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Implementing mHealth for Schizophrenia in Community Mental Health Settings

Primary Purpose

Schizophrenia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FOCUS
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cascade Mental Health Care
  • NEW Alliance Counseling Services
  • Compass Health
  • Valley Cities
  • Peninsula Behavioral Health
  • Sound Health
  • Frontier Behavioral Health
  • Comprehensive Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Internal Facilitation

External Facilitation

Arm Description

mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS.

mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 14, 2019
Last Updated
November 4, 2020
Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04147897
Brief Title
Implementing mHealth for Schizophrenia in Community Mental Health Settings
Official Title
Implementing mHealth for Schizophrenia in Community Mental Health Settings
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (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
Yes

5. Study Description

Brief Summary
Randomized control trial examining two mHealth intervention strategies.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Internal Facilitation
Arm Type
Active Comparator
Arm Description
mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS.
Arm Title
External Facilitation
Arm Type
Active Comparator
Arm Description
mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS.
Intervention Type
Device
Intervention Name(s)
FOCUS
Intervention Description
FOCUS is a self management mHealth application for people with serious mental illness.
Primary Outcome Measure Information:
Title
Change in PhQ9
Description
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.
Time Frame
0,3,6 months
Title
Change in GAD-7
Description
The Generalized Anxiety Disorder-7 measures generalized anxiety disorder. GAD-7 total score ranges from 0 to 21. Higher scores represent worsening of symptoms.
Time Frame
0,3,6 months
Title
Change in Insomnia Severity Index
Description
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.
Time Frame
0,3,6 months
Title
Change in Green Paranoid Thoughts Scale- ideas and persecution sub-scale
Description
The Green Paranoid Thoughts Scale (GPTS)- sub-scale: measures ideas of persecution. Scores range from 16-80. Higher scores represent worsening of symptoms.
Time Frame
0,3,6 months
Title
Change in Symptom Check List SCL9
Description
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.
Time Frame
0,3,6 months
Title
Change in Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ)
Description
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.
Time Frame
0,3,6 Months
Title
Change in Illness Management and Recovery Scale
Description
IMRS measures illness management and recovery. Scoring is a sum of all responses ranging from 15-75. Higher scores mean more severe symptoms.
Time Frame
0,3,6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
All participants need to be receiving clinical care at participating clinics who have partnered with the research team for this study. Inclusion: Chart diagnosis of SSD (i.e., schizophrenia, schizoaffective disorder, schizotypal disorder, delusional disorder, or schizophreniform disorder; 18 years or older; English-speaking; Own a smartphone that can support FOCUS and active data plan. Exclusion: Used FOCUS in the past; Plan to move or discontinue services at participating clinics in the upcoming 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dror Ben-Zeev, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cascade Mental Health Care
City
Chehalis
State/Province
Washington
ZIP/Postal Code
98532
Country
United States
Facility Name
NEW Alliance Counseling Services
City
Colville
State/Province
Washington
ZIP/Postal Code
99114
Country
United States
Facility Name
Compass Health
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Valley Cities
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Peninsula Behavioral Health
City
Port Angeles
State/Province
Washington
ZIP/Postal Code
98362
Country
United States
Facility Name
Sound Health
City
Seattle
State/Province
Washington
ZIP/Postal Code
98125
Country
United States
Facility Name
Frontier Behavioral Health
City
Spokane
State/Province
Washington
ZIP/Postal Code
99201
Country
United States
Facility Name
Comprehensive Healthcare
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Implementing mHealth for Schizophrenia in Community Mental Health Settings

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