Depression
Conditions
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.
Interventions
BEHAVIORALComputer-assisted CBT (CCBT)
Computer-assisted psychotherapy for depression using a computer program plus clinician support
OTHERTreatment as Usual (TAU)
Ordinary treatment for depression in primary care setting
Sponsors
University of Denver
University of York
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire - 9 | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Enjoyment and Satisfaction Questionnaire | 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 | Change from baseline after 12 weeks of treatment and 3 and 6 months after 12-week treatment ends | Record of medical and related services |
| Automatic Thoughts Questionnaire | 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 |
| Patient Attitudes and Expectations Scale | 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 | 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 |
| Quality of Well Being Scale | 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 |
Countries
United States
Outcome results
None listed