Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04498663
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2020-07-29
Brief Title:
The Pain Stress Interview Study for People With Chronic Pain
Sponsor:
Mark A Lumley
Organization:
Wayne State University
Study Overview
Official Title:
Emotion- and Relationship-Focused Therapeutic Interview for Chronic Musculoskeletal Pain A Randomized Trial
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 ie 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 eg 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 eg 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 ones cognitive behavioral and emotional responses to ones 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
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 11 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 ie 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 eg 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 eg 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 ones cognitive behavioral and emotional responses to ones 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None