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

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ClinicalTrials.gov Identifier: NCT00719979
Recruitment Status : Completed
First Posted : July 22, 2008
Last Update Posted : March 19, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
David Mohr, Northwestern University

Tracking Information
First Submitted Date  ICMJE July 18, 2008
First Posted Date  ICMJE July 22, 2008
Last Update Posted Date March 19, 2014
Study Start Date  ICMJE September 2009
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
  • Depression [ Time Frame: Measured at baseline and Weeks 6 & 12 (post treatment) ]
    PhQ-9 and diagnosis (using MINI)
  • Utilization and Attrition [ Time Frame: Baseline-Week 12 ]
    # logins
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2008)
  • Depression, as assessed by Hamilton Rating Scale for Depression (HRSD), the Patient Health Questionnaire-9 (PHQ-9), and the Structured Clinical Interview for DSM (SCID) Disorders-Major Depressive Disorders Module [ Time Frame: Measured at baseline and Weeks 4, 8, 12, and 16 ]
  • Attrition (in arms with I-CBT) [ Time Frame: Measured at baseline and Week 16 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
Patient Satisfaction (Satisfaction Index-Mental Health) [ Time Frame: Measured at baseline and Weeks 6 & 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2008)
I-CBT utilization (e.g., number of logins, average visit length, total time spent on the site, number of exercises completed), Health-Related Quality of Life (SF-36V), and Patient Satisfaction (Satisfaction Index-Mental Health) [ Time Frame: Measured at baseline and Weeks 4, 8, 12, and 16 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of a Technology Assisted Behavioral Intervention in Assisting People With Major Depressive Disorder
Official Title  ICMJE Integrated Telemental Health Intervention for Depression in Primary Care
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: iCBT and TeleCoaching
    Participants received the technology-assisted behavioral intervention (iCBT + TeleCoaching).
    Intervention: Behavioral: Behavioral intervention (iCBT + TeleCoach)
  • Experimental: iCBT(MoodManager)
    Participants received Internet-based cognitive behavioral therapy only.
    Interventions:
    • Behavioral: Behavioral intervention (iCBT + TeleCoach)
    • Behavioral: Internet-based cognitive behavioral therapy (I-CBT)
  • 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.
    Intervention: Behavioral: Treatment as usual / Wait-list control
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2012)
102
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2008)
70
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00719979
Other Study ID Numbers  ICMJE R34MH078922( U.S. NIH Grant/Contract )
DSIR 83-ATP ( Other Grant/Funding Number: NCT00719979 )
5P20MH090318-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Mohr, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: David C. Mohr, PhD Northwestern University
PRS Account Northwestern University
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP