Clinical trial NCT04482348: Reaction to Mind-Body Connection
Official title: Patient Reactions to Explanations of the Mind-Body Connection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: cognitive health
social health
emotional health
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* all new or return orthopaedic patients aged 18 to 89 years old

Exclusion Criteria:

* Illiteracy
* Cognitive problems which patient was not able to fill surveys

Primary outcomes:
measure: resonance with the explanation of more pain than expected
timeFrame: up to 24 weeks
measure: Self-Assessment Manikins(SAM)
timeFrame: up to 24 weeks
Secondary outcomes:
measure: demographic survey
timeFrame: up to 24 weeks
measure: GAD-2
timeFrame: up to 24 weeks
measure: PCS-4
timeFrame: up to 24 weeks
measure: PSEQ-2
timeFrame: up to 24 weeks
measure: PHQ-2
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dell Medical School, University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: David Ring, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.