It seems obvious that the non-specific effect of any intervention is closely related to its credibility and plausibility as a therapeutic intervention i.e. its “face validity”. Now, some of the effects associated with meditation must be non-specific, i.e. comprising a mixture of placebo, therapeutic contact, spontaneous improvement, and so on, whereas some, hopefully, are specific to meditation alone. One might even propose that different meditation techniques have varying proportions of specific and non-specific effects. Within the context of an RCT, the control strategy should ideally:

• elicit all the non-specific effects that meditation might have, but have none of meditation’s specific effects;
• not have any specific effects of its own.

By fulfilling these criteria the control strategy makes the RCT methodology sensitive to any specific effects of meditation that might be detectable.

Dr Ramesh Manocha

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The fact that the mental silence construct, more than any other factor my research, correlated positively with a wide range of health measures raises interesting implications in several areas of study. The findings emanating from my research imply that the notion of mental silence and its associated yogic philosophy, may be important in the ongoing development of our understanding of meditation and the various definitions and taxonomies that relate to it. It also provides some new clues for scholars interested in the “essential factors” of religiosity and the question as to why some forms of religiosity are beneficial and others not. Furthermore, it provides empirical data that may help to progress the ongoing debate about the theoretical differences between “religiousness” and “spirituality”. Perhaps most important of all they provide empirical evidence of a positive relationship between a well-defined state of consciousness and health and wellbeing. That, it is asserted, constitutes a significant contribution to the nascent field of consciousness research as well as our understandings of health. It implies a nexus between religiosity, consciousness and health that is accessible to measurement. The practical ramifications are that meditation may have a valuable role to play in the promotion of mental health and the prevention of mental illness primarily as a result of the beneficial impact of the mental silence experience.

Dr Ramesh Manocha

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The diversity, and apparent impotence, of many meditative practices makes the construction of sham meditation quite feasible since researchers can develop rationales to justify almost any method that approximates the expectations of trial participants.

For instance, Smith’s (1995) RCT compared TM to an imitation exercise designed to closely mimic the entire technique, except for the proprietary mantra. Forty four participants practiced one of the 2 techniques for 24 weeks, with the same instructions for frequency and duration only to find that no difference between the 2 methods was detectable. This study used well validated self-reporting measures shown in other studies to be quite sensitive to the effects of meditative practices.

Similarly Dua (1992) compared a form of meditation that he developed to a “negative thought reduction” method as well as to a “negative thought enhancement placebo” for the management of anger in a small RCT and found no differences between the practices in any of the outcome measures at the end of the treatment period.

On the other hand, Wolf (2003) compared a meditation based on a traditional Sanskrit mantra (the maha mantra) with a pseudo mantra and observed substantial differences in post treatment outcomes.

In smaller trials, Rai (1988, 1993) observed a number of significant differences when he compared Sahaja Yoga meditation to “mimicking exercises” in the treatment of asthma, hypertension and stress.

Dr Ramesh Manocha

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It may not be practically possible to devise and implement an ideal control method for meditation trials, nevertheless it is important to select a strategy that approximates that ideal. The bare minimum criteria for a control process in meditation research should therefore be:

• First, high face validity as a therapeutic/stress management intervention in its own right. It should actually appear to be a credible meditation technique if that is the expectation of participants.
• Second, a process that involves relaxation and reduction of somatic arousal since this is the nearest conventionally understood phenomenon that meditation resembles and from which it needs to be distinguished.

Given these considerations there are two ideal strategies: sham meditation and the head-to-head comparison.

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The observations of previous randomised controlled trials assessing meditation could lead to three possible conclusions:

1. Meditation is in fact no more effective than other approaches to rest and relaxation. Yet meditative traditions have existed for thousands of years and at least in India, are widely perceived to have specific and unique features. In other words history and culture do not agree with the idea that meditation is simply a method of mundane relaxation. While this “test of history” does not provide proof of efficacy, it does encourage the undertaking of a thorough examination of the phenomenon before it is discarded as mere folklore and superstition.

2. The measures which have so far been used to assess the effects of meditation are not sensitive to the specific effects of meditation. The wide variety of outcome measures used means that if the specific effects of meditation are not detectable, then the effects are either too small or too esoteric for mundane study. Yet classical descriptions of meditation suggest that despite the metaphysical basis of meditation, its effects do manifest themselves in mundane dimensions such as health and behaviour, implying that at least some of the many measures available to researchers should be able to detect a differential effect. Again, while this might be satisfactorily applied to the genre as a whole, there appear to be isolated exceptions which suggests that certain as yet undetermined categories may be able to generate specific effects. Yet our analysis of the aggregated data has not yet yielded a pattern with sufficient clarity to identify the features of that category.

3. The methods that have been labelled as “meditation” in the trials do not consistently reflect the true nature of meditation. This is the most interesting and important issue and therefore merits considerable discussion. The functional and conceptual definition determines the nature of the intervention, which in turn influences the choice of the control method that ought to be used and therefore the validity and generality of the findings. Yet defining meditation has proven to be a difficult challenge for modern researchers. While early empirical reports seemed to show that measurable distinctions between meditation and rest or simple relaxation existed, rigorous trials did not support these perceptions. As a result, much of the research work on meditation has been based on the assumption that meditation techniques are much the same despite minor external and superficial differences. Indeed Western researchers have proposed that most meditative processes are physiologically similar to simple rest and relaxation and the high quality physiological trial data seems to support this. These perceptions have thus given rise to an assumption of “psycho-physiological uniformity”.

This last idea is the key to the problem because in fact both Western meditation enthusiasts and Western scientists, despite their opposing views, have failed to apprehend a key factor that underlies the ancient tradition of meditation: The idea that meditation necessarily involves the experience of mental silence.

Dr Ramesh Manocha

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In order to effectively tease out the effects of mental silence as opposed to the effects of other aspects of Sahaja Yoga meditation it was obviously necessary to use randomised controlled trial methodology. Having refined the practical approach in previous clinics it became possible to develop a standardised, instructional strategy whose structure could also be mirrored in control strategies in order to optimise the exclusion of non-specific effects.

The first attempt at this was a well-designed RCT involving 59 participants in which SYM was compared to a standard stress management programme for sufferers of moderate to severe asthma (on pre-stabilised, optimised treatment but who remained symptomatic). This trial was designed to compare two similarly active and credible interventions in which the main critical difference was the use of mental silence in the SYM group. While both groups experienced similar improvements in a number of outcome measures, the SYM group demonstrated significantly greater improvements in clinically important subjective measures such as aspects of asthma specific quality of life, mood state and, notably, an objective measure of disease severity known as airway hyper-responsiveness. The outcomes suggest: first, that mental silence does appear to have a specific effect on mood as well as some aspects of quality of life; second, that mental silence also has some effect on pathophysiology itself. Although well designed the sample size was small and drop out rates were somewhat higher than expected thereby raising the possibility that important effects were not detectable because of type 2 errors in the statistical analysis. A larger sample size was needed to overcome this possibility. Moreover, although mental silence had been compared to stress management, it would be more informative to determine its effect in comparison to an intervention that more closely resembled a non-mental silence approach to meditation.

Taking these considerations into account, a second, larger RCT of mental silence orientated meditation is reported. SYM, as an example of the mental silence approach, was compared to a “non-mental silence” approach to meditation. SYM was, on average, twice as effective as the comparator in reducing work related stress, general depressive symptoms and anxiety.

Thus in two well-designed RCTs in which the mental silence approach to meditation was compared to highly credible and active controls, substantial differences in therapeutic effects were observed, clearly suggesting that a specific effect is associated with mental silence orientated meditation techniques.

Dr Ramesh Manocha

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A national survey of Sahaja Yoga meditation practitioners using standardised measures revealed that meditators experienced significantly better levels of quality of life and mental health as compared to population data drawn from national health surveys using the same instruments. Similar surveys of populations practising Western forms of religiosity also reported better health than the general population but the meditators appeared to experience substantially greater advantages. Remarkably, analysis revealed a robust and consistent relationship between reported frequency of mental silence experience and health scores, especially mental health, thereby providing support for my central hypothesis that is that the experiential mental silence aspect of meditation is associated with health benefits. An association however does not prove causality and so it became necessary to conduct observational experiments to determine if meditation, and more specifically, mental silence, was specifically responsible for the health benefits observed in the health survey.

Dr Ramesh Manocha

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Explanatory factors for the observed effects of meditation and their particular importance in behaviour therapy research include the following 3 categories:

Category 1. Factors which are common to all strategies such as social support or therapeutic contact. Many clinical researchers have observed that controls with high face validity seem more likely to generate effects of similar magnitude to the intervention. Expectancy alone has also been shown in a number of studies positively to influence the apparent effect of meditation. An important factor which relates to the plausibility of the control interventions is the participant’s expectation that they will experience a benefit (or detriment)45. Despite this, only 24 studies took specific steps to gauge either the participants’ expectation of benefit or the perceived credibility of the various interventions.

Category 2. The possibility that strategies that draw volunteers from the community without using a predetermined threshold of dysfunction end up recruiting samples containing significant proportions of participants with sub-clinical scores. These “worried well”46 have little scope to improve, exerting a ceiling effect on the chosen measures and thus dilute any apparent effect of the intervention. In other words, behaviour therapy trials, especially trials that recruit from the general community, and even more especially those community-recruited trials seeking to demonstrate behavioural changes in normal participants (i.e. those with no diagnosed psychopathology) are fundamentally prone to type 2 errors in study design47. Since meditation was developed as a practice for everyday use by normal people rather than those with psychopathology, researchers have frequently recruited from the community. This issue is therefore of particular relevance to the work presented in this thesis.

Category 3. Other factors include regression to the mean. This is a phenomenon that most commonly occurs in studies in which participants are selected because they have extreme values on a certain variable, such as in clinical trials for which specific eligibility criteria are set. In this case, the participants will manifest an improvement simply because of the natural tendency for variables to approach the population mean over time, regardless of any effect (or lack thereof) from the intervention being studied48,and poor choice of outcome measures which are not specific and sensitive enough to detect change.

Dr Ramesh Manocha

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Of great interest is that the yoga tradition does not just describe philosophical, moral, metaphysical associations between mind, behaviour and health but actually describes the mechanism by which they are interconnected. This is the system of chakras (energy plexuses) and nadis (energy channels). Described since ancient times, the physical body is said to be energized via a complex network of 72,000 nadis and their associated chakras, not unlike the ancient Western understandings of the four “humors”—blood, bile, phlegm and pneuma. Yogic exercises and disciplines are directed at manipulating the subtle energetic system in order to bring about shifts in energy flux which not only impact on physical function, but also on cognitive style, mood and consciousness.

States of enlightened consciousness, whether they be described as self-realization, moksha or sahaja can be characterized by the awakening of an energy called kundalini. This energy is said to lie dormant at or near the base of the spine. At the time of awakening it rises through the spine to enter the brain and then exit via the crown of the head. The kundalini has been described variously and has been compared to many other psycho-cultural and archetypal symbols. For a useful diagramme, see Subbarayappa, 1997.

The ancient subtle-energetic mechanics of the chakra system may offer important clues in the quest to comprehensively describe and integrate the otherwise rather disparate psycho-physiological pathways that are coming to be recognized in modern science.

Dr Ramesh Manocha

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The yogic idea of mental silence implies first, that taming of the mind is the key to successful personal development and second, that the untamed mind is a fundamental factor in the development of disease. These ancient ideas are reflected in modern scientific evidence which demonstrates the deleterious impact of stress and negative affect (emotion/mood) and the constructive impact of positive moods on health. In fact this evidence forms the basis of modern theories such as the bio-psychosocial model of health, positive psychology (and specifically the ideas of mental hygiene, flow state, peak experience and plateau experience) and the religion–health connection (to be discussed later). It represents a development of the idea of psychosomatic disease postulated in the 1970s, psychoneuro-immunology and mind-body medicine.

For more discussion on the aims of yoga check Dr Ramesh Manocha’s site.

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