The Impact of Co-existing Chronic Pain and Mental Health QUERI Conditions:QUERI Implementation Seminar Series

Matthew J. Bair, MD, MS

Research Scientist, Roudebush VA Center of Excellence on Implementing Evidence Based Practice and Regenstrief Institute, Inc

Assistant Professor of Medicine, IU School of Medicine, Indianapolis

June 28, 2007

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OUTLINE
        - The “Pain Problem”
        -  The “Depression Problem”
        -  Pain and Depression Dyad
        -  SCAMP Study
        - Baseline Analyses
        -  Questions and Answers

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Objectives
        - To discuss the impact of co-existing chronic pain and depression/anxiety 
        - To introduce a model to assess and treat both chronic pain and depression (anxiety) concurrently

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Brief Visits

Complicated

Patients

Clinical Reminders

Minimal Resources

JCAHO & VHA

Mandate to

Manage pain

Policies

Guidelines

Expectations

Managing PAIN in Primary Care: 

Issues and Challenges 

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PAIN CRISES
        -  Pain accounts for 20% of all clinic visits
        -  Analgesics = 12% of all prescriptions (# 2)
        -  $100 billion dollars/yr in health care costs
        -  Excessive surgery (e.g., back pain)
        -  Leading cause of work loss & disability
        -  Leading reason for alternative medicine

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Consequences of Under-treatment of Chronic Pain
        - Physiologic (CV, GI, immune)
        - Psychological (depression, anxiety)
        - Diminished quality of Life
        - Impairment of activities
        - Large impact on working age adults
        - Absenteeism, unemployment, and under-employment

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VETERAN STORIES
        - “Doc, I hurt all day- 24/7”
        - “Nothing works for my pain” 
        - “I can’t do anything because of my pain so I stay in bed all day”
        - “I can’t deal with this (pain)...it’s depressing”
        - “On a scale of 0 to 10 my pain is a 20! If I don’t get some relief fast I will blow my head off!”  

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Prevalence of chronic non-cancer pain in Primary Care 
        - 44% (VA); 25 %(university, PCC)

             (Reid et al,2002 )    

48%   VA Primary Care - Palo Alto VA                        

              (Clark, JD, 2002)

71 % VA Primary Care – Western New York (Crosby et al 2006)

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Pain:  5th Vital Sign in Primary Care and Association with Depression
        - 301 primary care Veteran patients
        - Mean age = 60; 91% men; 85% white
        - Depression in 28% (PHQ-9 ≥ 10)
        - Pain in 76%
        -  Mild			21% (score of  1-3)
        -  Moderate		31% (score of  4-6)
        -  Severe		22% (score of 7-10)

Bair MJ, Williams LS, Kroenke K. J Gen Intern Med 2004;19 (Supplement 1):123.

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Pain Severity as Correlate of Depression

Bair MJ, Williams LS, Kroenke K. J Gen Intern Med 2004;19 (Supplement 1):123.
| Pain Severity | Odds Ratio (95% CI) for Depression |
|---------------|------------------------------------|
| Mild          | 2.2    (1.1 - 4.4)                 |
| Moderate      | 5.2    (2.2-12.5)                  |
| Severe        | 12.0    (4.1-34.4)                 |

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Global Burden of Disease

Ischemic heart disease 

Major Depression

Traffic accidents

Cerebrovascular disease

COPD

Year 2020

Murray and Lopez, 1996

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Depressed Patients Usually Present with Physical Symptoms

69%

Presented

ONLY With Physical 

Symptoms

Other

N = 1146 patients with major depression

1. Simon GE, et al. N. Engl J Med. 1999;341(18):1329-1335.

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Unrecognized and Untreated Depression
        - Interferes with treatment and rehab
        - May increase pain intensity and disability
        - Decrease pain threshold and tolerance
        - Magnification of medical symptoms
        - Less successful treatment outcomes

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RECIPROCAL RELATIONSHIP

Pain

Depression

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Depression and Negative Pain Outcomes
        - Depression is associated with
        - ↑ pain complaints and intensity
        - ↑ disability
        - ↑ functional limitations
        - ↑ utilization (office visits, hospitalizations)
        - ↑ costs
        - ↑ risk of nonrecovery	

Bair MJ, et al. Arch Intern Med. 2003;163(20):2433-2445.

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Pain and Negative Depression Outcomes
        - PAIN ASSOCIATED WITH:
        -  ⁭ depressive symptoms
        -  ⁭ functional limitations
        -  ⁭ unemployment rate
        -  frequent use of opioid analgesics
        -  frequent pain-related doctor visits
        -  worse self-rated health

Von Korff M. Grading the severity of chronic pain. Pain 1992; 50:133-149

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Severity of Pain is Associated with Poor Depression Outcome

Bair MJ, et al. Psychosom Med. 2004;66(1):17-22.

N=573

Odds Ratio for Poor Depression Response** Relative to Patients Without Pain

*

*P<.05 vs patients with no baseline pain

1.5

4.1

ARTIST=A Randomized Trial Investigating SSRI Treatment.**Poor depression treatment response defined as Symptom Checklist-20 >1.3. Pain severity was measured by the SF-36 pain severity item

Baseline Pain Severity

2.0

*

(n=144)

(n=170)

(n=81)

No effect relative to patients without pain at baseline

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What Symptoms are the Most Resistant?

Adapted from: Greco T, et al. J Gen Intern Med. 2004;19(8):813-818.

Improvement

Treatment Effect Size

Emotional

Physical

ARTIST=A Randomized Trial Investigating SSRI Treatment.

0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

Baseline

1 Month

3 Months

6 Months

9 Months

N=573

Nonsomatic depressive Sx

Positive well-being

Non-pain somatic Sx

Pain somatic Sx

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Residual Symptoms Predict Relapse

Slide Modified: 

Review: by SHARIE SIPOWICZ 4/8/2003 1:23:11 PM  SL32    Rev:  2152

Jackie Strasser 4/10/03

Reviewer Memo: 

Source: 

Memo: 

*Based on Item 13 (general somatic symptoms) of the HAM-D17.

Paykel ES, et al. Psychol Med. 1995;25(6):1171-1180.

% Relapse

Patients With ResidualDepressive Symptoms

Patients With No ResidualDepressive Symptoms

25%

76%

94%hadPhysicalSymptoms

© 2006 NogginStorm Labs

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Integrated Model

Physical Symptoms

Psychological Symptoms

PAIN 

is the most common physical symptom

DEPRESSION most common psychological symptom

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Research Spectrum for Pain

      Basic 
        - Neurosciences
        - Genetics
        - Pharmacology
        - Imaging

Translational

Clinical Trials

Other Clinical
        - Epidemiology
        - Health services

    Social
        - Qualitative
        - Behavioral
        - Sociological

YOU ARE HERE

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Primary Care Pain and Depression Trial
        -  Stepped Care for Affective disorders and Musculokeletal Pain study
        - Funded by National Institute of Mental Health-RO1 MH071268-01

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SCAMP STUDY TEAM
        - Kurt Kroenke, MD: Principal Investigator
        - Matt Bair, MD: Co-I (Medical Director)
        - Teresa Damush, PhD: Co-I ( Health psychology)
        - Jason Sutherland, PhD: Co-I (Biostatistics)
        - Shawn Hoke (Project Manager)
        - Carol Kempf, RN and Gloria Nicholas, RN
        - Monica Huffman and Celeste Nicholas
        - Jingwei Wu (Data analyst)

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Comorbidity of Pain and Depression Is Common 
        - Reviews have demonstrated a   strong association
        - 30-60% overlap
        - Coexisting musculoskeletal pain with depression is very common 

Bair MJ, et al. Arch Intern Med. 2003;163(20):2433-2445.

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What is a Stepped-Care Intervention? 
        - Starting with lower intensity, less costly treatments (Step 1) 
        - “Stepping up” to more intensive, costly, or complex treatments 
        - In patients that are “poor responders”
        - Low Back Pain (Von Korff), PGW Syndrome (Engel)

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 SCAMP DESIGN

PAIN (back or hip/knee)

Stepped Care

Usual Care

NONDEPRESSED

DEPRESSED

randomized

(n = 250)

(n = 250)

Outcome Assessment at 1, 3, 6, and 12 months

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HYPOTHESES Depression/pain care management will, compared to usual care:

Primary Hypothesis
        - Reduce pain and/or depression severity

Secondary Hypotheses
        - Improve health-related quality of life (HRQL), 	including work and social functioning
        - Improve pain beliefs/behaviors
        - Be cost-effective in terms of QALYs

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STUDY SITES
        -  Roudebush VAMC medicine clinics
        -  University primary care clinics

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Clinical Trial Inclusion
        -  Pain located in low back, hip or knee
        - Persistent pain for > 3 months 
        - Brief Pain Inventory score of  5 (moderate pain severity)
        - Moderate depression (PHQ-9  10)

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Exclusion Criteria
        - Non-English speaking
        - Moderately severe cognitive impairment
        - Bipolar disorder or schizophrenia
        - Current disability claim being adjudicated for pain 
        - Tried to cut down on drugs or alcohol in the past year
        - Currently pregnant or planning to become pregnant
        - Anticipated life expectancy ≤ 12 months  

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Cohort Inclusion
        - Had to have a PHQ-9 depression score < 8 
        - Identical inclusion/exclusion criteria to participants in trial
        - To elucidate frequency & predictors of incident depression in patients with musculoskeletal pain 

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Step 1 -- Pharmacotherapy
| WHEN     | WHERE  | WHAT (Treatment Action)            |
|----------|--------|------------------------------------|
| Baseline | Clinic | Antidepressant started             |
| 1 wk     | Phone  | Check adherence & side effects |
| 3 wk     | Phone  | Adjust dose if needed              |
| 6 wk     | Clinic | Change antidepressant if needed    |
| 9 wk     | Phone  | Adjust dose if needed              |
| 12 wk    | Clinic | Decide if step 2 is warranted      |

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Antidepressant Selection
        - Venlafaxine
        - Fluoxetine
        - Sertraline
        - Citalopram
        - Buproprion
        - Mirtazepine
        - Nortriptyline

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Step 2 – Pain Self-Management
| WHEN  | WHERE  | WHAT (Treatment Action)       |
|-------|--------|-------------------------------|
| 12 wk | Clinic | PSMP – Session 1              |
| 14 wk | Phone  | PSMP – Session 2              |
| 16 wk | Clinic | PSMP – Session 3              |
| 18 wk | Phone  | PSMP – Session 4              |
| 20 wk | Clinic | PSMP – Session 5              |
| 22 wk | Phone  | PSMP – Session 6              |
| 24 wk | Clinic | Close Phase 2.  Phone q 3 mo. |

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Pain Self-Management Program (example components)
        - Education – pain; vocabulary; red flags;
        - Identifying /modifying fears and beliefs
        - Goal-setting and problem-solving
        - Exercise – strengthening; aerobic; etc.
        - Relaxation; deep-breathing;
        - Handling pain flare-ups         
        - Working with clinicians and employers

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DETAILS OF TREATMENT
        - All aspects of intervention delivered by nurse case manager
        - Weekly case management meetings
        - Regular contacts with participants to monitor depression/pain, response to treatment, introduction of self-management strategies

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SCAMP CONCEPTUAL MODEL

Anti-depressant

Pain Self-management

Depression severity

Pain    severity
        -  Impaired Function/QoL
        -  Increased Health Costs
        -  Demographics
        -  Other Psych.

-- Anxiety

-- Stressors
        -  Pain

-- Coping

-- Beliefs

COVARIATES

+

+

−

−

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MEASURES
        - Brief Pain Inventory
        - SCL-20 depression scale
        - HRQL:  	-- generic (SF-36) 

				-- pain-specific (Roland)
        - Other pain (coping, beliefs, self-mgmt)
        - Other psych (anxiety, somatization)
        - Health care utilization (costs)

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BASELINE DATA

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Baseline Characteristics SCAMP Participants 
| Baseline Characteristic           | Stepped Care(N=123) | Usual  Care(N=127) | Non depressed(N=250) |
|-----------------------------------|---------------------|--------------------|----------------------|
| Mean (SD) age, yr                 | 55.2 (12.6)         | 55.8 (11.0)        | 62.5 (14.1)          |
| Women, n (%)                      | 69 (56.1%)          | 63 (49.6%)         | 127 (50.8%)          |
| Race, n (%)                       |
| White                             | 75 (61.0%)          | 76 (59.8%)         | 140 (56.0%)          |
| Black                             | 42 (34.1%)          | 49 (38.6.7%)       | 100 (40.2%)          |
| Married, n (%)                    | 48 (39.0%)          | 44 (34.7%)         | 97 (38.8%)           |
| Mean (SD) no. of medical diseases | 2.7 (1.6)           | 2.6 (1.4)          | 2.6 (1.4)            |
| Clinical site, n (%)              |
| University clinics                | 73 (59.3%)          | 75 (59.1%)         | 152 (60.8%)          |
| Veteran   administration (VA)     | 50 (40.7%)          | 52 (40.9%)         | 99 (39.2%)           |

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  (n=86)           (n=79)         (n=54)          (n=53)          (n=45) 

Depression 

(PHQ-9)

Pain 

(BPI)

Response of pain and depression in SCAMP Trial during Phase 1 (optimized antidepressant therapy) and Phase 2 (pain self-management)

End of Phase 1

End of Phase 2

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Impact of Depression and Anxiety Alone and in Combination among Primary Care Patients with Chronic Musculoskeletal Pain 

Baseline data analysis

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BACKGROUND
        - Individually, depression and anxiety are strongly associated with chronic pain. 
        - Little is known how psychiatric comorbidity affects patients with pain. 

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Symptom Triangle of Reciprocating Adverse Effects

Depression

Anxiety

Pain

–

–

–

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STUDY OBJECTIVE
        - Among patients w/ chronic pain:
        - Individual and combined impact of depression and/or anxiety
        - Pain intensity
        - Pain interference
        - Disability days
        - Health-related quality of life (HRQL) 

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METHODS
        - Baseline analysis of SCAMP data
        - 4 cohorts identified
        - Pain only 
        - Pain and Anxiety 
        - Pain and Depression 
        - Pain, Anxiety, and Depression 

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ANALYSES
        - ANOVA models to compare baseline differences four groups
        - pain intensity/interference
        - Disability days
        - HRQL 

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ANALYSES
        - MANOVA to model pain severity and pain interference concurrently
        - Interaction testing
        - Covariates:
        - Sociodemographics, medical comorbidity, study site, and pain location

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RESULTS

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Pain Only

Pain Score

Pain & Anxiety

Pain & Depression 

Pain, Anxiety, & Depression

BPI Interference

BPI Severity

Patients with concomitant pain, depression, and anxiety had more severe pain

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Psychiatric Comorbidity & Disability in 500 pts with musculoskeletal pain

Bair, Damush, Wu, Sutherland, Kroenke (abstract at SGIM meeting, 2007)
| Depression   and/or    Anxiety  | %   | Roland Disability Score | Disability Days past 3 mo |
|---------------------------------|-----|-------------------------|---------------------------|
| Pain only                       | 54% | 12.1                    | 18                        |
| Pain & Anxiety              | 7%  | 15.5                    | 33                        |
| Pain & Depression           | 15% | 17.9                    | 37                        |
| Pain, Anxiety, & Depression | 25% | 18.1                    | 42                        |

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Pain only

SF-36 Scale

Pain & Anxiety

Pain & Depression

Pain, Anxiety, & Depression

Social

Vitality

General

Pain

Poorer HRQL seen in those with pain and psychiatric comorbidity

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MANOVA Model Predicting Pain Severity and Interference
| Variables            | F Value | P-value |
|----------------------|---------|---------|
| Age                  | 2.24    | 0.1075  |
| Medical diseases     | 1.38    | 0.2525  |
| Gender               | 0.49    | 0.6148  |
| Education            | 3.80    | 0.0231  |
| Employment           | 4.13    | 0.0026  |
| Marital              | 0.04    | 0.9595  |
| Pain location        | 1.82    | 0.1630  |
| Clinic site          | 6.52    | 0.0016  |
| Depression * Anxiety | 5.88    | 0.0030  |

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Study Strengths
        - Large, multi-site primary care study
        - Analytic plan that assessed independent & combined effects of depression and anxiety on variety of pain outcomes
        - Use of validated measures with good psychometric properties

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Study Limitations
        - Cross-sectional data
        - Single academic medical center
        - Self-report measures for depression and anxiety (rather than structured clinical interviews)

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CONCLUSION
        - Among primary care patients with chronic musculoskeletal pain
        - We found an independent and additive associations between depression and/or anxiety AND
        - Pain intensity/interference
        - Disability days
        - HRQL 

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IMPLICATIONS
        - Psychiatric comorbidity among chronic pain patients is common
        - Associated with poor clinical outcomes as well as patient suffering
        - Represents complex management challenges for VA providers caring for these patients 

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QUESTIONS/COMMENTS

mbair@iupui.edu

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