Improving Depression Management (IDMPC)

February 7, 2024 updated by: VA Office of Research and Development

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • West Los Angeles, California, United States, 90073-1003
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cCBT Enhanced Collaborative Care
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
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.
Active Comparator: Usual Care
Participants in the usual care arm will receive the usual care provided as described below.
Behavioral: Usual Care
Primary Care Provider supported usual care typically includes medication prescription and referrals to specialty mental health, including Primary Care - Mental Health Integration services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS Global Health
Time Frame: 3-months
The 10-item PROMIS Global Health assesses health-related quality of life and is summarized into "Physical Health" (e.g., physical functioning, pain, fatigue) and "Mental Health" (e.g., emotional problems, social functioning).
3-months
Generalized Anxiety Disorder (GAD-7)
Time Frame: 3-months
The 7-item Generalized Anxiety Disorder (GAD-7) is among the most commonly used and best validated anxiety measures in primary care settings.
3-months
Patient Activation Measure (PAM)
Time Frame: 3-months
The 13-item Patient Activation Measure (PAM) will be used to assess an individual's knowledge, skill, and confidence for self-management.
3-months
PTSD Checklist for DSM-5 (PCL-5)
Time Frame: 3-months
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-reported measure that will be used to assesses PTSD symptoms and symptom change.
3-months
Behavioral Activation for Depression Scale (BADS-SF)
Time Frame: 3-months
The 9-item Behavioral Activation for Depression Scale (BADS-SF) will also be used to examine behavioral activation as an intermediary to depression symptomatology outcomes.
3-months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Engagement
Time Frame: 3-months
Treatment engagement will be conceptualized as the number of cCBT sessions completed.
3-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Lucinda B Leung, MD MPH PhD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

June 17, 2023

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 9, 2021

First Posted (Actual)

September 20, 2021

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDX 21-004
  • IK2HX002867 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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