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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Computer-assisted CBT (CCBT); Other: Treatment as Usual (TAU)

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
• Enrollment (Actual): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire - 9	Self-report scale for depression	Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Automatic Thoughts Questionnaire	Self-report measure of negative cognitions	Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends
Quality of Life Enjoyment and Satisfaction Questionnaire	Self-report measure of quality of life	Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends
Client Service Receipt Inventory	Record of medical and related services	Change from baseline after 12 weeks of treatment and 3 and 6 months after 12-week treatment ends
Quality of Well Being Scale	Self-report measure of well-being	Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment periods ends
Patient Attitudes and Expectations Scale	Assessment of patient attitudes toward treatment	Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment periods ends
Generalized Anxiety Disorder - 7	Self-report measure of anxiety	Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: University of York; University of Denver
• Investigators: Principal Investigator: Jesse Wright, M.D., Ph.D., University of Louisville

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: March 1, 2016
• First Posted (Estimated): March 7, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 15.0640; R18HS024047 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO