mHealth for Psychosis Help-seeking
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
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Seattle, Washington, United States, 98195
- University of Washington
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: NORTH "Lite"
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.
|
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.
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Experimental: NORTH "Full"
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Treatment Seeking Steps
Time Frame: Baseline, 6 weeks, 12 weeks
|
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 (range from 0 to 34).
Increases in MASS scores were intended as an outcome of the proposed study (i.e.
encouraging help-seeking).
|
Baseline, 6 weeks, 12 weeks
|
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Change in Treatment-related Attitudes/Beliefs (Treatment Beliefs)
Time Frame: Baseline, 6 weeks, 12 weeks
|
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, 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, and thus scores range from 8 to 40 with higher scores indicating more stigmatizing attitudes toward treatment. |
Baseline, 6 weeks, 12 weeks
|
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Change in Treatment-related Attitudes/Beliefs (Treatment Seeking Attitudes)
Time Frame: Baseline, 6 weeks, 12 weeks
|
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, 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 Seeking assesses individuals' attitudes toward seeking mental health treatments. It is totaled as a sum, and thus scores range from 8 to 40 with higher scores indicating more stigmatizing attitudes toward treatment seeking. |
Baseline, 6 weeks, 12 weeks
|
|
Change in Internalized Stigma
Time Frame: Baseline, 6 weeks, 12 weeks
|
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.
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Baseline, 6 weeks, 12 weeks
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Change in Perceived Stress**
Time Frame: Baseline, 6 weeks, 12 weeks
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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. **NOTE: At baseline, the version provided to participants included the version of the PSQ that instructing participants to report on the past "year or two" while 6-week and 12-week assessments ask participants to report on the previous "month or so." While totals are still reported (as these still provide some information about intervention effects) these numbers should be interpreted with caution and in concert with other collected measures that include items about stress levels and coping with consistent reporting periods at all time points. |
Baseline, 6 weeks, 12 weeks
|
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Change in Resilience / Coping
Time Frame: Baseline, 6 weeks, 12 weeks
|
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.
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Baseline, 6 weeks, 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Symptoms (Positive)
Time Frame: Baseline, 6 weeks, 12 weeks
|
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.
|
Baseline, 6 weeks, 12 weeks
|
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Change in Symptoms (Negative)
Time Frame: Baseline, 6 weeks, 12 weeks
|
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 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.
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Baseline, 6 weeks, 12 weeks
|
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Change in Symptoms (Depressive)
Time Frame: Baseline, 6 weeks, 12 weeks
|
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 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
|
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Change in Recovery
Time Frame: Baseline, 6 weeks, 12 weeks
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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.
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Baseline, 6 weeks, 12 weeks
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Change in Functioning
Time Frame: Baseline, 6 weeks, 12 weeks
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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 from 0 to 30 with higher scores indicating greater functional impairment.
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Baseline, 6 weeks, 12 weeks
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Intervention Acceptability / Usability
Time Frame: 6 weeks
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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.
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6 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Benjamin Buck, PhD, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00009039
- K23MH122504-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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