Technology-Assisted Implementation of a Mobile Health Program for Serious Mental Illness

NCT05725785 | Completed

• 2 other identifiers: STUDY00016266DI-2021C3-24542
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 3

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.

Conditions

Schizophrenia; Bipolar Disorder; Major Depressive Disorder; Schizo Affective Disorder

Keywords

serious mental illness; mHealth; digital health; schizophrenia; implementation; smartphone; SMI

Outcome Measures

Primary Outcomes (7)

• Change in psychiatric functioning

  Change in the psychiatric functioning will be measured by the Symptom Checklist-9 (SCL-9). This nine-item questionnaire is used to assess psychiatric functioning with a maximum score of 36 and a minimum score of 0. Higher scores on this scale indicates worse functioning.

  Baseline, 3-months

• Change in depressive symptoms

  Change in the depressive symptoms will be measured by the Beck Depression Inventory-2 (BDI-2). This 21-item questionnaire is used to assess depressive symptoms with a maximum score of 63 and a minimum score of 0. Higher scores on this scale indicates worse functioning.

  Baseline, 3-months

• Change in auditory verbal hallucinations

  Change in the auditory verbal hallucinations will be measured by the Hamilton Program for Schizophrenia Voices (HPSVQ). This 13-item questionnaire is used to assess auditory verbal hallucinations with a maximum score of 36 and a minimum score of 0. Higher scores on this scale indicate worse functioning.

  Baseline, 3-months

• Change in recovery oriented thinking

  Recovery of patient will be measured using the Recovery Assessment Scale (RAS). RAS has 24-items that assess 5 factors related to recovery including Hope, Goal Directedness, and Domination by Symptoms. The maximum score on this scale is 120 and the minimum score is 24. A higher score on this scale indicated improved functioning.

  Baseline, 3-months

• Change in perceived quality of life

  Quality of Life will be assessed using a 6-item Quality of Life scale of general wellbeing, interpersonal relations, participation in activities, and role functioning. Patients respond on a 7-point scale with a maximum score of 42 and a minimum score of 6. A higher score on this scale indicated a higher quality of life.

  Baseline, 3-months

• Patient Satisfaction with FOCUS

  Patient satisfaction related to their use of the FOCUS system will will be assessed by a 5-item questionnaire on a 7-point scale asking about..... The maximum score on this scale is and the minimum is 35 and the minimum score on this scale is 5. A higher score on this scale indicates higher satisfaction with the FOCUS system.

  3-months

• Patient Engagement with FOCUS

  Patient engagement will be the number of weeks FOCUS was used, during the 12-week intervention period. Data for FOCUS usage will be captured automatically on FOCUS software.

  3-months

Study Arms (1)

FOCUS participants

OTHER

FOCUS is a smartphone application system designed to improve illness self-management and facilitate recovery in individuals with serious mental illness. It delivers both system initiated (i.e. pre-programmed) and patient initiated (i.e. on demand) real-time assessment to individuals in their own environment.

Behavioral: FOCUS participants

Interventions

FOCUS participants BEHAVIORAL

Participants using FOCUS will be given access to the FOCUS application and trained by the mHealth support specialist on how to use the functions of the smartphone (i.e. using a touchscreen, call, text) and different features of the FOCUS intervention.

FOCUS participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (3)

Places for People

St Louis, Missouri, 63118, United States

Location

Community Partners

Dover, New Hampshire, 03820, United States

Location

The Mental Health Center of Greater Manchester

Manchester, New Hampshire, 03103, United States

Location

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Depressive Disorder, Major; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder

Study Officials

• Dror Ben Zeev, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Psychiatry

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 13, 2023
• Study Start: August 1, 2023
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (3)