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Trial record 16 of 3324 for:    Louisville

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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Computer-assisted CBT (CCBT) Other: Treatment as Usual (TAU) Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dissemination of Computer-assisted Cognitive-behavior Therapy for Depression in Primary Care
Study Start Date : May 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Computer-assisted CBT (CCBT)
12 weeks of CCBT for depression
Behavioral: Computer-assisted CBT (CCBT)
Computer-assisted psychotherapy for depression using a computer program plus clinician support
Active Comparator: Treatment as Usual (TAU)
Treatment as usual by primary care physicians
Other: Treatment as Usual (TAU)
Ordinary treatment for depression in primary care setting



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



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:

  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.

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): NCT02700009


Contacts
Contact: Jesse Wright, M.D., Ph.D. 5029317323 jwright@iglou.com
Contact: Carol Wahl 5025884886 carol.wahl@louisville.edu

Locations
United States, Kentucky
University of Louisville, School of Medicine Recruiting
Louisville, Kentucky, United States, 40202
Contact: Jesse Wright, M.D., Ph.D.    502-931-7323    jwright@iglou.com   
Contact: Carol Wahl    502-588-4886    carol.wahl@louisville.edu   
Principal Investigator: Jesse H Wright, M.D., Ph.D.         
Sub-Investigator: Becky Antle, Ph.D.         
Sub-Investigator: Tracy Eells, Ph.D.         
Sub-Investigator: Renee Girdler, M.D.         
Sub-Investigator: Jesse Owen, Ph.D.         
Sponsors and Collaborators
University of Louisville
University of Denver
University of York
Investigators
Principal Investigator: Jesse Wright, M.D., Ph.D. University of Louisville

Responsible Party: Jesse H Wright, MD, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT02700009     History of Changes
Other Study ID Numbers: R18HS024047 ( U.S. AHRQ Grant/Contract )
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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