# Presentation: 160674

## 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**

## OUTLINE

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

## 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

## Managing PAIN in Primary Care: 

***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

## 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**

## 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

## 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!”

## 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)

## 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.

## Pain Severity as Correlate of Depression

| 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) |

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

## Global Burden of Disease

**Ischemic heart disease **
**Major Depression**
**Traffic accidents**
**Cerebrovascular disease**
**COPD**

_**Year 2020**_

**Murray and Lopez, 1996**

## 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.

## 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

## RECIPROCAL RELATIONSHIP

**Pain**

**Depression**

**RECIPROCAL RELATIONSHIP**

## 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.**

## 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

## Severity of Pain is Associated with Poor Depression Outcome

**Severity of Pain is Associated with Poor Depression Outcome**

**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

## What Symptoms are the Most Resistant?

**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**

## 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%****had****Physical****Symptoms**

- © 2006 NogginStorm Labs

## Integrated Model

**Physical Symptoms**

**Psychological Symptoms**

**PAIN**** **
**is the most common physical symptom**

**DEPRESSION**** most common psychological symptom**

## Research Spectrum for Pain

**      **_**Basic **_
**Neurosciences**
**Genetics**
**Pharmacology**
**Imaging**

**Translational**

**Clinical Trials**

_**Other Clinical**_
**Epidemiology**
**Health services**

**    **_**Social**_
**Qualitative**
**Behavioral**
**Sociological**

**YOU ARE HERE**

## Primary Care Pain and Depression Trial

** ****S****tepped ****C****are for ****A****ffective disorders and ****M****usculokeletal ****P****ain study**
**Funded by National Institute of Mental Health-RO1 MH071268-01**

## 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)

## 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.

## 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)

##  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**

## 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**

## STUDY SITES

-  Roudebush VAMC medicine clinics
* *University primary care clinics

## 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)

## 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

## 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

## 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 |

## Antidepressant Selection

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

## 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. |

## 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

## 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

## 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**

**+**

**+**

**−**

**−**

## 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)**

## BASELINE DATA

## 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%)  |

**Baseline Characteristics SCAMP Participants**** **

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

-   (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**

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

- Baseline data analysis

## BACKGROUND

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

## Symptom Triangle of Reciprocating Adverse Effects

**Depression**

**Anxiety**

**Pain**

**–**

**–**

**–**

## 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) **

## METHODS

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

## ANALYSES

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

## ANALYSES

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

## RESULTS

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

**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**

## Psychiatric Comorbidity & Disability in 500 pts with musculoskeletal pain

|  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 |

- Bair, Damush, Wu, Sutherland, Kroenke (abstract at SGIM meeting, 2007)

## Poorer HRQL seen in those with pain and psychiatric comorbidity

**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**

## 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  |

## 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

## Study Limitations

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

## 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**

## 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**

## QUESTIONS/COMMENTS

- mbair@iupui.edu