Mental Health Wellness 1NCT04482348
Crafted Communication for Biopsychosocial Care in Musculoskeletal Practice
A study testing Explanation in people with Mental Health Wellness 1, run by University of Texas at Austin at 1 site in United States.
Trial summary
New and return patients seeing an orthopedic specialist were randomized to evaluate one of 7 brief explanations of the mind-body connection with variations in cognitive, emotional, or physiology-based explanations. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Explanation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all new or return orthopaedic patients aged 18 to 89 years old
Who cannot join
- Illiteracy
- Cognitive problems which patient was not able to fill surveys
Trial locations and contacts
1 site in 1 country.
United States1 site
Dell Medical School, University of Texas at Austin
Austin, Texas, 78701
About this study
Official title: Can Crafted Communication Strategies Allow Musculoskeletal Specialists to Address Health Within the Biopsychosocial Paradigm?
New and return patients seeing an orthopedic specialist were randomized to evaluate one of 7 brief explanations of the mind-body connection with variations in cognitive, emotional, or physiology-based explanations. Reactions were measured as resonance (Likert scale) and Self-Assessment Manikins (SAM) for happiness, excitement, and control. Patients also completed demographic and mental and emotional health surveys. Overall 304 patients were included (mean age 49 -17, range 18 to 87; 51% men). Multilevel multivariable linear regression models were constructed to assess factors associated with resonance, happiness, excitement, and control.
Read the detailed description
Study design the investigators obtained institutional review board approval and prospectively enrolled 308 patients in this cross-sectional study over a 4-month period. All patients were seen at one of four participating orthopaedic offices in a large urban area. the investigators included all new or return orthopaedic patients aged 18 to 89 years old. After the visit with the surgeon, a research assistant not involved in patient care explained the study to the patient and asked them to participate. the investigators obtained a waiver for written consent; completing the questionnaires represented consent.
Outcomes measures Each patient read one of 7 randomly selected explanations for more pain than expected on a tablet. There were 2 cognitively-framed explanations ("the mind is a great story teller"; one positively- and one negatively framed), 2 emotionally-framed explanation ("stressed or down"; one positively- and one negatively framed), one mixed emotion and cognition ("mind and body work together"), and two physically based explanations ("over-excited state", "overstimulated")
Subjects completed the following questionnaires: (1) a demographic survey including the following variables: age, sex, race/ethnicity, marital status, work status, insurance status, level of education, number of i) people living in the household, ii) children living in the household, iii) adults living in the household, iv) adults who generate income; (2) the Generalized Anxiety Disorder 2-item version (GAD-2); (3) the Patient Health Questionnaire 2-item version (PHQ-2); (4) the Pain Self-Efficacy Questionnaire 2-item version (PSEQ-2); and (5) the Pain Catastrophizing Scale 4-item version (PCS-4).
Patients rated resonance with the explanation of more pain than expected on a 5-point Likert scale as follows from 1 to 5: "nope I don't buy it", "this doesn't make sense", "I'm not sure how I feel about this", "this makes sense", and "absolutely, that makes perfect sense".
Self-Assessment Manikins (SAM; a picture-oriented instrument) were used to measure 3 affective dimensions, happiness, excitement and control in response to the explanation.
The happiness dimension ranges from a smiling happy to a frowning unhappy SAM figure. The excitement dimension ranges from an excited wide-eyed to a relaxed sleepy SAM figure. The control dimension is represented with a changing size of the SAM figure and ranges from a small to a large SAM figure; the largest represents the most control in the situation.
The GAD-2 is a 2-item questionnaire (0=not at all to 3=nearly every day) that measures symptoms of anxiety in the last two weeks. Total score ranges from 0 to 6, with higher scores indicating more symptoms of anxiety.
The PCS-4 measures less adaptive thoughts in response to nociception on a 4-item scale (0=not at all to 4=all the time). The scale contains two items on magnification, one item on rumination, and one item on helplessness. Total score ranges from 0 to 16, higher scores indicate more catastrophic thoughts.
The PSEQ-2 measures two beliefs: that one can engage in activities and enjoy life in spite of pain. The total score ranges from 0 (not at all confident) to 12 (completely confident).
The PHQ-2 is a 2-item questionnaire that measures symptoms of depression.
- Conditions
- Mental Health Wellness 1
- Being tested
- Explanation
- Keywords
- cognitive health, social health, emotional health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExplanationOther
Explanation provided to patients for more pain than expected
| Study group | Role | What they receive |
|---|---|---|
| the mind is a great story teller-positively framed | Active comparator | explanations for more pain than expected Receives: Other: Explanation |
| the mind is a great story teller-negatively framed | Active comparator | explanations for more pain than expected Receives: Other: Explanation |
| emotionally-framed explanation-stressed or down-positive frame | Active comparator | explanations for more pain than expected Receives: Other: Explanation |
| emotionally-framed explanation-stressed or down-negative frame | Active comparator | explanations for more pain than expected Receives: Other: Explanation |
| mixed emotion and cognition ("mind and body work together") | Active comparator | explanations for more pain than expected Receives: Other: Explanation |
| physically based explanations "over-excited state" | Active comparator | explanations for more pain than expected Receives: Other: Explanation |
| physically based explanations "overstimulated" | Active comparator | explanations for more pain than expected Receives: Other: Explanation |
What is being measured
The primary outcome is the main question the study is designed to answer.
resonance with the explanation of more pain than expected
Patients rated resonance with the explanation of more pain than expected on a 5-point Likert scale from 1 to 5, as follows: "nope, I don't buy it," "this doesn't make sense," "I'm not sure how I feel about this," "this makes sense," and "absolutely, that makes perfect sense." Likert scales are valid for measuring variation in opinion. This specific Likert scale is new and specific to this study, and so no minimum clinically important difference has been defined. Given how the scale is anchored, a difference of about 1 point seems relevant.
Measured: up to 24 weeks
Self-Assessment Manikins(SAM)
Self-assessment manikins (SAMs), a picture-oriented instrument, were used to measure three affective dimensions of happiness, stimulation/excitement, and security/control in response to the explanations. The happiness dimension ranges from a smiling, happy SAM figure to a frowning, unhappy figure. The excitement dimension ranges from an excited, wide-eyed SAM figure to a relaxed, sleepy figure. The control dimension is represented by an SAM figure that changes in size and ranges from a small SAM figure to a large one; the largest figure represents the greatest feeling of security and control. With respect to written explanations of the mind-body connection, we favored greater feelings of happiness and control and relatively neutral feelings of excitement.
Measured: up to 24 weeks
Secondary outcomes (5)
demographic survey
age, sex, race/ethnicity, marital status, work status, insurance status, level of education, number of i) people living in the household, ii) children living in the household, iii) adults living in the household, iv) adults who generate income
Measured: up to 24 weeks
GAD-2
a 2-item questionnaire (0=not at all to 3=nearly every day) that measures symptoms of anxiety in the last two weeks. Total score ranges from 0 to 6, with higher scores indicating more symptoms of anxiety
Measured: up to 24 weeks
PCS-4
measures less adaptive thoughts in response to nociception on a 4-item scale (0=not at all to 4=all the time). The scale contains two items on magnification, one item on rumination, and one item on helplessness. Total score ranges from 0 to 16, higher scores indicate more catastrophic thoughts
Measured: up to 24 weeks
PSEQ-2
measures two beliefs: that one can engage in activities and enjoy life in spite of pain. The total score ranges from 0 (not at all confident) to 12 (completely confident).
Measured: up to 24 weeks
PHQ-2
a 2-item questionnaire (0=not at all to 3=nearly every day) that measures symptoms of depression in the last two weeks. Total score ranges from 0 to 6, with higher scores indicating more symptoms of depression
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Aug 2019
- Primary completion1 Dec 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- New and return patients seeing an orthopedic specialist were randomized to evaluate one of 7 brief explanations of the mind-body connection with variations in cognitive, emotional, or physiology-based explanations.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ring, University of Texas at Austin
- Investigators
- David Ring, MD, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482348
- Sponsor's protocol ID
- 2019-01-0084
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2020
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez AI, Kortlever JTP, Brown LE, Ring D, Queralt M. Can Crafted Communication Strategies Allow Musculoskeletal Specialists to Address Health Within the Biopsychosocial Paradigm? Clin Orthop Relat Res. 2021 Jun 1;479(6):1217-1223. doi: 10.1097/CORR.0000000000001635.
PubMed 33411452
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Crafted Communication Strategies Allow Musculoskeletal Specialists to Address Health Within the Biopsychosocial Paradigm?
- ClinicalTrials.gov ID
- NCT04482348
- Acronym / sponsor ID
- 2019-01-0084
- Conditions
- Mental Health Wellness 1
- Keywords
- cognitive health, social health, emotional health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
New and return patients seeing an orthopedic specialist were randomized to evaluate one of 7 brief explanations of the mind-body connection with variations in cognitive, emotional, or physiology-based explanations. Reactions were measured as resonance (Likert scale) and Self-Assessment Manikins (SAM) for happiness, excitement, and control. Patients also completed demographic and mental and emotional health surveys. Overall 304 patients were included (mean age 49 -17, range 18 to 87; 51% men). Multilevel multivariable linear regression models were constructed to assess factors associated with resonance, happiness, excitement, and control.
Detailed description
Study design the investigators obtained institutional review board approval and prospectively enrolled 308 patients in this cross-sectional study over a 4-month period. All patients were seen at one of four participating orthopaedic offices in a large urban area. the investigators included all new or return orthopaedic patients aged 18 to 89 years old. After the visit with the surgeon, a research assistant not involved in patient care explained the study to the patient and asked them to participate. the investigators obtained a waiver for written consent; completing the questionnaires represented consent.
Outcomes measures Each patient read one of 7 randomly selected explanations for more pain than expected on a tablet. There were 2 cognitively-framed explanations ("the mind is a great story teller"; one positively- and one negatively framed), 2 emotionally-framed explanation ("stressed or down"; one positively- and one negatively framed), one mixed emotion and cognition ("mind and body work together"), and two physically based explanations ("over-excited state", "overstimulated")
Subjects completed the following questionnaires: (1) a demographic survey including the following variables: age, sex, race/ethnicity, marital status, work status, insurance status, level of education, number of i) people living in the household, ii) children living in the household, iii) adults living in the household, iv) adults who generate income; (2) the Generalized Anxiety Disorder 2-item version (GAD-2); (3) the Patient Health Questionnaire 2-item version (PHQ-2); (4) the Pain Self-Efficacy Questionnaire 2-item version (PSEQ-2); and (5) the Pain Catastrophizing Scale 4-item version (PCS-4).
Patients rated resonance with the explanation of more pain than expected on a 5-point Likert scale as follows from 1 to 5: "nope I don't buy it", "this doesn't make sense", "I'm not sure how I feel about this", "this makes sense", and "absolutely, that makes perfect sense".
Self-Assessment Manikins (SAM; a picture-oriented instrument) were used to measure 3 affective dimensions, happiness, excitement and control in response to the explanation.
The happiness dimension ranges from a smiling happy to a frowning unhappy SAM figure. The excitement dimension ranges from an excited wide-eyed to a relaxed sleepy SAM figure. The control dimension is represented with a changing size of the SAM figure and ranges from a small to a large SAM figure; the largest represents the most control in the situation.
The GAD-2 is a 2-item questionnaire (0=not at all to 3=nearly every day) that measures symptoms of anxiety in the last two weeks. Total score ranges from 0 to 6, with higher scores indicating more symptoms of anxiety.
The PCS-4 measures less adaptive thoughts in response to nociception on a 4-item scale (0=not at all to 4=all the time). The scale contains two items on magnification, one item on rumination, and one item on helplessness. Total score ranges from 0 to 16, higher scores indicate more catastrophic thoughts.
The PSEQ-2 measures two beliefs: that one can engage in activities and enjoy life in spite of pain. The total score ranges from 0 (not at all confident) to 12 (completely confident).
The PHQ-2 is a 2-item questionnaire that measures symptoms of depression.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
- Model description
- New and return patients seeing an orthopedic specialist were randomized to evaluate one of 7 brief explanations of the mind-body connection with variations in cognitive, emotional, or physiology-based explanations.
| Arm | Type | Receives |
|---|---|---|
| the mind is a great story teller-positively framed | Active comparator | Other: Explanationexplanations for more pain than expected |
| the mind is a great story teller-negatively framed | Active comparator | Other: Explanationexplanations for more pain than expected |
| emotionally-framed explanation-stressed or down-positive frame | Active comparator | Other: Explanationexplanations for more pain than expected |
| emotionally-framed explanation-stressed or down-negative frame | Active comparator | Other: Explanationexplanations for more pain than expected |
| mixed emotion and cognition ("mind and body work together") | Active comparator | Other: Explanationexplanations for more pain than expected |
| physically based explanations "over-excited state" | Active comparator | Other: Explanationexplanations for more pain than expected |
| physically based explanations "overstimulated" | Active comparator | Other: Explanationexplanations for more pain than expected |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all new or return orthopaedic patients aged 18 to 89 years old
Key exclusion criteria (2 listed)
- Illiteracy
- Cognitive problems which patient was not able to fill surveys
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 |
|---|---|---|
| ExplanationExplanation provided to patients for more pain than expected | Other | emotionally-framed explanation-stressed or down-negative frame, emotionally-framed explanation-stressed or down-positive frame, mixed emotion and cognition ("mind and body work together"), physically based explanations "over-excited state", physically based explanations "overstimulated", the mind is a great story teller-negatively framed, the mind is a great story teller-positively framed |
Primary outcome
resonance with the explanation of more pain than expected
Time frame: up to 24 weeks
Patients rated resonance with the explanation of more pain than expected on a 5-point Likert scale from 1 to 5, as follows: "nope, I don't buy it," "this doesn't make sense," "I'm not sure how I feel about this," "this makes sense," and "absolutely, that makes perfect sense." Likert scales are valid for measuring variation in opinion. This specific Likert scale is new and specific to this study, and so no minimum clinically important difference has been defined. Given how the scale is anchored, a difference of about 1 point seems relevant.
Self-Assessment Manikins(SAM)
Time frame: up to 24 weeks
Self-assessment manikins (SAMs), a picture-oriented instrument, were used to measure three affective dimensions of happiness, stimulation/excitement, and security/control in response to the explanations. The happiness dimension ranges from a smiling, happy SAM figure to a frowning, unhappy figure. The excitement dimension ranges from an excited, wide-eyed SAM figure to a relaxed, sleepy figure. The control dimension is represented by an SAM figure that changes in size and ranges from a small SAM figure to a large one; the largest figure represents the greatest feeling of security and control. With respect to written explanations of the mind-body connection, we favored greater feelings of happiness and control and relatively neutral feelings of excitement.
5 secondary outcomes
demographic survey
Time frame: up to 24 weeks
GAD-2
Time frame: up to 24 weeks
PCS-4
Time frame: up to 24 weeks
PSEQ-2
Time frame: up to 24 weeks
PHQ-2
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Derived from this study: PubMed 33411452Gonzalez AI, Kortlever JTP, Brown LE, Ring D, Queralt M. Can Crafted Communication Strategies Allow Musculoskeletal Specialists to Address Health Within the Biopsychosocial Paradigm? Clin Orthop Relat Res. 2021 Jun 1;479(6):1217-1223. doi: 10.1097/CORR.0000000000001635.
- Individual participant dataSharing planned: No
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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.
David Ring, MD, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Explanation in people with Mental Health Wellness 1, run by University of Texas at Austin 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 2 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 31 Jul 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
resonance with the explanation of more pain than expected (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. 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 NCT04482348, 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 31 Jul 2025.