NCT04349033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

February 10, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

March 12, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

April 13, 2020

Results QC Date

July 31, 2023

Last Update Submit

March 11, 2024

Conditions

Chronic Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Pain Interference

    Change from Baseline to 1-month follow-up

  • Pain Stages of Change Questionnaire

    Change from Baseline to 1-month follow-up

  • Pain Catastrophizing Scale

    Change from Baseline to 1-month follow-up

  • Emotional Distress

    Change from Baseline to 1-month follow-up

Study Arms (3)

Emotional Disclosure and Brain Education

EXPERIMENTAL

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

Emotional Disclosure only

ACTIVE COMPARATOR

Patients are interviewed about stress and other emotional issues only.

Behavioral: Emotional Disclosure Only

Pain Information Control

PLACEBO COMPARATOR

Patients are interviewed about their pain history and experience.

Behavioral: Pain Information Control

Interventions

Emotional Disclosure and Brain EducationBEHAVIORAL

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 and Brain Education
Emotional Disclosure OnlyBEHAVIORAL

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

Emotional Disclosure only
Pain Information ControlBEHAVIORAL

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

Pain Information Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic musculoskeletal Pain

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California Center for Self-report Science

Los Angeles, California, 90089-3332, United States

Location

Related Publications (1)

  • 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.

    PMID: 37363989DERIVED

Limitations and Caveats

Patient debriefing was conducted at the end of the VH session and before the follow-up assessment.

Results Point of Contact

Title
Dr. Mark A. Lumley, Professor
Organization
Wayne State University
mlumley@wayne.edu
3135772247

Study Officials

  • Doerte U Junghaenel, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

  • Mark A Lumley, PhD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 16, 2020

Study Start

February 10, 2021

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

March 12, 2024

Results First Posted

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Full, anonymized data set

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Starting 1 year after study end, for 5 years.
Access Criteria
Contact the study PI

Locations

US(1)