Mobile Apps for the Treatment of Depression

December 14, 2015 updated by: Central Arkansas Veterans Healthcare System

Evaluation of Mood Coach in the Treatment of Major Depressive Disorder

Smartphone applications (apps) may be well-suited as a low cost adjunctive tool for increasing the adherence of individuals to psychotherapy treatments which may subsequently increase symptom reduction and improve clinical outcomes. Apps offer the opportunity for real-time tracking of behavior and have the ability to provide prompt feedback and reminders in a convenient, readily available technology. The immediacy and convenience of apps may be responsible for the observed improvements in adherence on the part of the patients relative to traditional paper-and-pencil tracking and practice of skills taught in psychotherapy. These features are relevant to behavioral activation (BA) protocols, the effects of which are often attenuated by failure to adhere to regular practice and tracking of behavior. The Mood Coach app is a BA protocol developed to provide a convenient means of planning and tracking activity, and monitoring mood responses to scheduled increases in activity. This project evaluates the utility of this app as an adjunct to standard BA treatment. The investigators predict that participants assigned to the BA+app condition will demonstrate greater adherence to the BA treatment compared to the standard BA condition. The investigators also predict that the participants in the BA+app condition will report greater satisfaction with the app compared to the standard BA protocol that utilizes paper and pencil materials.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • North Little Rock, Arkansas, United States, 72114
        • Central Arkansas Veterans Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Veterans aged 18 and older
  • Speak and understand English
  • Meet criteria for major depressive disorder
  • Willing to participate in psychotherapy for depression

Exclusion Criteria:

  • Current psychotic disorder diagnosis
  • Current bipolar disorder
  • Diagnosed with a substance use disorder that is not currently being addressed by a non-study provider
  • Patients receiving a concurrent evidence-based psychotherapy for depression or PTSD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral activation plus mobile app
Standard behavioral activation protocol with the addition of the Mood Coach mobile app to replace the paper and pencil forms used in the standard protocol.
Behavioral: Behavioral activation plus mobile app
Active Comparator: Standard behavioral activation
Standard behavioral activation protocol using paper and pencil forms for treatment delivery and homework completion.
Behavioral: Standard behavioral activation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Behavioral Activation for Depression Scale-Short Form
Time Frame: Week 1, Week 4, Week 8
Measures symptoms of depression consistent with a behavioral deficits model in a brief format.
Week 1, Week 4, Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression Anxiety Stress Scales-21
Time Frame: Week 1, Week 4, Week 8
Assesses symptoms of depression, anxiety, and stress in a brief format.
Week 1, Week 4, Week 8

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Homework Compliance Rating Scale
Time Frame: Week 4, Week 8
Assesses the amount of effort put into the weekly behavioral activation homework. Completed by the participant and the study clinician.
Week 4, Week 8
Treatment Evaluation Inventory-Short Form
Time Frame: Week 4, Week 8
Assesses the degree to which the treatment provided in the project is deemed acceptable by the participant. The measure used in the present project is modified from the original to better assess the treatment procedures in an adult population.
Week 4, Week 8
Perceptions of Computerized Therapy Questionnaire-Patient Version
Time Frame: Week 1, Week 8
Measures participants' opinion of computerized and computer-assisted psychotherapy.
Week 1, Week 8
Mini-International Neuropsychiatric Interview
Time Frame: Week 1, Week 8
Clinician-administered brief diagnostic interview for psychiatric diagnoses. The selected sections for this project include the major depressive disorder, dysthymic disorder, bi-polar disorder, panic disorder, obsessive-compulsive disorder, generalized anxiety, disorder, social anxiety disorder, post-traumatic stress disorder, and substance use disorder sections.
Week 1, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Arkansas Veterans Healthcare System

Collaborators

National Center for PTSD

Investigators

  • Principal Investigator: Robert E Brady, Ph.D., Central Arkansas Veterans Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

December 4, 2013

First Submitted That Met QC Criteria

December 26, 2013

First Posted (Estimate)

December 31, 2013

Study Record Updates

Last Update Posted (Estimate)

December 15, 2015

Last Update Submitted That Met QC Criteria

December 14, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 529128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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