The Pain & Stress Interview Study for People With Chronic Pain

NCT04498663 | Completed

• 1 other identifier: IRB-20-04-2070
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain

Keywords

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Change in pain severity from baseline to 6-week follow-up

  Brief Pain Inventory pain severity scale (0 - 10; higher values = greater pain severity)

  6-week follow-up

Secondary Outcomes (8)

• Change in pain interference from baseline to 6-week follow-up

  6-week follow-up

• Change in pain anxiety from baseline to 6-week follow-up

  6-week follow-up

• Change in anxiety from baseline to 6-week follow-up

  6-week follow-up

• Change in depression from baseline to 6-week follow-up

  6-week follow-up

• Change in anger from baseline to 6-week follow-up

  6-week follow-up

Other Outcomes (4)

• Change in alcohol use frequency from baseline to 6-week follow-up

  6-week follow-up

• Change in pain medication use from baseline to 6-week follow-up

  6-week follow-up

• Change in affect phobia from baseline to 6-week follow-up

  6-week follow-up

Study Arms (2)

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.

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.

Interventions

Emotion- and Relationship-Focused Therapeutic Interview BEHAVIORAL

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.

Therapeutic Interview Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mark A. Lumley: lead

Study Sites (1)

Wayne State University Department of Psychology

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

• 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.

  PMID: 37479050 DERIVED

MeSH Terms

Conditions

Musculoskeletal Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Lumley, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Both patient and research assistant interviewer will be blinded to condition assignment during the baseline assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Distinguished Professor of Psychology

Model Details: Participants will be randomized at a 1:1 ratio to one of two groups--either the therapeutic interview condition or the waitlist control condition.

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 4, 2020
• Study Start: September 10, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: August 2, 2022

Record last verified: 2022-07

Locations

US (1)