mHealth for Psychosis Help-seeking

Study Overview
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Brief Summary
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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.

Official Title
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User-centered Design of a Mobile Health Intervention to Promote Help-seeking and Reduce Duration of Untreated Illness Among Young Adults With Early Psychosis

Conditions
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Psychosis

Intervention / Treatment
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* Behavioral: NORTH
* Behavioral: NORTH Lite


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NORTH<br>Participants in the experimental arm will be provided access to the Full NORTH smartphone application designed to support young adults at risk for psychosis. They will also have access to the research team by phone for technical troubleshooting and support as necessary. | Behavioral: NORTH<br>* NORTH is a native mobile app that provides on-demand content to young adults at risk for psychosis to improve or maintain their well-being, coping skills, and healthy habits, knowledge of psychosis, and provide help-seeking resources.<br>|
| Experimental: NORTH Lite<br>Participants in the control arm will be provided access to the NORTH Lite smartphone application designed to support young adults at risk for psychosis. They will also have access to the research team by phone for technical troubleshooting and support as necessary. | Behavioral: NORTH Lite<br>* NORTH Lite contains the same on-demand lessons, practices and tracking features found in the Full NORTH mobile application but does not include help-seeking resources.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in treatment-seeking attitudes | Help-Seeking Attitudes and Stigma will be measured primarily using the Endorsed and Anticipated Stigma Inventory (EASI). The 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, 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. | Baseline, 6 weeks, 12 weeks | 
| 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 higher scores indicate more severe internalization of mental illness stigma. | Baseline, 6 weeks, 12 weeks | 
| 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), with higher scores indicating higher levels of perceived stress. | Baseline, 6 weeks, 12 weeks | 
| 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 | Baseline, 6 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in symptoms | The Community Assessment of Psychic Experiences (CAPE-42) will be used to assess positive, negative and general psychopathology symptoms of participants. 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 is scored by summing individual frequencies and distress levels for subscales of positive symptoms, depressive symptoms, and negative symptoms, and the Distress Score is weighted by the number of symptoms experienced. | Baseline, 6 weeks, 12 weeks | 
| 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). This will allow the study team to assess psychological changes relevant to psychosocial treatments for psychosis, which in this case is the NORTH intervention. | Baseline, 6 weeks, 12 weeks | 
| 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 first three items measure to what extent symptoms have disrupted different aspects of daily life on a scale (0 = Not at all, 10 = Severely), and are followed by two items measuring presenteeism and absenteeism in the preceding week. | Baseline, 6 weeks, 12 weeks | 
| 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. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early psychosis, Psychosis risk, Duration of untreated psychosis