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mHealth Intervention for Schizophrenia
N/A
Waitlist Available
Led By Dror Ben-Zeev, 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
Chart diagnosis of SSD (i.e., schizophrenia, schizoaffective disorder, schizotypal disorder, delusional disorder, or schizophreniform disorder;
English-speaking;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0,3,6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at whether two different ways of using cellphones can help people manage their health.
Who is the study for?
This trial is for adults over 18 with a smartphone and data plan, who have used the FOCUS app before, speak English, and are treated at certain clinics. They must have schizophrenia or related disorders but can't join if they plan to move or stop clinic services soon.
What is being tested?
The study is testing two mobile health (mHealth) strategies using the FOCUS app in people with schizophrenia. It's a randomized control trial, meaning participants are randomly assigned to one of the intervention groups.
What are the potential side effects?
Since this trial involves mHealth interventions rather than medications, traditional side effects aren't expected. However, there may be indirect effects like increased anxiety or stress due to technology use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a schizophrenia spectrum disorder.
Select...
I speak English.
Select...
I am 18 years old or older.
Select...
I have used FOCUS before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0,3,6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0,3,6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in GAD-7
Change in Green Paranoid Thoughts Scale- ideas and persecution sub-scale
Change in Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Internal FacilitationActive Control1 Intervention
mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS.
Group II: External FacilitationActive Control1 Intervention
mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS.
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,662 Total Patients Enrolled
254 Trials studying Schizophrenia
89,728 Patients Enrolled for Schizophrenia
University of WashingtonLead Sponsor
1,815 Previous Clinical Trials
1,912,745 Total Patients Enrolled
7 Trials studying Schizophrenia
1,304 Patients Enrolled for Schizophrenia
Dror Ben-Zeev, PhDPrincipal InvestigatorUniversity of Washington
6 Previous Clinical Trials
1,098 Total Patients Enrolled
5 Trials studying Schizophrenia
738 Patients Enrolled for Schizophrenia
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