Comprehensive vs. Assisted Management of Mood and Pain Symptoms

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.

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).