Clinical trial NCT05050227: Improving Depression Management
Official title: Improving Depression Management in Primary Care (CDA 19-108)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Keywords: depression
primary health care
cognitive behavioral therapy
veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-09-20
Enrollment: 57
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: 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 Angeles 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.

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)

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 3-months
Secondary outcomes:
measure: PROMIS Global Health
timeFrame: 3-months
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: 3-months
measure: Patient Activation Measure (PAM)
timeFrame: 3-months
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: 3-months
measure: Behavioral Activation for Depression Scale (BADS-SF)
timeFrame: 3-months
Other outcomes:
measure: Treatment Engagement
timeFrame: 3-months
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Lucinda B Leung, MD MPH PhD
role: PRINCIPAL_INVESTIGATOR
References: