Exclusion criteria included (1) failure to 
accurately complete consent comprehension questions or (2) being unengaged in mental health 
services because of having completed or "graduated" from a specialty mental health program.  
 
Recruitment. Participants are recruited through online study ads (i.e. Google, Instagram, and 
YouTube) as well as distribution through mental health advocacy organization and treatment websites 
and listservs. 
 
Procedures. All screeners and study questionnaires are completed through online data capture (i.e. 
REDCap). Once participants click a link to the study landing page from a recruitment ad or posting, 
they are required to demonstrate understanding of study details through a comprehension 
questionnaire, provide informed consent and are subject to a series of steps to ensure eligibility for 
the study and identity verification. Study team members evaluate screening data and conduct 

confirmatory synchronous screening by phone. The invitation to complete the baseline assessment is 
sent to participants after eligibility confirmation via text message. After baseline is complete, 
participants are invited to asked to complete an installation session wherein they are introduced to 
their intervention, and oriented to study details. Participants are randomized to condition (via a pre-set 
stratified randomization algorithm, see above) at the time of the installation session.  
 
Once participants have installed and been oriented to their study app, members of the study team are 
available to answer questions about study interventions or respond to concerns about the study. Up 
to three times during the study period, participants receive outreach via text message and phone call 
if they stopped using the app for five consecutive days (confirmed via app usage logs). This outreach 
assesses for technical issues or concerns from participants about app use. Subsequent assessments 
are sent to participants via text messages 6 and 12 weeks after they installed the NORTH app, and 
participants are also invited to complete weekly questionnaires to report actual treatment engagement 
frequency. Participants are compensated with $60 gift cards for completing each assessment battery 
(or, in the case of baseline, baseline and installation session both).  
 
Interventions. NORTH (Normalizing ORientation to Treatment and Help-Seeking) is a self-guided 
iOS mobile app designed to provide self-guided coping support to individuals experiencing early 
psychosis. It combines video, audio, and written text, and draws on principles of cognitive behavior 
therapy and motivational enhancement. While both NORTH “full” and NORTH “lite” contain lessons 
(i.e. introductory modules to new skills), practices (i.e. opportunities to practice skills through video 
coaching or written prompts), and tracking (i.e. rating changes in a well-being score over time), only 
participants with NORTH “full” receive in-app treatment-seeking and psychoeducational content. Note 
that all participants regardless of condition receive thorough materials about mental health symptoms, 
treatment options, and crisis resources. For participants in the NORTH “full” condition, treatment-
seeking and in-depth psychoeducation is a focus of interactive mHealth content, whereas in the “lite” 
arm, only the self-management components can be found in-app. 
 
Outcome Measures. Primary and secondary registered measures are listed below. 
 
Measure 
Construct 
Description 
Time Frame 
Measure to 
Assess Steps to 
Service (MASS) 
Change in Treatment 
Seeking Steps 
Treatment seeking will be measured 
using the Measure to Assess Steps to 
Service (MASS). The MASS is a 17-item 
self-report assessment of steps taken 
towards the attainment of mental health 
treatment, including research, social 
support, and engagement with service 
provider steps. Each item is endorsed on 
a three-point Likert scale (0 = No, I have 
not done this, 1 = I have done this once or 
twice, 2 = I have done this multiple times). 
The MASS is scored by summing 
individual items with higher scores 
indicating greater levels of treatment-
seeking actions. 
Baseline, 6 
weeks, 12 weeks 
Endorsed and 
Anticipated Stigma 
Inventory (EASI) – 
Beliefs about 
Treatment / Beliefs 
about Treatment-
Seeking subscales 
Change in Treatment-
related Attitudes / 
Beliefs 
Help-Seeking Attitudes and Stigma will be 
measured primarily using 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, 
Baseline, 6 
weeks, 12 weeks 

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. 
 
The Beliefs About Treatment scale 
assesses individuals' beliefs about the 
efficacy and usefulness of mental health 
treatments. It is totaled as a sum, with 
higher scores indicating more stigmatizing 
attitudes toward treatment. 
 
The Beliefs About Treatment Seeking 
scale assesses individuals' attitudes 
toward seeking mental health treatments. 
It is totaled as a sum, with higher scores 
indicating more stigmatizing attitudes 
toward treatment seeking. 
Internalized 
Stigma of Mental 
Illness Inventory 
(ISMI-9) 
Change in Internalized 
Stigma 
The Internalized Stigma of Mental Health 
Inventory, Brief (ISMI-9) will provide 
additional insight into the strength of 
participants' internalized stigma of mental 
illness. 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 totaled as a mean score. Thus scores 
range from 1 to 4 with higher scores 
indicating more severe internalization of 
mental illness stigma. 
Baseline, 6 
weeks, 12 weeks 
Perceived Stress 
Questionnaire 
(PSQ) 
Change in Perceived 
Stress 
Perceived stress will be measured using 
the Perceived Stress Questionnaire 
(PSQ), which is a 30-item, self-report 
questionnaire that examines the 
experience of stress independent of a 
specific and objective occasion. Items are 
endorsed on a four-point scale (1 = 
Almost never, 4 = Usually), and are 
summed for a total score (ranging from 30 
to 120), with higher scores indicating 
higher levels of perceived stress. 
Baseline, 6 
weeks, 12 weeks 
Brief Resilience 
Scale (BRS) 
Change in Resilience / 
Coping 
The Brief Resilience Scale (BRS) will be 
used to assess resiliency. The BRS is a 
self-report form that consists of six 
resiliency statements that participants 
agree or disagree with on a five-point 
scale (1 = Strongly disagree, 5 = Strongly 
agree). Scores are totaled as a mean, 
and thus range from 1 to 5, with higher 
scores indicating greater resilience. 
Baseline, 6 
weeks, 12 weeks 

Community 
Assessment of 
Psychic 
Experiences  
Change in Symptoms 
The Community Assessment of Psychic 
Experiences (CAPE-42) will be used to 
assess positive, negative and depressive 
symptoms of psychosis. The CAPE-42 is 
a self-report, 42 two-part item 
assessment that measures both the 
frequency of experiencing symptoms 
(four-point scale, 1 = Never, 4 = Almost 
Always) as well as the distress level (four-
point scale, 1 = Not Distressed, 4 = Very 
Distressed) associated with each 
endorsed symptom. The CAPE weighted 
score can be calculated by summing the 
frequency and distress item responses.  
 
The positive subscale is 20 items and is 
totaled as a mean response ranging from 
2 to 8, with higher scores indicating more 
frequent and distressing positive 
symptoms. 
 
The negative subscale is 14 items and is 
totaled as a mean response ranging from 
2 to 8, with higher scores indicating more 
frequent and distressing negative 
symptoms. 
 
The depressive subscale is 8 items and is 
totaled as a mean response ranging from 
2 to 8, with higher scores indicating more 
frequent and distressing depressive 
symptoms. 
Baseline, 6 
weeks, 12 weeks 
Choice of 
Outcome in CBT 
for Psychoses, 
Short-Form 
(CHOICE-SF) 
Change in Recovery 
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). Scores on 
the CHOICE-SF are totaled as mean 
score across all standard items, and thus 
range from 0 to 10 with higher scores 
reflecting improved recovery. 
Baseline, 6 
weeks, 12 weeks 
Sheehan Disability 
Scale 
Change in Functioning Functioning will be measured using the 
Sheehan Disability Scale (SDS). The 
SDS is a short, five-item self-report form 
that assesses disability and functional 
impairment. The total score is the sum of 
three items measure to what extent 
symptoms have disrupted different 
aspects of daily life on a scale (0 = Not at 
all, 10 = Severely), thus the scale ranges 
Baseline, 6 
weeks, 12 weeks 

from 0 to 30 with higher scores indicating 
greater functional impairment. 
Modified Usability 
Scale 
Intervention 
Acceptability / 
Usability 
Usability/Acceptability will be assessed 
with a modified version of the System 
Usability Scale derived from our group's 
previous work developing mHealth 
interventions. This composite measure, 
which comprises 26 items based on four 
measures - the System Usability Scale, 
Post Study System Usability Scale, 
Technology Assessment Model 
Measurement Scales, and Usefulness, 
Satisfaction and Ease Questionnaire - 
assesses participants' experiences with 
the intervention during the study period (1 
= Disagree, 2 = Neutral, 3 = Agree). While 
this measure is often interpreted 
qualitatively by item, we will also compare 
the overall score, which will comprise an 
average and thus range from 1 to 3, with 
higher scores reflecting higher 
acceptability and usability. 
6 weeks 
 
DATA ANALYTIC PLAN 
 
Clinical-trial data analyses. Linear regression will be used for continuous outcomes wherein 
participant and treatment condition are clustered as independent variables (i.e. adjusting for the 
baseline value of the outcome measure relevant to each model). We will separately model outcomes 
at 6 weeks and 12 weeks respectively. Within-condition changes will also be modeled using linear 
regression with assessment and value at baseline as independent variables. Effect sizes will be 
estimated using Cohen’s d and 95% confidence intervals. Mean imputation is used to generate total 
scale scores consistent with measure convention (i.e. totaling sums or means) in instances when 
participants complete fewer than 50% of scale items. Descriptive outcome measures (i.e. measures 
of usability and acceptability) will be described qualitatively as well as compared with independent-
samples t-tests. As this is a pilot trial with limited statistical power, we will model and interpret 
direction and size of effects for primary outcomes.