Depression Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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