Efficacy of Electronic Cognitive Behavioral Therapy Application to Treat Major Depressive Disorder
The primary objective of this study is to evaluate the safety and efficacy of an electronic cognitive behavioral therapy application (eCBT Mood) compared to a control group consisting of a mood monitoring handheld computer application in the treatment of patients with mild to moderate major depressive disorder.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Comparator-Controlled, Two-Arm, Parallel Group Study to Determine the Safety and Efficacy of eCBT Mood®, a Handheld, Computerized, Electronic Cognitive Behavioral Therapy Application, in Patients With Major Depressive Disorder|
- Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Change from baseline to Week 8 ] [ Designated as safety issue: No ]
- Automatic Thoughts Questionnaire-Revised (ATQ-R) [ Time Frame: Change from baseline to Week 8 ] [ Designated as safety issue: No ]
- Beck Depression Inventory, 2nd Edition [ Time Frame: Change from baseline to Week 8 ] [ Designated as safety issue: No ]
- Profile of Mood States, Short-Form (POMS-SF) [ Time Frame: Change from baseline to Week 8 ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: As assessed at each of 9 visits over 8 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: eCBT Mood
Electronic cognitive behavioral therapy application running on the iPhone and iPod Touch.
Behavioral: eCBT Mood
A handheld, computerized, electronic cognitive behavioral therapy (CBT) application
No Intervention: Mood Tracker
Mood monitoring application running on the iPhone and iPod Touch
This is a prospective, randomized, comparator-controlled, two-arm, parallel group study to examine the safety and efficacy of eCBT Mood, a handheld, computerized, electronic cognitive behavioral therapy (CBT) application, in patients with major depressive disorder (MDD). The study will involve 100 patients with mild to moderate MDD randomly assigned to daily use of either a CBT application focused on depression ('eCBT Mood'; MindApps, llc) or a comparator-controlled group using a mood monitoring application ('Mood Tracker'; GP International). This study design and duration of the study is consistent with other studies employing comparator-controlled designs in the study of CBT interventions, including computerized CBT interventions, among patients with MDD (e.g., Andrews et al., 2010; McKendree-Smith et al., 2003).
After being screened to ensure that the patients meet the required diagnostic, depression severity, and other inclusion criteria, patients will be randomly assigned (1:1) to use either eCBT Mood, a computer application running on the Apple® iPhone™ or iPod Touch® handheld computer platforms. The application includes: (1) a psychoeducation module on the relationships among thoughts, feelings, and behaviors, (2) a 6-item daily depression assessment with the option to e-mail the summary score and suicidal ideation assessment response to a 3rd party, (3) a negative automatic thought identification module, (4) a feelings and thoughts log, (5) a module enabling the user to challenge their negative automatic thoughts, (6) an assessment and challenge module regarding core beliefs which underlie many automatic thoughts, (7) optional compliance reminders to use the application or take medicines, and (8) links to behavioral science-based online content regarding MDD from PsychCentral (see www.psychcentral.com). In contrast, the comparator control condition will use Mood Tracker, which is also a a computer application running on the Apple iPhone or iPod Touch handheld computer platforms. This application enables users to rate their mood using expressive faces on a daily basis, log about their daily feelings, and also has an option enabling an e-mail to be sent to a 3rd party regarding their daily mood ratings.
Throughout the 8-week study period, patients will complete both in-person and telephone-based assessments of their depression severity, mood, frequency of negative automatic thoughts, and safety assessments.
|Contact: Michael Hufford, PhDfirstname.lastname@example.org|
|United States, Florida|
|Compass Research, LLC: North Clinic||Recruiting|
|Leesburg, Florida, United States, 34748|
|Contact: Michael Maddock 352-314-0801 email@example.com|
|Principal Investigator: James McDonough, MD|
|Compass Research LLC||Not yet recruiting|
|Orlando, Florida, United States, 32806|
|Contact: Donna Flowers 321-202-2581 firstname.lastname@example.org|
|Principal Investigator: James McDonough, MD|
|Study Chair:||Michael Hufford, Phd||CEO of MindApps|