Clinical trial NCT02024620: Mobile Apps for the Treatment of Depression
Official title: Evaluation of Mood Coach in the Treatment of Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Major Depressive Disorder
Keywords: depression
technology
psychotherapy
behavioral activation
Lead sponsor: Central Arkansas Veterans Healthcare System
Sponsor class: FED
Collaborators: name: National Center for PTSD
First posted: 2013-12-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Behavioral Activation for Depression Scale-Short Form
timeFrame: Week 1, Week 4, Week 8
Secondary outcomes:
measure: Change in Depression Anxiety Stress Scales-21
timeFrame: Week 1, Week 4, Week 8
Other outcomes:
measure: Homework Compliance Rating Scale
timeFrame: Week 4, Week 8
measure: Treatment Evaluation Inventory-Short Form
timeFrame: Week 4, Week 8
measure: Perceptions of Computerized Therapy Questionnaire-Patient Version
timeFrame: Week 1, Week 8
measure: Mini-International Neuropsychiatric Interview
timeFrame: Week 1, Week 8
Locations:
city: North Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System
state: Arkansas
Study officials:
affiliation: Central Arkansas Veterans Healthcare System
name: Robert E Brady, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.