An interventional study of eCBT Mood in Major Depressive Disorder, sponsored by MindApps. Withdrawn at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-10-14.
Sponsored by MindApps · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
Electronic cognitive behavioral therapy application running on the iPhone and iPod Touch.
Behavioral: eCBT Mood
Mood monitoring application running on the iPhone and iPod Touch
A handheld, computerized, electronic cognitive behavioral therapy (CBT) application
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: Change from baseline to Week 8
Automatic Thoughts Questionnaire-Revised (ATQ-R)
Time frame: Change from baseline to Week 8
Beck Depression Inventory, 2nd Edition
Time frame: Change from baseline to Week 8
Profile of Mood States, Short-Form (POMS-SF)
Time frame: Change from baseline to Week 8
Adverse events
Time frame: As assessed at each of 9 visits over 8 weeks
This study is withdrawn, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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