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Behavioral Intervention

mHealth App for Psychosis

N/A
Recruiting
Led By Benjamin Buck, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 12 weeks
Awards & highlights

Study Summary

This trial will test a mobile health app to help young people at risk for psychosis to improve their health and connect to treatment options.

Who is the study for?
This trial is for young adults aged 18-30 in the U.S. who are at risk for psychosis but haven't been treated with antipsychotic meds or regular psychotherapy recently. They must own an iPhone and be within five years of their first psychotic episode or symptom onset.Check my eligibility
What is being tested?
The study tests a mobile health intervention, NORTH, designed to help those at risk for psychosis. It compares the full version (with lessons, practices, tracking, and help-seeking resources) against a 'Lite' version that lacks help-seeking features.See study design
What are the potential side effects?
Since this trial involves a digital intervention rather than medication, traditional side effects aren't expected. However, users may experience discomfort or stress from self-monitoring symptoms or engaging with mental health content.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in internalized stigma
Change in perceived stress
Change in resilience / coping
+2 more
Secondary outcome measures
Change in functioning
Change in recovery
Change in symptoms
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: NORTH "Lite"Experimental Treatment1 Intervention
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.
Group II: NORTHExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,743 Previous Clinical Trials
1,847,810 Total Patients Enrolled
2 Trials studying Psychosis
660 Patients Enrolled for Psychosis
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,630 Total Patients Enrolled
46 Trials studying Psychosis
10,659 Patients Enrolled for Psychosis
Benjamin Buck, PhDPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

NORTH (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05905601 — N/A
Psychosis Research Study Groups: NORTH, NORTH "Lite"
Psychosis Clinical Trial 2023: NORTH Highlights & Side Effects. Trial Name: NCT05905601 — N/A
NORTH (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05905601 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this trial restricted to those aged 70 or below?

"The requirements to partake in this medical study are strict, with the age range of participants spanning from 18 to 30 years. In contrast, there are 123 investigations catered for minors and 282 directed at patients over 65."

Answered by AI

What is the aggregate tally of individuals participating in this clinical investigation?

"Affirmative. Clinicaltrials.gov states that this research is continuing to recruit participants, with the trial having first been posted on June 15th 2023 and most recently updated July 24th 2023. The study requires 60 patients from a single site."

Answered by AI

Are there any vacancies left for the participants in this experiment?

"As per information on clinicaltrials.gov, this experiment is currently recruiting patients with the first posting date being June 15th 2023. The details of the trial have been recently adjusted, as evidenced by its most recent amendment occurring July 24th 2023."

Answered by AI

Is my profile compatible with the parameters of this trial?

"This trial is seeking 60 participants aged between 18 and 30 that are at a heightened risk of psychosis, as indicated by the Prodromal Questionnaire Brief (Savill et al., 2018) and Community Assessment of Psychic Experiences (CAPE-P15; Jaya et al., 2021 & Bukenaite et al., 2017). Other requirements for enrollment include: US residency, no more than 5 years since first psychotic episode, possession of an iPhone device, and lack of engagement in specialty mental health treatment. Additionally, online data collection checks must be completed to confirm symptomology (Moritz et al.: 2013)."

Answered by AI

What is the primary aim of this research?

"The primary outcome being assessed over a baseline, 6 week and 12 week time frame is an alteration of treatment-seeking attitudes. Additionally, the secondary outcomes include modifications to recovery as per the CHOICE-SF scale, changes in functioning using SDS and intervention acceptability/usability gauged by means of a modified System Usability Scale."

Answered by AI
~25 spots leftby Jan 2025