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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00719979 |
This study will develop and evaluate the effectiveness of technology-assisted psychotherapy, 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.
Condition | Intervention | Phase |
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Depression |
Behavioral: Technology-assisted psychotherapy (TAP) Behavioral: Internet-based cognitive behavioral therapy (I-CBT) Behavioral: Treatment as usual (TAU)/wait-list control |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Integrated Telemental Health Intervention for Depression in Primary Care |
Estimated Enrollment: | 70 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive technology-assisted psychotherapy.
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Behavioral: Technology-assisted psychotherapy (TAP)
TAP will include 12 weeks of Internet-based cognitive behavioral therapy combined with brief telephone and email support from a therapist.
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2: Experimental
Participants will receive Internet-based cognitive behavioral therapy.
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Behavioral: Technology-assisted psychotherapy (TAP)
TAP will include 12 weeks of Internet-based cognitive behavioral therapy combined with brief telephone and email support from a therapist.
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. Treatment will last 12 weeks.
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3: Active Comparator
Participants will receive treatment as usual.
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Behavioral: Treatment as usual (TAU)/wait-list control
TAU will include standard treatment from participants' primary care physicians. Participants will be able to choose between TAP and I-CBT treatment options after a 16-week wait-list period.
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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 psychotherapy 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 therapies can reduce cost, extend specialized treatment over broad geographic areas, and permit considerable flexibility in scheduling of treatment components. Technology-assisted psychotherapy (TAP) is a specific form of telecommunication psychotherapy that incorporates Web-based Internet, e-mail, and telephone therapies. Further study is needed to determine the effectiveness of TAP in reducing depressive symptoms and attrition rates in people with MDD. This pilot study will first develop TAP, 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 TAP 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 TAP, I-CBT alone, or TAU. Participants assigned to TAP and I-CBT will both undergo 12 weeks of Web-based Internet therapy consisting of modules to help them learn skills to manage their moods. Participants will be asked to access the Web site every day or two to complete the modules and to practice the learned techniques. Participants assigned to TAP will also receive weekly telephone-based counseling from a therapist and will be able to communicate with the therapist via email throughout treatment. Participants assigned to TAU will receive standard treatment from their primary care physicians and will be able to choose between TAP and I-CBT treatment options after a 16-week wait-list period. All participants will undergo repeat initial assessments at Weeks 4, 8, and 12 of treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer Duffecy, PhD | 312-503-1900 | j-duffecy@northwestern.edu |
Contact: David C. Mohr, PhD | 312-503-1403 | d-mohr@northwestern.edu |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60612 |
Principal Investigator: | David C. Mohr, PhD | Northwestern University |
Responsible Party: | Northwestern University ( David C. Mohr, PhD/Professor ) |
Study ID Numbers: | R34 MH078922, DSIR 83-ATP |
Study First Received: | July 18, 2008 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00719979 |
Health Authority: | United States: Federal Government |
Major Depressive Disorder Cognitive Behavior Therapy Psychotherapy |
Technology Assisted Internet Primary Care |
Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |