Effectiveness of a Technology Assisted Behavioral Intervention in Assisting People With Major Depressive Disorder
Integrated Telemental Health Intervention for Depression in Primary Care
3 other identifiers
interventional
102
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 depression
Started Sep 2009
Typical duration for phase_1 depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2008
CompletedFirst Posted
Study publicly available on registry
July 22, 2008
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedMarch 19, 2014
January 1, 2013
1.7 years
July 18, 2008
March 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Depression
PhQ-9 and diagnosis (using MINI)
Measured at baseline and Weeks 6 & 12 (post treatment)
Utilization and Attrition
\# logins
Baseline-Week 12
Secondary Outcomes (1)
Patient Satisfaction (Satisfaction Index-Mental Health)
Measured at baseline and Weeks 6 & 12
Study Arms (3)
iCBT and TeleCoaching
EXPERIMENTALParticipants received the technology-assisted behavioral intervention (iCBT + TeleCoaching).
iCBT(MoodManager)
EXPERIMENTALParticipants received Internet-based cognitive behavioral therapy only.
Treatment as usual / Wait-list control
ACTIVE COMPARATORParticipants 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.
Interventions
TABI will include 12 weeks of Internet-based cognitive behavioral therapy (iCBT) combined with brief telephone and email support from a coach.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University
Chicago, Illinois, 60612, United States
Related Publications (1)
Mohr DC, Duffecy J, Ho J, Kwasny M, Cai X, Burns MN, Begale M. A randomized controlled trial evaluating a manualized TeleCoaching protocol for improving adherence to a web-based intervention for the treatment of depression. PLoS One. 2013 Aug 21;8(8):e70086. doi: 10.1371/journal.pone.0070086. eCollection 2013.
PMID: 23990896DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David C. Mohr, PhD
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 18, 2008
First Posted
July 22, 2008
Study Start
September 1, 2009
Primary Completion
May 1, 2011
Study Completion
July 1, 2012
Last Updated
March 19, 2014
Record last verified: 2013-01