Improving Depression Management

NCT05050227 | Completed Results

• 2 other identifiers: CDX 21-004IK2HX002867
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression

Keywords

depression; primary health care; cognitive behavioral therapy; veterans

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire (PHQ-9)

  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).

  3-months

Secondary Outcomes (5)

• 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

Other Outcomes (1)

• Treatment Engagement

  3-months

Study Arms (2)

cCBT Enhanced Collaborative Care

EXPERIMENTAL

Participants in the intervention arm will receive computerized cognitive behavioral therapy (cCBT) supported by a depression care manager in addition to the usual care provided.

Behavioral: cCBT Enhanced Collaborative Care

Usual Care

ACTIVE COMPARATOR

Participants in the usual care arm will receive the usual care provided as described below.

Behavioral: Usual Care

Interventions

cCBT Enhanced Collaborative Care BEHAVIORAL

Computerized CBT (cCBT) will be delivered supported by a depression care manger who will facilitate access to cCBT, promote and monitor cCBT use, reinforce CBT concepts (during outside CBT session "homework"), and monitor mental health symptoms for each participant.

cCBT Enhanced Collaborative Care

Usual Care BEHAVIORAL

Primary Care Provider supported usual care typically includes medication prescription and referrals to specialty mental health, including Primary Care - Mental Health Integration services.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 37 self-identified male individuals and 37 self-identified female individual will be enrolled in the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Lucinda B. Leung, MD, PhD, MPH
• Organization: VA Greater Los Angeles Healthcare System, UCLA David Geffen School of Medicine

lleung@mednet.ucla.edu

310-478-3711

Study Officials

• Lucinda B Leung, MD MPH PhD

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 20, 2021
• Study Start: November 1, 2021
• Primary Completion: June 17, 2023
• Study Completion: June 30, 2025
• Last Updated: July 20, 2025
• Results First Posted: September 19, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)