Virtual Human Technology for Patients With Chronic Pain

NCT ID: NCT04349033

Last Updated: 2024-03-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-10

Study Completion Date

2021-08-01

Brief Summary

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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

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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.

Conditions

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Chronic Musculoskeletal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Emotional Disclosure and Brain Education

Intervention Type BEHAVIORAL

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 stress and other emotional issues only.

Group Type ACTIVE_COMPARATOR

Emotional Disclosure Only

Intervention Type BEHAVIORAL

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 experience.

Group Type PLACEBO_COMPARATOR

Pain Information Control

Intervention Type BEHAVIORAL

Patients are interviewed about their pain history and other basic, non-disclosure information about their health.

Interventions

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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.

Intervention Type BEHAVIORAL

Emotional Disclosure Only

Patients are interviewed about a number of aspects of their lives, but without brain education

Intervention Type BEHAVIORAL

Pain Information Control

Patients are interviewed about their pain history and other basic, non-disclosure information about their health.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Chronic musculoskeletal Pain

Exclusion Criteria

* Non-English speaking
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role collaborator

Wayne State University

OTHER

Sponsor Role lead

Responsible Party

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Mark A. Lumley

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Doerte U Junghaenel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Mark A Lumley, PhD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

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University of Southern California Center for Self-report Science

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Junghaenel DU, Schneider S, Lucas G, Boberg J, Weinstein FM, Richeimer SH, Stone AA, Lumley MA. Virtual Human-Delivered Interviews for Patients With Chronic Pain: Feasibility, Acceptability, and a Pilot Randomized Trial of Standard Medical, Psychosocial, and Educational Interviews. Psychosom Med. 2023 Sep 1;85(7):627-638. doi: 10.1097/PSY.0000000000001228. Epub 2023 Jun 16.

Reference Type DERIVED
PMID: 37363989 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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UP-19-00230

Identifier Type: -

Identifier Source: org_study_id

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