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| ID | Type | Description | Link |
|---|---|---|---|
| IK2HX002867 | U.S. NIH Grant/Contract | View source |
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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).
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 Angeles 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cCBT Enhanced Collaborative Care | Experimental | 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. |
|
| Usual Care | Active Comparator | Participants in the usual care arm will receive the usual care provided as described below. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cCBT Enhanced Collaborative Care | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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-months |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Global Health | 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". |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Engagement | Treatment engagement will be conceptualized as the number of cCBT sessions completed. The minimum number of sessions is 0 and the maximum is 11. A higher number indicates more cCBT sessions completed, but isn't indicative of a better or worse outcome. | 3-months |
Inclusion Criteria:
Exclusion Criteria:
37 self-identified male individuals and 37 self-identified female individual will be enrolled in the study
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| Name | Affiliation | Role |
|---|---|---|
| Lucinda B Leung, MD MPH PhD | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073-1003 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Usual Care | Participants in the usual care arm will receive the usual care provided as described below. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. The minimum score is 0, the maximum is 27. A higher score indicates a worse outcome (i.e. more severe depression symptoms). | Posted | Mean | Standard Deviation | score on a scale | 3-months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lucinda B. Leung, MD, PhD, MPH | VA Greater Los Angeles Healthcare System, UCLA David Geffen School of Medicine | 310-478-3711 | lleung@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 19, 2021 | Jun 14, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 18, 2021 | Mar 9, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
| Usual Care | Behavioral | Primary Care Provider supported usual care typically includes medication prescription and referrals to specialty mental health, including Primary Care - Mental Health Integration services. |
|
| 3-months |
| 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. 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. | 3-months |
| 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. The minimum score is 0, the maximum is 100. Higher scores indicate a better outcome (i.e., higher patient activation). | 3-months |
| 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. The minimum score is 0, the maximum is 80. Higher score indicate a worse outcome (i.e., more severe PTSD symptoms). | 3-months |
| 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. The minimum score is 0, the maximum is 54. Higher scores indicate a better outcome (i.e., higher activation). | 3-months |
| BG001 | Usual Care | Participants in the usual care arm will receive the usual care provided as described below. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Patient Health Questionnaire (PHQ-9) | The minimum score is 0, the maximum is 27. A higher score indicates a worse outcome (i.e. more severe depression symptoms). | Mean | Standard Deviation | units on a scale |
|
| OG001 | Usual Care | Participants in the usual care arm will receive the usual care provided as described below. 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. |
|
|
| Secondary | PROMIS Global Health | 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". | Posted | Mean | Standard Deviation | t-score | 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. 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. | Posted | Mean | Standard Deviation | score on a scale | 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. The minimum score is 0, the maximum is 100. Higher scores indicate a better outcome (i.e., higher patient activation). | Posted | Mean | Standard Deviation | score on a scale | 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. The minimum score is 0, the maximum is 80. Higher score indicate a worse outcome (i.e., more severe PTSD symptoms). | Posted | Mean | Standard Deviation | score on a scale | 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. The minimum score is 0, the maximum is 54. Higher scores indicate a better outcome (i.e., higher activation). | Posted | Mean | Standard Deviation | score on a scale | 3-months |
|
|
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| Other Pre-specified | Treatment Engagement | Treatment engagement will be conceptualized as the number of cCBT sessions completed. The minimum number of sessions is 0 and the maximum is 11. A higher number indicates more cCBT sessions completed, but isn't indicative of a better or worse outcome. | Usual care participants were not given the opportunity to use the cCBT program. | Posted | Mean | Standard Deviation | number of sessions | 3-months |
|
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|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Usual Care | Participants in the usual care arm will receive the usual care provided as described below. 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. | 0 | 28 | 0 | 28 | 0 | 28 |
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