Mobile Apps for the Treatment of Depression

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• Status: Withdrawn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: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Behavioral activation plus mobile app; Behavioral: Standard behavioral activation

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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	Measures participants' opinion of computerized and computer-assisted psychotherapy.	Week 1, Week 8
Mini-International Neuropsychiatric Interview	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

• 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

General Publications

• Newman MG, Szkodny LE, Llera SJ, Przeworski A. A review of technology-assisted self-help and minimal contact therapies for anxiety and depression: is human contact necessary for therapeutic efficacy? Clin Psychol Rev. 2011 Feb;31(1):89-103. doi: 10.1016/j.cpr.2010.09.008. Epub 2010 Oct 14.
• Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.

Study record dates

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: depression; psychotherapy; behavioral activation; technology
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 529128