Evaluation of mHealth for Serious Mental Illness

NCT ID: NCT04068467

Last Updated: 2021-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2021-05-01

Brief Summary

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

Detailed Description

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Conditions

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Schizophrenia Schizoaffective Disorder Major Depressive Disorder Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Active

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

Group Type EXPERIMENTAL

Smartphone App

Intervention Type OTHER

The application consists of content areas focused on mental health.

Waitlist Control

Waitlist control.

Group Type ACTIVE_COMPARATOR

Waitlist Control

Intervention Type OTHER

Waitlist control

Interventions

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Smartphone App

The application consists of content areas focused on mental health.

Intervention Type OTHER

Waitlist Control

Waitlist control

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Dror Ben-Zeev

Professor, School of Medicine: Psychiatry and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dror Ben-Zeev, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34766913 (View on PubMed)

Other Identifiers

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STUDY00006898

Identifier Type: -

Identifier Source: org_study_id

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