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Evaluation of mHealth for Serious Mental Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04068467
Recruitment Status : Completed
First Posted : August 28, 2019
Last Update Posted : August 11, 2021
Information provided by (Responsible Party):
Dror Ben-Zeev, University of Washington

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

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Major Depressive Disorder Bipolar Disorder Other: Smartphone App Other: Waitlist Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of mHealth for Serious Mental Illness
Actual Study Start Date : January 6, 2020
Actual Primary Completion Date : May 1, 2021
Actual Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
Experimental: Active
Instructed to download the app and use the app daily for 30 days.
Other: Smartphone App
The application consists of content areas focused on mental health.

Active Comparator: Waitlist Control
Waitlist control.
Other: Waitlist Control
Waitlist control

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04068467

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United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
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Principal Investigator: Dror Ben-Zeev, PhD University of Washington
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Responsible Party: Dror Ben-Zeev, Professor, School of Medicine: Psychiatry and Behavioral Sciences, University of Washington Identifier: NCT04068467    
Other Study ID Numbers: STUDY00006898
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dror Ben-Zeev, University of Washington:
Schizoaffective Disorder
Mobile Application
Health Technology
Mobile Health
Serious Mental Illness
Electronic Health
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mood Disorders
Bipolar and Related Disorders