Efficacy of Electronic Cognitive Behavioral Therapy Application to Treat Major Depressive Disorder

October 12, 2015 updated by: MindApps

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Leesburg, Florida, United States, 34748
        • Compass Research, LLC: North Clinic
      • Orlando, Florida, United States, 32806
        • Compass Research LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: Change from baseline to Week 8
Change from baseline to Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Automatic Thoughts Questionnaire-Revised (ATQ-R)
Time Frame: Change from baseline to Week 8
Change from baseline to Week 8
Beck Depression Inventory, 2nd Edition
Time Frame: Change from baseline to Week 8
Change from baseline to Week 8
Profile of Mood States, Short-Form (POMS-SF)
Time Frame: Change from baseline to Week 8
Change from baseline to Week 8

Other Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: As assessed at each of 9 visits over 8 weeks
As assessed at each of 9 visits over 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MindApps

Investigators

  • Study Chair: Michael Hufford, Phd, CEO of MindApps

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

December 16, 2012

First Submitted That Met QC Criteria

December 16, 2012

First Posted (Estimate)

December 19, 2012

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 12, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eCBT 201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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