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OpenTrials
Completed

NCT Number: NCT04068467

Evaluation of mHealth for Serious Mental Illness

This study is a waitlist control trial evaluating the acceptability and preliminary efficacy of a smartphone application with people with mental illness.

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Key information

Conditions

Schizophrenia Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or older
  • Owns an Android or iPhone smartphone with WiFi or 3G/4G capabilities (required for data transmission)
  • Has diagnosis of Schizophrenia, Schizoaffective Disorder, Bipolar Disorder or Major Depression
  • English speaker

Exclusion criteria

  • Does not live in the U.S.
  • Has already participated in the study
  • Unavailable for 60 days
  • Currently incarcerated or hospitalized

Treatment and study plan

Smartphone app

Other

The application consists of content areas focused on mental health.

Waitlist Control

Other

Waitlist control

Primary outcomes

  1. Change in Depressive Symptoms

    Time frame: Baseline, 30 days, 60 days

    The Beck Depression Inventory is a self-reported 21-item inventory, scores range from 0-63 and items are summed to compute the total score. A higher score represents more depressive symptoms.

  2. Change in Paranoid Thinking

    Time frame: Baseline, 30 days, 60 days

    The Green Paranoid Thoughts Scale Parts A & B is a 32-item scale, the total score is summed with a range of 16-80. A higher score represents more symptoms of paranoid thinking.

  3. Change in Anxiety Symptoms

    Time frame: Baseline, 30 days, 60 days

    The Generalized Anxiety Disorder 7-item Scale is summed with a total score range of 0-21. Higher scores represent more symptoms of anxiety.

  4. Change in Psychotic Symptoms

    Time frame: Baseline, 30 days, 60 days

    The Hamilton Program for Schizophrenia Voices Questionnaire is a 13-item questionnaire, 9 of the items are scored 0 (least severe or impairing) to 4 (most severe). The total score is intended to indicate the overall severity of psychotic symptoms. Total score range is 0-36. The remaining 4 items are intended to assess qualitative aspects.

  5. Participant Acceptability

    Time frame: 30 days

    Participant Acceptability/Usability Ratings Scale is a 26-item scale measuring participant-rated acceptability of the intervention. Participants rate statements on a scale of Disagree (0), Neutral (1), or Agree (2). Items are summed to create a total score and a higher total score indicates greater acceptability.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 28, 2019
Registry last updated
Aug 11, 2021

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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