Improving Depression Management

Depression Clinical Trial

— IDMPC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05050227
• Other study ID #: CDX 21-004
• Secondary ID: IK2HX002867
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: June 30, 2025
• Est. primary completion date: June 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Engagement	Treatment engagement will be conceptualized as the number of cCBT sessions completed.	3-months
Primary	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.	3-months
Secondary	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).	3-months
Secondary	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.	3-months
Secondary	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.	3-months
Secondary	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.	3-months
Secondary	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.	3-months