N/A
N=294
Comprehensive vs. Assisted Management of Mood and Pain Symptoms
Pain · Depression · Anxiety · Musculoskeletal · Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT01757301 ↗Enrolled (actual)
294
Serious AEs
16.3%
Results posted
Mar 2019
Primary outcome: Primary: Composite Z-score of Pain-anxiety-depression Severity — -0.52; -0.65 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Assisted Symptom Management (ASM) (Other); Comprehensive Symptom Management (CSM) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Z-score of Pain-anxiety-depression Severity |
-0.52; -0.65 | — |
| SECONDARY Pain Average/Enjoyment of Life/General Activities Pain Scale (PEG) |
6.0; 6.1 | — |
| SECONDARY Patient Health Questionnaire 9-item Depression Scale (PHQ-9) |
11.4; 10.3 | — |
| SECONDARY Generalized Anxiety Disorder 7-Item Anxiety Scale (GAD-7) |
8.4; 7.5 | — |
| SECONDARY Brief Pain Inventory (BPI) |
5.0; 5.0 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT01757301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.