The Efficacy of Mindfulness-Based Stress Reduction
(MBSR) as an Adjunctive Therapy for Hypertension
and Associated Psychological Comorbidities
Principal Investigator: leena abdelsalam
Submitting Institution: university of minya
Date of Submission: 28th dec 2025
1. Introduction and Background
Hypertension is a major global public health concern and a leading contributor to
cardiovascular morbidity and mortality. Beyond its physiological consequences,
hypertension substantially impairs patients’ quality of life and is frequently
accompanied by psychological comorbidities such as depression, anxiety, and
chronic stress. These psychosocial factors not only reduce well-being but may also
negatively influence blood pressure control and treatment adherence.
Despite these interconnections, current hypertension management strategies are
predominantly pharmacological and often fail to adequately address psychological
distress. This gap highlights the need for effective, non-pharmacological adjunctive
interventions that target both the physiological and psychological dimensions of
hypertension.
Mindfulness-Based Stress Reduction (MBSR) is a structured, evidence-based
intervention designed to enhance stress regulation, emotional resilience, and overall
well-being. As an adjunct to routine medical care, MBSR is particularly well suited to
address the complex clinical profile of individuals with hypertension. Emerging
evidence suggests that mindfulness-based interventions may improve both
cardiovascular and mental health outcomes, warranting further rigorous
investigation.
2. Statement of the Problem
While antihypertensive medications are effective in lowering blood pressure, they do
not directly address the psychological burden commonly experienced by individuals
with hypertension. Depression, anxiety, and stress are prevalent in this population
and are associated with poorer health outcomes and reduced quality of life.
There is a clear need for adjunctive therapies that complement pharmacological
treatment by addressing psychological comorbidities while also contributing to
improved blood pressure control. However, evidence supporting the routine
integration of such interventions into hypertension care remains limited, particularly
from randomized clinical trials.
3. Review of Relevant Literature
This proposed study is grounded in existing evidence, most notably the randomized
clinical trial conducted by Babak et al. (2022), which examined the effects of MBSR
on blood pressure, mental health, and quality of life in hypertensive adult women.
Key findings from Babak et al. (2022) include:
• Blood Pressure Reduction: Participants in the MBSR group experienced a
significant reduction in mean systolic blood pressure (from 142.82 mmHg to
133.7 mmHg) and diastolic blood pressure (from 86.12 mmHg to 79.15
mmHg). In contrast, the control group showed no improvement, with a slight
increase in systolic blood pressure (P = 0.001).
• Mental Health Outcomes: The intervention group demonstrated significant
improvements in depression, anxiety, and stress levels as measured by the
DASS-21 (P < 0.05). Although the original text reported an increase in scores,
the study’s conclusions indicate a reduction in psychological distress.
• Quality of Life: Participants receiving MBSR reported a significant
improvement in overall quality of life compared to controls.
While these findings provide compelling preliminary evidence, replication in a new
cohort is necessary to strengthen external validity and support broader clinical
application. The present study seeks to build upon and confirm these results through
a rigorously designed randomized clinical trial.
4. Research Aim and Objectives
4.1 Aim
To evaluate the efficacy of a 12-week Mindfulness-Based Stress Reduction (MBSR)
program as an adjunctive therapy for improving blood pressure, mental health, and
quality of life in adult women with Stage I or II hypertension.
4.2 Objectives
Primary Objective
1. To determine the effect of a 12-week MBSR program on systolic and diastolic
blood pressure compared to routine care.
Secondary Objectives
1. To assess changes in depression, anxiety, and stress levels using the
Depression, Anxiety, and Stress Scale-21 (DASS-21).
2. To evaluate changes in health-related quality of life using the 36-Item Short
Form Survey (SF-36).
5. Research Hypothesis
A 12-week Mindfulness-Based Stress Reduction (MBSR) program will result in a
statistically significant reduction in systolic and diastolic blood pressure, decreased
symptoms of depression, anxiety, and stress, and improved quality of life among
adult women with Stage I or II hypertension compared to those receiving routine care
alone.
6. Research Design and Methodology
6.1 Study Design
A randomized clinical trial (RCT) with two parallel groups: an intervention group and
a routine care control group.
6.2 Study Population and Sample
The study will include 80 adult women diagnosed with Stage I or II hypertension,
recruited from affiliated clinical settings. Inclusion and exclusion criteria will be
applied to ensure a homogenous and clinically appropriate sample.
6.3 Intervention
• Intervention Group: Participants will receive standard medical care in addition
to a structured 12-week MBSR program delivered by a certified instructor.
• Control Group: Participants will receive routine hypertension care only.
6.4 Data Collection and Outcome Measures
Assessments will be conducted at baseline and one week following completion of the
intervention.
• Primary Outcome:
o Systolic and diastolic blood pressure measured using calibrated
equipment.
• Secondary Outcomes:
o Depression, anxiety, and stress assessed using DASS-21.
o Quality of life assessed using the SF-36 questionnaire.
6.5 Data Analysis
Data will be analyzed using:
• Paired t-tests for within-group comparisons
• Independent t-tests for between-group comparisons
• Multivariate Analysis of Covariance (MANCOVA) to control for baseline
differences
7. Ethical Considerations
This study will adhere strictly to ethical standards for research involving human
participants.
• Approval will be obtained from the [Name of Institution] Institutional Review
Board (IRB).
• Written informed consent will be secured from all participants.
• Participant confidentiality will be maintained through anonymized data coding
and secure storage.
• All participants will continue receiving standard medical care throughout the
study.
8. Significance and Potential Impact
This study has the potential to strengthen the evidence base supporting MBSR as a
low-cost, non-invasive adjunctive therapy for hypertension. By addressing both blood
pressure and psychological well-being, the intervention may contribute to improved
clinical outcomes, enhanced quality of life, and a more holistic model of hypertension
care.
Findings from this research may inform clinical guidelines and encourage the
integration of mindfulness-based interventions into routine cardiovascular care.
9. Budget Narrative and Justification
Funding is requested to support personnel, intervention delivery, materials,
participant compensation, and data analysis. Each budget category is directly
aligned with the study’s objectives and methodological requirements, ensuring
efficient and responsible use of resources.
10. References
Babak, A., Motamedi, N., Mousavi, S. Z., & Ghasemi Darestani, N. (2022). Effects of
Mindfulness-Based Stress Reduction on Blood Pressure, Mental Health, and Quality
of Life in Hypertensive Adult Women: A Randomized Clinical Trial Study. Journal of
Tehran University Heart Center, 17(3), 127–133.
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