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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Mohr, Northwestern University
ClinicalTrials.gov Identifier:
NCT00719979
First received: July 18, 2008
Last updated: March 18, 2014
Last verified: January 2013

July 18, 2008
March 18, 2014
September 2009
May 2011   (final data collection date for primary outcome measure)
  • Depression [ Time Frame: Measured at baseline and Weeks 6 & 12 (post treatment) ] [ Designated as safety issue: No ]
    PhQ-9 and diagnosis (using MINI)
  • Utilization and Attrition [ Time Frame: Baseline-Week 12 ] [ Designated as safety issue: No ]
    # logins
  • 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 ] [ Designated as safety issue: No ]
  • Attrition (in arms with I-CBT) [ Time Frame: Measured at baseline and Week 16 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00719979 on ClinicalTrials.gov Archive Site
Patient Satisfaction (Satisfaction Index-Mental Health) [ Time Frame: Measured at baseline and Weeks 6 & 12 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effectiveness of a Technology Assisted Behavioral Intervention in Assisting People With Major Depressive Disorder
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • 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.
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
July 2012
May 2011   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00719979
R34 MH078922, DSIR 83-ATP, 5P20MH090318-02
Yes
David Mohr, Northwestern University
Northwestern University
National Institute of Mental Health (NIMH)
Principal Investigator: David C. Mohr, PhD Northwestern University
Northwestern University
January 2013

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