A Brief Intervention for Chronic Pain in Primary Care

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Lisa Matero，Henry Ford Health System

Tracking Information

First Submitted Date ^ICMJE

September 20, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

September 20, 2018

Estimated Primary Completion Date

June 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Insomnia Severity Index[ Time Frame: 5 weeks post-baseline ]
This measure assess difficulty with sleep. Total scores range from 0-28, with greater numbers indicating greater sleep difficulty.
Pain Catastrophizing Scale[ Time Frame: 5 weeks post-baseline ]
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[ Time Frame: 5 weeks post-baseline ]
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[ Time Frame: Six months after baseline ]
The number of primary and specialty care visits, prescriptions written, emergency room visits, and hospital admissions

Descriptive Information

Brief Title ^ICMJE

A Brief Intervention for Chronic Pain in Primary Care

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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.

Study Arms

Experimental: Intervention Group
Participants will engage in a 5 session psychotherapy intervention focused on improving pain and mood.
No Intervention: Control Group
Patients will receive treatment as usual from their care providers.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 30, 2020

Estimated Primary Completion Date

June 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Lisa Matero，Henry Ford Health System

Study Sponsor ^ICMJE

Henry Ford Health System

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Henry Ford Health System

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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