Anxiety, Depression, Fibromyalgia, Musculoskeletal, Pain
Conditions
Keywords
Pain, Depression, Anxiety, Musculoskeletal, Fibromyalgia
Brief summary
Pain is the most common presenting symptom in medical outpatients, and depression and anxiety are the two most common mental disorders. All three conditions are often inadequately treated and result in substantial disability, reduced health-related quality of life, and increased health care costs and utilization. Additionally, pain, anxiety, and depression (PAD) are frequently comorbid with one another and have reciprocal negative effects on treatment response and additive effects on adverse health outcomes. The PAD triad is especially burdensome in Veterans, with their high prevalence of chronic pain, depression, PTSD, and other anxiety disorders. The Comprehensive vs. Assisted Management of Mood and Physical Symptoms (CAMMPS) study is a randomized comparative effectiveness trial designed to test the relative effectiveness of a lower-resource vs. a higher-resource enhancement of usual primary care in the management of Veterans suffering from with pain plus comorbid anxiety and/or depression.
Detailed description
The Comprehensive vs. Assisted Management of Mood and Physical Symptoms (CAMMPS) study is a randomized comparative effectiveness trial designed to test the relative effectiveness of a lower-resource vs. a higher-resource enhancement of usual primary care in the management of Veterans suffering from with pain plus comorbid anxiety and/or depression. This is a single-site study enrolling Veterans. Patients followed in primary care clinics at the Roudebush VAMC will be eligible if they have clinically significant levels of pain plus comorbid anxiety and/or depression. A total of 300 eligible patients who provide informed consent will be randomized to one of two treatment arms. One group (n=150) will receive assisted symptom management (ASM) consisting of automated symptom monitoring by interactive voice recording or Internet and prompted pain self-management guided by symptom levels. The second group (n=150) will receive comprehensive symptom management (CSM) which combines ASM with optimized medication management delivered by a nurse-physician specialist team and facilitated mental health care. This team will partner with both VA primary care physicians and psychologists embedded in primary care to monitor and adjust treatments using evidence-based analgesic and antidepressant algorithms, reinforced self-management, and care coordination. The investigators postulate that although both interventions are likely to be beneficial, CSM will be superior to ASM. In short, this trial compares: 1) usual care plus assisted symptom management (ASM) vs. 2) usual care plus ASM plus optimized medication and care management and facilitated mental health care (CSM). Outcomes will be assessed at baseline, 1, 3, 6, and 12 months. The primary outcome is a composite pain-anxiety-depression severity score. Secondary outcomes include individual pain, anxiety, and depression scores; functional status and health-related quality of life; treatment satisfaction; and perceived barriers and facilitators of the CSM and ASM interventions. The rationale for ASM is preliminary evidence of its effectiveness and its lower use of resources. The rationale for CSM is that the addition of optimized medication management, facilitated mental health care, and coordination with both primary care physicians/Patient Aligned Care Teams (PACTs) and psychologists for the PAD symptoms should substantially enhance the benefits of ASM.
Interventions
OTHERAssisted Symptom Management (ASM)
There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.
OTHERComprehensive Symptom Management (CSM)
This arm couples ASM with care management by a nurse-physician team, thus testing combined therapy vs. monotherapy (ASM only).
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
Individuals must be patients of the Richard L. Roudebush VAMC in Indianapolis, Indiana Individuals will be eligible if they have pain plus comorbid anxiety and/or depression. * Pain must: * be musculoskeletal, either localized (in the arms, legs, back, or neck) or widespread (fibromyalgia) * have persisted 3 months or longer despite a trial of at least one analgesic medication * at least moderate in severity, defined as a Brief Pain Inventory average severity score of 5 or greater * Depression must be of at least moderate severity, defined as a PHQ-8 score of 10 or greater with either depressed mood and/or anhedonia being endorsed, OR * Anxiety must be of at least moderate severity, defined as a GAD-7 score of 10 or greater, OR * A composite mood score (anxiety and depression) of sufficient severity, defined as a GAD-7 + PHQ-8 score of 12 or greater.
Exclusion criteria
Individuals will be excluded if they: * do not speak English * have moderately severe cognitive impairment as defined by a validated 6-item cognitive screener * have schizophrenia, bipolar disorder or other psychosis * have other severe mental illness and/or high risk of suicide * are pregnant * have an anticipated life expectancy of less than 12 months. Patients who are on antidepressants but still meet the PHQ-9 and/or GAD-7 entry criterion for clinical depression and/or anxiety may still be eligible if they have been on an adequate dose of the antidepressant for an adequate duration of time (i.e., 12 weeks).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Z-score of Pain-anxiety-depression Severity | 12 months | The primary outcome measure is the composite z-score of the main pain, anxiety, and depression measures in this trial: the BPI, GAD-7, PHQ-9, respectively. A standard z-score is calculated for each scale as follows: subject's scale score minus the sample mean divided by the sample standard deviation. A composite pain-anxiety-depression score is the average of the standard z-scores for the 3 scales. This is a scale of effect size where 0 represents no change from baseline, and a negative number means improvement and a positive number means worsening. Each unit means one standard deviation change from the group at baseline. Practical minimum value= -2.0, maximum value= +2.0. Positive number indicates greater symptoms severity/worse outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Average/Enjoyment of Life/General Activities Pain Scale (PEG) | 12 months | The PEG is a 3-item validated version of the Brief Pain Inventory. Minimum value = 0; maximum value = 10. Higher scores indicate greater symptom severity/worse outcomes. |
| Patient Health Questionnaire 9-item Depression Scale (PHQ-9) | 12 months | The PHQ-9 has been used in hundreds of research studies as a depression severity and outcome measure and, now translated into more than 80 languages, is among the most widely used depression measures in clinical practice. Minimum value = 0; maximum value = 27. Higher scores indicate greater symptom severity/worse outcomes. |
| Generalized Anxiety Disorder 7-Item Anxiety Scale (GAD-7) | 12 months | The GAD-7 is an anxiety severity measure, validated in several thousand primary care patients and increasingly used in clinical research and practice. It is also a good first-line measure for estimating the probability of 4 common anxiety disorders in primary care - generalized anxiety disorder, panic disorder, post-traumatic stress disorder, and social anxiety disorder. Minimum value = 0; maximum value = 21. Higher scores indicate greater symptom severity/worse outcomes. |
| Brief Pain Inventory (BPI) | 12 months | The BPI rates the intensity of pain on 4 items (current, worst, least, and average pain in past week), and the interference in 7 areas (mood, physical activity, work, social activity, relations with others, sleep, enjoyment of life). Minimum value = 0; maximum value = 10. Higher scores indicate greater symptom severity/worse outcomes. |
Countries
United States
Participant flow
Pre-assignment details
Two participants were excluded from the study after enrollment. Both participants failed screening and were considered ineligible.
Participants by arm
| Arm | Count |
|---|---|
| Assisted Symptom Management (ASM) There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.
Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules. | 147 |
| Comprehensive Symptom Management (CSM) This arm couples ASM with care management by a nurse-physician team, thus testing combined therapy vs. monotherapy (ASM only).
Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse-physician team, thus testing combined therapy vs. monotherapy (ASM only). | 147 |
| Total | 294 |
Baseline characteristics
| Characteristic | Assisted Symptom Management (ASM) | Total | Comprehensive Symptom Management (CSM) |
|---|---|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 11.7 | 57.4 years STANDARD_DEVIATION 12.1 | 56.9 years STANDARD_DEVIATION 12.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 45 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) White | 117 Participants | 233 Participants | 116 Participants |
| Region of Enrollment United States | 147 Participants | 294 Participants | 147 Participants |
| Sex: Female, Male Female | 14 Participants | 37 Participants | 23 Participants |
| Sex: Female, Male Male | 133 Participants | 257 Participants | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 147 | 2 / 147 |
| other Total, other adverse events | 13 / 147 | 72 / 147 |
| serious Total, serious adverse events | 18 / 147 | 30 / 147 |
Outcome results
Primary
Composite Z-score of Pain-anxiety-depression Severity
The primary outcome measure is the composite z-score of the main pain, anxiety, and depression measures in this trial: the BPI, GAD-7, PHQ-9, respectively. A standard z-score is calculated for each scale as follows: subject's scale score minus the sample mean divided by the sample standard deviation. A composite pain-anxiety-depression score is the average of the standard z-scores for the 3 scales. This is a scale of effect size where 0 represents no change from baseline, and a negative number means improvement and a positive number means worsening. Each unit means one standard deviation change from the group at baseline. Practical minimum value= -2.0, maximum value= +2.0. Positive number indicates greater symptoms severity/worse outcomes.
Time frame: 12 months
Population: Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Assisted Symptom Management (ASM) | Composite Z-score of Pain-anxiety-depression Severity | -0.52 units on a scale | Standard Deviation 1.05 |
| Comprehensive Symptom Management (CSM) | Composite Z-score of Pain-anxiety-depression Severity | -0.65 units on a scale | Standard Deviation 0.94 |
Secondary
Brief Pain Inventory (BPI)
The BPI rates the intensity of pain on 4 items (current, worst, least, and average pain in past week), and the interference in 7 areas (mood, physical activity, work, social activity, relations with others, sleep, enjoyment of life). Minimum value = 0; maximum value = 10. Higher scores indicate greater symptom severity/worse outcomes.
Time frame: 12 months
Population: Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Assisted Symptom Management (ASM) | Brief Pain Inventory (BPI) | 5.0 units on a scale | Standard Deviation 2.3 |
| Comprehensive Symptom Management (CSM) | Brief Pain Inventory (BPI) | 5.0 units on a scale | Standard Deviation 2.2 |
Secondary
Generalized Anxiety Disorder 7-Item Anxiety Scale (GAD-7)
The GAD-7 is an anxiety severity measure, validated in several thousand primary care patients and increasingly used in clinical research and practice. It is also a good first-line measure for estimating the probability of 4 common anxiety disorders in primary care - generalized anxiety disorder, panic disorder, post-traumatic stress disorder, and social anxiety disorder. Minimum value = 0; maximum value = 21. Higher scores indicate greater symptom severity/worse outcomes.
Time frame: 12 months
Population: Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Assisted Symptom Management (ASM) | Generalized Anxiety Disorder 7-Item Anxiety Scale (GAD-7) | 8.4 units on a scale | Standard Deviation 6.2 |
| Comprehensive Symptom Management (CSM) | Generalized Anxiety Disorder 7-Item Anxiety Scale (GAD-7) | 7.5 units on a scale | Standard Deviation 5.4 |
Secondary
Pain Average/Enjoyment of Life/General Activities Pain Scale (PEG)
The PEG is a 3-item validated version of the Brief Pain Inventory. Minimum value = 0; maximum value = 10. Higher scores indicate greater symptom severity/worse outcomes.
Time frame: 12 months
Population: Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Assisted Symptom Management (ASM) | Pain Average/Enjoyment of Life/General Activities Pain Scale (PEG) | 6.0 units on a scale | Standard Deviation 1.9 |
| Comprehensive Symptom Management (CSM) | Pain Average/Enjoyment of Life/General Activities Pain Scale (PEG) | 6.1 units on a scale | Standard Deviation 2 |
Secondary
Patient Health Questionnaire 9-item Depression Scale (PHQ-9)
The PHQ-9 has been used in hundreds of research studies as a depression severity and outcome measure and, now translated into more than 80 languages, is among the most widely used depression measures in clinical practice. Minimum value = 0; maximum value = 27. Higher scores indicate greater symptom severity/worse outcomes.
Time frame: 12 months
Population: Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Assisted Symptom Management (ASM) | Patient Health Questionnaire 9-item Depression Scale (PHQ-9) | 11.4 units on a scale | Standard Deviation 5.9 |
| Comprehensive Symptom Management (CSM) | Patient Health Questionnaire 9-item Depression Scale (PHQ-9) | 10.3 units on a scale | Standard Deviation 5.3 |