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Clinical Trials/NCT05050227
NCT05050227
Completed
Not Applicable

Improving Depression Management in Primary Care (CDA 19-108)

VA Office of Research and Development1 site in 1 country57 target enrollmentNovember 1, 2021
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
VA Office of Research and Development
Enrollment
57
Locations
1
Primary Endpoint
Patient Health Questionnaire (PHQ-9)
Status
Completed
Last Updated
9 months ago

Overview

Brief Summary

Depression is disabling and affects one in five Veterans. VA's Primary Care-Mental health Integration (PC-MHI) enables specialists to support medication treatment in primary care, but timely and sufficient access to psychotherapy is unattainable despite Veteran preference for psychotherapy. This study aims to close the gap in psychotherapy access for VA primary care patients with depression by adapting and pilot testing PC-MHI collaborative care models to improve uptake of computerized cognitive behavioral therapy (cCBT).

Detailed Description

Background: VA's Primary Care-Mental Health Integration (PC-MHI) is rooted in evidence-based collaborative care models, where care managers, mental health specialists, and primary care providers jointly treat depression in primary care. While PC-MHI enabled specialists to support medication treatment in primary care, timely and sufficient access to psychotherapy is unattainable. Alternative therapy modalities are needed. Significance/Impact: Depression is disabling and affects one in five Veterans. Psychotherapy is preferred by Veterans, but fraught with multilevel barriers (e.g., staff availability, patient travel to clinic, limited clinic hours). Without enhancing existing PC-MHI models to enable better primary care patient access to effective psychotherapies, Veteran engagement in depression treatment is unlikely to improve. Innovation: This study aims to close the gap in psychotherapy access for VA primary care patients with depression by adapting PC-MHI collaborative care models to improve uptake of computerized cognitive behavioral therapy (cCBT). cCBT is accessible 24/7 via the internet and has effectively treated depression in more than 30 trials. With modest specialist support, it is non-inferior to face-to-face psychotherapy. PC-MHI can facilitate Veteran uptake of cCBT, using an evidence-based collaborative care model to provide the follow-up care management and mental health specialist back-up that characterizes the most effective cCBT trials. Specific Aims/Methodology: To pilot test the feasibility, acceptability, and potential effects of cCBT-enhanced collaborative care on Veterans' depression symptoms and related outcomes in VA Greater Los Aneles Healthcare System. A pilot randomized controlled trial (RCT) will be conducted to examine feasibility, acceptability, and potential effects on depression, patient activation, and health-related quality of life in VA primary care patients with depression receiving either (1) cCBT-enhanced collaborative care (n=37) or (2) usual care (n=37) in West Los Angeles VA, from baseline to 3-months (post-intervention). Next Steps/Implementation: Adapting PC-MHI's collaborative care model to incorporate cCBT can improve access to psychotherapy and engage the \~400,000 untreated Veterans with depression who prefer psychotherapy, especially OIF/OEF/OND Veterans seeking care that is convenient.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
June 30, 2025
Last Updated
9 months ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Have access to computer (mobile or desktop), internet, telephone, and email
  • Able to read English text on a computer screen
  • Score 10 or higher on the PHQ-9

Exclusion Criteria

  • Have moderate-high suicide risk (e.g., suicide flag) or active suicidality
  • Have other serious mental illness (e.g. bipolar disorder, psychosis)
  • Have medical disorder that would prevent/interfere with participation (e.g. dementia/cognitive impairment, terminal illness)

Outcomes

Primary Outcomes

Patient Health Questionnaire (PHQ-9)

Time Frame: 3-months

The Patient Health Questionnaire (PHQ-9) is a scale commonly used to measure and categorize depression symptoms. It is already administered as part of routine primary care at our study site. The minimum score is 0, the maximum is 27. A higher score indicates a worse outcome (i.e. more severe depression symptoms).

Secondary Outcomes

  • PROMIS Global Health(3-months)
  • Generalized Anxiety Disorder (GAD-7)(3-months)
  • Patient Activation Measure (PAM)(3-months)
  • PTSD Checklist for DSM-5 (PCL-5)(3-months)
  • Behavioral Activation for Depression Scale (BADS-SF)(3-months)

Study Sites (1)

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