Comprehensive vs. Assisted Management of Mood and Pain Symptoms

Completed · Not applicable

Conditions studied: Pain, Depression, Anxiety, Musculoskeletal, Fibromyalgia

In brief

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.

Key facts

Study ID

NCT01757301

Run by

VA Office of Research and Development

People needed

296

Starts

2014-01-02

Expected to finish

2017-11-30

Last updated by the study team

2019-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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