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Stepped Telemental Health Care Intervention for Depression

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01906476
First Posted: July 24, 2013
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Mohr, Northwestern University
  Purpose
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).

Condition Intervention
Depression Behavioral: Stepped Care Behavioral: Telephone Cognitive Behavior Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stepped Telemental Health Care Intervention for Depression

Further study details as provided by David Mohr, Northwestern University:

Primary Outcome Measures:
  • 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.


Enrollment: 312
Study Start Date: February 2015
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Active Comparator: Telephone Cognitive Behavior Therapy
Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).
Behavioral: Telephone Cognitive Behavior Therapy
Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01906476


Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: David C Mohr, Ph.D. Northwestern University
  More Information

Responsible Party: David Mohr, Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01906476     History of Changes
Other Study ID Numbers: R01MH095753-01A1-RCTTH
R01MH095753-01A1 ( U.S. NIH Grant/Contract )
First Submitted: July 17, 2013
First Posted: July 24, 2013
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by David Mohr, Northwestern University:
Depression
Telephone Cognitive Behavior Therapy
Internet Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders