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Feasibility of a Technology-Based Treatment Support System

Primary Purpose

Depression, Depressive Disorder, Major

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mobile App

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Amita Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mobile App

Treatment as Usual

Arm Description

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

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

Outcomes

Primary Outcome Measures

Retention

Number of completed sessions

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.

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.

Secondary Outcome Measures

Depression

Depression as measured by the PHQ-9

Full Information

NCT ID

NCT03121937

First Posted

April 11, 2017

Last Updated

October 8, 2018

Sponsor

Northwestern University

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT03121937

Brief Title

Feasibility of a Technology-Based Treatment Support System

Official Title

Feasibility of a Technology-Based Treatment Support System

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Terminated

Why Stopped

No longer able to recruit participants

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

June 30, 2018 (Actual)

Study Completion Date

June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Depressive Disorder, Major

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mobile App

Arm Type

Experimental

Arm Description

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

Arm Title

Treatment as Usual

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Mobile App

Intervention Description

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

Primary Outcome Measure Information:

Title

Retention

Description

Number of completed sessions

Time Frame

8 weeks

Title

Adherence

Description

Time Frame

8 weeks

Title

Satisfaction

Description

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Depression

Description

Depression as measured by the PHQ-9

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen M Schueller, PhD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Amita Health

City

Arlington Heights

State/Province

Illinois

ZIP/Postal Code

60004

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Feasibility of a Technology-Based Treatment Support System

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