A Brief Intervention for Chronic Pain in Primary Care

Study Overview
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Brief Summary
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The purpose of this research study is to investigate potential benefits of a behavioral intervention for co-occurring chronic pain and distress that is delivered in a primary care clinic.

Official Title
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A Brief Intervention for Co-occurring Pain and Distress in Primary Care

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic pain condition A current patient within the Henry Ford Health System Academic Internal Medicine Clinic in Detroit Has been within the Henry Ford Health System for at least 6 months Exclusion Criteria: Current behavioral health treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Participants will engage in a 5 session psychotherapy intervention focused on improving pain and mood. | Behavioral: Psychotherapy<br>* Participants will complete 5, 60 minutes sessions. At each session, participants will learn strategies that have been shown to improve pain functioning and/or mood for patients who have chronic pain. The intervention will be delivered in the patient's primary care clinic.<br>|
| No Intervention: Control Group<br>Patients will receive treatment as usual from their care providers. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory | The Brief Pain Inventory measures pain severity and pain functioning. Pain severity is comprised of 4 questions on a 0-10 scale for pain at it's worst in the past week, the least in the past week, on average, and then currently. Each item is scored separately and higher scores indicate greater pain severity. There are then 12 daily activities in which the participants rates on a scale of 0-10 regarding how much the pain interferes with the activity (10 being the highest interference). These are all scored separately. | 5 weeks post-baseline | 
| Hospital Anxiety and Depression Scale | This measure assesses the severity of depression and anxiety. Scores on each of the subscale (e.g., depression and anxiety) range from 0-21 with higher scores indicating greater severity. | 5 weeks post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index | This measure assess difficulty with sleep. Total scores range from 0-28, with greater numbers indicating greater sleep difficulty. | Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups | 
| Pain Catastrophizing Scale | This measure assesses catastrophizing thoughts about pain. Total scores range from 0-52 with higher scores indicating greater catastrophizing. The three subscales are rumination (range= 0-16), magnification (range= 0-12), and helplessness (range= 0-24). | Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups | 
| Satisfaction with Life Scale | This measure assesses how satisfied a patient is with their life. Total scores range from 7-35 with higher scores indicating greater satisfaction. | Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups | 
| Health care utilization | The number of primary and specialty care visits, prescriptions written, emergency room visits, and hospital admissions | Measured 6 months before and 6 months after study enrollment |