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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04349033
Other study ID # UP-19-00230
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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