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

NCT ID: NCT02700009

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2020-12-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Computer-assisted CBT (CCBT)

12 weeks of CCBT for depression

Group Type: EXPERIMENTAL

Computer-assisted CBT (CCBT)

Intervention Type: BEHAVIORAL

Computer-assisted psychotherapy for depression using a computer program plus clinician support

Treatment as Usual (TAU)

Treatment as usual by primary care physicians

Group Type: ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type: OTHER

Ordinary treatment for depression in primary care setting

Interventions

Computer-assisted CBT (CCBT)

Computer-assisted psychotherapy for depression using a computer program plus clinician support

Intervention Type: BEHAVIORAL

Treatment as Usual (TAU)

Ordinary treatment for depression in primary care setting

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Denver

OTHER

Sponsor Role: collaborator

University of York

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Jesse H Wright

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesse Wright, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville, School of Medicine

Louisville, Kentucky, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35142833 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R18HS024047

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

15.0640

Identifier Type: -

Identifier Source: org_study_id