NCT01752608

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

2.6 years

First QC Date

December 16, 2012

Last Update Submit

October 12, 2015

Conditions

Major Depressive Disorder

Keywords

DepressionReal-timeiPhoneCBTCognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

  • Montgomery-Åsberg Depression Rating Scale (MADRS)

    Change from baseline to Week 8

Secondary Outcomes (3)

  • Automatic Thoughts Questionnaire-Revised (ATQ-R)

    Change from baseline to Week 8

  • Beck Depression Inventory, 2nd Edition

    Change from baseline to Week 8

  • Profile of Mood States, Short-Form (POMS-SF)

    Change from baseline to Week 8

Other Outcomes (1)

  • Adverse events

    As assessed at each of 9 visits over 8 weeks

Study Arms (2)

eCBT Mood

EXPERIMENTAL

Electronic cognitive behavioral therapy application running on the iPhone and iPod Touch.

Behavioral: eCBT Mood

Mood Tracker

NO INTERVENTION

Mood monitoring application running on the iPhone and iPod Touch

Interventions

eCBT MoodBEHAVIORAL

A handheld, computerized, electronic cognitive behavioral therapy (CBT) application

eCBT Mood

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Compass Research, LLC: North Clinic

Leesburg, Florida, 34748, United States

Location

Compass Research LLC

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Michael Hufford, Phd

    CEO of MindApps

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2012

First Posted

December 19, 2012

Study Start

October 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

US(2)