Feasibility of a Technology-Based Treatment Support System

NCT03121937 | Terminated DMC

• 2 other identifiers: STU00097492K08MH102336
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Depressive Disorder, Major

Outcome Measures

Primary Outcomes (3)

• Retention

  Number of completed sessions

  8 weeks

• Adherence

  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

  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 Outcomes (1)

• Depression

  8 weeks

Study Arms (2)

Mobile App

EXPERIMENTAL

Participants will receive a mobile app to be used during psychotherapy that syncs information with the participant's therapist from sessions.

Behavioral: Mobile App

Treatment as Usual

NO INTERVENTION

Participants will receive treatment as usual with aspects of the mobile app available through paper-based worksheets.

Interventions

Mobile App BEHAVIORAL

The mobile app "mConnect" is an app designed to facilitate psychotherapy for depression and includes mood tracking, goal setting, and communication

Mobile App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Amita Health

Arlington Heights, Illinois, 60004, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Stephen M Schueller, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Preventive Medicine

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 20, 2017
• Study Start: August 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: October 10, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)