Skip to main content
OpenTrials
Completed

NCT Number: NCT03692468

A Brief Intervention for Chronic Pain in Primary Care

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychotherapy

Behavioral

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Insomnia Severity Index

    Time frame: Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups

    This measure assess difficulty with sleep. Total scores range from 0-28, with greater numbers indicating greater sleep difficulty.

  2. Pain Catastrophizing Scale

    Time frame: Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups

    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).

  3. Satisfaction with Life Scale

    Time frame: Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups

    This measure assesses how satisfied a patient is with their life. Total scores range from 7-35 with higher scores indicating greater satisfaction.

  4. Health care utilization

    Time frame: Measured 6 months before and 6 months after study enrollment

    The number of primary and specialty care visits, prescriptions written, emergency room visits, and hospital admissions

Other outcomes

  1. Chronic Pain Acceptance Questionnaire

    Time frame: Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups

    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).

  2. Mindful Attention Awareness Scale

    Time frame: Administered at baseline, 5 weeks post-baseline, and 1 month and 6-month follow-ups

    This measure assess the extent to which someone is using mindful awareness. Total scores range from 15-90 with greater scores indicating greater mindfulness.

  3. Montreal Cognitive Assessment

    Time frame: Administered at baseline

    Brief screen of cognitive functioning; scores range from 0-30

  4. Brief Medical Numbers Test

    Time frame: Administered at baseline

    Brief screen of health numeracy; scores range from 0-4

  5. Rapid Estimate of Adult Learning in Medicine

    Time frame: Administered at baseline

    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

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 2, 2018
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.