Clinical trial NCT02700009: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: University of Denver
name: University of York
First posted: 2016-03-07
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Patient Health Questionnaire - 9
timeFrame: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends
Secondary outcomes:
measure: Automatic Thoughts Questionnaire
timeFrame: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends
measure: Quality of Life Enjoyment and Satisfaction Questionnaire
timeFrame: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends
measure: Client Service Receipt Inventory
timeFrame: Change from baseline after 12 weeks of treatment and 3 and 6 months after 12-week treatment ends
measure: Quality of Well Being Scale
timeFrame: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment periods ends
measure: Patient Attitudes and Expectations Scale
timeFrame: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment periods ends
measure: Generalized Anxiety Disorder - 7
timeFrame: Change from baseline after 12 weeks of treatment and 3 and 6 months after the 12-week treatment period ends
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville, School of Medicine
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Jesse Wright, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.