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The Pain & Stress Interview Study for People With Chronic Pain

Primary Purpose

Musculoskeletal Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotion- and Relationship-Focused Therapeutic Interview
Sponsored by
Mark A. Lumley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain focused on measuring Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a chronic primary musculoskeletal pain condition
  • significant history of childhood adversity (score of 3 or higher on the Adverse Childhood Experiences (ACE) Scale.

Exclusion Criteria:

  • current psychotic disorder
  • unable communicate in English
  • unable to read
  • surgery scheduled within 2 months

Sites / Locations

  • Wayne State University Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Therapeutic Interview Condition

Waitlist Control Condition

Arm Description

The therapeutic interview for chronic pain will be a one-session interview lasting approximately 90 minutes. The goals of the therapeutic interview are to promote awareness of the role of trauma and interpersonal stress in pain, to encourage experience of emotions associated with interpersonal stressors and conflicts, and to encourage more adaptive interpersonal communication in current relationships.

Participants in the waitlist control condition will receive a delayed interview (after 6-week follow-up assessment), if they choose to do so.

Outcomes

Primary Outcome Measures

Change in pain severity from baseline to 6-week follow-up
Brief Pain Inventory pain severity scale (0 - 10; higher values = greater pain severity)

Secondary Outcome Measures

Change in pain interference from baseline to 6-week follow-up
Brief Pain Inventory pain interference scale (0 - 10; higher values = greater pain interference)
Change in pain anxiety from baseline to 6-week follow-up
Pain Anxiety Symptom Scale-20 (sum ranges from 0 to 100; higher values = greater pain anxiety
Change in anxiety from baseline to 6-week follow-up
PROMIS anxiety scale (0 to 4; higher values = greater anxiety)
Change in depression from baseline to 6-week follow-up
PROMIS depression scale (0 to 4; higher values = greater depression)
Change in anger from baseline to 6-week follow-up
PROMIS anger scale (0 to 4; higher values = greater anger)
Change in pain attributions to psychological processes from baseline to 6-week follow-up
Pain attributions psychological subscale (0 to 4; higher values = greater psychological attribution)
Change in pain attributions to brain processes from baseline to 6-week follow-up
Pain attributions brain subscale (0 to 4; higher values = greater brain attributions)
Change in pain beliefs (harm, control, emotion) from baseline to 6-week follow-up
Survey of Pain Attitudes subscales (1 to 5; higher values = stronger beliefs)

Full Information

First Posted
July 29, 2020
Last Updated
July 28, 2022
Sponsor
Mark A. Lumley
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1. Study Identification

Unique Protocol Identification Number
NCT04498663
Brief Title
The Pain & Stress Interview Study for People With Chronic Pain
Official Title
Emotion- and Relationship-Focused Therapeutic Interview for Chronic Musculoskeletal Pain: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 10, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark A. Lumley

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of the study is to determine whether a brief, therapeutic interview can help patients improve their pain and health by addressing psychological issues that are known to drive chronic musculoskeletal pain. This randomized, controlled trial tests the efficacy of a brief, one-session therapeutic interview for patients with chronic musculoskeletal pain and histories of childhood adversity. Adults with chronic musculoskeletal pain will be randomized to either a therapeutic interview condition or a waitlist control condition. The therapeutic interview will be 90-minute session during which participants will be encouraged to disclose stressful experiences, express important emotions, and identify connections between their life stress and their pain, which we hope will increase their psychological attributions for pain and reduce their pain, interpersonal problems, and psychological distress. The study will compare the therapeutic interview condition to a delayed interview condition and will follow patients for 6 weeks to identify changes in response to the interview. Participants in the therapeutic interview condition are expected to show more improvement on pain severity, pain interference, psychological distress, interpersonal function, and psychological attitudes toward pain at follow-up, relative to participants in the delayed interview condition.
Detailed Description
This study is a randomized controlled trial to test the efficacy of a brief, one-session therapeutic interview for patients who are seeking biomedical care for their chronic musculoskeletal pain and who also have self-reported trauma histories. Participants will be randomized to either a therapeutic interview condition or a waitlist control condition and and will follow patients for 6 weeks to identify health and attitude changes in response to the interview. This study will recruit adults with chronic musculoskeletal pain and reported histories of childhood adversity. Participants will be adults with primary musculoskeletal pain such as low back pain, neck pain, and fibromyalgia. In addition, only those patients who also report a significant history of childhood adversity will be eligible for this study, as determined by a score of 3 or higher on the Adverse Childhood Experiences (ACE) Scale. Patients will be excluded if they: a) have a current psychotic disorder or b) are unable to communicate in English, or c) are scheduled for an upcoming surgery within the next 2 months. Participants will be allowed to engage in this study regardless of current medication use or engagement in other treatment. Patients who are interested in participating will complete a brief online screening to determine eligibility and will be provided with basic information about the study. Once consented, baseline measures will be completed online, and participants will be randomized, 1:1, to the therapeutic interview condition or waitlist control condition. Those who are randomized to the therapeutic interview condition will complete their interview as soon as possible after completing baseline measures. The interview will be conducted either in-person at the Stress & Health Laboratory at Wayne State University, or remotely via a secure telehealth platform (depending on COVID-19 restrictions). Follow-up measures will be administered at 6 weeks after the interview (or at the equivalent time for the waitlist group). Participants in the waitlist control condition will be given the opportunity to receive the therapeutic interview after completion of the follow-up measures. The therapeutic interview will be a one-session interview lasting approximately 90 minutes. The interview will be conducted by trained interviewers (i.e., clinical psychology graduate students). The goals of the therapeutic interview are to promote awareness of the role of trauma and interpersonal stress in pain, to encourage experience of emotions associated with interpersonal stressors and conflicts, and to encourage more adaptive interpersonal communication in current relationships. The interview has five primary components. The first component involves eliciting a brief pain history from the participants. The next component explores participants' stressful life experiences, including those that occurred during their childhood and those that might be affecting their current life. The next component will introduce participants to a model of emotions that illustrates how suppressing important, healthy feelings in relationships can lead to symptoms (e.g. anxiety, pain, stress). Participants will be encouraged to identify the feelings that are most difficult for them to express in relationships and the ways in which avoiding these feelings leads to prolonged stress or worse pain. The next component involves encouraging participants to identify key, conflictual relationships and to express their previously avoided, healthy feelings (e.g. assertion, tenderness, grief). The final and 5th component will explore how the interview affected their beliefs about the role of stress and emotions in pain. The interviewer will provide a summary of their strengths and areas for improvement related to their emotions and interpersonal functioning. There will be clinical outcomes that reflect changes in pain severity and pain interference, pain-related anxiety, and emotional distress. There will be behavioral outcomes that capture changes in patients' interpersonal assertiveness, substance use, and adaptive affective functioning (defined as one's cognitive, behavioral, and emotional responses to one's healthy feelings or needs). Finally, there will be attitudinal outcomes that reflect changes in patients' attributions about the role of psychological and brain-based factors in pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain
Keywords
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized at a 1:1 ratio to one of two groups--either the therapeutic interview condition or the waitlist control condition.
Masking
None (Open Label)
Masking Description
Both patient and research assistant interviewer will be blinded to condition assignment during the baseline assessment.
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Interview Condition
Arm Type
Experimental
Arm Description
The therapeutic interview for chronic pain will be a one-session interview lasting approximately 90 minutes. The goals of the therapeutic interview are to promote awareness of the role of trauma and interpersonal stress in pain, to encourage experience of emotions associated with interpersonal stressors and conflicts, and to encourage more adaptive interpersonal communication in current relationships.
Arm Title
Waitlist Control Condition
Arm Type
No Intervention
Arm Description
Participants in the waitlist control condition will receive a delayed interview (after 6-week follow-up assessment), if they choose to do so.
Intervention Type
Behavioral
Intervention Name(s)
Emotion- and Relationship-Focused Therapeutic Interview
Intervention Description
In this study, the therapeutic interview will be one-session lasting 90 minutes. Participants will explore prior and ongoing stressful life experiences. Participants will be educated about the role of stress in pain and will be encouraged to identify links between stressors, psychological and emotional conflicts related to the stressors, and their pain symptoms. The interview will encourage the experience and expression of previously avoided emotions related to interpersonal stressors.
Primary Outcome Measure Information:
Title
Change in pain severity from baseline to 6-week follow-up
Description
Brief Pain Inventory pain severity scale (0 - 10; higher values = greater pain severity)
Time Frame
6-week follow-up
Secondary Outcome Measure Information:
Title
Change in pain interference from baseline to 6-week follow-up
Description
Brief Pain Inventory pain interference scale (0 - 10; higher values = greater pain interference)
Time Frame
6-week follow-up
Title
Change in pain anxiety from baseline to 6-week follow-up
Description
Pain Anxiety Symptom Scale-20 (sum ranges from 0 to 100; higher values = greater pain anxiety
Time Frame
6-week follow-up
Title
Change in anxiety from baseline to 6-week follow-up
Description
PROMIS anxiety scale (0 to 4; higher values = greater anxiety)
Time Frame
6-week follow-up
Title
Change in depression from baseline to 6-week follow-up
Description
PROMIS depression scale (0 to 4; higher values = greater depression)
Time Frame
6-week follow-up
Title
Change in anger from baseline to 6-week follow-up
Description
PROMIS anger scale (0 to 4; higher values = greater anger)
Time Frame
6-week follow-up
Title
Change in pain attributions to psychological processes from baseline to 6-week follow-up
Description
Pain attributions psychological subscale (0 to 4; higher values = greater psychological attribution)
Time Frame
6-week follow-up
Title
Change in pain attributions to brain processes from baseline to 6-week follow-up
Description
Pain attributions brain subscale (0 to 4; higher values = greater brain attributions)
Time Frame
6-week follow-up
Title
Change in pain beliefs (harm, control, emotion) from baseline to 6-week follow-up
Description
Survey of Pain Attitudes subscales (1 to 5; higher values = stronger beliefs)
Time Frame
6-week follow-up
Other Pre-specified Outcome Measures:
Title
Change in alcohol use frequency from baseline to 6-week follow-up
Description
Alcohol use item (1 to 7; higher = greater alcohol use)
Time Frame
6-week follow-up
Title
Change in pain medication use from baseline to 6-week follow-up
Description
Item assessing pain medication use (1 to 5; higher = greater medication use)
Time Frame
6-week follow-up
Title
Change in affect phobia from baseline to 6-week follow-up
Description
Affect Phobia Test (1 to 5; lower values = affect phobia)
Time Frame
6-week follow-up
Title
Change in assertiveness from baseline to 6-week follow-up
Description
Rathus Assertiveness Schedule short form (- 3 to + 3; higher values = greater assertion)
Time Frame
6-week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a chronic primary musculoskeletal pain condition significant history of childhood adversity (score of 3 or higher on the Adverse Childhood Experiences (ACE) Scale. Exclusion Criteria: current psychotic disorder unable communicate in English unable to read surgery scheduled within 2 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Lumley, PhD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University Department of Psychology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

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The Pain & Stress Interview Study for People With Chronic Pain

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