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Computer-assisted Cognitive-Behavior Therapy for Depression in Primary Care

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ClinicalTrials.gov Identifier: NCT02700009
Recruitment Status : Recruiting
First Posted : March 7, 2016
Last Update Posted : March 2, 2018
Sponsor:
Collaborators:
University of Denver
University of York
Information provided by (Responsible Party):
Jesse H Wright, MD, University of Louisville

February 25, 2016
March 7, 2016
March 2, 2018
May 2016
December 2019   (Final data collection date for primary outcome measure)
Patient Health Questionnaire - 9 [ Time Frame: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends ]
Self-report scale for depression
Same as current
Complete list of historical versions of study NCT02700009 on ClinicalTrials.gov Archive Site
  • Automatic Thoughts Questionnaire [ Time Frame: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends ]
    Self-report measure of negative cognitions
  • Quality of Life Enjoyment and Satisfaction Questionnaire [ Time Frame: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends ]
    Self-report measure of quality of life
  • Client Service Receipt Inventory [ Time Frame: Change from baseline after 12 weeks of treatment and 3 and 6 months after 12-week treatment ends ]
    Record of medical and related services
  • Quality of Well Being Scale [ Time Frame: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment periods ends ]
    Self-report measure of well-being
  • Patient Attitudes and Expectations Scale [ Time Frame: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment periods ends ]
    Assessment of patient attitudes toward treatment
  • Generalized Anxiety Disorder - 7 [ Time Frame: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends ]
    Self-report measure of anxiety
Same as current
Not Provided
Not Provided
 
Computer-assisted Cognitive-Behavior Therapy for Depression in Primary Care
Dissemination of Computer-assisted Cognitive-behavior Therapy for Depression in Primary Care
Computer-assisted cognitive-behavior therapy, a treatment that has been shown to be effective in previous studies in psychiatric settings, will be disseminated into primary care - a health care setting where there are significant problems in receiving adequate treatment for depression. Computer-assisted cognitive-behavior therapy will feature a low-cost method of delivering therapy designed to be replicated and sustained in other primary care settings. Feasibility and effectiveness will be tested by randomly assigning 320 primary care patients with depression to receive either computer-assisted cognitive-behavior therapy or treatment as usual.

Computer-assisted cognitive-behavior therapy (CCBT) for depression in primary care will be evaluated in a trial with 320 patients randomly assigned to CCBT or treatment as usual (TAU). The study will disseminate a therapy method found to be effective in psychiatric settings into primary care - a setting where there have been significant problems in delivery of adequate, evidence-based treatment for depression. The study will include a high percentage of disadvantaged patients - a population that has been largely ignored in previous research in CCBT. There have been no previous studies of CCBT for depression in primary care that have enrolled large numbers of disadvantaged patients. The form of CCBT used in this study is designed to increase access to effective therapy, provide a cost-effective method, and be a sustainable model for wide-spread use in primary care.

In order to deliver therapy in a practical manner that can be replicated in other primary care practices, patients with significant symptoms of depression will receive treatment with an empirically supported computer program that builds cognitive-behavior therapy skills. Support for CCBT will be provided by telephone and/or e-mail contact with a care coordinator instead of the face-to-face treatment with a cognitive-behavior therapist that has been a part of CCBT delivery in mental health settings. Novel features of this treatment program include: 1) fully detailed and replicable method for integrating clinician support with CCBT in primary care; 2) delivery of CCBT to a population with high percentage of disadvantaged patients; 3) integration of CCBT into the primary care delivery model; 4) highly interactive, multimedia computer program with adaptations for persons who may have lower levels of education or computer experience; 5) advanced cost-benefit analysis including data on actual health care utilization and costs; 6) exploration of moderators and predictors of treatment outcome.

Outcome will be assessed by measuring CCBT completion rate, comprehension of CBT concepts, and satisfaction with treatment; in addition to ratings of depressive symptoms, negative thoughts, and quality of life. The cost-effectiveness analysis and exploration of possible predictors of outcome should help clinicians, health care organizations, and others plan further dissemination of CCBT in primary care.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Depression
  • Behavioral: Computer-assisted CBT (CCBT)
    Computer-assisted psychotherapy for depression using a computer program plus clinician support
  • Other: Treatment as Usual (TAU)
    Ordinary treatment for depression in primary care setting
  • Experimental: Computer-assisted CBT (CCBT)
    12 weeks of CCBT for depression
    Intervention: Behavioral: Computer-assisted CBT (CCBT)
  • Active Comparator: Treatment as Usual (TAU)
    Treatment as usual by primary care physicians
    Intervention: Other: Treatment as Usual (TAU)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
Same as current
December 2019
December 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patient Health Questionnaire score of 10 or above
  2. Age 18 or above

Exclusion Criteria:

  1. Refusal to provide informed consent
  2. Inability to read English text on computer screen
  3. Significant suicidal thoughts, intent, plan, or behavior reported on Columbia Suicide Severity Rating Scale
  4. Severe or poorly controlled medical disorders that would interfere with participation in CCBT (e.g., liver failure, terminal cancer)
  5. Dementia or other organic brain disorders that would prevent participation in CCBT
  6. Diagnosis of any psychotic disorder or bipolar disorder.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Jesse Wright, M.D., Ph.D. 5029317323 jwright@iglou.com
Contact: Carol Wahl 5025884886 carol.wahl@louisville.edu
United States
 
 
NCT02700009
R18HS024047( U.S. AHRQ Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Undecided
Jesse H Wright, MD, University of Louisville
University of Louisville
  • University of Denver
  • University of York
Principal Investigator: Jesse Wright, M.D., Ph.D. University of Louisville
University of Louisville
March 2018

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