Mobile Apps for the Treatment of Depression

Major Depressive Disorder Clinical Trial

Official title:

Evaluation of Mood Coach in the Treatment of Major Depressive Disorder

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02024620
• Other study ID #: 529128
• Status: Withdrawn
• Phase: N/A
• First received: December 4, 2013
• Last updated: December 14, 2015
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: December 2015
• Source: Central Arkansas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Behavioral activation plus mobile app

• Standard behavioral activation

Locations

Country	Name	City	State
United States	Central Arkansas Veterans Healthcare System	North Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Central Arkansas Veterans Healthcare System	National Center for PTSD

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	Perceptions of Computerized Therapy Questionnaire-Patient Version	Measures participants' opinion of computerized and computer-assisted psychotherapy.	Week 1, Week 8	No
Other	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	No
Primary	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	No
Secondary	Change in Depression Anxiety Stress Scales-21	Assesses symptoms of depression, anxiety, and stress in a brief format.	Week 1, Week 4, Week 8	No