Implementing mHealth for Schizophrenia in Community Mental Health Settings

Schizophrenia Clinical Trial

Official title:

Implementing mHealth for Schizophrenia in Community Mental Health Settings

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04147897
• Other study ID #: STUDY00006141
• Secondary ID: 1R01MH116057-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 16, 2020
• Est. completion date: April 1, 2024

Study information

• Verified date: November 2020
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized control trial examining two mHealth intervention strategies.

Description:

The investigators will conduct a multi-site site hybrid type III effectiveness/implementation study in Washington State. The study involves a systematic head-to-head comparison between External Facilitation (EF) and Internal Facilitation (IF) implementation models applied to the FOCUS mHealth intervention.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: April 1, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

All participants need to be receiving clinical care at participating clinics who have partnered with the research team for this study.

Inclusion:

1. Chart diagnosis of SSD (i.e., schizophrenia, schizoaffective disorder, schizotypal disorder, delusional disorder, or schizophreniform disorder;

2. 18 years or older;

3. English-speaking;

4. Own a smartphone that can support FOCUS and active data plan.

Exclusion:

1. Used FOCUS in the past;

2. Plan to move or discontinue services at participating clinics in the upcoming 6 months.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Device:
• FOCUS
FOCUS is a self management mHealth application for people with serious mental illness.

Locations

Country	Name	City	State
United States	Cascade Mental Health Care	Chehalis	Washington
United States	NEW Alliance Counseling Services	Colville	Washington
United States	Compass Health	Everett	Washington
United States	Valley Cities	Federal Way	Washington
United States	Peninsula Behavioral Health	Port Angeles	Washington
United States	Sound Health	Seattle	Washington
United States	Frontier Behavioral Health	Spokane	Washington
United States	Comprehensive Healthcare	Yakima	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PhQ9	The Patient Health Questionnaire (PHQ)-9 is the major depressive disorder (MDD) module of the full PHQ. Total scores range from 0-27. Higher scores represent worsening of symptoms.	0,3,6 months
Primary	Change in GAD-7	The Generalized Anxiety Disorder-7 measures generalized anxiety disorder. GAD-7 total score ranges from 0 to 21. Higher scores represent worsening of symptoms.	0,3,6 months
Primary	Change in Insomnia Severity Index	The Insomnia Severity Index (ISI) is a brief screening assessment tool designed to evaluate insomnia.Total scores range from 0-28. Higher scores represent worsening of symptoms.	0,3,6 months
Primary	Change in Green Paranoid Thoughts Scale- ideas and persecution sub-scale	The Green Paranoid Thoughts Scale (GPTS)- sub-scale: measures ideas of persecution. Scores range from 16-80. Higher scores represent worsening of symptoms.	0,3,6 months
Primary	Change in Symptom Check List SCL9	The Symptom Check List-9 is a brief version of the SCL-90, which aims to evaluate a broad range of psychological problems and symptoms of psychopathology. Total scores are calculated (sum of all responses) then divided by 9 for an average global score. Total sum scores range from 0-36. Average global scores range from 0-4. Higher scores mean more severe symptoms.	0,3,6 months
Primary	Change in Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ)	A 9-item measure specifically designed to quantify characteristics of auditory hallucinations including frequency, negative content, loudness, duration, interference with life, distress, impact on self-appraisal, and compliance with commands.Total score is a sum of all 9 items. Total HPSVQ scores range from 0-36. Higher scores mean more severe symptoms.	0,3,6 Months
Primary	Change in Illness Management and Recovery Scale	IMRS measures illness management and recovery. Scoring is a sum of all responses ranging from 15-75. Higher scores mean more severe symptoms.	0,3,6 months