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OpenTrials
Completed

NCT Number: NCT04147897

Implementing mHealth for Schizophrenia in Community Mental Health Settings

Randomized control trial examining two mHealth intervention strategies.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cascade Mental Health Care, Chehalis, Washington, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FOCUS

Device

FOCUS is a self management mHealth application for people with serious mental illness.

Primary outcomes

  1. Patient Health Questionnaire (PHQ)-9

    Time frame: 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 more severe symptoms.

  2. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 0,3,6 months

    The Generalized Anxiety Disorder-7 (GAD-7) measures generalized anxiety disorder symptoms. GAD-7 total score ranges from 0 to 21. Higher scores represent more severe symptoms.

  3. Insomnia Severity Index (ISI)

    Time frame: 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 more severe symptoms.

  4. Green Paranoid Thoughts Scale- Part B

    Time frame: 0,3,6 months

    The Green Paranoid Thoughts Scale (GPTS)- part B measures ideas of persecution. Scores range from 16-80. Higher scores represent more severe symptoms.

  5. Symptom Check List (SCL-9)

    Time frame: 0,3,6 months

    The Symptom Check List-9 (SCL-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 as sum of all responses. Total sum scores range from 0-36. Higher scores mean more severe symptoms.

  6. Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ)

    Time frame: 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.

  7. Illness Management and Recovery Scales (IMRS)

    Time frame: 0,3,6 months

    The Illness Management and Recovery Scales (IMRS) measure illness management and recovery. Scoring is a sum of all responses ranging from 15-75. Higher scores mean less severe symptoms.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2019
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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