Improving Depression Management

Not Applicable

Active, not recruiting

Conditions: Depression

Interventions: Behavioral: Usual Care
Behavioral: cCBT Enhanced Collaborative Care

Registration Number: NCT05050227

Lead Sponsor: VA Office of Research and Development

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 57

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 & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Participants in the usual care arm will receive the usual care provided as described below.
cCBT Enhanced Collaborative Care	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.

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9)	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. The minimum score is 0, the maximum is 27. A higher score indicates a worse outcome (i.e. more severe depression symptoms).

Secondary Outcome Measures

Name	Time	Method
PROMIS Global Health	3-months	The 10-item PROMIS Global Health assesses health-related quality of life and is summarized into "physical health" (physical functioning, pain, fatigue) and "mental health" (emotional problems, social functioning). Raw scores are summed (minimum score for either physical health or mental health=4, maximum score for either =20) and converted to a t-score by using a conversion table (minimum t-score for physical health=16.2, maximum =67.7; minimum t-score for mental health=21.2, maximum =67.6). A score of 50, with a standard deviation of 10, is the average for the United States general population. For both the physical and mental health, a higher score indicates a better outcome (i.e., better health). For physical health, a score of 35 or less is reflective of "poor" physical health, and 36-42 of "fair". Similarly, for mental health, a score of 29 or less is reflective of "poor" mental health, 29-40 of "fair".
Generalized Anxiety Disorder (GAD-7)	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. The minimum score is 0, the maximum is 21. Higher scores indicate a worse outcome (i.e., more severe anxiety). For reference: scores of 0-4=minimal anxiety, 5-9=mild anxiety, 10-14=moderate anxiety, and 15-21=severe anxiety.
Patient Activation Measure (PAM)	3-months	The 13-item Patient Activation Measure (PAM) will be used to assess an individual's knowledge, skill, and confidence for self-management. The minimum score is 0, the maximum is 100. Higher scores indicate a better outcome (i.e., higher patient activation).
PTSD Checklist for DSM-5 (PCL-5)	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. The minimum score is 0, the maximum is 80. Higher score indicate a worse outcome (i.e., more severe PTSD symptoms).
Behavioral Activation for Depression Scale (BADS-SF)	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. The minimum score is 0, the maximum is 54. Higher scores indicate a better outcome (i.e., higher activation).