A Brief Intervention for Chronic Pain in Primary Care

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Behavioral: Psychotherapy

• Registration Number: NCT03692468
• Lead Sponsor: Henry Ford Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-20
• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-02
• Primary Completion: 2020-04-21
• Study Completion: 2020-11-18
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Psychotherapy	Participants will engage in a 5 session psychotherapy intervention focused on improving pain and mood.

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale	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	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 Outcome Measures

Name	Time	Method
Satisfaction with Life Scale	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.
Health care utilization	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
Pain Catastrophizing Scale	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).
Insomnia Severity Index	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.

Trial Locations

Locations (1)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States