Abstract & Commentary
Spirituality and In Vitro Fertilization
By Howell Sasser, PhD
Associate, Performance Measurement, American College of Physicians, Philadelphia, PA
Dr Sasser reports no financial relationships relevant to this field of study.
Synopsis:In a randomized study conducted among Chinese women undergoing in vitro fertilization therapy, those receiving a body-mind-spirit intervention combining well-being, resilience, and spiritual transformation experiences with principles of Chinese philosophy showed significantly lower state and trait anxiety, greater tranquility and resilience, and smaller declines in daily functioning and physical distress, as compared with control participants who received no intervention.
Source:Chan CHY, et al. Incorporating spirituality in psychosocial group intervention for women undergoing in vitro fertilization: A prospective randomized controlled study. Psychol Psychother 2012;85:356-373.
A research group in Hong Kong developed
an integrated body-mind-spirit (I-BMS)
intervention combining typical "Western" elements (well-being, resilience, spiritual transformation) with culturally relevant content from Chinese philosophy. Exercises, usually done in groups, included meditation, breathing exercises, journaling, and didactic content about the physical processes of stress and relaxation.
To test the I-BMS intervention in a high-stress life setting, the group recruited 339 women who were beginning in vitro fertilization (IVF) treatment. The goal of the study was not to try to influence the outcome of IVF, but rather to use it to provide context for the intervention. Women who agreed to participate were assigned randomly to I-BMS or to a control group that received nothing from the study. Those in the I-BMS study arm attended four weekly sessions, each lasting 3 hours, in groups of 7-10, and did additional exercises at home.
Study outcomes were assessed using the Chinese State-Trait Anxiety Inventory, the Importance of Childbearing Index, the Chinese version of the Kansas Marital Satisfaction Scale, and a Body-Mind-Spirit Well-Being Inventory developed by the investigators. Participants also provided socioeconomic and medical information.
The effect of the I-BMS intervention as compared with the control condition was assessed for the period from study randomization until the day ovarian stimulation began (T0-T1), and from then until embryo transfer was attempted (T1-T2), as well as over the complete study period (T0-T2). A summary of the study findings is shown in Table 1. Briefly, the intervention group improved on key measures of anxiety and spirituality while the control group worsened. On other measures, both groups improved or declined, but the I-BMS group showed more desirable changes. Interestingly, the intervention appeared to be most effective in the short term in dealing with cognitive effects (anxiety, importance of childbearing) and in the longer term with more practical effects (marital satisfaction, physical distress). The fact that some outcomes only showed significant changes when measured over the total study period suggests a gain in the "potency" of I-BMS over time. There was no significant difference by study group in IVF outcomes.
A number of factors influence how we should assess the results of this study. The first, and most important, is attrition. Over the course of the study, 31 I-BMS and 57 control participants were lost to follow-up, producing attrition rates of 18% and 34.1%, respectively. A portion of these (n = 34) were attributable to IVF-related causes (pregnancy, treatment delay, or termination), but the remainder were voluntary withdrawals from the study. While some dropouts, especially in a no-intervention control group, are to be expected, a rate much above 20% is cause for concern. The investigators found several statistically significant differences between those who dropped out of the study and those who remained, including higher baseline marital satisfaction, lower baseline importance of childbearing, and shorter marital duration among the dropouts. However, they do not report how these characteristics were distributed between dropouts from the intervention and control groups. This makes it difficult to say exactly how attrition may have affected the study's findings, although it raises doubts about the integrity of randomization as a way of making the study groups comparable on potentially confounding factors. It seems appropriate as a consequence to view the results with some suspicion.
A second issue deals with timing. The study investigators describe at what points in the IVF treatment process they measured the various outcomes (study enrollment — presumably before any treatment, the day ovarian stimulation began, and the day embryo transfer took place), but the study intervention is described simply as taking place "before treatment." It is unclear how long the interval between the study intervention and the beginning of IVF was or whether it was roughly the same for all women in the intervention group. This leaves the reader to guess at important clinical details such as the value of practice and internalization after the intervention and before a stressful event, and the likely duration of the treatment effect. This is all the more important given the apparent pattern of changing effects over time. The absence of clear description of the methods limits both the strength and the generalizability of the study's findings.
Two other study design factors are important to note. First, the I-BMS treatment was compared with a no-intervention control. This raises the possibility of a "nocebo" effect, in which the control group's responses are affected negatively by the awareness that they are not receiving something. The study's results would be more compelling had I-BMS been compared with another active intervention — a point made by the investigators as a goal of future research. Second, the study group was composed of women only. This removed one element of heterogeneity (i.e., raised internal validity), but given that the study focused on IVF, is regrettable. Male spouses/partners were understood to be present in the participants' lives. Had these men at least been assessed, if not included fully in the study, it would have been possible to determine their role in raising or lowering their female partners' levels of stress. We are also left with no concrete sense of how appropriate this intervention would be for male patients.
In its favor, the study tested an integrative intervention that included culturally relevant content and delivery. It combined cross-cultural elements (meditation, guided imagery, physical activity) with Chinese philosophy and a sensitivity to the importance of marriage and childbearing in Chinese culture. This awareness that behavioral and cognitive interventions are tied to (or at least influenced by) specific circumstances aids both in their evaluation and use in practice. This study also took place in the course of a genuine, acute stressor — IVF therapy. This seems to be more demanding a test of the treatment effect than would have been possible in the context of daily "background" stress. While this may not be a wholly generalizable experience, it contains elements common to many stressful situations — high personal stakes, limited control of complex processes, problems in applying routine coping skills to an unfamiliar situation — which does much to show its possible benefits in other contexts.
What should clinicians and patients take away from this study? One clear message seems to be the value of being forearmed. This and similar interventions help those who use them to develop coping resources that can be drawn on later. While this can be seen most readily in how we react to clearly defined, high-stress events, the same techniques can be used to help manage "ordinary" daily stresses.
A second clear message is the need to choose treatment strategies carefully. The attention the investigators in this study paid to cultural and situational factors certainly improved the fit between the intervention and those who received it. It is worthwhile to consider where and for whom an intervention was developed — one size does not fit all. Many interventions have been validated in various ethnic, linguistic, gender, and age groups, and this information is usually readily available. (A good source for this information for mind-body interventions is the National Registry of Evidence-Based Programs and Practices, a website sponsored by the Substance Abuse and Mental Health Services Administration of the U.S. Department of Health and Human Services. It can be found at www.nrepp.samhsa.gov.) It is also important to note that interventions with many parts may need to be viewed as integrated units — in other words not as menus from which selected parts can be extracted.
Finally, it is important for both clinicians and patients to be aware that coping strategies can be effective — and should be employed — even if they do not alter the outcome of the event creating the stress. In this case, IVF outcomes were no different with or without I-BMS. Even so, the intervention gave the women who received it a way of managing part of a situation that was largely outside their control. Regardless of the IVF outcome, they gained a means of thinking about and reacting to it. This is valuable whenever clinician and patient must confront difficult and uncertain prognoses.