Clinical trial NCT05725785: Technology-Assisted Implementation of a Mobile Health Program for Serious Mental Illness
Official title: Technology-Assisted Implementation of a Mobile Health Program for Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Major Depressive Disorder
Schizo Affective Disorder
Keywords: serious mental illness
mHealth
digital health
schizophrenia
implementation
smartphone
SMI
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2023-02-13
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn about how a digital training platform can enhance implementation and effectiveness of a validated mHealth system, called FOCUS, in people with serious mental illness. The main question this research aims to answer is whether patients obtain similar outcomes to previous FOCUS studies when using FOCUS with clinicians trained on a newly developed digital training platform.

Participants will be asked to use the FOCUS smartphone application and receive mobile health coaching from clinicians who have been trained using the digital training platform.

Detailed description: Widely available technologies can help overcome the capacity constraints of brick-and mortar community mental health centers (CMHCs), expand the reach of evidence-based mental healthcare, and provide much needed illness management skills and resources for people with serious mental illness (SMI). With funding from the NIMH, PCORI, and CMMI, the investigators developed and tested FOCUS--a multi-modal smartphone illness self-management system that is shown to be feasible, usable, highly engaging, and effective among people with SMI.

The current project facilitates translation of FOCUS into routine care at CMHCs using implementation strategies of practice facilitation, implementation resource teams, and the development of accessible training materials. The investigators are proposing a technology-assisted training and implementation model designed to address system needs that have emerged since the COVID-19 pandemic and enhance sustainability of FOCUS at CMHCs. The new tools and strategies used in the project will facilitate improved training and implementation in new treatment settings, reaching a far larger number of patients who otherwise would not receive FOCUS and improving the sustainability of this tool, even in high turnover settings.

This trial is a prospective multi-site site single arm implementation study in three community mental health centers located in New Hampshire and Missouri. The investigators will develop and evaluate a digital training platform to aid in the implementation of FOCUS and utilize the platform to improve the availability, reach, impact, and sustainability of the FOCUS intervention in CMHCs. Patient participants will utilize FOCUS for a 12-week period at CMHCs where clinicians have been trained using the digital training platform. Investigators will compare patient outcomes to results of previous trials where clinicians were trained using more traditional, in-person training and support methods.

Eligibility criteria: Inclusion Criteria:

* Chart diagnosis of a serious mental illness (i.e., schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder)
* 18 years of age or older
* English-speaking
* Have access to a smartphone that can support FOCUS

Exclusion Criteria:

• Plan to move or discontinue services at the participating community mental health center in the next three months

Primary outcomes:
measure: Change in psychiatric functioning
timeFrame: Baseline, 3-months
measure: Change in depressive symptoms
timeFrame: Baseline, 3-months
measure: Change in auditory verbal hallucinations
timeFrame: Baseline, 3-months
measure: Change in recovery oriented thinking
timeFrame: Baseline, 3-months
measure: Change in perceived quality of life
timeFrame: Baseline, 3-months
measure: Patient Satisfaction with FOCUS
timeFrame: 3-months
measure: Patient Engagement with FOCUS
timeFrame: 3-months
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Places for People
state: Missouri
city: Dover
country: United States
facility: Community Partners
state: New Hampshire
city: Manchester
country: United States
facility: The Mental Health Center of Greater Manchester
state: New Hampshire
Study officials:
affiliation: University of Washington
name: Dror Ben Zeev, PhD
role: PRINCIPAL_INVESTIGATOR
References: