Chronic Musculoskeletal Pain
Conditions
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.
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.
Interventions
BEHAVIORALPain Information Control
Patients are interviewed about their pain history and other basic, non-disclosure information about their health.
BEHAVIORALEmotional Disclosure Only
Patients are interviewed about a number of aspects of their lives, but without brain education
BEHAVIORALEmotional 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.
Sponsors
University of Southern California
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic musculoskeletal Pain
Exclusion criteria
* Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Interference | Change from Baseline to 1-month follow-up | Brief Pain Inventory (7 interference items; range: 0.0 to 10.0; higher = more interference) |
| Pain Stages of Change Questionnaire | 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 |
| Pain Catastrophizing Scale | Change from Baseline to 1-month follow-up | Pain catastrophizing (range: 0.0 to 4.0; higher scores = more catastrophizing) |
| Emotional Distress | 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 |
Countries
United States
Participant flow
Recruitment details
Enrollment started on February 10, 2021, and the study concluded on August 1, 2021
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| Emotional Disclosure Only (Psychosocial Interview) 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 | 34 |
| 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. | 31 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 | 1 |
Baseline characteristics
| Characteristic | Emotional Disclosure and Brain Education (Educational Interview) | Total | Pain Information Control (Standard Interview) | Emotional Disclosure Only (Psychosocial Interview) |
|---|---|---|---|---|
| Age, Continuous | 50.03 years STANDARD_DEVIATION 14.99 | 51.04 years STANDARD_DEVIATION 14.53 | 45.84 years STANDARD_DEVIATION 13.21 | 56.65 years STANDARD_DEVIATION 13.68 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 76 Participants | 24 Participants | 30 Participants |
| Region of Enrollment United States | 29 Participants | 94 Participants | 31 Participants | 34 Participants |
| Sex: Female, Male Female | 26 Participants | 82 Participants | 28 Participants | 28 Participants |
| Sex: Female, Male Male | 3 Participants | 12 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 34 | 0 / 31 |
| other Total, other adverse events | 0 / 29 | 0 / 34 | 0 / 31 |
| serious Total, serious adverse events | 0 / 29 | 0 / 34 | 0 / 31 |
Outcome results
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)
Time frame: Change from Baseline to 1-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emotional Disclosure and Brain Education (Educational Interview) | Pain Intensity | -0.21 score on a scale | Standard Error 0.19 |
| Emotional Disclosure Only (Psychosocial Interview) | Pain Intensity | -0.56 score on a scale | Standard Error 0.17 |
| Pain Information Control (Standard Interview) | Pain Intensity | -0.09 score on a scale | Standard Error 0.17 |
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
Time frame: Change from Baseline to 1-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emotional Disclosure and Brain Education (Educational Interview) | Emotional Distress | -0.31 score on a scale | Standard Error 0.14 |
| Emotional Disclosure Only (Psychosocial Interview) | Emotional Distress | -0.16 score on a scale | Standard Error 0.13 |
| Pain Information Control (Standard Interview) | Emotional Distress | -0.06 score on a scale | Standard Error 0.13 |
Secondary
Pain Catastrophizing Scale
Pain catastrophizing (range: 0.0 to 4.0; higher scores = more catastrophizing)
Time frame: Change from Baseline to 1-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emotional Disclosure and Brain Education (Educational Interview) | Pain Catastrophizing Scale | -0.19 score on a scale | Standard Error 0.11 |
| Emotional Disclosure Only (Psychosocial Interview) | Pain Catastrophizing Scale | -0.15 score on a scale | Standard Error 0.1 |
| Pain Information Control (Standard Interview) | Pain Catastrophizing Scale | -0.06 score on a scale | Standard Error 0.1 |
Secondary
Pain Interference
Brief Pain Inventory (7 interference items; range: 0.0 to 10.0; higher = more interference)
Time frame: Change from Baseline to 1-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emotional Disclosure and Brain Education (Educational Interview) | Pain Interference | -0.82 score on a scale | Standard Error 0.37 |
| Emotional Disclosure Only (Psychosocial Interview) | Pain Interference | -1.27 score on a scale | Standard Error 0.33 |
| Pain Information Control (Standard Interview) | Pain Interference | -0.31 score on a scale | Standard Error 0.35 |
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
Time frame: Change from Baseline to 1-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Emotional Disclosure and Brain Education (Educational Interview) | Pain Stages of Change Questionnaire | 0.30 score on a scale | Standard Error 0.26 |
| Emotional Disclosure Only (Psychosocial Interview) | Pain Stages of Change Questionnaire | -0.18 score on a scale | Standard Error 0.23 |
| Pain Information Control (Standard Interview) | Pain Stages of Change Questionnaire | -0.30 score on a scale | Standard Error 0.24 |