Virtual Human Technology for Patients With Chronic Pain

Virtual Human Technology for Patients With Chronic Pain: Experimental Study of Pain Neuroscience and Emotional Disclosure

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.

Study Overview

• Status: Completed
• Conditions: Chronic Musculoskeletal Pain
• Intervention / Treatment: Behavioral: Emotional Disclosure and Brain Education; Behavioral: Emotional Disclosure Only; Behavioral: Pain Information Control

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 Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90089-3332
      • University of Southern California Center for Self-report Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Chronic musculoskeletal Pain

Exclusion Criteria:

• Non-English speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Emotional Disclosure and Brain Education; Patients are interviewed about a number of aspects of their lives (stress, other illnesses, personality, adverse childhood experiences), and these are explored as part of education of the brain's role in their pain.
Active Comparator: Emotional Disclosure only; Patients are interviewed about stress and other emotional issues only.	Behavioral: Emotional Disclosure Only; Patients are interviewed about a number of aspects of their lives, but without brain education
Placebo Comparator: Pain Information Control; Patients are interviewed about their pain history and experience.	Behavioral: Pain Information Control; Patients are interviewed about their pain history and other basic, non-disclosure information about their health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	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)	Change from Baseline to 1-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Interference	Brief Pain Inventory (7 interference items; range: 0.0 to 10.0; higher = more interference)	Change from Baseline to 1-month follow-up
Pain Stages of Change Questionnaire	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	Change from Baseline to 1-month follow-up
Pain Catastrophizing Scale	Pain catastrophizing (range: 0.0 to 4.0; higher scores = more catastrophizing)	Change from Baseline to 1-month follow-up
Emotional Distress	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	Change from Baseline to 1-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readiness / motivation to engage in pain self-management (Subscales of Precontemplation, Contemplation, Action, Maintenance; Range on each subscale: 1.0 to 5.0; higher scores = more endorsement of that stage of change)	Pain Stages of Change Questionnaire	Baseline to 1-month follow-up
Pain attitudes (Subscales of Control, Medication use, Disability, Emotion, Harm, Brain attributions, Psychological attributions; range 0.0 to 4.0; higher scores indicate more endorsement of each attitude)	Survey of Pain Attitudes	Baseline to 1-month follow-up
Pain catastrophizing (range: 0.0 to 4.0; higher scores = more catastrophizing)	Pain Catastrophizing Scale	Baseline to 1-month follow-up
Opioid use (range 0 to 6; higher scores = more opioid misuse)	Opioid Use Questionnaire	Baseline to 1-month follow-up

Collaborators and Investigators

• Sponsor: Wayne State University
• Collaborators: University of Southern California
• Investigators: Principal Investigator: Doerte U Junghaenel, PhD, University of Southern California; Principal Investigator: Mark A Lumley, PhD, Wayne State University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Chronic Pain; Musculoskeletal Pain
• Other Study ID Numbers: UP-19-00230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Full, anonymized data set
• IPD Sharing Time Frame: Starting 1 year after study end, for 5 years.
• IPD Sharing Access Criteria: Contact the study PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No