Comprehensive vs. Assisted Management of Mood and Pain Symptoms

NCT01757301 | Completed Results DMC

• 1 other identifier: IIR 12-095
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Depression; Anxiety; Musculoskeletal; Fibromyalgia

Keywords

Pain; Depression; Anxiety; Musculoskeletal; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Composite Z-score of Pain-anxiety-depression Severity

  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.

  12 months

Secondary Outcomes (4)

• Pain Average/Enjoyment of Life/General Activities Pain Scale (PEG)

  12 months

• Patient Health Questionnaire 9-item Depression Scale (PHQ-9)

  12 months

• Generalized Anxiety Disorder 7-Item Anxiety Scale (GAD-7)

  12 months

• Brief Pain Inventory (BPI)

  12 months

Study Arms (2)

Assisted Symptom Management (ASM)

ACTIVE COMPARATOR

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)

Comprehensive Symptom Management (CSM)

EXPERIMENTAL

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)

Interventions

Assisted Symptom Management (ASM) OTHER

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)

Comprehensive Symptom Management (CSM) OTHER

This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).

Comprehensive Symptom Management (CSM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Related Publications (2)

• Toussaint A, Kroenke K, Baye F, Lourens S. Comparing the Patient Health Questionnaire - 15 and the Somatic Symptom Scale - 8 as measures of somatic symptom burden. J Psychosom Res. 2017 Oct;101:44-50. doi: 10.1016/j.jpsychores.2017.08.002. Epub 2017 Aug 2.

  PMID: 28867423 BACKGROUND

• Kroenke K, Evans E, Weitlauf S, McCalley S, Porter B, Williams T, Baye F, Lourens SG, Matthias MS, Bair MJ. Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) trial: Study design and sample characteristics. Contemp Clin Trials. 2018 Jan;64:179-187. doi: 10.1016/j.cct.2017.10.006. Epub 2017 Oct 12.

  PMID: 29031492 BACKGROUND

MeSH Terms

Conditions

Pain; Depression; Anxiety Disorders; Fibromyalgia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Erica Evans
• Organization: Richard L. Roudebush VA Medical Center

erica.evans2@va.gov

317-988-3476

Study Officials

• Kurt Kroenke, MD

  Richard L. Roudebush VA Medical Center, Indianapolis, IN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 28, 2012
• Study Start: January 2, 2014
• Primary Completion: July 31, 2017
• Study Completion: November 30, 2017
• Last Updated: March 13, 2019
• Results First Posted: March 13, 2019

Record last verified: 2019-03

Locations

US (1)