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
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Behavioral intervention (iCBT + TeleCoach) Behavioral: Internet-based cognitive behavioral therapy (I-CBT) Behavioral: Treatment as usual / Wait-list control||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Integrated Telemental Health Intervention for Depression in Primary Care|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||July 2012|
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.
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.
- 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
- Patient Satisfaction (Satisfaction Index-Mental Health) [ Time Frame: Measured at baseline and Weeks 6 & 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719979
|United States, Illinois|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||David C. Mohr, PhD||Northwestern University|