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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
Results First Posted : April 2, 2020
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
David Mohr, Northwestern University

Tracking Information
First Submitted Date  ICMJE July 17, 2013
First Posted Date  ICMJE July 24, 2013
Results First Submitted Date  ICMJE April 9, 2019
Results First Posted Date  ICMJE April 2, 2020
Last Update Posted Date April 2, 2020
Actual Study Start Date  ICMJE February 2015
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2020)
  • Depression [ Time Frame: Baseline, midtreatment, end of treatment, 3 month post treatment, and 6 month post-treatment follow-up ]
    To measure changes in the Quick Inventory of Depressive Symptomatology (QIDS) over time. The QIDS is made up of 16 items and has a possible range of scores of 0 to 27. Higher scores represent worse outcomes.
  • Cost-Effectiveness [ Time Frame: Baseline to end of treatment ]
    Measure the ratio of the difference in costs and difference in effectiveness between the two groups, Stepped care minus Telephone Cognitive Behavior Therapy. Below are reported individual cost means and standard deviations for therapist costs during study.
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2013)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stepped Telemental Health Care Intervention for Depression
Official Title  ICMJE Stepped Telemental Health Care Intervention for Depression
Brief Summary 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).
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • 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
Publications * Mohr DC, Lattie EG, Tomasino KN, Kwasny MJ, Kaiser SM, Gray EL, Alam N, Jordan N, Schueller SM. A randomized noninferiority trial evaluating remotely-delivered stepped care for depression using internet cognitive behavioral therapy (CBT) and telephone CBT. Behav Res Ther. 2019 Dec;123:103485. doi: 10.1016/j.brat.2019.103485. Epub 2019 Sep 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2017)
312
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2013)
310
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01906476
Other Study ID Numbers  ICMJE R01MH095753-01A1-RCTTH
R01MH095753-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Mohr, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David C Mohr, Ph.D. Northwestern University
PRS Account Northwestern University
Verification Date March 2020

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