NCT03692468

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

September 20, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2020

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

1.6 years

First QC Date

September 20, 2018

Last Update Submit

December 6, 2022

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Insomnia Severity Index

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

  • Pain Catastrophizing Scale

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

  • Satisfaction with Life Scale

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

  • Health care utilization

    Measured 6 months before and 6 months after study enrollment

Other Outcomes (5)

  • Chronic Pain Acceptance Questionnaire

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

  • Mindful Attention Awareness Scale

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

  • Montreal Cognitive Assessment

    Administered at baseline

  • +2 more other outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: Psychotherapy

Control Group

NO INTERVENTION

Patients will receive treatment as usual from their care providers.

Interventions

PsychotherapyBEHAVIORAL

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Current behavioral health treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (2)

  • Miller-Matero LR, Gavrilova L, Hecht LM, Autio K, Tobin ET, Braciszewski JM, Maye M, Felton JW, Ahmedani BK. A brief psychological intervention for chronic pain in primary care: Examining long-term effects from a pilot randomized clinical trial. Pain Pract. 2022 Jul;22(6):564-570. doi: 10.1111/papr.13134. Epub 2022 Jun 14.

    PMID: 35665994DERIVED

  • Miller-Matero LR, Hecht LM, Miller MK, Autio K, Pester BD, Tobin ET, Patel S, Braciszewski JM, Maye M, Ahmedani BK. A Brief Psychological Intervention for Chronic Pain in Primary Care: A Pilot Randomized Controlled Trial. Pain Med. 2021 Jul 25;22(7):1603-1611. doi: 10.1093/pm/pnaa444.

    PMID: 33616190DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Staff Psychologist

Study Record Dates

First Submitted

September 20, 2018

First Posted

October 2, 2018

Study Start

September 20, 2018

Primary Completion

April 21, 2020

Study Completion

November 18, 2020

Last Updated

December 7, 2022

Record last verified: 2022-12

Locations

US(1)