Feasibility of a Technology-Based Treatment Support System

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility of a Technology-Based Treatment Support System

Conditions
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Depression, Depressive Disorder, Major

Intervention / Treatment
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* Behavioral: Mobile App


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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