Research Proposal I wrote while pursuing my Masters

 

 

 

 

 

 

 

 

Effects of Clinically Provided Guided Meditation on Anxiety and Depression Severity

Martin A. Jacobs

Kaplan University

 

Abstract

 

The purpose of this document is to propose research in the area of cognitive mindfulness with the intention of exploring the potential benefits towards anxiety and depression, when guided meditation is utilized in a clinical therapeutic setting similar to Cognitive Behavioral Therapy (CBT). The facilitator will be a licensed psychologist who has also received the proposed program of guided meditation and completed a competency test. Participants will include current clients of the facilitator in addition to new clients that will be selected from the local area. Participants will be split into two primary groups consisting of moderate to extensive meditative practice experience and a second group having little to no meditative practice experience. This will create a quasi-experiment designed to account for possible covariance between experienced and non-experienced meditators. Each of these groups will be split into two additional groups consisting of a treatment group that will receive the guided meditation intervention and a group that will not. This is a mixed, between-subjects design with non-equivalent control groups.

Introduction

                Anxiety and depression are extremely prevalent in our society and despite the potential benefits of current remedies which include medications and various forms of psychotherapy, the numbers of those persons being diagnosed seem to be growing at an exponential rate. Guided meditation is a type of meditation in which the ability to achieve mindfulness is improved due to the focus of mind being drawn and guided in a particular way by the facilitator of the meditative session. It is well known in the field of psychology that the severity of anxiety and depression are correlated to the amount of negative rumination occurring in the mind. Foley et al. (2010, pg. 1, para. 1) offers the following definition of rumination taken from an article published in the Journal of Abnormal Psychology, “Rumination is the process of repetitive, passive thinking or brooding about aspects of negative experience without action to relieve the situation”. (Nolen-Hoeksema, 1991). Mindfulness is a state of mind in which one becomes aware of the mind as a potential function of one’s desires separate from the thinking mind (EGO), in that the mind is a tool that can be utilized to serve ones inner will. In cases of anxiety and depression, it is the will that serves the mind in that ones will is severely debilitated due to excessive negative rumination. It is the belief of this author that when specifically designed guided meditation is given in a clinical setting similar to CBT, along with instructions for continuing practice at home, the severity levels of anxiety and depression can be reduced at a rate far surpassing any current remedies.

                The guided meditation will be developed to include several focus-areas that will enhance ones self-view; including awareness of one’s thought processes, relationship of mind and body, self-love, and relationship with the external world. Mindfulness and the reduction of negative rumination are achieved as a byproduct of the higher level objectives. These practices have been around for centuries and are very common in eastern spirituality such as Buddhism. The fundamental concept driving this research effort is the belief that we are born without fear, fully capable of loving ourselves and others, and that negative traumatic experiences create the mental conditions known as anxiety and depression in response to a fear of reoccurrence. Therefore, the process is one in which we remove the learned negative responses in an effort to return to our natural state, a state based on love of one’s self and others.

                The potential benefits of these practices are well known, as one only need speak to a practicing Buddhist to sense their state of bliss and peace. Unfortunately, this is not enough to serve as evidence on a scientific level. This study is intended to test the potential benefits in the same clinical setting that current remedies are applied. This is the first study of this type to be applied in a clinical therapeutic trial known to this author, based on an extensive review of current available literature. However, this is not the first study of cognitive mindfulness as a potential benefit to symptoms of anxiety and depression. The studies in the following section are being utilized as supportive evidence that the research being proposed is worthwhile and could be a tremendous benefit to the multitudes of individuals currently suffering from these disorders.

Literature Review

                The unifying theme of the articles included in this review relate to a proposed research question which asks whether or not guided meditation would be a beneficial treatment for patients with anxiety and/or depression when given in a clinical therapeutic fashion comparable to CBT. The articles included here all deal with testing the benefits of cognitive mindfulness, including meditation, on attributes including but not limited to, anxiety and depression. All studies included in this review were published in peer reviewed journals within the last five years.

                Foley et al. (2010) evaluated the potential benefits of Mindfulness-Based Cognitive Therapy (MBCT) for a group of 115 individuals diagnosed with cancer. This was the first test of MBCT done in an oncology setting under the hypothesis that MCBT would benefit patients through improvements in anxiety, depression, distress and quality of life. The participants attended 8 weekly 2 hour sessions in addition to a 1 full day training session and meditated daily for no more than 1 hour. Assessments were taken at baseline immediately prior to treatment and immediately after, along with an assessment given at 12 weeks post completion. Depression was measured using the 17-item structured interview Hamilton Rating Scale for depression (HAM-D) while anxiety was measured with 14-item structured interview Hamilton Anxiety Rating Scale (HAM-A). The results indicated clinically significant improvement in all categories as compared to the control groups including a showing of the improvements being maintained over time. Foley et al. (2010) suggest there is a potential for this group (cancer patients) to invest more effort into this type of trial than would others (non-cancer patients); something the authors address by suggesting further research in the dynamic they referred to as “striving”.

                As far as a critical analysis, it was difficult to find areas to suggest improvement that the authors did not already address. The meditation methods utilized focused on patterns of negative thinking (rumination) and were modified to meet the needs of the particular group. Blind methods were utilized whenever assessment measures were taken and well known diagnostic measures were utilized. The list of suggested further research was very comprehensive. However, the suggestion for future research comparing motivational differences between various groups, including patients of chronic depression, was noteworthy as these patients make up a portion of the current research perspective participants. This study relates to others in that statistically significant improvements were found in both anxiety and depression. While “striving” must be considered in the oncology environment, it will have no bearing on the current research proposal.

                Kemeny et al. conducted research much more intensive and complex in that it attempted to answer the conceived limitations of self-report diagnostic measures by adding complementary task based affect measures and utilizing biometric responses to these tasks such as pre and post-test blood pressure and respiration measures. The trial group consisted of 82 healthy female school teachers in relationships. According to Kemeny et al. (2012) school teachers represented a group whose daily lives are stressful as well as being a group in which benefits of the program would extend to a secondary group, the students. An 8 week training session included 42 total hours of on-site training in addition to at home meditation practice which was approved by the Institutional Review Board (IRB) of the University of California. The results indicated a strong decline in self-reported depression at post-test and 5 months later. They also found a strong correlation and lasting affect between rumination and mindfulness in that as rumination declined, mindfulness increased. Another noteworthy find was a correlation between at home meditation adherence, anxiety, and mindfulness in that the more hours spent meditating at home per guidelines, the lower trait anxiety and the higher the mindfulness. Kemeny et al. (2012) conclude that combining mindfulness practice with scientific emotional study techniques in intensive short term (8 week) programs can result in improved cognitive behavioral patterns that not only increase a more positive sense of well-being, but also extend into an overall improved social dynamic.

                This study attempted to address several issues that seem prevalent in the area of common criticism’s directed at studies of this type. They utilized a large sample size, employed task based measures and biometrics to complement self-reports, and coordinated with field experts such as a Buddhist contemplative scholar and emotional experts on their training program. The authors explain that it would be difficult to perform sub sample analysis if men were included due to different autonomic nervous system responses between the sexes. However, they do suggest further research including both sexes. This study is similar to the Sahdra study in that measures were utilized to compliment self-reporting as diagnostics as well as the use of experts and authentic Buddhist methodology. The clinical setting and intensity of training are similar to the first study. The utilization of only one sex is of slight concern but it’s not enough to disregard this study as supportive research. This study shows significant improvements in anxiety and depression as did the others but also shows significant correlations relating to the adherence to consistency of home practice, which should remain a focal point of any further research in this area.

This third and last study was unique in that intensive meditation training was conducted in a 3 month secluded retreat setting. In addition to meditation training, a 32 minute response inhibition task (RIT) was utilized to gauge self-regulation. Participants were selected from responses to advertisements with specific requirements of having attended a minimum of three previous meditation retreats of 5 -10 days, at least one of which had been led by Dr. Wallace, the current retreat facilitator. Ages ranged from 21-70 and all agreed to non-use of tobacco and recreational drugs for 3 months preceding the retreat. The meditation included seven focus areas and was performed from 6-10 hours a day over the three month period. Measurements included both self-report and RIT taken before and immediately following the retreat and again five months later. The purpose of this study was to determine whether positive changes in attentive control and adaptive functioning could be attained through intensive meditation training. The authors found significant results with both the treatment group and the wait list group in post-test as well as maintained results over time. According to Sahdra et al. (2011), they are the first study they are aware of “to demonstrate that the capacity of self-regulation can be enhanced in a lasting manner”. (p. 309, para. 3)

Some areas that should be questioned are first, the requirement to have attended 3 previous meditation retreats. While it may be true that the potential for participants to successfully endure the rigors of such a retreat increases, it also seems likely that the success rate of positive outcomes could be biased as compared to a potential lay group in which this practice may be applied. The intensity of the meditation also seems a bit radical at 6 – 10 hours a day. This study relates to the second in the application of measures in addition to self-reporting and the inclusion of authentic eastern Buddhist concepts. This article does support the concept that meditative practices show positive results relating to themes such as rumination and mindfulness; however, the utilization of this study as anecdotal evidence supporting new research similar to the proposed primary research question is limited based on the radical nature of this study.

                All three articles reviewed resulted in statistical significant results regarding positive benefits of cognitive mindfulness as it relates to the symptom severity of anxiety and depression. In addition, two of the three articles provide significant findings in a correlation between the number of hours spent at home meditating and the reduction in symptom severity of anxiety. Subsequently, this research will ensure emphasis is placed on this significance when designing the at home meditation aspect of this study. While two of the three articles chose to enhance internal validity through utilization of biometric variable measures, this research will rely on self-reporting due to cost issues related to this type of measure.

                The newly proposed research question asks, “Can guided meditation aid in the reduction of symptom severity related to anxiety and depression in a clinical therapeutic setting”? The hypothesis for this research question is listed below:

Ho: Anxiety/Depression scores for guided meditation + CBT group = Anxiety/Depression scores for CBT only group.

 

Ha: Anxiety/Depression scores for guided meditation + CBT group ≠ Anxiety/Depression scores for CBT only group.

 

This hypothesis will answer the research question through an experimental research study utilizing self-reported quantitative measures. Levels of anxiety/and depression will be measured utilizing a self-reported interval-scale measuring symptom severity between 0-10 with 0 representing no symptoms and 10 representing the participants most severe symptom experience. A control group of participants will be given standard Cognitive Based Therapy (CBT) while a test group receives CBT in addition to guided meditation over an 8 week period. Further design details will be discussed in the method section of this document. Based on the extensive history of cognitive mindfulness practice in eastern spirituality combined with the very significant results of the scientific research review, this author believes the proposed research has an enormous potential for providing significant benefits as a therapeutic treatment in a clinical setting similar to CBT. This research is necessary to establish a scientific evidence base that could be utilized to advance current study findings, ensure effectiveness or non-effectiveness in the proposed setting, and provide a foundation for suggested further research based on the results.

 

 

 

Method

Participants

                This study is unique in that the facilitator must be a licensed practicing psychotherapist. This poses a challenge as the facilitator must also be trained in the proposed meditation practices to the point of being considered highly qualified. For this reason, the facilitator will be required to complete the proposed program first and pass a competency test. The participants for this study will be at least 18 years of age and be comprised of both males and females. They will have a diagnosis of anxiety, depression, or both. Participants having diagnoses with higher severity will be allowed as long as symptoms of anxiety and/or depression also exist. While anxiety and depression symptom severity will serve as the primary variables for this study, measures relating to other diagnoses will be evaluated post-test to determine if a possible positive co-relation exists between the program and symptom reduction of higher severity diagnoses. This information will be included in the results to support further research possibilities.

                The participants for this study will consist of the facilitator’s current clients and clients to be recruited to achieve a larger sample size. The preferred location will be a major city in the west. It is believed that this area would facilitate a greater positive response due to the recent growth in popularity of eastern spiritual practices in the area. Non-client participants will be recruited by placing ads on craigslist, hanging flyers at local spiritual type businesses including but not limited to spiritual centers and yoga class locations. Students at nearby Universities will also be recruited to participate in the program. 

                All attempts will be made to recruit an equal number of participants having moderate to extensive experience with meditative practices as those who have little to none. This is to facilitate a mixed covariate design of between subjects which will be discussed further in the following sections.

                Many studies of this nature require participants to refrain from smoking and recreational drug use for a specified time prior to the study, however, it is the strong belief of this author, based on personal experience, that this concept may conceal the true power of mindfulness practice in that one does not overcome addictions so that they may learn mindfulness; rather, mindfulness when learned and applied facilitates an increased probability of overcoming addictions. For this reason, addiction and attachment problems to which participants are aware will be documented and tracked to facilitate a longitudinal study on the effects of successfully completing a guided meditation treatment program on the long term ability to overcome addictions.

Materials/Apparatus

                Several commercially available assessment metrics will be utilized to determine pre and post intervention variable measures. Pre and post intervention measures for depression will be collected utilizing the 17-item structured interview Hamilton Rating Scale for Depression. Anxiety levels will be measured utilizing the 14 item structured interview version of the Hamilton Anxiety Rating Scale. According to Foley et al., (2010), both the depression and anxiety Hamilton Scales require the practicing clinician to consider the previous week’s symptom severity related to frequency and intensity. In addition to the measures to collect anxiety and depression, the 36 item Experiences in Close Relationship scale will be utilized to collect data for the associated longitudinal study relating to addictions and attachments. Utilizing additional scales not relative to the primary variables will also assist with internal validity in that participants will have difficulty determining the true purpose of the experiment which can lead to participant bias. All scales to be utilized are well known in the industry and have long histories of successful application in both research as well as clinical practice.

                In addition to the forms utilized to collect the self-report measures previously mentioned, a website will be designed to be utilized for the at home meditation portion of the program. A web site utilized for at home guided meditation provides several benefits over disc based training. Monitoring the time spent doing individual meditation can be automated and displayed with additional metrics such as which days and how many hours per day. Expenses are actually lowered as no physical material is needed. There is one central copy of the program with access being controlled by the web site and appropriate access controls. However, a disc based copy of the meditation program will be included with the submission of this document for review and potential approval by the appropriate review board.  

Measures

                As previously mentioned, the symptom severity for anxiety and depression will be collected pre and post intervention utilizing the Hamilton scales for anxiety and depression. These levels represent the dependent (criterion) variables. The guided meditation represents the independent variable. Each participant will receive 4 weekly hourly facilitated sessions to become familiar with the process. Participants will then be instructed to log in to the web site and begin at home meditation sessions that will be monitored by the central website. Each participant will need to complete a minimum amount of at home meditation per week to remain in the program. Data collected by the website will be utilized along with the Hamilton scales to facilitate inferential statistics utilized to increase internal and external validity.

 

 

Procedure

                Once the facilitator has been selected, they will be required to complete the guided meditation program and pass a competency test. Participants will be recruited per the details outlined in the participant section of this document. As previously mentioned, participants will be split into two groups based on previous meditative practice experience.        This additional covariant variable will be utilized to create a quasi-experiment within the actual experiment. This is done to address the variance potential of this quasi variable. It’s possible that participants with previous meditation practice may achieve positive results that are not necessarily attributable to the independent variable itself. The two primary groups will then be placed into two additional even groups, one consisting of participants who will receive the treatment, and a control group who will be placed on a wait list and receive no guided meditation. This is a between subjects design utilizing non-equivalent control groups. This design is incorporated to increase internal validity by reducing the impact of variance potential while simultaneously increasing external validity by providing maximum variance data that can be incorporated into post treatment inferential statistical analysis.

                Participants who are not previous clients of the facilitator will be seen for 4 weeks prior to intervention in order to establish participant baselines and in order for the facilitator and participant to establish a trusting relationship. Baselines for previous clients will be established utilizing existing records of recent sessions. Participants will be given online access and instructions for creating their individual accounts along with instructions for completing the Hamilton assessments online prior to the first in person session. The first official in-person session will consist of a review of the experiment including disclosure of the participant rights and expectations. Once the participant is fully informed and signs all appropriate documents an initial short guided meditation session will be provided for the treatment group participants. The wait list control group will go through the same procedure except they will not receive any guided meditation. To re-iterate, both the treatment group and the control group will consist of participants having previous meditative practice as well as participants who have none.

                Participants in the treatment group will undergo 4 weekly sessions including guided meditation while the control group will receive 4 weekly sessions of traditional therapy. At the end of the 4 weekly sessions, the treatment group participants will be instructed to begin the at home meditation practice. The control group will continue with traditional psychotherapy. The at home portion of the experiment will continue for 8 weeks with a minimum requirement of 4 hourly guided meditation sessions per week. The minimum 4 hours of weekly guided meditation are pre-determined and must be completed in order. Participants are encouraged to meditate as much as they want and additional types of guided meditation sessions will be available beyond the 4 hours of required sessions. This can be thought of in terms of class requirements at a University whereby certain core courses are required and additional electives are available as optional courses based on the student’s preference. The treatment group will continue the weekly in person sessions with traditional psychotherapy in addition to short discussions related to the progress of at home meditation along with an opportunity to address any issues that may occur.

                At the end of the 8 weekly home meditation sessions participants will complete the Hamilton self-report measures, along with any additional questionnaires the facilitator makes available. The control group will also complete all online assessments in the same time frame.

The information will then be tabulated and provided to the experiment statistical expert who will run the appropriate inferential statistics to be included in the final report.

 

Ethical Considerations

                Bordens and Abbott (2013) stress the importance of obtaining informed consent as a practical method of dealing with many of the ethical considerations surrounding experiments using human participants. The participants in this study will receive pertinent information about the purpose of the research, the methods utilized, what is expected of them (requirements), what they can expect from the experiment (rights), and receive informed consent relating to their ability to withdraw from the experiment at any time. The intervention phase will not begin for any participant until that participant has received the pertinent information and signed the appropriate documents.  The participants in this study are required to be at least 18 years of age which means parental consent will not be required. In addition to the ethical consideration mentioned, the full spectrum of ethical guidelines expressed in the 2002 APA Ethical Principles that Apply to Human Research Participants will be strictly adhered to in this study.

Summary

                Cognitive mindfulness is a practice that has been around for centuries in eastern spiritual circles. Guided meditation is a form of cognitive mindfulness entrainment that enhances the potential of success by a facilitator leading participants through various stages of mindfulness practices. Guided meditation has been shown to provide significant improvements in the symptom severity of anxiety and depression in three recent experimental studies reviewed in this proposal. In an extensive literature search for peer reviewed studies in which cognitive mindfulness was measured against anxiety and depression over the last five years, no studies other than the three reviewed in this proposal were found. This suggests that the proposed study will be the first to be conducted in the proposed environment. The proposed experiment has the potential to evolve into a clinical therapeutic treatment option for psychologists that may well surpass current treatment option benefit potential. This research will also serve to enhance the current field research in this area and provide a foundation for further suggested research in the area of cognitive mindfulness benefits toward anxiety and depression as a potential clinical therapy option.           

 

References

Bordens, K.S. and Abbott, B.B (2013). Research Design and Methods: A Process Approach, 9th Ed. New York, NY: McGraw Hill

Foley, E., Baillie, A., Huxter, M., Price, M., & Sinclair, E. (2010). Mindfulness-based cognitive therapy for individuals whose lives have been affected by cancer: A randomized controlled trial. Journal Of Consulting And Clinical Psychology, 78(1), 72-79. doi:10.1037/a0017566

Kemeny, M. E., Foltz, C., Cavanagh, J. F., Cullen, M., Giese-Davis, J., Jennings, P., & ... Ekman, P. (2012). Contemplative/emotion training reduces negative emotional behavior and promotes prosocial responses. Emotion, 12(2), 338-350. doi:10.1037/a0026118

Nolen-Hoeksema, S. (1991). Responses to depression and their effects on the duration of depressive episodes. Journal of Abnormal Psychology,100, 569–582.

Sahdra, B. K., MacLean, K. A., Ferrer, E., Shaver, P. R., Rosenberg, E. L., Jacobs, T. L., & ... Saron, C. D. (2011). Enhanced response inhibition during intensive meditation training predicts improvements in self-reported adaptive socioemotional functioning. Emotion, 11(2), 299-312. doi:10.1037/a0022764