Computer-assisted Cognitive-Behavior Therapy for Depression in Primary Care
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer-assisted CBT (CCBT)
Treatment as Usual (TAU)
Sponsored by

About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria:
- Patient Health Questionnaire score of 10 or above
- Age 18 or above
Exclusion Criteria:
- Refusal to provide informed consent
- Inability to read English text on computer screen
- Significant suicidal thoughts, intent, plan, or behavior reported on Columbia Suicide Severity Rating Scale
- Severe or poorly controlled medical disorders that would interfere with participation in CCBT (e.g., liver failure, terminal cancer)
- Dementia or other organic brain disorders that would prevent participation in CCBT
- Diagnosis of any psychotic disorder or bipolar disorder.
Sites / Locations
- University of Louisville, School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Computer-assisted CBT (CCBT)
Treatment as Usual (TAU)
Arm Description
12 weeks of CCBT for depression
Treatment as usual by primary care physicians
Outcomes
Primary Outcome Measures
Patient Health Questionnaire - 9
Self-report scale for depression
Secondary Outcome Measures
Automatic Thoughts Questionnaire
Self-report measure of negative cognitions
Quality of Life Enjoyment and Satisfaction Questionnaire
Self-report measure of quality of life
Client Service Receipt Inventory
Record of medical and related services
Quality of Well Being Scale
Self-report measure of well-being
Patient Attitudes and Expectations Scale
Assessment of patient attitudes toward treatment
Generalized Anxiety Disorder - 7
Self-report measure of anxiety
Full Information
NCT ID
NCT02700009
First Posted
February 25, 2016
Last Updated
November 9, 2022
Sponsor
University of Louisville
Collaborators
University of Denver, University of York
1. Study Identification
Unique Protocol Identification Number
NCT02700009
Brief Title
Computer-assisted Cognitive-Behavior Therapy for Depression in Primary Care
Official Title
Dissemination of Computer-assisted Cognitive-behavior Therapy for Depression in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
University of Denver, University of York
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computer-assisted CBT (CCBT)
Arm Type
Experimental
Arm Description
12 weeks of CCBT for depression
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
Treatment as usual by primary care physicians
Intervention Type
Behavioral
Intervention Name(s)
Computer-assisted CBT (CCBT)
Intervention Description
Computer-assisted psychotherapy for depression using a computer program plus clinician support
Intervention Type
Other
Intervention Name(s)
Treatment as Usual (TAU)
Intervention Description
Ordinary treatment for depression in primary care setting
Primary Outcome Measure Information:
Title
Patient Health Questionnaire - 9
Description
Self-report scale for depression
Time Frame
Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends
Secondary Outcome Measure Information:
Title
Automatic Thoughts Questionnaire
Description
Self-report measure of negative cognitions
Time Frame
Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends
Title
Quality of Life Enjoyment and Satisfaction Questionnaire
Description
Self-report measure of quality of life
Time Frame
Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends
Title
Client Service Receipt Inventory
Description
Record of medical and related services
Time Frame
Change from baseline after 12 weeks of treatment and 3 and 6 months after 12-week treatment ends
Title
Quality of Well Being Scale
Description
Self-report measure of well-being
Time Frame
Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment periods ends
Title
Patient Attitudes and Expectations Scale
Description
Assessment of patient attitudes toward treatment
Time Frame
Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment periods ends
Title
Generalized Anxiety Disorder - 7
Description
Self-report measure of anxiety
Time Frame
Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient Health Questionnaire score of 10 or above
Age 18 or above
Exclusion Criteria:
Refusal to provide informed consent
Inability to read English text on computer screen
Significant suicidal thoughts, intent, plan, or behavior reported on Columbia Suicide Severity Rating Scale
Severe or poorly controlled medical disorders that would interfere with participation in CCBT (e.g., liver failure, terminal cancer)
Dementia or other organic brain disorders that would prevent participation in CCBT
Diagnosis of any psychotic disorder or bipolar disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesse Wright, M.D., Ph.D.
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville, School of Medicine
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35142833
Citation
Wright JH, Owen J, Eells TD, Antle B, Bishop LB, Girdler R, Harris LM, Wright RB, Wells MJ, Gopalraj R, Pendleton ME, Ali S. Effect of Computer-Assisted Cognitive Behavior Therapy vs Usual Care on Depression Among Adults in Primary Care: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2146716. doi: 10.1001/jamanetworkopen.2021.46716.
Results Reference
derived
Learn more about this trial
Computer-assisted Cognitive-Behavior Therapy for Depression in Primary Care
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