Virtual Human Technology for Patients With Chronic Pain

Not Applicable

Completed

• Conditions: Chronic Musculoskeletal Pain
• Interventions: Behavioral: Pain Information Control; Behavioral: Emotional Disclosure Only; Behavioral: Emotional Disclosure and Brain Education

• Registration Number: NCT04349033
• Lead Sponsor: Wayne State University

Brief Summary

The experimental study compares three virtual human interviews of patients with chronic musculoskeletal pain: Emotional disclosure and brain, emotional disclosure only, basic information control. Effects on attitudes and clinical outcomes at 1-month follow-up are assessed.

Detailed Description

Emotional disclosure about stressors and other private experiences has been found to be helpful for some people with chronic musculoskeletal pain. Also, helping patients understand the role of the brain in pain has been helpful. We have developed a virtual human interviewer to help patients talk about their pain and their lives. We will conduct an experimental study to compare the effects of several different types of VH interviews. Patients with chronic pain will be randomized to receive one of three VH interviews: emotional disclosure and brain education; emotional disclosure alone; or a control basic pain interview. Patients will be assessed at baseline and 1-month follow-up on a range of attitudinal and clinical measures to determine how these different interviews affect outcomes.

Study Timeline

• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-16
• Study Start: 2021-02-10
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01
• Results First Submitted: 2023-07-31
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-11
• Last Update Submitted: 2024-03-11
• Results First Posted: 2024-03-12
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Chronic musculoskeletal Pain

Exclusion Criteria

• Non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain Information Control	Pain Information Control	Patients are interviewed about their pain history and experience.
Emotional Disclosure only	Emotional Disclosure Only	Patients are interviewed about stress and other emotional issues only.
Emotional Disclosure and Brain Education	Emotional Disclosure and Brain Education	Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain.

Primary Outcome Measures

Name	Time	Method
Pain Intensity	Change from Baseline to 1-month follow-up	Brief Pain Inventory (average of the 4 pain intensity rating items: highest, lowest, average, now). Range: 0.0 to 10.0 (higher = more severe pain)

Secondary Outcome Measures

Name	Time	Method
Emotional Distress	Change from Baseline to 1-month follow-up	Self-rating of how "depressed," "anxious," "angry," and "guilty" participant was during last week on 0 to 4 scale. Ratings averaged; higher means = more distress
Pain Stages of Change Questionnaire	Change from Baseline to 1-month follow-up	Pain Stages of Change Questionnaire assesses readiness / motivation to engage in pain self-management. Sum of subscales of Contemplation + Action + Maintenance - Precontemplation; Range = 0 to 12; higher scores = more readiness to change
Pain Interference	Change from Baseline to 1-month follow-up	Brief Pain Inventory (7 interference items; range: 0.0 to 10.0; higher = more interference)
Pain Catastrophizing Scale	Change from Baseline to 1-month follow-up	Pain catastrophizing (range: 0.0 to 4.0; higher scores = more catastrophizing)

Trial Locations

Locations (1)

University of Southern California Center for Self-report Science; 🇺🇸 Los Angeles, California, United States