Trial Outcomes & Findings for Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety (NCT NCT03365375)

Results Overview

Difference in GAD-7 score at enrollment compared to assessment at 3 months. Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe \> 15

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

Measured at 3 months

Results posted on

2024-01-24

Participant Flow

We screened patients who presented to the Emergency Department (ED) with chest pain. We assessed their risk for major adverse cardiac events (MACE) using the HEART score and for anxiety with the GAD-7. Enrolled subjects were assigned to either arm depending upon enrollment period. In the 8 weeks prior to the MBSR course commencement all subjects enrolled were assigned to Arm 2: MBSR. This period was immediately followed by 8 weeks of enrollment in Arm 1: Standard Referral.

Participant milestones

Participant milestones
Measure	Usual Care Referral Subjects will be referred for primary care provider (PCP) follow up and/or to psychiatry for further management and treatment of elevated anxiety levels according to standard of care.	MBSR Referral MBSR Referral: Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions.
Overall Study STARTED	14	14
Overall Study COMPLETED	14	9
Overall Study NOT COMPLETED	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care Referral Subjects will be referred for primary care provider (PCP) follow up and/or to psychiatry for further management and treatment of elevated anxiety levels according to standard of care.	MBSR Referral MBSR Referral: Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions.
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	0	4

Baseline Characteristics

Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care Referral n=14 Participants Subjects will be referred for primary care provider (PCP) follow up and/or to psychiatry for further management and treatment of elevated anxiety levels according to standard of care.	MBSR Referral n=14 Participants MBSR Referral: Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions.	Total n=28 Participants Total of all reporting groups
Age, Continuous	43.3 years STANDARD_DEVIATION 9.3 • n=5 Participants	38.9 years STANDARD_DEVIATION 11.9 • n=7 Participants	41.2 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
GAD-7 at enrollment	15.9 units on a scale STANDARD_DEVIATION 4.4 • n=5 Participants	14.9 units on a scale STANDARD_DEVIATION 3.1 • n=7 Participants	15.3 units on a scale STANDARD_DEVIATION 3.6 • n=5 Participants

PRIMARY outcome

Timeframe: Measured at 3 months

Difference in GAD-7 score at enrollment compared to assessment at 3 months. Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe \> 15

Outcome measures

Outcome measures
Measure	Usual Care Referral n=12 Participants Subjects will be referred for primary care provider (PCP) follow up and/or to psychiatry for further management and treatment of elevated anxiety levels according to standard of care.	MBSR Referral n=6 Participants MBSR Referral: Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions.
Mean Difference in Generalized Anxiety Disorder -7 (GAD-7)	5.3 score on a scale Standard Deviation 5.4	3.2 score on a scale Standard Deviation 8.1

SECONDARY outcome

Timeframe: Measured at 45 days, 6 months, and 12 months

Anxiety Severity by total score. Range 0-21. Mild 5-9; Moderate (10-14); Severe \> 15