Back to resultsmHealth for Psychosis Help-seeking
Primary Purpose
Psychosis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NORTH
NORTH "Lite"
Sponsored by
About this trial
This is an interventional treatment trial for Psychosis focused on measuring Early psychosis, Psychosis risk, Duration of untreated psychosis
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.
Sites / Locations
- University of WashingtonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
NORTH
NORTH "Lite"
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT05905601
First Posted
May 26, 2023
Last Updated
July 24, 2023
Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05905601
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
January 15, 2025 (Anticipated)
Study Completion Date
April 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
Early psychosis, Psychosis risk, Duration of untreated psychosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NORTH
Arm Type
Experimental
Arm Description
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.
Arm Title
NORTH "Lite"
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
NORTH
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
NORTH "Lite"
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in treatment seeking steps
Description
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.
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Change in treatment-seeking attitudes
Description
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.
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Change in internalized stigma
Description
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.
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Change in perceived stress
Description
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.
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Change in resilience / coping
Description
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
Time Frame
Baseline, 6 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change in symptoms
Description
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.
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Change in recovery
Description
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.
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Change in functioning
Description
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.
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Intervention acceptability / usability
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erica Whiting, BS
Phone
206-474-7794
Email
whitinge@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin E Buck, PhD
Phone
206-221-8518
Email
buckbe@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Buck, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Department of Psychiatry and Behavioral Sciences
Phone
206-543-3750
12. IPD Sharing Statement
Learn more about this trial
mHealth for Psychosis Help-seeking
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