EB004 Assignment Critical Appraisal Worksheet

Full APA formatted citation of selected article.

Article #1

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Hoge, E. A., Bui, E., Mete, M., Dutton, M. A., Baker, A. W., & Simon, N. M. (2022). Mindfulness-Based stress reduction vs escitalopram for the treatment of adults with anxiety disorders: A randomized clinical trial. Journal of the American Medical Association (JAMA) Psychiatry, 80(1), 13–21. https://doi.org/10.1001/jamapsychiatry.2022.3679

Wang, M., Zhang, H., Zhang, X., Zhao, Q., Chen, J., Hu, C., Feng, R., Liu, D., Fu, P., Zhang, C., Cao, J., Yue, J., Yu, H., Yang, H., Liu, B., Xiong, W., Tong, H., Zhu, S., & Yang, Y. (2023). Effects of an online brief modified mindfulness-based stress reduction therapy for anxiety among Chinese adults: A randomized clinical trial. Journal of Psychiatric Research, 161, 27–33. https://doi.org/10.1016/j.jpsychires.2023.03.009

Fisher, V., Li, W. W., & Malabu, U. (2023). The effectiveness of mindfulness-based stress reduction (MBSR) on the mental health, HbA1C, and mindfulness of diabetes patients: A systematic review and meta-analysis of randomised controlled trials. Applied Psychology: Health and Well-Being, 15(4), 1733–1749. https://doi.org/10.1111/aphw.12441

Yu, J., Han, M., Miao, F., & Hua, D. (2023). Using mindfulness-based stress reduction to relieve loneliness, anxiety, and depression in cancer patients: A systematic review and meta-analysis. Medicine, 102(37), e34917–e34917. https://doi.org/10.1097/md.0000000000034917

Evidence Level *

(I, II, or III)

Level II – Evidence from a single, well-designed Randomized Controlled Trial (RCT).

Level II – Evidence from a single, well-designed Randomized Controlled Trial (RCT).

Level I – Evidence from a systematic review or meta-analysis of all relevant RCTs.

Level I – Evidence from a systematic review or meta-analysis of all relevant RCTs.

Conceptual Framework

Describe the theoretical basis for the study (If there is not one mentioned in the article, say that here).**

The theoretical basis of the study consists of the principles of mindfulness that most likely posits that automatic cognitive and emotional reactivity tendencies that are underlying the anxiety disorders can be disrupted through the introduction of a non-judgmental and present-moment awareness. It works on the assumption that MBSR equips one with the ability to have a different relationship with painful thoughts and feelings, which minimizes their intensity and effect.

The research is anchored on the main principles of MBSR yet modified to fit in a digital setting. The idea is that the very processes of mindfulness formation: the cultivation of awareness and a decrease in reactivity can be efficiently triggered even with the help of a simplified digitally presented program which makes it a practical tool to use in the process of anxiety management in a scalable manner.

This review is based on holistic model of chronic illness that proposes that mental and physical health are interrelated. According to the framework, MBSR has the potential to reduce mental health symptoms such as anxiety by minimizing psychological stress and enhancing emotion regulation, but it can also have a positive impact on physiological disease mechanisms, such as glycemic control in diabetes.

According to the bio psychosocial model of cancer care according to which a cancer diagnosis and treatment is a grave psychological disturbance. The framework assumes that MBSR treats this distress through skills that patients learn to cope with fear, uncertainty and symptoms related to treatment thus alleviating anxiety, depression and isolation.

Design/Method

Describe the design and how the study was carried out (In detail, including inclusion/exclusion criteria).

Design: Non-inferiority randomized clinical trial (RCT).

Design: 276 adults with a known anxiety disorder (GAD, Social Anxiety, Panic Disorder) were randomly allocated (1:1 ratio) to an 8 weeks, in-person, MBSR program or daily doses of the antidepressant, escitalopram. The primary outcome was measured after 8 weeks and then followed up after 12 and 24 weeks.

Inclusion Criteria: Adults over 18 years old and with primary DSM-5 anxiety disorder.

Exclusion Criteria: High risk of suicide, bipolar/psychotic, recent CBT/MBSR, substance use disorder, medical contraindication to escitalopram.

Design: Randomized Controlled Trial.

Method: A total of 170 Chinese adults who had significant symptoms of anxiety were randomly assigned to either a 2-week online brief modified MBSR intervention or to a wait list control group. Measurement of outcomes was done at the end of the intervention.

Inclusion Criteria: Adults who scored high on a standardized scale of anxiety.

Exclusion Criteria: Psychiatric disorders, psychotherapy concurrently or inability to use the online platform.

Design: Systematic Review and Meta-Analysis.

Method: The research was carried out in compliance with the PRISMA principles. MBSR RCTs on adults with diabetes were identified systematically by the researchers in various databases. The pooling of data was done through random-effects models. Possibility of bias was measured, and heterogeneity was investigated.

Inclusion Criteria: RCTs of conventional MBSR among adult diabetes patients which reported mental health (anxiety, depression, stress) or mindfulness outcomes.

Exclusion Criteria Non-RCTs, non-controlled studies, interventions that were not standard MBSR.

Design: Systematic Review and Meta-Analysis.

Method: In-depth search of various databases of RCTs and controlled clinical trials of MBSR among cancer patients. Applied the Cochrane tool in assessment of risk-of-bias. Random-effects models were used to calculate pooled effect sizes, Standardized Mean Differences (SMDs).

Inclusion Criteria: MBSR controlled trials (RCTs and others) in cancer patients of loneliness, anxiety, or depression.

Exclusion Criteria: Interventions that were not MBSR and studies that did not present pertinent outcomes.

Sample/Setting

The number and characteristics of

patients, attrition rate, etc.

Sample Size: 276 participants.

Attributes: Adults having a formal diagnosis of an anxiety disorder. The sample was constructed in such a way that it represented a normal clinical population who was seeking treatment of anxiety.

Setting: Clinical research setting in out-patient.

Attrition Rate: Extremely high rate of completion 94.2% at the 8-week primary endpoint. The attrition was low and was equal in the MBSR as well as the escitalopram groups.

Sample Size: 170 participants.

Features: Adults of the population with high anxiety symptoms.

Location: Online, totally remote.

Attrition Rate: There was reported as 10% attrition rate which is normal when it comes to an online trial. The causes were recorded and did not have a significant difference across groups.

Sample: Synthesized information on a number of major RCTs contained in the review.

Setting: The setting of the included studies on different clinical and community settings.

Sample: Combined data of multiple primary studies of cancer patients who were at different stages of treatment and survivorship.

Location: Mainly, oncology clinics and cancer centers.

Major Variables Studied

List and define dependent and independent variables

Independent Variable: The treatment modality (MBSR vs. Escitalopram).

Dependent Variables:

– Primary: Severity of anxiety symptoms (Using the Clinical Global Impression of Severity scale).

Secondary: Responsiveness to treatment, remission, dropouts and adverse events.

Independent Variable: Online brief MBSR program vs. Waitlist control.

Dependent Variables: The anxiety symptoms self-reported.

Independent Variable: MBSR intervention.

Dependent Variables: Anxiety, depression, stress, mindfulness, and glycemic control (HbA1c).

Independent Variable: MBSR intervention.

Dependent Variables: Loneliness, anxiety, and depression.

Measurement

Identify primary statistics used to answer clinical questions (You need to list the actual tests done).

Tool Used: The principal outcome was assessed based on the Clinical Global Impression of Severity (CGI-S) scale, which is a valid and standard measurement instrument in psychiatric clinical research administered by clinicians.

Statistics: A linear mixed model was employed to make comparisons on the change in the CGI-S score between baseline and the week 8. To assess whether MBSR was not unacceptably inferior to escitalopram, a preset non-inferiority margin was used.

Tool Used: A self-report measure of anxiety, Self-Rating Anxiety Scale (SAS), is a well-known and proven scale.

Statistics: ANCOVA was performed to assess the post-intervention SAS scores in the groups with the baseline scores adjusted. Other demographic and baseline comparisons were done by means of T-tests and chi-square tests.

Tools Used: Several scales that have been verified in the literature e.g. the Hospital Anxiety and Depression Scale (HADS) and the Depression Anxiety Stress Scales (DASS).

Statistics: Effect sizes have been calculated using Hedges g. The heterogeneity was measured using I2. Subgroup and sensitivity analyses were conducted to investigate the areas of variation.

Tools Used: Differing scales have been validated that include the Hospital Anxiety and Depression Scale (HADS) and the UCLA Loneliness Scale.

Statistics: Standardized Mean Difference (SMD) having 95 percent confidence interval. Heterogeneity was measured using I2 statistic.

Data Analysis Statistical or

Qualitative findings

(You need to enter the actual numbers determined by the statistical tests or qualitative data).

Findings: MBSR was discovered as not inferior to escitalopram. The average score change in CGI-S was -1.37 with MBSR and -1.43 with escitalopram with a difference of 0.06 (95% CI, -0.38 to 0.26) which fell within the non-inferiority margin.

Significance: This gives strong evidence that an 8-week MBSR intervention is statistically and clinically effective as an alternative to a first-line pharmacological intervention against anxiety disorders.

Findings: The group with MBSR brief online brief intervention had a much larger decrease in anxiety scores than the waitlist control group (F = 28.31, p < .001).

Significance: It proves that a truncated, digitally modified version of MBSR can be a useful intervention in the reduction of anxiety, and make it much more accessible.

Findings: MBSR showed a medium, significant effect on the alleviation of anxiety in patients with diabetes (Hedges g = -0.57, 95%CI -0.80-0.34). There were also significant benefits in depression, stress and mindfulness.

Significance: This Level I evidence demonstrates that MBSR is a very useful intervention in alleviating anxiety and the overall mental health of the patients with a comorbid long-term medical condition.

Findings: MBSR was found to have a large and significant impact on the decrease in anxiety among cancer patients (SMD = -0.67, 95 percent CI: -1.05 to -0.29). Loneliness and depression also had considerable decreases in the review.

Significance: The meta-analysis presented here is a compelling piece of evidence that MBSR is a multi-effective, multi-benefit psychosocial intervention that can be used to reduce distress in the vulnerable cancer demographic.

Findings and Recommendations

General findings and recommendations of the research

General Findings: MBSR does not show any uncertainty with escitalopram in terms of alleviating the severity of anxiety in adults with anxiety disorders. The two treatments were associated with considerable clinical improvements.

Recommendations: MBSR can be recommended as a first-line intervention to be used in anxiety disorders to offer a non-pharmacological approach as an evidence-based alternative to medications. Clinicians are advised to discuss these two options with the patients with respect to patient preference.

General Findings: A short, web-based, and adapted MBSR intervention is effective in reducing the self-reported levels of the anxiety symptoms in adults in a significant contrast to no intervention.

Recommendations: Shortly and online-based mindfulness courses ought to be created and enacted to help more people access mental health. They are especially prescribed to persons who have mild to moderate anxiety or are used as a preventive measure.

General Findings: MBSR is a useful practice that can enhance the management of mental health outcomes, specifically anxiety and depression among diabetic patients. The glycemic control effect (HbA1c) was not always meaningful.

Recommendations: MBSR needs to be incorporated into the routine diabetes care programs to deal with the high levels of anxiety and depression in this group where a bio psychosocial approach of disease management should be promoted.

General Findings: MBSR is a very useful method of alleviating anxiety, depression, and loneliness among cancer patients.

Recommendations: MBSR ought to be a routine maintenance of a psycho-oncology and supportive care systems that must be provided to all cancer patients during their treatment and survivorship experience to reduce instances of psychological distress.

Appraisal and Study Quality

Describe the general worth of this research to practice.

What are the strengths and limitations of study?

What are the risks associated with implementation of the suggested practices or processes detailed in the research?

What is the feasibility of use in your practice?

Worth to Practice: Extremely high. This paper presents some of the best and direct evidence in favor of MBSR being a first-line treatment of anxiety.

Strengths: There are high methodological rigor such as randomization, outcome assessor blinding, pre-registered protocol, low attrition, and clear non-inferiority design. The results have been reinforced by the active, first-line comparator (escitalopram) usage.

Limitations: The follow-up on 6 months restricts the knowledge of the long-term results. Samples were volunteers who either accepted to do therapy or have medication which is not representative of all patients.

Risks of Implementation: Low. MBSR is an intervention with low risks of physical harm. The major threat is that programs should be facilitated by experienced instructors to guarantee fidelity and efficacy.

Feasibility: Great in the environment where trained MBSR facilitators are available. Is another possible choice of patients with non-pharmacological preferences?

Worth to Practice: High especially in respect to its emphasis on scalability and accessibility. It deals with a serious requirement of low-cost, affordable interventions.

Strengths: Good ecological validity to apply in real world, selection bias controlled by randomization, targeted at a new and applicable delivery format.

Limitations: Waitlist control may artificially increase effect sizes; due to short-term duration and no long term follow-up; the use of self-report measures only means a potential source of bias.

Risks of Implementation: Very low. The first risk is the one that makes the digital platform easy to use and that the participants should be properly guided to prevent frustration.

Feasibility: Very high. It is one of the most practicable and widely spread formats of MBSR due to its online and brief character.

Worth to Practice: Very high. It gives a good evidence base to incorporate MBSR in the treatment of diabetes to overcome high comorbidity of diabetes and anxiety.

Strengths: Strict systematic study; quantitative synthesis, a perfect estimate of effect; analysis of heterogeneity and risk of bias increases validity of findings.

Limitations: The quality and the specific protocol of the included RCTs were different. Some of the outcomes had moderate-high heterogeneity.

Risks of Implementation: Low. MBSR is noninvasive and more so effective in such a population as polypharmacy is at issue.

Feasibility: The mode of treatment in diabetes clinics and integrated care is high, and it favors a holistic approach.

Worth to Practice: And very high for oncology and supportive care environments. It confirms MBSR as one of the foundations of psychosocial care in cancer patients.

Strengths: Targets a very specific and vulnerable group; indicates huge effect sizes of various psychological outcomes; employs strict systematic review strategies.

Limitations: The number of studies available for some outcomes (like loneliness) was small. There was a potential for publication bias.

Risks of Implementation: Very low. It is a supportive, non-invasive intervention that empowers patients during a difficult time.

Feasibility: Having been in place and quite viable in most comprehensive cancer facilities; can be described as a best practice in psycho-oncology.

Key findings

1. The MBSR was statistically no worse than escitalopram.

The anxiety levels were clinically significantly reduced in both groups.

The escitalopram group showed more adverse events in comparison to the MBSR group.

1. MBSR is capable of statistically significant anxiety reduction after 2 weeks of an online program.

The intervention is very accessible as it is delivered digitally.

A summarized version does not lose therapeutic efficacy to reduce symptoms.

1. The effect of MBSR on the reduction of anxiety among diabetic patients is medium and significant (Hedges g = -0.57).

There were also major gains on depression, stress and mindfulness.

The effect on such physiological outcomes as HbA1c is less evident and might take long-term research.

1. The effect of MBSR on the reduction of anxiety among the cancer patients is large and significant (SMD = -0.67).

2. It can also be used to treat comorbid depression and loneliness.

3. It is a multi-benefit intervention which deals with multiple aspects of psychosocial distress at the same time.

Outcomes

The research has offered Level II evidence that a standardized 8-week MBSR program is an effective monotherapy in the treatment of anxiety disorders and provides a similar outcome when compared to pharmacotherapy but at a superior safety profile.

This paper shows that the fundamental advantages of MBSR are replicable and presentable in a highly scaled and adaptable form, and this has a significant potential to enhance public health.

The current meta-analysis offers solid, Level I data that MBSR is a powerful psychological intervention in a medically comorbid population, and effectively manages the mental impact burden patients have with chronic disease.

The current study synthesizes the evidence of MBSR as an ideal practice, non-pharmacological intervention in cancer care, with the capacity to bring significant changes in the mental health of a risk group experiencing a life-changing disease.

General Notes/Comments

It is a historic study, which compares a mindfulness intervention to first-line medication directly and rigorously. Its results can redefine treatment practices in a great way and empower patients who request non-pharmacological treatment. The results of the study are supported by the high adherence rates in the two groups.

The present research can be of great value when digital health is becoming more popular. Although the comparison with the entire 8-week program and its long-term impact are not known, it demonstrates the proof of concept that online, abbreviated, mindfulness is a useful and efficient intervention to manage anxiety.

This review eloquently presents the case on integrated care. It also allows the medical setting to quantify the positive impact on anxiety and thus provides a clear evidence base to refer patients with diabetes to MBSR programs, which may positively affect the state of psychological well-being and increase their participation in self-care.

Of special interest is the high effect size of anxiety. The present review highlights that MBSR is not a fringe, wellness exercise but a fundamental clinical treatment tool to overcome the debilitating anxiety that comes with cancer. Its capability to also affect loneliness points out the fact that it serves in combating the social and emotional isolation that may also come with a diagnosis.