NCT04068467

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 6, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

August 11, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

August 7, 2019

Last Update Submit

August 10, 2021

Conditions

SchizophreniaSchizoaffective DisorderMajor Depressive DisorderBipolar Disorder

Keywords

SchizophreniaSchizoaffective DisorderMobile ApplicationSMIEHealthE-HealthHealth TechnologymHealthm-HealthMobile HealthSerious Mental IllnessElectronic Health

Outcome Measures

Primary Outcomes (5)

  • 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.

    Baseline, 30 days, 60 days

  • 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.

    Baseline, 30 days, 60 days

  • 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.

    Baseline, 30 days, 60 days

  • 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.

    Baseline, 30 days, 60 days

  • 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.

    30 days

Study Arms (2)

Active

EXPERIMENTAL

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

Other: Smartphone App

Waitlist Control

ACTIVE COMPARATOR

Waitlist control.

Other: Waitlist Control

Interventions

Smartphone AppOTHER

The application consists of content areas focused on mental health.

Active
Waitlist ControlOTHER

Waitlist control

Waitlist Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • 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.

    PMID: 34766913DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersDepressive Disorder, MajorBipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersDepressive DisorderMood DisordersBipolar and Related Disorders

Study Officials

  • Dror Ben-Zeev, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Medicine: Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 28, 2019

Study Start

January 6, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

August 11, 2021

Record last verified: 2021-08

Locations

US(1)