Computer-assisted Cognitive-Behavior Therapy for Depression in Primary Care

Depression Clinical Trial

Official title:

Dissemination of Computer-assisted Cognitive-behavior Therapy for Depression in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700009
• Other study ID #: 15.0640
• Secondary ID: R18HS024047
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 2020

Study information

• Verified date: November 2022
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Computer-assisted CBT (CCBT)
Computer-assisted psychotherapy for depression using a computer program plus clinician support

Other:
• Treatment as Usual (TAU)
Ordinary treatment for depression in primary care setting

Locations

Country	Name	City	State
United States	University of Louisville, School of Medicine	Louisville	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
University of Louisville	University of Denver, University of York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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