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Clinical Trials/NCT04068467
NCT04068467
Completed
N/A

Evaluation of mHealth for Serious Mental Illness

University of Washington1 site in 1 country315 target enrollmentJanuary 6, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
University of Washington
Enrollment
315
Locations
1
Primary Endpoint
Change in Depressive Symptoms
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
January 6, 2020
End Date
May 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dror Ben-Zeev

Professor, School of Medicine: Psychiatry and Behavioral Sciences

University of Washington

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 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.

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.

Study Sites (1)

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