Reaction to Mind-Body Connection

Mental Health Wellness 1 Clinical Trial

Official title:

Patient Reactions to Explanations of the Mind-Body Connection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04482348
• Other study ID #: 2019-01-0084
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: July 2020
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: January 30, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

Other:
• Explanation
Explanation provided to patients for more pain than expected

Locations

Country	Name	City	State
United States	Dell Medical School, University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resonance with the explanation of more pain than expected	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".	up to 24 weeks
Primary	Self-Assessment Manikins(SAM)	to measure 3 affective dimensions, happiness, excitement and control in response to the explanation	up to 24 weeks
Secondary	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	up to 24 weeks
Secondary	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	up to 24 weeks
Secondary	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	up to 24 weeks
Secondary	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)	up to 24 weeks
Secondary	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	up to 24 weeks