A Brief Intervention for Chronic Pain in Primary Care

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03692468
• Other study ID #: Pain in Primary Care
• Status: Completed
• Phase: N/A
• Start date: September 20, 2018
• Est. completion date: November 18, 2020

Study information

• Verified date: December 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 18, 2020
• Est. primary completion date: April 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Psychotherapy
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.

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chronic Pain Acceptance Questionnaire	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).	Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups
Other	Mindful Attention Awareness Scale	This measure assess the extent to which someone is using mindful awareness. Total scores range from 15-90 with greater scores indicating greater mindfulness.	Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups
Other	Montreal Cognitive Assessment	Brief screen of cognitive functioning; scores range from 0-30	Administered at baseline
Other	Brief Medical Numbers Test	Brief screen of health numeracy; scores range from 0-4	Administered at baseline
Other	Rapid Estimate of Adult Learning in Medicine	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	Administered at baseline
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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