search
Back to results

Evaluation of mHealth for Serious Mental Illness

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone App
Waitlist Control
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective Disorder, Mobile Application, SMI, EHealth, E-Health, Health Technology, mHealth, m-Health, Mobile Health, Serious Mental Illness, Electronic Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active

Waitlist Control

Arm Description

Instructed to download the app and use the app daily for 30 days.

Waitlist control.

Outcomes

Primary Outcome Measures

Change in Depressive Symptoms
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
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
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
August 7, 2019
Last Updated
August 10, 2021
Sponsor
University of Washington
search

1. Study Identification

Unique Protocol Identification Number
NCT04068467
Brief Title
Evaluation of mHealth for Serious Mental Illness
Official Title
Evaluation of mHealth for Serious Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Major Depressive Disorder, Bipolar Disorder
Keywords
Schizophrenia, Schizoaffective Disorder, Mobile Application, SMI, EHealth, E-Health, Health Technology, mHealth, m-Health, Mobile Health, Serious Mental Illness, Electronic Health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Instructed to download the app and use the app daily for 30 days.
Arm Title
Waitlist Control
Arm Type
Active Comparator
Arm Description
Waitlist control.
Intervention Type
Other
Intervention Name(s)
Smartphone App
Intervention Description
The application consists of content areas focused on mental health.
Intervention Type
Other
Intervention Name(s)
Waitlist Control
Intervention Description
Waitlist control
Primary Outcome Measure Information:
Title
Change in Depressive Symptoms
Description
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.
Time Frame
Baseline, 30 days, 60 days
Title
Change in Paranoid Thinking
Description
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.
Time Frame
Baseline, 30 days, 60 days
Title
Change in Anxiety Symptoms
Description
The Generalized Anxiety Disorder 7-item Scale is summed with a total score range of 0-21. Higher scores represent more symptoms of anxiety.
Time Frame
Baseline, 30 days, 60 days
Title
Change in Psychotic Symptoms
Description
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.
Time Frame
Baseline, 30 days, 60 days
Title
Participant Acceptability
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dror Ben-Zeev, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34766913
Citation
Ben-Zeev D, Chander A, Tauscher J, Buck B, Nepal S, Campbell A, Doron G. A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE. J Med Internet Res. 2021 Nov 12;23(11):e29201. doi: 10.2196/29201.
Results Reference
derived

Learn more about this trial

Evaluation of mHealth for Serious Mental Illness

We'll reach out to this number within 24 hrs