Feasibility of a Technology-Based Treatment Support System

October 8, 2018 updated by: Stephen Schueller, Northwestern University
This study aims to evaluate a technology-based treatment support system for patients undergoing the treatment of depression. The investigators will explore the usefulness of the technology-based treatment support system as an adjunct to psychotherapy for depression.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study aims to evaluate a technology-based treatment support system "mConnect" for patients undergoing the treatment of depression. This system will be evaluated by conducting a randomized controlled trial where patients will either receive the mConnect mobile app or treatment as usual.

Study Type

Interventional

Enrollment (Actual)

11

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
    • Illinois
      • Arlington Heights, Illinois, United States, 60004
        • AMITA Health

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • English-speaking
  • Currently enrolled in outpatient treatment
  • Current diagnosis of major depressive disorder
  • Ownership of a smartphone device compatible with the mobile app

Exclusion Criteria

  • visual, hearing, voice, or motor impairment that would prevent completion of the study procedures or use of mobile phone
  • diagnosis of a psychotic disorder, bipolar disorder, dissociative disorder, substance use disorder, or other diagnosis for which participation in this trial is inappropriate, severe suicidality (has ideation, plan, and intent).
  • having completed more than 3 sessions of psychotherapy with current therapist

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile App
Participants will receive a mobile app to be used during psychotherapy that syncs information with the participant's therapist from sessions.
Behavioral: Mobile App
The mobile app "mConnect" is an app designed to facilitate psychotherapy for depression and includes mood tracking, goal setting, and communication
No Intervention: Treatment as Usual
Participants will receive treatment as usual with aspects of the mobile app available through paper-based worksheets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention
Time Frame: 8 weeks
Number of completed sessions
8 weeks
Adherence
Time Frame: 8 weeks
The use of the mobile app. This data will be collected passively by the mobile app sending the following information to the secure server: the date and time the mobile app is launched, the date and time any information is entered into the mobile app, the content of any information entered into the mobile app, the date and time any lessons within the mobile app are read by the participant.
8 weeks
Satisfaction
Time Frame: 8 weeks
Participant satisfaction with the mobile app will be assessed with a patient version of the Mobile App Rating Scale (MARS) that addresses engagement, functionality, aesthestics, information quality, and one subjective rating of the app as a whole.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: 8 weeks
Depression as measured by the PHQ-9
8 weeks

Collaborators and Investigators

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

Sponsor

Northwestern University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Stephen M Schueller, PhD, Northwestern University

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)

August 1, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

April 11, 2017

First Submitted That Met QC Criteria

April 17, 2017

First Posted (Actual)

April 20, 2017

Study Record Updates

Last Update Posted (Actual)

October 10, 2018

Last Update Submitted That Met QC Criteria

October 8, 2018

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00097492
  • K08MH102336 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Depression

Clinical Trials on Mobile App

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe