Musculoskeletal PainNCT04498663
The Pain & Stress Interview Study for People With Chronic Pain
A study testing Emotion- and Relationship-Focused Therapeutic Interview in people with Musculoskeletal Pain, run by Mark A. Lumley at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Emotion- and Relationship-Focused Therapeutic Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a chronic primary musculoskeletal pain condition
- significant history of childhood adversity (score of 3 or higher on the Adverse Childhood Experiences (ACE) Scale.
Who cannot join
- current psychotic disorder
- unable communicate in English
- unable to read
- surgery scheduled within 2 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Wayne State University Department of Psychology
Detroit, Michigan, 48202
About this study
Official title: Emotion- and Relationship-Focused Therapeutic Interview for Chronic Musculoskeletal Pain: A Randomized Trial
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.
Read the 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.
- Conditions
- Musculoskeletal Pain
- Being tested
- Emotion- and Relationship-Focused Therapeutic Interview
- Keywords
- Chronic Pain
- Medical subject headings
- Musculoskeletal Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion- and Relationship-Focused Therapeutic InterviewBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Interview Condition | Experimental | 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. Receives: Behavioral: Emotion- and Relationship-Focused Therapeutic Interview |
| Waitlist Control Condition | No intervention | Participants in the waitlist control condition will receive a delayed interview (after 6-week follow-up assessment), if they choose to do so. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain severity from baseline to 6-week follow-up
Brief Pain Inventory pain severity scale (0 - 10; higher values = greater pain severity)
Measured: 6-week follow-up
Secondary outcomes (8)
Change in pain interference from baseline to 6-week follow-up
Brief Pain Inventory pain interference scale (0 - 10; higher values = greater pain interference)
Measured: 6-week follow-up
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
Measured: 6-week follow-up
Change in anxiety from baseline to 6-week follow-up
PROMIS anxiety scale (0 to 4; higher values = greater anxiety)
Measured: 6-week follow-up
Change in depression from baseline to 6-week follow-up
PROMIS depression scale (0 to 4; higher values = greater depression)
Measured: 6-week follow-up
Change in anger from baseline to 6-week follow-up
PROMIS anger scale (0 to 4; higher values = greater anger)
Measured: 6-week follow-up
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)
Measured: 6-week follow-up
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)
Measured: 6-week follow-up
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)
Measured: 6-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start10 Sep 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark A. Lumley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mark A. Lumley, Wayne State University
- Investigators
- Mark Lumley, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498663
- Sponsor's protocol ID
- IRB-20-04-2070
- Status last verified
- Jul 2022
- First submitted
- 29 Jul 2020
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Krohner S, Town J, Cannoy CN, Schubiner H, Rapport LJ, Grekin E, Lumley MA. Emotion-Focused Psychodynamic Interview for People with Chronic Musculoskeletal Pain and Childhood Adversity: A Randomized Controlled Trial. J Pain. 2024 Jan;25(1):39-52. doi: 10.1016/j.jpain.2023.07.017. Epub 2023 Jul 20.
PubMed 37479050
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion- and Relationship-Focused Therapeutic Interview for Chronic Musculoskeletal Pain: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04498663
- Acronym / sponsor ID
- IRB-20-04-2070
- Conditions
- Musculoskeletal Pain
- Keywords
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Mark A. LumleyUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Interview Condition | Experimental | Behavioral: Emotion- and Relationship-Focused Therapeutic InterviewThe 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. |
| Waitlist Control Condition | No intervention | –Participants in the waitlist control condition will receive a delayed interview (after 6-week follow-up assessment), if they choose to do so. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- a chronic primary musculoskeletal pain condition
- significant history of childhood adversity (score of 3 or higher on the Adverse Childhood Experiences (ACE) Scale.
Key exclusion criteria (4 listed)
- current psychotic disorder
- unable communicate in English
- unable to read
- surgery scheduled within 2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion- and Relationship-Focused Therapeutic InterviewIn 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. | Behavioural | Therapeutic Interview Condition |
Primary outcome
Change in pain severity from baseline to 6-week follow-up
Time frame: 6-week follow-up
Brief Pain Inventory pain severity scale (0 - 10; higher values = greater pain severity)
8 secondary outcomes
Change in pain interference from baseline to 6-week follow-up
Time frame: 6-week follow-up
Change in pain anxiety from baseline to 6-week follow-up
Time frame: 6-week follow-up
Change in anxiety from baseline to 6-week follow-up
Time frame: 6-week follow-up
Change in depression from baseline to 6-week follow-up
Time frame: 6-week follow-up
Change in anger from baseline to 6-week follow-up
Time frame: 6-week follow-up
Change in pain attributions to psychological processes from baseline to 6-week follow-up
Time frame: 6-week follow-up
Change in pain attributions to brain processes from baseline to 6-week follow-up
Time frame: 6-week follow-up
Change in pain beliefs (harm, control, emotion) from baseline to 6-week follow-up
Time frame: 6-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Derived from this study: PubMed 37479050Krohner S, Town J, Cannoy CN, Schubiner H, Rapport LJ, Grekin E, Lumley MA. Emotion-Focused Psychodynamic Interview for People with Chronic Musculoskeletal Pain and Childhood Adversity: A Randomized Controlled Trial. J Pain. 2024 Jan;25(1):39-52. doi: 10.1016/j.jpain.2023.07.017. Epub 2023 Jul 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Lumley, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion- and Relationship-Focused Therapeutic Interview in people with Musculoskeletal Pain, run by Mark A. Lumley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain severity from baseline to 6-week follow-up (time frame: 6-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04498663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.