Improving Depression Management (IDMPC)
Primary Purpose
Depression
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cCBT Enhanced Collaborative Care
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring depression, primary health care, cognitive behavioral therapy, veterans
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)
Sites / Locations
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
cCBT Enhanced Collaborative Care
Usual Care
Arm Description
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.
Participants in the usual care arm will receive the usual care provided as described below.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
PROMIS Global Health
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).
Generalized Anxiety Disorder (GAD-7)
The 7-item Generalized Anxiety Disorder (GAD-7) is among the most commonly used and best validated anxiety measures in primary care settings.
Patient Activation Measure (PAM)
The 13-item Patient Activation Measure (PAM) will be used to assess an individual's knowledge, skill, and confidence for self-management.
PTSD Checklist for DSM-5 (PCL-5)
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.
Behavioral Activation for Depression Scale (BADS-SF)
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.
Full Information
NCT ID
NCT05050227
First Posted
September 9, 2021
Last Updated
August 11, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT05050227
Brief Title
Improving Depression Management
Acronym
IDMPC
Official Title
Improving Depression Management in Primary Care (CDA 19-108)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
June 17, 2023 (Actual)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, primary health care, cognitive behavioral therapy, veterans
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cCBT Enhanced Collaborative Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants in the usual care arm will receive the usual care provided as described below.
Intervention Type
Behavioral
Intervention Name(s)
cCBT Enhanced Collaborative Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Primary Care Provider supported usual care typically includes medication prescription and referrals to specialty mental health, including Primary Care - Mental Health Integration services.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
3-months
Secondary Outcome Measure Information:
Title
PROMIS Global Health
Description
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).
Time Frame
3-months
Title
Generalized Anxiety Disorder (GAD-7)
Description
The 7-item Generalized Anxiety Disorder (GAD-7) is among the most commonly used and best validated anxiety measures in primary care settings.
Time Frame
3-months
Title
Patient Activation Measure (PAM)
Description
The 13-item Patient Activation Measure (PAM) will be used to assess an individual's knowledge, skill, and confidence for self-management.
Time Frame
3-months
Title
PTSD Checklist for DSM-5 (PCL-5)
Description
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.
Time Frame
3-months
Title
Behavioral Activation for Depression Scale (BADS-SF)
Description
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.
Time Frame
3-months
Other Pre-specified Outcome Measures:
Title
Treatment Engagement
Description
Treatment engagement will be conceptualized as the number of cCBT sessions completed.
Time Frame
3-months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
37 self-identified male individuals and 37 self-identified female individual will be enrolled in the study
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucinda B Leung, MD MPH PhD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073-1003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improving Depression Management
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