Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) Trial

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01757301
First received: December 20, 2012
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Pain
Depression
Anxiety
Musculoskeletal
Fibromyalgia
Other: Assisted Symptom Management (ASM)
Other: Comprehensive Symptom Management (CSM)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) Trial

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Composite Z-score of pain-anxiety-depression severity as assessed by Brief Pain Inventory, GAD-7, and PHQ-9 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The primary outcome measure will be the composite z-score of the main pain, anxiety, and depression measures in this trial: the Brief Pain Inventory, GAD-7, and PHQ-9, respectively. These 3 symptom scales total 27 items: 11 items for pain, 9 for depression, and 7 for anxiety. A standard z-score will be 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 will be the average of the standard z-scores for the 3 scales.


Secondary Outcome Measures:
  • PEG (3-item validated version of the Brief Pain Inventory) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • PHQ-9 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • GAD-7 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Brief Pain Inventory [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Other: 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: Comprehensive Symptom Management (CSM)
This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).
Other: Comprehensive Symptom Management (CSM)
This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).

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. We 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/PACTs and psychologists for the PAD symptoms should substantially enhance the benefits of ASM.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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-9 score of 10 or greater with either depressed mood and/or anhedonia being endorsed.

Anxiety must be of at least moderate severity, defined as a GAD-7 score of 10 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
  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757301

Locations
United States, Indiana
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States, 46202-2884
Sponsors and Collaborators
Investigators
Principal Investigator: Kurt Kroenke, MD Richard Roudebush VA Medical Center, Indianapolis
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01757301     History of Changes
Other Study ID Numbers: IIR 12-095
Study First Received: December 20, 2012
Last Updated: August 13, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Pain
Depression
Anxiety
Musculoskeletal
Fibromyalgia

Additional relevant MeSH terms:
Depression
Depressive Disorder
Fibromyalgia
Myofascial Pain Syndromes
Pain
Behavioral Symptoms
Mental Disorders
Mood Disorders
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Rheumatic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014