Trial Outcomes & Findings for Virtual Human Technology for Patients With Chronic Pain (NCT NCT04349033)

NCT ID: NCT04349033

Last Updated: 2024-03-12

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 94 participants
• Primary outcome timeframe: Change from Baseline to 1-month follow-up
• Results posted on: 2024-03-12

Participant Flow

Enrollment started on February 10, 2021, and the study concluded on August 1, 2021

Participant milestones

Measure	Emotional Disclosure and Brain Education ("Educational Interview") Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain. 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 ("Psychosocial Interview") Patients are interviewed about stress, psychosocial risk factors, and other emotional issues, but with no feedback or brain-related education. Emotional Disclosure Only: Patients are interviewed about a number of aspects of their lives, but without brain education	Pain Information Control ("Standard Interview") Patients are interviewed about their pain history and experience. Pain Information Control: Patients are interviewed about their pain history and other basic, non-disclosure information about their health.
Overall Study STARTED	29	34	31
Overall Study COMPLETED	26	33	30
Overall Study NOT COMPLETED	3	1	1

Reasons for withdrawal

Measure	Emotional Disclosure and Brain Education ("Educational Interview") Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain. 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 ("Psychosocial Interview") Patients are interviewed about stress, psychosocial risk factors, and other emotional issues, but with no feedback or brain-related education. Emotional Disclosure Only: Patients are interviewed about a number of aspects of their lives, but without brain education	Pain Information Control ("Standard Interview") Patients are interviewed about their pain history and experience. Pain Information Control: Patients are interviewed about their pain history and other basic, non-disclosure information about their health.
Overall Study Lost to Follow-up	3	1	1

Baseline Characteristics

Virtual Human Technology for Patients With Chronic Pain

Baseline characteristics by cohort

Measure	Emotional Disclosure and Brain Education ("Educational Interview") n=29 Participants Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain. 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 ("Psychosocial Interview") n=34 Participants Patients are interviewed about stress and other emotional issues only. Emotional Disclosure Only: Patients are interviewed about a number of aspects of their lives, but without brain education	Pain Information Control ("Standard Interview") n=31 Participants Patients are interviewed about their pain history and experience. Pain Information Control: Patients are interviewed about their pain history and other basic, non-disclosure information about their health.	Total n=94 Participants Total of all reporting groups
Age, Continuous	50.03 years STANDARD_DEVIATION 14.99 • n=5 Participants	56.65 years STANDARD_DEVIATION 13.68 • n=7 Participants	45.84 years STANDARD_DEVIATION 13.21 • n=5 Participants	51.04 years STANDARD_DEVIATION 14.53 • n=4 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	28 Participants n=7 Participants	28 Participants n=5 Participants	82 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	30 Participants n=7 Participants	24 Participants n=5 Participants	76 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	29 Participants n=5 Participants	34 Participants n=7 Participants	31 Participants n=5 Participants	94 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Emotional Disclosure and Brain Education ("Educational Interview") n=29 Participants Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain. 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 ("Psychosocial Interview") n=34 Participants Patients are interviewed about stress, psychosocial risk factors, and other emotional issues, but with no feedback or brain-related education. Emotional Disclosure Only: Patients are interviewed about a number of aspects of their lives, but without brain education	Pain Information Control ("Standard Interview") n=31 Participants Patients are interviewed about their pain history and experience. Pain Information Control: Patients are interviewed about their pain history and other basic, non-disclosure information about their health.
Pain Intensity	-0.21 score on a scale Standard Error 0.19	-0.56 score on a scale Standard Error 0.17	-0.09 score on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: Change from Baseline to 1-month follow-up

Brief Pain Inventory (7 interference items; range: 0.0 to 10.0; higher = more interference)

Outcome measures

Measure	Emotional Disclosure and Brain Education ("Educational Interview") n=29 Participants Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain. 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 ("Psychosocial Interview") n=34 Participants Patients are interviewed about stress, psychosocial risk factors, and other emotional issues, but with no feedback or brain-related education. Emotional Disclosure Only: Patients are interviewed about a number of aspects of their lives, but without brain education	Pain Information Control ("Standard Interview") n=31 Participants Patients are interviewed about their pain history and experience. Pain Information Control: Patients are interviewed about their pain history and other basic, non-disclosure information about their health.
Pain Interference	-0.82 score on a scale Standard Error 0.37	-1.27 score on a scale Standard Error 0.33	-0.31 score on a scale Standard Error 0.35

SECONDARY outcome

Timeframe: Change from Baseline to 1-month follow-up

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

Outcome measures

Measure	Emotional Disclosure and Brain Education ("Educational Interview") n=29 Participants Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain. 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 ("Psychosocial Interview") n=34 Participants Patients are interviewed about stress, psychosocial risk factors, and other emotional issues, but with no feedback or brain-related education. Emotional Disclosure Only: Patients are interviewed about a number of aspects of their lives, but without brain education	Pain Information Control ("Standard Interview") n=31 Participants Patients are interviewed about their pain history and experience. Pain Information Control: Patients are interviewed about their pain history and other basic, non-disclosure information about their health.
Pain Stages of Change Questionnaire	0.30 score on a scale Standard Error 0.26	-0.18 score on a scale Standard Error 0.23	-0.30 score on a scale Standard Error 0.24

SECONDARY outcome

Timeframe: Change from Baseline to 1-month follow-up

Pain catastrophizing (range: 0.0 to 4.0; higher scores = more catastrophizing)

Outcome measures

Measure	Emotional Disclosure and Brain Education ("Educational Interview") n=29 Participants Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain. 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 ("Psychosocial Interview") n=34 Participants Patients are interviewed about stress, psychosocial risk factors, and other emotional issues, but with no feedback or brain-related education. Emotional Disclosure Only: Patients are interviewed about a number of aspects of their lives, but without brain education	Pain Information Control ("Standard Interview") n=31 Participants Patients are interviewed about their pain history and experience. Pain Information Control: Patients are interviewed about their pain history and other basic, non-disclosure information about their health.
Pain Catastrophizing Scale	-0.19 score on a scale Standard Error 0.11	-0.15 score on a scale Standard Error 0.10	-0.06 score on a scale Standard Error 0.10

SECONDARY outcome

Timeframe: Change from Baseline to 1-month follow-up

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

Outcome measures

Measure	Emotional Disclosure and Brain Education ("Educational Interview") n=29 Participants Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain. 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 ("Psychosocial Interview") n=34 Participants Patients are interviewed about stress, psychosocial risk factors, and other emotional issues, but with no feedback or brain-related education. Emotional Disclosure Only: Patients are interviewed about a number of aspects of their lives, but without brain education	Pain Information Control ("Standard Interview") n=31 Participants Patients are interviewed about their pain history and experience. Pain Information Control: Patients are interviewed about their pain history and other basic, non-disclosure information about their health.
Emotional Distress	-0.31 score on a scale Standard Error 0.14	-0.16 score on a scale Standard Error 0.13	-0.06 score on a scale Standard Error 0.13

Adverse Events

Emotional Disclosure and Brain Education ("Educational Interview")

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Emotional Disclosure Only ("Psychosocial Interview")

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pain Information Control ("Standard Interview")

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mark A. Lumley, Professor

Wayne State University

Phone: 3135772247

Email: mlumley@wayne.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place