Back to resultsA Brief Intervention for Chronic Pain in Primary Care
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
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
Sites / Locations
- Henry Ford Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
Participants will engage in a 5 session psychotherapy intervention focused on improving pain and mood.
Patients will receive treatment as usual from their care providers.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Insomnia Severity Index
This measure assess difficulty with sleep. Total scores range from 0-28, with greater numbers indicating greater sleep difficulty.
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).
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.
Health care utilization
The number of primary and specialty care visits, prescriptions written, emergency room visits, and hospital admissions
Full Information
NCT ID
NCT03692468
First Posted
September 20, 2018
Last Updated
December 6, 2022
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT03692468
Brief Title
A Brief Intervention for Chronic Pain in Primary Care
Official Title
A Brief Intervention for Co-occurring Pain and Distress in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
April 21, 2020 (Actual)
Study Completion Date
November 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants will engage in a 5 session psychotherapy intervention focused on improving pain and mood.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients will receive treatment as usual from their care providers.
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brief Pain Inventory
Description
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.
Time Frame
5 weeks post-baseline
Title
Hospital Anxiety and Depression Scale
Description
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.
Time Frame
5 weeks post-baseline
Secondary Outcome Measure Information:
Title
Insomnia Severity Index
Description
This measure assess difficulty with sleep. Total scores range from 0-28, with greater numbers indicating greater sleep difficulty.
Time Frame
Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups
Title
Pain Catastrophizing Scale
Description
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).
Time Frame
Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups
Title
Satisfaction with Life Scale
Description
This measure assesses how satisfied a patient is with their life. Total scores range from 7-35 with higher scores indicating greater satisfaction.
Time Frame
Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups
Title
Health care utilization
Description
The number of primary and specialty care visits, prescriptions written, emergency room visits, and hospital admissions
Time Frame
Measured 6 months before and 6 months after study enrollment
Other Pre-specified Outcome Measures:
Title
Chronic Pain Acceptance Questionnaire
Description
This measure assess acceptance of chronic pain. Total scores range from 0-120 with higher scores indicating greater acceptance. There are 2 subscales: Activity Engagement (range= 0-66) and Pain Willingness (range= 0-54).
Time Frame
Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups
Title
Mindful Attention Awareness Scale
Description
This measure assess the extent to which someone is using mindful awareness. Total scores range from 15-90 with greater scores indicating greater mindfulness.
Time Frame
Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups
Title
Montreal Cognitive Assessment
Description
Brief screen of cognitive functioning; scores range from 0-30
Time Frame
Administered at baseline
Title
Brief Medical Numbers Test
Description
Brief screen of health numeracy; scores range from 0-4
Time Frame
Administered at baseline
Title
Rapid Estimate of Adult Learning in Medicine
Description
Brief screen of health literacy; patients are categorized into a reading level: at least 9th grade, 7th-8th grade, 4th-6th grade, and 3rd grade or less
Time Frame
Administered at baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35665994
Citation
Miller-Matero LR, Gavrilova L, Hecht LM, Autio K, Tobin ET, Braciszewski JM, Maye M, Felton JW, Ahmedani BK. A brief psychological intervention for chronic pain in primary care: Examining long-term effects from a pilot randomized clinical trial. Pain Pract. 2022 Jul;22(6):564-570. doi: 10.1111/papr.13134. Epub 2022 Jun 14.
Results Reference
derived
PubMed Identifier
33616190
Citation
Miller-Matero LR, Hecht LM, Miller MK, Autio K, Pester BD, Tobin ET, Patel S, Braciszewski JM, Maye M, Ahmedani BK. A Brief Psychological Intervention for Chronic Pain in Primary Care: A Pilot Randomized Controlled Trial. Pain Med. 2021 Jul 25;22(7):1603-1611. doi: 10.1093/pm/pnaa444.
Results Reference
derived
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A Brief Intervention for Chronic Pain in Primary Care
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