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A Brief Intervention for Chronic Pain in Primary Care

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03692468
Enrollment
61
Registered
2018-10-02
Start date
2018-09-20
Completion date
2020-11-18
Last updated
2022-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

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.

Interventions

BEHAVIORALPsychotherapy

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.

Sponsors

Henry Ford Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hospital Anxiety and Depression Scale5 weeks post-baselineThis 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 Inventory5 weeks post-baselineThe 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

MeasureTime frameDescription
Insomnia Severity IndexAdministered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-upsThis measure assess difficulty with sleep. Total scores range from 0-28, with greater numbers indicating greater sleep difficulty.
Pain Catastrophizing ScaleAdministered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-upsThis 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 ScaleAdministered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-upsThis measure assesses how satisfied a patient is with their life. Total scores range from 7-35 with higher scores indicating greater satisfaction.
Health care utilizationMeasured 6 months before and 6 months after study enrollmentThe number of primary and specialty care visits, prescriptions written, emergency room visits, and hospital admissions

Other

MeasureTime frameDescription
Mindful Attention Awareness ScaleAdministered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-upsThis measure assess the extent to which someone is using mindful awareness. Total scores range from 15-90 with greater scores indicating greater mindfulness.
Montreal Cognitive AssessmentAdministered at baselineBrief screen of cognitive functioning; scores range from 0-30
Brief Medical Numbers TestAdministered at baselineBrief screen of health numeracy; scores range from 0-4
Rapid Estimate of Adult Learning in MedicineAdministered at baselineBrief 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
Chronic Pain Acceptance QuestionnaireAdministered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-upsThis 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026