Implementing mHealth for Schizophrenia in Community Mental Health Settings

Not Applicable

Active, not recruiting

• Conditions: Schizophrenia
• Interventions: Device: FOCUS

• Registration Number: NCT04147897
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-11-01
• Study Start: 2020-06-16
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-13
• Primary Completion: 2024-09-15
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 303

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internal Facilitation	FOCUS	mHealth specialist is a trained clinician embedded in the clinical team offering the mHealth intervention, FOCUS.
External Facilitation	FOCUS	mHealth specialist is a trained clinician external to the clinical team offering the mHealth intervention, FOCUS.

Primary Outcome Measures

Name	Time	Method
Change in PhQ9	0,3,6 months	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	0,3,6 months	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 Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ)	0,3,6 Months	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 Green Paranoid Thoughts Scale- ideas and persecution sub-scale	0,3,6 months	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 Illness Management and Recovery Scale	0,3,6 months	IMRS measures illness management and recovery. Scoring is a sum of all responses ranging from 15-75. Higher scores mean more severe symptoms.
Change in Insomnia Severity Index	0,3,6 months	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 Symptom Check List SCL9	0,3,6 months	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.

Trial Locations

Locations (8)

NEW Alliance Counseling Services; 🇺🇸 Colville, Washington, United States

Compass Health; 🇺🇸 Everett, Washington, United States

Cascade Mental Health Care; 🇺🇸 Chehalis, Washington, United States

Frontier Behavioral Health; 🇺🇸 Spokane, Washington, United States

Comprehensive Healthcare; 🇺🇸 Yakima, Washington, United States

Sound Health; 🇺🇸 Seattle, Washington, United States

Valley Cities; 🇺🇸 Federal Way, Washington, United States

Peninsula Behavioral Health; 🇺🇸 Port Angeles, Washington, United States