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Feasibility of a Technology-Based Treatment Support System

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ClinicalTrials.gov Identifier: NCT03121937
Recruitment Status : Terminated (No longer able to recruit participants)
First Posted : April 20, 2017
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Stephen Schueller, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Depression Depressive Disorder, Major Behavioral: Mobile App Not Applicable

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  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of a Technology-Based Treatment Support System
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Retention [ Time Frame: 8 weeks ]
    Number of completed sessions

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Depression [ Time Frame: 8 weeks ]
    Depression as measured by the PHQ-9



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03121937


Locations
United States, Illinois
Amita Health
Arlington Heights, Illinois, United States, 60004
Sponsors and Collaborators
Northwestern University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Stephen M Schueller, PhD Northwestern University

Responsible Party: Stephen Schueller, Assistant Professor of Preventive Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT03121937     History of Changes
Other Study ID Numbers: STU00097492
K08MH102336 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms