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Effectiveness of Technology Assisted Psychotherapy in Treating People With Major Depressive Disorder
This study is not yet open for participant recruitment.
Verified by National Institute of Mental Health (NIMH), August 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00719979
  Purpose

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
Depression
Behavioral: Technology-assisted psychotherapy (TAP)
Behavioral: Internet-based cognitive behavioral therapy (I-CBT)
Behavioral: Treatment as usual (TAU)/wait-list control
Phase I

MedlinePlus related topics: Depression Mental Health
U.S. FDA Resources
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

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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
1: Experimental
Participants will receive technology-assisted psychotherapy.
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.
2: Experimental
Participants will receive Internet-based cognitive behavioral therapy.
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.
3: Active Comparator
Participants will receive treatment as usual.
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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV diagnosis of MDD as assessed using the Mini Mental State Exam (MINI) plus a score of 16 or greater on the HRSD
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719979

Contacts
Contact: Jennifer Duffecy, PhD 312-503-1900 j-duffecy@northwestern.edu
Contact: David C. Mohr, PhD 312-503-1403 d-mohr@northwestern.edu

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Investigators
Principal Investigator: David C. Mohr, PhD Northwestern University
  More Information

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

Keywords provided by National Institute of Mental Health (NIMH):
Major Depressive Disorder
Cognitive Behavior Therapy
Psychotherapy
Technology Assisted
Internet
Primary Care

Study placed in the following topic categories:
Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 13, 2009