Chronic Musculoskeletal PainNCT04349033

Virtual Human Technology for Patients With Chronic Pain

A study testing Emotional Disclosure and Brain Education and Emotional Disclosure Only in people with Chronic Musculoskeletal Pain, run by Wayne State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Musculoskeletal Pain
What is being tested?: Emotional Disclosure and Brain Education and Emotional Disclosure Only
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 94 participants
Where: 1 siteUnited States
Study dates: 10 Feb 2021to 1 Aug 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chronic musculoskeletal Pain

Who cannot join

Non-English speaking

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Southern California Center for Self-report Science
Los Angeles, California, 90089-3332

Other trials in United States

About this study

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

Read the 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.

Conditions: Chronic Musculoskeletal Pain
Being tested: Emotional Disclosure and Brain Education, Emotional Disclosure Only, Pain Information Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04349033
Study group	Role	What they receive
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. Receives: Behavioral: Emotional Disclosure and Brain Education
Emotional Disclosure only	Active comparator	Patients are interviewed about stress and other emotional issues only. Receives: Behavioral: Emotional Disclosure Only
Pain Information Control	Placebo comparator	Patients are interviewed about their pain history and experience. Receives: Behavioral: Pain Information Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Change from Baseline to 1-month follow-up

Secondary outcomes (4)

Pain Interference
Brief Pain Inventory (7 interference items; range: 0.0 to 10.0; higher = more interference)
Measured: Change from Baseline to 1-month follow-up
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
Measured: Change from Baseline to 1-month follow-up
Pain Catastrophizing Scale
Pain catastrophizing (range: 0.0 to 4.0; higher scores = more catastrophizing)
Measured: Change from Baseline to 1-month follow-up
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
Measured: Change from Baseline to 1-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 20211 Aug 2021

First posted16 Apr 2020
Study start10 Feb 2021
Primary completion1 Aug 2021
Study completion1 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04349033
Sponsor's protocol ID: UP-19-00230
Status last verified: Mar 2024
First submitted: 13 Apr 2020
Last updated: 12 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Full, anonymized data set

Publications

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.
PubMed 37363989

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Musculoskeletal Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Virtual Human Technology for Patients With Chronic Pain: Experimental Study of Pain Neuroscience and Emotional Disclosure
ClinicalTrials.gov ID: NCT04349033
Acronym / sponsor ID: UP-19-00230
Conditions: Chronic Musculoskeletal Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Wayne State UniversityUniversity, hospital or other
Collaborators: University of Southern California
Study start: 10 Feb 2021 (actual)
Primary completion: 1 Aug 2021 (actual)
Study completion: 1 Aug 2021 (actual)
First posted: 16 Apr 2020 (actual)
Results: Posted 12 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Emotional Disclosure and Brain Education	Experimental	Behavioral: Emotional Disclosure and Brain EducationPatients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain.
Emotional Disclosure only	Active comparator	Behavioral: Emotional Disclosure OnlyPatients are interviewed about stress and other emotional issues only.
Pain Information Control	Placebo comparator	Behavioral: Pain Information ControlPatients are interviewed about their pain history and experience.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Chronic musculoskeletal Pain

Key exclusion criteria (1 listed)

Non-English speaking

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Emotional Disclosure and Brain EducationPatients 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.	Behavioural	Emotional Disclosure and Brain Education
Emotional Disclosure OnlyPatients are interviewed about a number of aspects of their lives, but without brain education	Behavioural	Emotional Disclosure only
Pain Information ControlPatients are interviewed about their pain history and other basic, non-disclosure information about their health.	Behavioural	Pain Information Control

Primary outcome

Pain Intensity
Time frame: Change from Baseline to 1-month follow-up
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)

4 secondary outcomes

Pain Interference
Time frame: Change from Baseline to 1-month follow-up
Pain Stages of Change Questionnaire
Time frame: Change from Baseline to 1-month follow-up
Pain Catastrophizing Scale
Time frame: Change from Baseline to 1-month follow-up
Emotional Distress
Time frame: Change from Baseline to 1-month follow-up

Results and safety

Results posted to the registry on 12 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Emotional Disclosure and Brain Education ("Educational Interview")	29	26
Emotional Disclosure Only ("Psychosocial Interview")	34	33
Pain Information Control ("Standard Interview")	31	30

Primary outcome: Pain Intensity

Time frame: Change from Baseline to 1-month follow-up. Mean (Standard Error). Unit: score on a scale

Measure	Emotional Disclosure and Brain Education ("Educational Interview") n = 29	Emotional Disclosure Only ("Psychosocial Interview") n = 34	Pain Information Control ("Standard Interview") n = 31
Value	-0.21 (0.19)	-0.56 (0.17)	-0.09 (0.17)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the 1-hour virtual interview with the patients, which was held remotely (via telehealth) with a research assistant, and then during the 1-month follow-up period, through the completion of on-line questionnaires.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Emotional Disclosure and Brain Education ("Educational Interview")	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Emotional Disclosure Only ("Psychosocial Interview")	0 of 34 (0%)	0 of 34 (0%)	0 of 34
Pain Information Control ("Standard Interview")	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Limitations and caveats (from the sponsor): Patient debriefing was conducted at the end of the VH session and before the follow-up assessment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37363989Junghaenel 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.
Individual participant dataSharing planned: Yes. Full, anonymized data set

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Doerte U Junghaenel, PhD principal investigator

University of Southern California

Mark A Lumley, PhD principal investigator

Wayne State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Emotional Disclosure and Brain Education and Emotional Disclosure Only in people with Chronic Musculoskeletal Pain, run by Wayne State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (time frame: Change from Baseline to 1-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04349033, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.