Overview

This trial is active, not recruiting.

Conditions pain, depression, anxiety, musculoskeletal, fibromyalgia
Treatments assisted symptom management (asm), comprehensive symptom management (csm)
Phase phase 3
Sponsor VA Office of Research and Development
Start date January 2014
End date June 2017
Trial size 300 participants
Trial identifier NCT01757301, IIR 12-095

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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.
(Experimental)
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).

Primary Outcomes

Measure
Composite Z-score of pain-anxiety-depression severity
time frame: 12 months

Secondary Outcomes

Measure
PEG (3-item validated version of the Brief Pain Inventory)
time frame: 12 months
PHQ-9
time frame: 12 months
GAD-7
time frame: 12 months
Brief Pain Inventory
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) Trial
Principal investigator Kurt Kroenke, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.