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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068467
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Dror Ben-Zeev, University of Washington

Tracking Information
First Submitted Date  ICMJE August 7, 2019
First Posted Date  ICMJE August 28, 2019
Last Update Posted Date February 21, 2020
Actual Study Start Date  ICMJE January 6, 2020
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of mHealth for Serious Mental Illness
Official Title  ICMJE Evaluation of mHealth for Serious Mental Illness
Brief Summary This study is a waitlist control trial evaluating the acceptability and preliminary efficacy of a smartphone application with people with mental illness.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar Disorder
  • Major Depressive Disorder
Intervention  ICMJE
  • Other: Smartphone App
    The application consists of content areas focused on mental health.
  • Other: Waitlist Control
    Waitlist control
Study Arms  ICMJE
  • Experimental: Active
    Instructed to download the app and use the app daily for 30 days.
    Intervention: Other: Smartphone App
  • Active Comparator: Waitlist Control
    Waitlist control.
    Intervention: Other: Waitlist Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 19, 2020)
100
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2019)
20
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Suzanne M Meller, MPH, MSW 206-221-7364 smeller@uw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04068467
Other Study ID Numbers  ICMJE STUDY00006898
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dror Ben-Zeev, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dror Ben-Zeev, PhD University of Washington
PRS Account University of Washington
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP