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

Withdrawn before enrolling · Not applicable

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT01752608

Run by

MindApps

People needed

0

Starts

2012-10-01

Expected to finish

2015-05-01

Last updated by the study team

2015-10-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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