Effectiveness of a Technology Assisted Behavioral Intervention in Assisting People With Major Depressive Disorder
Primary Purpose
Depression
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Behavioral intervention (iCBT + TeleCoach)
Internet-based cognitive behavioral therapy (I-CBT)
Treatment as usual / Wait-list control
Sponsored by

About this trial
This is an interventional treatment trial for Depression focused on measuring Major Depressive Disorder, Cognitive Behavior Therapy, Technology Assisted, Internet, Primary Care
Eligibility Criteria
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
Sites / Locations
- Northwestern University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
iCBT and TeleCoaching
iCBT(MoodManager)
Treatment as usual / Wait-list control
Arm Description
Participants received the technology-assisted behavioral intervention (iCBT + TeleCoaching).
Participants received Internet-based cognitive behavioral therapy only.
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.
Outcomes
Primary Outcome Measures
Depression
PhQ-9 and diagnosis (using MINI)
Utilization and Attrition
# logins
Secondary Outcome Measures
Patient Satisfaction (Satisfaction Index-Mental Health)
Full Information
NCT ID
NCT00719979
First Posted
July 18, 2008
Last Updated
March 18, 2014
Sponsor
Northwestern University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00719979
Brief Title
Effectiveness of a Technology Assisted Behavioral Intervention in Assisting People With Major Depressive Disorder
Official Title
Integrated Telemental Health Intervention for Depression in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Major Depressive Disorder, Cognitive Behavior Therapy, Technology Assisted, Internet, Primary Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iCBT and TeleCoaching
Arm Type
Experimental
Arm Description
Participants received the technology-assisted behavioral intervention (iCBT + TeleCoaching).
Arm Title
iCBT(MoodManager)
Arm Type
Experimental
Arm Description
Participants received Internet-based cognitive behavioral therapy only.
Arm Title
Treatment as usual / Wait-list control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral intervention (iCBT + TeleCoach)
Intervention Description
TABI will include 12 weeks of Internet-based cognitive behavioral therapy (iCBT) combined with brief telephone and email support from a coach.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based cognitive behavioral therapy (I-CBT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual / Wait-list control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression
Description
PhQ-9 and diagnosis (using MINI)
Time Frame
Measured at baseline and Weeks 6 & 12 (post treatment)
Title
Utilization and Attrition
Description
# logins
Time Frame
Baseline-Week 12
Secondary Outcome Measure Information:
Title
Patient Satisfaction (Satisfaction Index-Mental Health)
Time Frame
Measured at baseline and Weeks 6 & 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C. Mohr, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23990896
Citation
Mohr DC, Duffecy J, Ho J, Kwasny M, Cai X, Burns MN, Begale M. A randomized controlled trial evaluating a manualized TeleCoaching protocol for improving adherence to a web-based intervention for the treatment of depression. PLoS One. 2013 Aug 21;8(8):e70086. doi: 10.1371/journal.pone.0070086. eCollection 2013.
Results Reference
derived
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Effectiveness of a Technology Assisted Behavioral Intervention in Assisting People With Major Depressive Disorder
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