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Clinical Trials/NCT03692468
NCT03692468
Completed
Not Applicable

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

Henry Ford Health System1 site in 1 country61 target enrollmentSeptember 20, 2018
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Henry Ford Health System
Enrollment
61
Locations
1
Primary Endpoint
Hospital Anxiety and Depression Scale
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 20, 2018
End Date
November 18, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lisa Matero

Senior Staff Psychologist

Henry Ford Health System

Eligibility Criteria

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

Outcomes

Primary Outcomes

Hospital Anxiety and Depression Scale

Time Frame: 5 weeks post-baseline

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.

Brief Pain Inventory

Time Frame: 5 weeks post-baseline

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.

Secondary Outcomes

  • Satisfaction with Life Scale(Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups)
  • Health care utilization(Measured 6 months before and 6 months after study enrollment)
  • Pain Catastrophizing Scale(Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups)
  • Insomnia Severity Index(Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups)

Study Sites (1)

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