Understanding the Efficacy of Mobile Apps as Intervention for Depression in Adults When Deployed as Part of Primary Care.

April 26, 2019 updated by: Pauli Lieponis, Actualize Therapy

Implementing an Innovative Suite of Mobile Applications for Depression and Anxiety

The clinical study is meant to optimize the mobile intervention, to develop a robust implementation plan for the mobile intervention within primary care, and to conduct an effectiveness trial, randomizing 128 participants in order to understand effect on severity of depression and anxiety symptoms, cost-effectiveness, and usability of mobile apps.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Positive screen on PHQ-9

Exclusion Criteria:

  • Does not own or use a mobile smart phone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Waitlist Control
8 weeks of treatment as usual followed by 8 weeks of IntelliCare treatment.
Experimental: Experimental
8 weeks of IntelliCare treatment followed by 8 weeks of treatment as usual.
Behavioral: IntelliCare
A suite of mobile apps that use principles of computerized therapy to decrease symptoms of depression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms of depression
Time Frame: 8 weeks
Using the PHQ-9 screener
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actualize Therapy

Collaborators

University of Arkansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2018

Primary Completion (Actual)

April 4, 2019

Study Completion (Actual)

April 4, 2019

Study Registration Dates

First Submitted

April 10, 2018

First Submitted That Met QC Criteria

April 16, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Actual)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 26, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Main

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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