Depression
Conditions
Keywords
depression, primary health care, cognitive behavioral therapy, veterans
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 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.
Interventions
BEHAVIORALcCBT 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.
BEHAVIORALUsual Care
Primary Care Provider supported usual care typically includes medication prescription and referrals to specialty mental health, including Primary Care - Mental Health Integration services.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment Engagement | 3-months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| 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. | 28 |
| Total | 57 |
Baseline characteristics
| Characteristic | cCBT Enhanced Collaborative Care | Total | Usual Care |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 11 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 46 Participants | 22 Participants |
| Age, Continuous | 49.9 years STANDARD_DEVIATION 17.6 | 49.9 years STANDARD_DEVIATION 16.3 | 49.8 years STANDARD_DEVIATION 15.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 18 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 38 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Patient Health Questionnaire (PHQ-9) | 15.4 units on a scale STANDARD_DEVIATION 4.9 | 15.1 units on a scale STANDARD_DEVIATION 5 | 14.6 units on a scale STANDARD_DEVIATION 5.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 17 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) White | 10 Participants | 19 Participants | 9 Participants |
| Region of Enrollment United States | 29 Participants | 57 Participants | 28 Participants |
| Sex: Female, Male Female | 8 Participants | 17 Participants | 9 Participants |
| Sex: Female, Male Male | 21 Participants | 40 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 28 |
| other Total, other adverse events | 0 / 29 | 0 / 28 |
| serious Total, serious adverse events | 0 / 29 | 0 / 28 |
Outcome results
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).
Time frame: 3-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| cCBT Enhanced Collaborative Care | Patient Health Questionnaire (PHQ-9) | 12.6 score on a scale | Standard Deviation 5.2 |
| Usual Care | Patient Health Questionnaire (PHQ-9) | 15.2 score on a scale | Standard Deviation 5.1 |
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).
Time frame: 3-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| cCBT Enhanced Collaborative Care | Behavioral Activation for Depression Scale (BADS-SF) | 21.4 score on a scale | Standard Deviation 9.1 |
| Usual Care | Behavioral Activation for Depression Scale (BADS-SF) | 22.6 score on a scale | Standard Deviation 7.8 |
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.
Time frame: 3-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| cCBT Enhanced Collaborative Care | Generalized Anxiety Disorder (GAD-7) | 9.6 score on a scale | Standard Deviation 5.8 |
| Usual Care | Generalized Anxiety Disorder (GAD-7) | 10.6 score on a scale | Standard Deviation 5.2 |
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).
Time frame: 3-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| cCBT Enhanced Collaborative Care | Patient Activation Measure (PAM) | 37.5 score on a scale | Standard Deviation 4.2 |
| Usual Care | Patient Activation Measure (PAM) | 38.6 score on a scale | Standard Deviation 5.4 |
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.
Time frame: 3-months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| cCBT Enhanced Collaborative Care | PROMIS Global Health | Physical Health | 38.3 t-score | Standard Deviation 7.1 |
| cCBT Enhanced Collaborative Care | PROMIS Global Health | Mental Health | 36.9 t-score | Standard Deviation 6.1 |
| Usual Care | PROMIS Global Health | Physical Health | 38.7 t-score | Standard Deviation 8.4 |
| Usual Care | PROMIS Global Health | Mental Health | 38.2 t-score | Standard Deviation 6.5 |
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).
Time frame: 3-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| cCBT Enhanced Collaborative Care | PTSD Checklist for DSM-5 (PCL-5) | 30.1 score on a scale | Standard Deviation 19.5 |
| Usual Care | PTSD Checklist for DSM-5 (PCL-5) | 34.0 score on a scale | Standard Deviation 16.7 |
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.
Time frame: 3-months
Population: Usual care participants were not given the opportunity to use the cCBT program.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| cCBT Enhanced Collaborative Care | Treatment Engagement | 6.7 number of sessions | Standard Deviation 4.9 |