Back to resultsVirtual Human Technology for Patients With Chronic Pain
Primary Purpose
Chronic Musculoskeletal Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotional Disclosure and Brain Education
Emotional Disclosure Only
Pain Information Control
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Musculoskeletal Pain
Eligibility Criteria
Inclusion Criteria:
- Chronic musculoskeletal Pain
Exclusion Criteria:
- Non-English speaking
Sites / Locations
- University of Southern California Center for Self-report Science
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Emotional Disclosure and Brain Education
Emotional Disclosure only
Pain Information Control
Arm Description
Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain.
Patients are interviewed about stress and other emotional issues only.
Patients are interviewed about their pain history and experience.
Outcomes
Primary Outcome Measures
Pain intensity (range: 0.0 to 10.0; higher = more severe pain)
Brief Pain Inventory (4 pain rating items)
Secondary Outcome Measures
Pain interference (range: 0.0 to 10.0; higher = more interference)
Brief Pain Inventory (7 interference items)
Full Information
NCT ID
NCT04349033
First Posted
April 13, 2020
Last Updated
August 13, 2021
Sponsor
Wayne State University
Collaborators
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT04349033
Brief Title
Virtual Human Technology for Patients With Chronic Pain
Official Title
Virtual Human Technology for Patients With Chronic Pain: Experimental Study of Pain Neuroscience and Emotional Disclosure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
University of Southern California
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Musculoskeletal Pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Emotional Disclosure and Brain Education
Arm Type
Experimental
Arm Description
Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain.
Arm Title
Emotional Disclosure only
Arm Type
Active Comparator
Arm Description
Patients are interviewed about stress and other emotional issues only.
Arm Title
Pain Information Control
Arm Type
Placebo Comparator
Arm Description
Patients are interviewed about their pain history and experience.
Intervention Type
Behavioral
Intervention Name(s)
Emotional Disclosure and Brain Education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Emotional Disclosure Only
Intervention Description
Patients are interviewed about a number of aspects of their lives, but without brain education
Intervention Type
Behavioral
Intervention Name(s)
Pain Information Control
Intervention Description
Patients are interviewed about their pain history and other basic, non-disclosure information about their health.
Primary Outcome Measure Information:
Title
Pain intensity (range: 0.0 to 10.0; higher = more severe pain)
Description
Brief Pain Inventory (4 pain rating items)
Time Frame
Baseline to 1-month follow-up
Secondary Outcome Measure Information:
Title
Pain interference (range: 0.0 to 10.0; higher = more interference)
Description
Brief Pain Inventory (7 interference items)
Time Frame
Baseline to 1-month follow-up
Other Pre-specified Outcome Measures:
Title
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)
Description
Pain Stages of Change Questionnaire
Time Frame
Baseline to 1-month follow-up
Title
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)
Description
Survey of Pain Attitudes
Time Frame
Baseline to 1-month follow-up
Title
Pain catastrophizing (range: 0.0 to 4.0; higher scores = more catastrophizing)
Description
Pain Catastrophizing Scale
Time Frame
Baseline to 1-month follow-up
Title
Opioid use (range 0 to 6; higher scores = more opioid misuse)
Description
Opioid Use Questionnaire
Time Frame
Baseline to 1-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic musculoskeletal Pain
Exclusion Criteria:
Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doerte U Junghaenel, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark A Lumley, PhD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California Center for Self-report Science
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-3332
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Virtual Human Technology for Patients With Chronic Pain
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