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Stepped Telemental Health Care Intervention for Depression

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ClinicalTrials.gov Identifier: NCT01906476
Recruitment Status : Completed
First Posted : July 24, 2013
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
David Mohr, Northwestern University

July 17, 2013
July 24, 2013
August 22, 2018
February 2015
April 2018   (Final data collection date for primary outcome measure)
  • Depression [ Time Frame: Baseline to end of treatment, and 6 month post-treatment follow-up ]
    To measure changes in depression over time
  • Cost-Effectiveness [ Time Frame: Baseline to end of treatment, and 6 month post-treatment follow-up ]
    Measure costs and effectiveness over time.
Depression Changes Over Time with Treatment and During Post-Treatment Follow-Up [ Time Frame: Measured at start of treatment (baseline), through end of treatment, and up to one year post-treatment follow-up ]
To measure changes in depression over time, the Quick Inventory of Depressive Symptomatology will be used to evaluate clinician-rated symptom severity and the Patient Health Questionnaire - 9 (PHQ9) will be used to evaluate self-reported depression.
Complete list of historical versions of study NCT01906476 on ClinicalTrials.gov Archive Site
Not Provided
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Stepped Telemental Health Care Intervention for Depression
Stepped Telemental Health Care Intervention for Depression
This is a randomized, controlled trial comparing telephone-cognitive behavior therapy (T-CBT) with a therapist to a "Stepped Care" intervention for depression treatment (iCBT with support from a telephone coach with the possibility of being stepped up to receiving T-CBT with a therapist).
Major depressive disorder (MDD) is common, with 12-month prevalence rates estimated to be between 6.6-10.3%. While many depressed patients state they would prefer psychological treatment to pharmacotherapy, substantial barriers to care exist, including cost, practical barriers such as time constraints and transportation, emotional barriers such as stigma, decreased motivation associated with depression itself, physical disability, and lack of availability of services. Telemental health has been proposed as a method of overcoming barriers to treatment. Research has focused primarily on two formats: the telephone and the Internet. Use of the telephone as a delivery medium produces reductions in depression equivalent to face-to-face psychological treatments, while also significantly reducing attrition. However, its success in outreach can also significantly increase costs for healthcare providing organizations. Internet interventions have the potential to produce moderate gains when supported by therapist or coach via brief telephone calls or e-mail but are also less expensive than standard therapy. Developing healthcare models that integrate treatment delivery media holds the promise of harnessing the advantages of each media, while minimizing the disadvantages. Stepped care models are a potentially useful framework for achieving such an integration. The stepped care model we will test initiates treatment with a validated, guided Internet cognitive behavioral therapy program. If patients fail to respond, they will be stepped up to a validated telephone-cognitive behavior therapy (T-CBT). The stepped care model will be compared to T-CBT in a randomized trial. Patients will be recruited from primary care and treated for up to 20 weeks, or until sustained remission is achieved.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • Behavioral: Stepped Care
    Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist
  • Behavioral: Telephone Cognitive Behavior Therapy
    Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).
  • Experimental: Stepped Care
    Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist
    Intervention: Behavioral: Stepped Care
  • Active Comparator: Telephone Cognitive Behavior Therapy
    Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).
    Intervention: Behavioral: Telephone Cognitive Behavior Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
312
310
April 2018
April 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has a DSM-IV diagnosis of non-psychotic major depressive disorder (MDD) as assessed using the Mini International Neuropsychiatric Interview (MINI), plus a score of 12 or greater on the Quick Inventory of Depressive Symptomatology - Clinician Rated (QIDS-C)
  • Has a phone, access to the Internet, and basic internet skills
  • Is at least 18 years of age
  • Is able to speak and read English
  • If currently taking an antidepressant medication, participant must have been on a stable dose for at least two weeks, and have no plans to change the dose

Exclusion Criteria:

  • Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures
  • Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, substance use or other diagnosis for which participation in this trial is either inappropriate or dangerous
  • Is severely suicidal (has ideation, plan, and intent)
  • Is currently receiving or planning to begin psychotherapy during the study treatment period
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01906476
R01MH095753-01A1-RCTTH
R01MH095753-01A1 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Undecided
David Mohr, Northwestern University
Northwestern University
Not Provided
Principal Investigator: David C Mohr, Ph.D. Northwestern University
Northwestern University
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP