Expired Study
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Chicago, Illinois 60612


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

R34 MH078922


NCT ID:

NCT00719979


Secondary ID:

DSIR 83-ATP


Study Acronym:


Brief Title:

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


Official Title:

Integrated Telemental Health Intervention for Depression in Primary Care


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Northwestern University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

102


Enrollment Type:

Actual


Overall Contact Information

Official Name:David C. Mohr, PhD
Principal Investigator
Northwestern University

Study Dates

Start Date:September 2009
Completion Date:July 2012
Completion Type:Actual
Primary Completion Date:May 2011
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:March 18, 2014
First Received Date:July 18, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Patient Satisfaction (Satisfaction Index-Mental Health)
Time Frame:Measured at baseline and Weeks 6 & 12
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Utilization and Attrition
Time Frame:Baseline-Week 12
Safety Issues:False
Description:# logins
Outcome Type:Primary Outcome
Measure:Depression
Time Frame:Measured at baseline and Weeks 6 & 12 (post treatment)
Safety Issues:False
Description:PhQ-9 and diagnosis (using MINI)

Study Interventions

Intervention Type:Behavioral
Name:Behavioral intervention (iCBT + TeleCoach)
Description:TABI will include 12 weeks of Internet-based cognitive behavioral therapy (iCBT) combined with brief telephone and email support from a coach.
Arm Name:iCBT and TeleCoaching
Intervention Type:Behavioral
Name:Internet-based cognitive behavioral therapy (I-CBT
Description: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.
Arm Name:iCBT(MoodManager)
Intervention Type:Behavioral
Name:Treatment as usual / Wait-list control
Description: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.
Arm Name:Treatment as usual / Wait-list control

Study Arms

Study Arm Type:Active Comparator
Arm Name:Treatment as usual / Wait-list control
Description: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.
Study Arm Type:Experimental
Arm Name:iCBT(MoodManager)
Description:Participants received Internet-based cognitive behavioral therapy only.
Study Arm Type:Experimental
Arm Name:iCBT and TeleCoaching
Description:Participants received the technology-assisted behavioral intervention (iCBT + TeleCoaching).

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Northwestern University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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