Virtual Human Technology for Patients With Chronic Pain

Chronic Musculoskeletal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04349033
• Other study ID #: UP-19-00230
• Status: Completed
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: March 2024
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic musculoskeletal Pain

Exclusion Criteria:

• Non-English speaking

Related Conditions & MeSH terms

• Chronic Musculoskeletal Pain
• Chronic Pain
• Musculoskeletal Pain

Intervention

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.
• Emotional Disclosure Only
Patients are interviewed about a number of aspects of their lives, but without brain education
• Pain Information Control
Patients are interviewed about their pain history and other basic, non-disclosure information about their health.

Locations

Country	Name	City	State
United States	University of Southern California Center for Self-report Science	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Pain Catastrophizing Scale	Pain catastrophizing (range: 0.0 to 4.0; higher scores = more catastrophizing)	Change from Baseline to 1-month follow-up
Secondary	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