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

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ClinicalTrials.gov Identifier: NCT01757301
Recruitment Status : Completed
First Posted : December 28, 2012
Results First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE December 20, 2012
First Posted Date  ICMJE December 28, 2012
Results First Submitted Date  ICMJE August 8, 2018
Results First Posted Date  ICMJE March 13, 2019
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE January 2, 2014
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
Composite Z-score of Pain-anxiety-depression Severity [ Time Frame: 12 months ]
The primary outcome measure is the composite z-score of the main pain, anxiety, and depression measures in this trial: the BPI, GAD-7, PHQ-9, respectively. A standard z-score is 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 is the average of the standard z-scores for the 3 scales. This is a scale of effect size where 0 represents no change from baseline, and a negative number means improvement and a positive number means worsening. Each unit means one standard deviation change from the group at baseline. Practical minimum value= -2.0, maximum value= +2.0. Positive number indicates greater symptoms severity/worse outcomes.
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2012)
Composite T-score of pain, anxiety and depression scales from the PROMIS-57 Profile [ Time Frame: 12 months ]
These 3 symptom scales total 25 items: 8 items each for depression and anxiety, and 9 items for pain. Conversion tables allow direct conversion of simple summed raw scores from PROMIS symptom scales into T-score values. T-Score distributions are standardized such that a score of 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score represents greater symptom severity.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • Pain Average/Enjoyment of Life/General Activities Pain Scale (PEG) [ Time Frame: 12 months ]
    The PEG is a 3-item validated version of the Brief Pain Inventory. Minimum value = 0; maximum value = 10. Higher scores indicate greater symptom severity/worse outcomes.
  • Patient Health Questionnaire 9-item Depression Scale (PHQ-9) [ Time Frame: 12 months ]
    The PHQ-9 has been used in hundreds of research studies as a depression severity and outcome measure and, now translated into more than 80 languages, is among the most widely used depression measures in clinical practice. Minimum value = 0; maximum value = 27. Higher scores indicate greater symptom severity/worse outcomes.
  • Generalized Anxiety Disorder 7-Item Anxiety Scale (GAD-7) [ Time Frame: 12 months ]
    The GAD-7 is an anxiety severity measure, validated in several thousand primary care patients and increasingly used in clinical research and practice. It is also a good first-line measure for estimating the probability of 4 common anxiety disorders in primary care - generalized anxiety disorder, panic disorder, post-traumatic stress disorder, and social anxiety disorder. Minimum value = 0; maximum value = 21. Higher scores indicate greater symptom severity/worse outcomes.
  • Brief Pain Inventory (BPI) [ Time Frame: 12 months ]
    The BPI rates the intensity of pain on 4 items (current, worst, least, and average pain in past week), and the interference in 7 areas (mood, physical activity, work, social activity, relations with others, sleep, enjoyment of life). Minimum value = 0; maximum value = 10. Higher scores indicate greater symptom severity/worse outcomes.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2012)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comprehensive vs. Assisted Management of Mood and Pain Symptoms
Official Title  ICMJE Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) Trial
Brief 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.
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. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Depression
  • Anxiety
  • Musculoskeletal
  • Fibromyalgia
Intervention  ICMJE
  • 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.
  • 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).
Study Arms  ICMJE
  • 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.
    Intervention: Other: Assisted Symptom Management (ASM)
  • 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).
    Intervention: Other: Comprehensive Symptom Management (CSM)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2019)
296
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2012)
300
Actual Study Completion Date  ICMJE November 30, 2017
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01757301
Other Study ID Numbers  ICMJE IIR 12-095
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kurt Kroenke, MD Richard L. Roudebush VA Medical Center, Indianapolis, IN
PRS Account VA Office of Research and Development
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP