Implementing mHealth for Schizophrenia in Community Mental Health Settings

University of Washington

Status: Active, not recruiting

Conditions: Schizophrenia

Treatments: Device: FOCUS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04147897

1R01MH116057-01A1 (U.S. NIH Grant/Contract)

STUDY00006141

Details and patient eligibility

About

Randomized control trial examining two mHealth intervention strategies.

Full 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.

Enrollment: 303 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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303 participants in 2 patient groups

Internal Facilitation

Active Comparator group

Description:

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

Treatment:

Device: FOCUS

External Facilitation

Active Comparator group

Description:

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

Treatment:

Device: FOCUS