Effectiveness of a Technology Assisted Behavioral Intervention in Assisting People With Major Depressive Disorder

March 18, 2014 updated by: David Mohr, Northwestern University

Integrated Telemental Health Intervention for Depression in Primary Care

This study will develop and evaluate the effectiveness of a technology-assisted behavioral intervention, consisting of Internet-based cognitive behavioral therapy combined with telephone and email support, in reducing depressive symptoms and improving treatment adherence in primary care patients with major depressive disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Major depressive disorder (MDD) is a common mental disorder, with up to 10.3% of the population experiencing the disorder in a given 12-month period. Symptoms of MDD include feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; excessive irritability and restlessness; inability to concentrate; and lack of enjoyment in previously enjoyed activities. Fortunately, MDD is treatable with forms of psychotherapy and/or antidepressant medications. Several studies have found that when given a choice, about two-thirds of depressed patients prefer psychotherapy treatment over antidepressant medication. Although psychotherapy treatments are both effective and desirable, a variety of barriers exist to initiating and sustaining psychotherapy. Only about 20% of all patients referred for psychotherapy treatments ever follow up. Of those who do initiate psychotherapy, nearly half drop out before completing treatment.

Delivering an intervention through telecommunication technologies, such as the telephone and Internet, has the potential to overcome many of the barriers to existing treatments for depression. For example, telephone- and Web-based interventions can reduce cost, extend specialized treatment over broad geographic areas, and permit considerable flexibility in scheduling of treatment components. Technology-assisted Behavioral Intervention(TABI) is a specific form of a telecommunication behavioral intervention that incorporates Web-based Internet, e-mail, and telephone intervention. Further study is needed to determine the effectiveness of TABI in reducing depressive symptoms and attrition rates in people with MDD. This pilot study will first develop TABI, which will consist of Internet-based cognitive behavioral therapy (I-CBT) accompanied by telephone and e-mail support. The study will then compare the effectiveness of TABI with the effectiveness of I-CBT alone and treatment as usual (TAU) in reducing depressive symptoms and improving treatment adherence in primary care patients with MDD.

Participation in the treatment phase of this study will last 12 weeks. All participants will first undergo initial assessments that will include a telephone interview and a series of questionnaires about mood. Eligible participants will then be assigned randomly to receive TABI, I-CBT alone, or TAU. Participants assigned to TABI and I-CBT will both undergo 12 weeks of a Web-based Internet intervention consisting of modules to help them learn skills to manage their moods. Participants assigned to TAU will receive standard treatment from their primary care physicians and will be able to choose between TABI and I-CBT treatment options after a 6-week wait-list period.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 1

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
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Northwestern University

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis of MDD as assessed using the Mini Mental State Exam (MINI)
  • Has a telephone, email account, computer, and broadband access to the Internet
  • Able to navigate the Internet
  • Able to speak and read English

Exclusion Criteria:

  • Hearing or voice impairment
  • Visual impairment that would prevent use of the workbook and completion of assessment materials
  • Meets criteria for dementia
  • Diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance abuse, or other diagnosis for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous
  • Currently receiving individual psychotherapy or planning to receive psychotherapy during the 12-week treatment phase of the study
  • Planning to be out of town or unavailable for treatment for 4 weeks or more during the scheduled treatment time
  • Exhibits severe suicidality, including ideation, plan, and intent

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: iCBT and TeleCoaching
Participants received the technology-assisted behavioral intervention (iCBT + TeleCoaching).
Behavioral: Behavioral intervention (iCBT + TeleCoach)
TABI will include 12 weeks of Internet-based cognitive behavioral therapy (iCBT) combined with brief telephone and email support from a coach.
Experimental: iCBT(MoodManager)
Participants received Internet-based cognitive behavioral therapy only.
Behavioral: Behavioral intervention (iCBT + TeleCoach)
TABI will include 12 weeks of Internet-based cognitive behavioral therapy (iCBT) combined with brief telephone and email support from a coach.
Behavioral: Internet-based cognitive behavioral therapy (I-CBT)
I-CBT will include access to an interactive Web-based intervention designed to teach and facilitate the use of cognitive behavioral skills. The intervention will last 12 weeks.
Active Comparator: Treatment as usual / Wait-list control
Participants received treatment as usual . For wait-list control, participants were not provided any intervention for 6 weeks, after which they were allowed to choose coached or self-directed moodManager.
Behavioral: Treatment as usual / Wait-list control
TAU will include standard treatment from participants' primary care physicians. Participants will be able to choose between TABI and I-CBT treatment options after a 6-week wait-list period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: Measured at baseline and Weeks 6 & 12 (post treatment)
PhQ-9 and diagnosis (using MINI)
Measured at baseline and Weeks 6 & 12 (post treatment)
Utilization and Attrition
Time Frame: Baseline-Week 12
# logins
Baseline-Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Satisfaction (Satisfaction Index-Mental Health)
Time Frame: Measured at baseline and Weeks 6 & 12
Measured at baseline and Weeks 6 & 12

Collaborators and Investigators

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

Sponsor

Northwestern University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: David C. Mohr, PhD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 18, 2008

First Submitted That Met QC Criteria

July 18, 2008

First Posted (Estimate)

July 22, 2008

Study Record Updates

Last Update Posted (Estimate)

March 19, 2014

Last Update Submitted That Met QC Criteria

March 18, 2014

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH078922 (U.S. NIH Grant/Contract)
  • DSIR 83-ATP (NCT00719979)
  • 5P20MH090318-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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