Feasibility of a Technology-Based Treatment Support System

Depression Clinical Trial

Official title:

Feasibility of a Technology-Based Treatment Support System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03121937
• Other study ID #: STU00097492
• Secondary ID: K08MH102336
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: April 2017
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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

Locations

Country	Name	City	State
United States	Amita Health	Arlington Heights	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention	Number of completed sessions	8 weeks
Primary	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
Primary	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	Depression	Depression as measured by the PHQ-9	8 weeks