Efficacy of Electronic Cognitive Behavioral Therapy Application to Treat Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eCBT Mood
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Real-time, iPhone, CBT, Cognitive behavioral therapy
Eligibility Criteria
Inclusion Criteria:
- Male or female patients between the ages of 18 and 65 at the date of consent.
- Diagnosis of MDD consistent with the DSM-IV-TR as assessment by the Mini International Neuropsychiatric Interview (MINI).
- Owns and has access to an iPhone or iPod Touch capable of downloading and running either eCBT or the comparator mood monitoring application.
- At the screening and visits, must exhibit mild to moderate MDD with scores between 17 and 34 on the MADRS, inclusive. Subjects with scores >34 on the MADRS will be referred by the Study Investigator for alternative psychotherapeutic and/or pharmacological care for their depression.
- Note that no subjects are to be discontinued from any pharmacotherapies used to treat depression solely for the purpose of qualifying for this study. Be willing and able to refrain from the following therapies for the duration of the study:
- All approved pharmacotherapies for MDD, including serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, tricyclic and tetracyclic antidepressants, bupropion, mood stabilizers, and adjunctive antipsychotics.
- Medical device therapies for depression, including transcranial magnetic stimulation, vagal stimulation, electroconvulsive shock therapy, and others.
- Beginning any type of group or individual psychotherapy.
- Beginning another clinical trial for major depressive disorder or other condition.
- Patients' primary language must be English.
- Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.
Exclusion Criteria:
- Depression severity, as measured by either:
- Clinician judgment that the patient's depression is too severe to make self-help resource a viable treatment option.
- Depression severity as measured by a scores >34 on the MADRS.
- Clinician assessed high risk of suicide or self-harm.
- Intellectual disability or physical limitation that would prevent use of the computerized handheld intervention.
- Comorbid psychopathology where the primary disorder is not depression.
- Within the past 3 months has had a course of treatment with psychotherapy or pharmacotherapy for depression.
Sites / Locations
- Compass Research, LLC: North Clinic
- Compass Research LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
eCBT Mood
Mood Tracker
Arm Description
Electronic cognitive behavioral therapy application running on the iPhone and iPod Touch.
Mood monitoring application running on the iPhone and iPod Touch
Outcomes
Primary Outcome Measures
Montgomery-Åsberg Depression Rating Scale (MADRS)
Secondary Outcome Measures
Automatic Thoughts Questionnaire-Revised (ATQ-R)
Beck Depression Inventory, 2nd Edition
Profile of Mood States, Short-Form (POMS-SF)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01752608
Brief Title
Efficacy of Electronic Cognitive Behavioral Therapy Application to Treat Major Depressive Disorder
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of enrollment
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MindApps
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Real-time, iPhone, CBT, Cognitive behavioral therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eCBT Mood
Arm Type
Experimental
Arm Description
Electronic cognitive behavioral therapy application running on the iPhone and iPod Touch.
Arm Title
Mood Tracker
Arm Type
No Intervention
Arm Description
Mood monitoring application running on the iPhone and iPod Touch
Intervention Type
Behavioral
Intervention Name(s)
eCBT Mood
Intervention Description
A handheld, computerized, electronic cognitive behavioral therapy (CBT) application
Primary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame
Change from baseline to Week 8
Secondary Outcome Measure Information:
Title
Automatic Thoughts Questionnaire-Revised (ATQ-R)
Time Frame
Change from baseline to Week 8
Title
Beck Depression Inventory, 2nd Edition
Time Frame
Change from baseline to Week 8
Title
Profile of Mood States, Short-Form (POMS-SF)
Time Frame
Change from baseline to Week 8
Other Pre-specified Outcome Measures:
Title
Adverse events
Time Frame
As assessed at each of 9 visits over 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients between the ages of 18 and 65 at the date of consent.
Diagnosis of MDD consistent with the DSM-IV-TR as assessment by the Mini International Neuropsychiatric Interview (MINI).
Owns and has access to an iPhone or iPod Touch capable of downloading and running either eCBT or the comparator mood monitoring application.
At the screening and visits, must exhibit mild to moderate MDD with scores between 17 and 34 on the MADRS, inclusive. Subjects with scores >34 on the MADRS will be referred by the Study Investigator for alternative psychotherapeutic and/or pharmacological care for their depression.
Note that no subjects are to be discontinued from any pharmacotherapies used to treat depression solely for the purpose of qualifying for this study. Be willing and able to refrain from the following therapies for the duration of the study:
All approved pharmacotherapies for MDD, including serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, tricyclic and tetracyclic antidepressants, bupropion, mood stabilizers, and adjunctive antipsychotics.
Medical device therapies for depression, including transcranial magnetic stimulation, vagal stimulation, electroconvulsive shock therapy, and others.
Beginning any type of group or individual psychotherapy.
Beginning another clinical trial for major depressive disorder or other condition.
Patients' primary language must be English.
Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.
Exclusion Criteria:
Depression severity, as measured by either:
Clinician judgment that the patient's depression is too severe to make self-help resource a viable treatment option.
Depression severity as measured by a scores >34 on the MADRS.
Clinician assessed high risk of suicide or self-harm.
Intellectual disability or physical limitation that would prevent use of the computerized handheld intervention.
Comorbid psychopathology where the primary disorder is not depression.
Within the past 3 months has had a course of treatment with psychotherapy or pharmacotherapy for depression.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Hufford, Phd
Organizational Affiliation
CEO of MindApps
Official's Role
Study Chair
Facility Information:
Facility Name
Compass Research, LLC: North Clinic
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Compass Research LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Electronic Cognitive Behavioral Therapy Application to Treat Major Depressive Disorder
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