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| Name | Class |
|---|---|
| University of Southern California | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Emotional Disclosure only | Active Comparator | Patients are interviewed about stress and other emotional issues only. |
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| Pain Information Control | Placebo Comparator | Patients are interviewed about their pain history and experience. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emotional Disclosure and Brain Education | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Interference | Brief Pain Inventory (7 interference items; range: 0.0 to 10.0; higher = more interference) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doerte U Junghaenel, PhD | University of Southern California | Principal Investigator |
| Mark A Lumley, PhD | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California Center for Self-report Science | Los Angeles | California | 90089-3332 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37363989 | Derived | 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. |
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Full, anonymized data set
Starting 1 year after study end, for 5 years.
Contact the study PI
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Enrollment started on February 10, 2021, and the study concluded on August 1, 2021
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Error | score on a scale | Change from Baseline to 1-month follow-up |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Patient debriefing was conducted at the end of the VH session and before the follow-up assessment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark A. Lumley, Professor | Wayne State University | 3135772247 | mlumley@wayne.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 22, 2019 | Mar 11, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 15, 2021 | Mar 11, 2024 | SAP_001.pdf |
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| Emotional Disclosure Only | Behavioral | Patients are interviewed about a number of aspects of their lives, but without brain education |
|
| Pain Information Control | Behavioral | Patients are interviewed about their pain history and other basic, non-disclosure information about their health. |
|
| Change from Baseline to 1-month follow-up |
| Pain Catastrophizing Scale | Pain catastrophizing (range: 0.0 to 4.0; higher scores = more catastrophizing) | 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 | Change from Baseline to 1-month follow-up |
| BG001 | 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 |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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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 |
| OG002 | 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. |
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| Secondary | Pain Interference | Brief Pain Inventory (7 interference items; range: 0.0 to 10.0; higher = more interference) | Posted | Mean | Standard Error | score on a scale | Change from Baseline to 1-month follow-up |
|
|
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| 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 | Posted | Mean | Standard Error | score on a scale | Change from Baseline to 1-month follow-up |
|
|
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| Secondary | Pain Catastrophizing Scale | Pain catastrophizing (range: 0.0 to 4.0; higher scores = more catastrophizing) | Posted | Mean | Standard Error | score on a scale | Change from Baseline to 1-month follow-up |
|
|
|
| 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 | Posted | Mean | Standard Error | score on a scale | Change from Baseline to 1-month follow-up |
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|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 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 | 0 | 34 | 0 | 34 | 0 | 34 |
| EG002 | 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. | 0 | 31 | 0 | 31 | 0 | 31 |
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