NCT07781228

Brief Summary

Depression is disabling and affects one in five Veterans. VA's Primary Care-Mental health Integration (PCMHI) 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 PCMHI collaborative care models to improve uptake of peer-supported computerized cognitive behavioral therapy (cCBT).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable depression

Timeline
36mo left

Started Sep 2026

Typical duration for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

2.5 years

First QC Date

August 19, 2026

Last Update Submit

August 19, 2026

Conditions

Keywords

Cognitive Behavioral TherapyDepressionVeterans HealthTelehealthmHealthPeer GroupPrimary Health CareChronic Care Management

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- and 6-month follow up

Secondary Outcomes (3)

  • Behavioral Activation for Depression Scale (BADS-SF)

    3- and 6-month follow up

  • Generalized Anxiety Disorder (GAD-7)

    3- and 6-month follow up

  • World Health Organization Disability Assessment Schedule (WHODAS 2.0)

    3- and 6-month follow up

Other Outcomes (1)

  • Treatment Engagement

    6-months

Study Arms (2)

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

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

Behavioral: Enhanced Usual Care (EUC)

Supported Online Self-help for Depression (SOS-Depression)

EXPERIMENTAL

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

Behavioral: Supported Online Self-help for Depression (SOS-Depression)

Interventions

Enhanced usual care includes all the usual depression care at the VA and access to an online therapy program with no peer support sessions. The online therapy program offered consists of several modules for depression care, specifically tailored for Veterans.

Enhanced Usual Care (EUC)

Supported Online Self-help for Depression (SOS-Depression) includes all the usual depression care at the VA and access to an online therapy program with support sessions with a peer. The online therapy program consists of several modules for depression care, specifically tailored for Veterans.

Supported Online Self-help for Depression (SOS-Depression)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be enrolled in the VHA and currently receiving primary care services at VA Los Angeles or San Diego
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

VA Greater Los Angeles Healthcare System

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

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Lucinda B Leung, MD, PhD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine and Psychiatry

Study Record Dates

First Submitted

August 19, 2026

First Posted

August 24, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

August 24, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

The data collected during this clinical trial will be made available to the research community by depositing de-identified data into the NIMH Data Archive (NDA). All of the NIMH Common Data Elements (CDEs) will be collected for this study, following the NIMH expectations. In addition to the CDEs required by the NDA, we will also submit data elements covering demographics and health outcomes, healthcare services use, and satisfaction. We will use NIH-endorsed CDEs when possible. * Sex * Marital status * Ethnicity * Race * Level of education * Work status * Housing status * Behavioral Activation for Depression Scale (BADS-SF) * Alcohol Use Disorders Identification Test (AUDIT-C) * Columbia-Suicide Severity Rating Scale (C-SSRS) * Posttraumatic Stress Disorder (PTSD) Checklist for DSM-5 * Client Satisfaction Questionnaire (CSQ-I) * System Usability Scale (SUS)

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
In accordance with NDA guidelines, we will complete the Collections' Data Expected section within six months of the grant award. Thereafter we will submit data every 6 months in accordance with the NDA Data Sharing Terms and Conditions Post-Award Milestones.
Access Criteria
UCLA is committed to the ideals of collaborative research, and as such, will adhere to the sponsors Grant Policy on Sharing of Unique Research Resources. The data collected for this research represent a valuable resource to the scientific community, and we will undertake all reasonable procedures to make them accessible to others, while respecting the special needs for confidentiality. The data collected during this clinical trial will be made available to the research community by depositing de-identified data into the NIMH Data Archive (NDA). The NDA houses, harmonizes, and shares all human-subjects data collected as part of NIMH-funded projects with the goal of accelerating progress in the research of mental health. NDA is one database infrastructure that supports efforts to make data collected by different laboratories as consistent as possible and allow other researchers to access those data for secondary use. NDA stores and shares clinical/phenotypic, imaging, genomic, and othe

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