West j nurs res 2012-tuck-712-35


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West j nurs res 2012-tuck-712-35

  1. 1. Western Journal of Nursing Research http://wjn.sagepub.com/ A Critical Review of a Spirituality Intervention Inez Tuck West J Nurs Res 2012 34: 712 originally published online 6 February 2012 DOI: 10.1177/0193945911433891 The online version of this article can be found at: http://wjn.sagepub.com/content/34/6/712 Published by: http://www.sagepublications.com On behalf of: Midwest Nursing Research Society Additional services and information for Western Journal of Nursing Research can be found at: Email Alerts: http://wjn.sagepub.com/cgi/alerts Subscriptions: http://wjn.sagepub.com/subscriptions Reprints: http://www.sagepub.com/journalsReprints.nav Permissions: http://www.sagepub.com/journalsPermissions.nav >> Version of Record - Sep 2, 2012 OnlineFirst Version of Record - Feb 6, 2012 Downloaded from wjn.sagepub.com at UNIVERSIDADE DE MOGI DAS CRUZ on October 29, 2013 What is This?
  2. 2. Articles A Critical Review of a Spirituality Intervention Western Journal of Nursing Research 34(6) 712­–735 © The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0193945911433891 http://wjn.sagepub.com Inez Tuck1 Abstract Although there is a growing interest in the topic of spirituality, there are few reports of spiritual interventions and limited empirical data to support their effectiveness. As health care practices become increasingly evidence based, the reliance on empirical data is critical. This article describes the spiritual intervention developed by the author and documents the testing of its effectiveness with clinical and nonclinical populations. The findings from a series of studies have been mixed. Preliminary studies reported that the intervention positively influenced patients’ outcomes, including overall quality of life and reduced selected stress responses. Significant positive trends were found that supported the potential effectiveness of the intervention for a variety of populations and clinical settings. However, subsequent testing in clinical trials indicated limited effect of the intervention although there were several noteworthy findings. The author discusses the implications of these findings for future investigations. Keywords spirituality, intervention, HIV, clinical trials The author believes that efforts to provide spiritual care as mandated by the Joint Commission for Accreditation of Healthcare Organizations (JCACHO, 1 North Carolina Agricultural and Technical State University, Greensboro, USA Corresponding Author: Inez Tuck, School of Nursing, North Carolina Agricultural and Technical State University, 1601 East Market Street, Greensboro, NC 27411, USA Email: ituck@ncat.edu
  3. 3. Tuck 713 2004) has had limited success. Many health professionals are reticent to provide spiritual care and have minimally met this standard. There remains an overreliance on documenting religious preferences and faith practices and referrals made to clergy or chaplains as major spiritual interventions. The lack of spiritual interventions tested in health care further limits the full implementation of this standard of care. The purpose of this article is to describe the development and testing of a spiritual intervention. Furthermore, the author recommends useful strategies to further this area of research. There are several factors that contribute to the paucity of spirituality interventions available in practice. A primary reason is the lack of agreement regarding the concept of spirituality. There is a wide array of definitions found in the literature. Burkhardt (1989) described three descriptive characteristics of spirituality: inner strength, unfolding mystery (meaning and purpose), and harmonious interconnectedness. Coyle (2002) later described three different attributes of spirituality as transcendent (belief in God or higher power), structuralist behaviorist (religious practices), and value guidance (personal values). The author posits that although many scholars have contributed to the literature, there is not a consensus regarding the definition of spirituality and its parameters or characteristics. Such conceptual limitations may have implications for measurement and testing. Second, nurses are reluctant to provide spiritual care. The author and colleagues in a series of related studies (Pullen, Tuck, & Mix, 1996; Tuck, Wallace, & Pullen, 2001; Wallace, Tuck, Boland, & Witucki, 2002) examined the spiritual perspectives and interventions made by mental health and parish nurses and found that nurses reported their personal affiliation with a religion and high levels of spirituality and yet, both groups reported reluctance in making spiritual interventions. Mental health nurses reported a greater reluctance. The findings from this series of studies indicated that one of the major barriers was the lack of knowledge and discomfort related to the appropriateness of providing spiritual care. Likewise, Vance (2001) reported that acute care nurses perceived themselves to be highly spiritual, but only slightly more than one fourth of them provided adequate spiritual care to their patients. Barriers reported by Vance were lack of time, education and training, and confidence; differences in faith between patient and nurse; and confusion over the difference between proselytizing and spiritual care. Anandarajah and Hight (2001) also found that a majority of health care providers failed to perform spiritual assessments. These studies consistently documented nurses’ reticence to provide spiritual care. Nurses’ lack of knowledge of appropriate spiritual interventions was a consistent finding of these studies.
  4. 4. 714 Western Journal of Nursing Research 34(6) Third, there are limited number of spiritual interventions available and there is a lack of evidence to support their effectiveness. This article describes the development and testing of one spiritual intervention over a 14-year period and briefly reports study findings. In this evidence-based culture of health care, until nurses are assured that spiritual interventions are valid and reliable, spiritual practices will likely remain relegated to clergy or to a few nurses who are comfortable with broaching the subject with patients and families. Clearly, these efforts are inadequate to fulfill the mandate of providing spiritual care to every patient. The author developed a spirituality intervention, and a systematic approach is proposed to describe its development. First of all, the spiritual intervention is described and linked to an array of clinical problems and research findings. Second, the author will briefly provide the conceptual background for the intervention. Third, a four-phase research model is used to describe the testing of the intervention, including study designs and the instruments used to measure outcomes and demonstrate treatment effect. The research model offers an approach to critique internal and external validity. Finally, the findings of these studies are briefly discussed along with implications for future research and practice. The Development of a Spiritual Intervention Linkage of Spirituality and Clinical Practice In the 1990s, the author studied the experience of living with chronic fatigue syndrome and schizophrenia, two stigmatizing illnesses, and found that participants described spirituality and religious beliefs as an essential source of support during difficult times (Tuck, duMont, Evans, & Shupe, 1997; Tuck, Wallace, Casalenuovo, & May, 2000). Although spirituality was not a study variable, it proved to be a figural part of the experience most notably found in the qualitative responses. Participant’s stories became the impetus for the author’s scholarly interest in spirituality and healing. Later, the author conducted regional and national surveys of nurses and an ethnography to examine spiritual interventions used in practice. Study findings included “being with” and being fully present with patients and offering religious materials and prayer. A significant finding of the ethnographic study was a taxonomy of spiritual interventions (Tuck & Wallace, 2000). While these descriptive qualitative studies elucidated lists of spiritual interventions used by nurses, their use was reported as infrequent and without empirical support of their effectiveness.
  5. 5. Tuck 715 Grounding a Spirituality Intervention in Research Early studies related spirituality with a number of chronic illnesses, including cancer and HIV/AIDS (Reed, 1986; Sowell et al., 2000). Spirituality was identified as a factor in maintaining health and well-being (Coleman & Holzemer, 1999; Smith, 1993). Hawks, Hull, Thalman, and Richins (1995) described spiritual health and its relationship to behavioral, emotional, and physical outcomes. Peri (1995) found that having a greater awareness of one’s spirituality resulted in an increase in the spiritual well-being of persons living with HIV. Kendall (1994) reported the core process of wellness spirituality in her grounded theory as essential to health and well-being. Other studies documented spirituality as a contributor to positive health outcomes and wellness (Gray, 1997; Kass et al., 1991; Levin, Chatters, & Taylor, 1995). Other studies conducted during the latter part of the 20th century explored the relationship of spirituality, stress, and coping. Regan-Kubinski and ShartsHopko (1995) interviewed 38 HIV-infected women from the perspective of the cognitive-transactional stress process (Lazarus & Folkman, 1984) and found that coping was related to newfound spirituality, a renewed spiritual commitment, or a reexamination of spiritual beliefs. Folkman (1997) in her work with persons with HIV disease asserted that under conditions of chronic and severe stress, spirituality and religiosity facilitate positive reappraisals of the difficult situation, and these reappraisals in turn support positive psychological states. . . . The use of spiritual beliefs and experiences at all stages of an enduring stressful condition is an aspect of coping that deserves systematic investigation. (p. 1214) Support for a Group Intervention A literature search in CINAHL and Medline/PubMed using the keywords of spiritual interventions yielded a small number of research studies that explored spirituality using a group approach. Reports of findings from two studies contributed to the author’s initial work in 1997. Germer (1996) offered a spiritual awareness group to 17 adult participants who reported the experience of discussing their spirituality as rare and beneficial. The qualitative findings indicated that learning from others, being able to express difficult emotions concerning spirituality in a supportive atmosphere, and gaining motivation to work on this area of one’s life were unanticipated outcomes of the intervention. Astin (1997), using an 8-week stress reduction meditation study, indicated a decline in physical and psychological symptoms
  6. 6. 716 Western Journal of Nursing Research 34(6) and an increased sense of self-control and spiritual awareness among the study’s participants. Several years later, Levine and Targ (2002) conducted a clinical trial of a sample of 191 women with breast cancer enrolled in a 12-week intervention and found that measures of spirituality and spiritual well-being accounted for 40% of the variance in functional well-being of the study’s participants. Phillips, Lakin, and Pargament (2002) offered a 7-week semistructured, spiritual, psychoeducational intervention in which participants discussed religious resources, spiritual struggles, forgiveness, and hope. In addition, Lechner et al. (2003) tested the effects of a 10-week group spiritually based cognitive-behavioral stress management (CBSM) group and an individual psychoeducation intervention and found that both interventions increased the quality of life. In conclusion, group facilitated approaches designed to provide spiritual care have significantly influenced the health outcomes for persons living with chronic diseases. The evidence for a group intervention was well documented in the literature. Description of the Spiritual Intervention The development of the spiritual intervention began in the late 1990s and at the same time there was a growing body of evidence that supported the relationship between spirituality and health outcomes. The spiritual growth group, SPIRIT©, was developed to fill the void of available spiritual interventions for research and practice. SPIRIT© was initially designed as an 8-week experience and was grounded in the substantive and research literature, the findings from previous studies conducted by the author, and her prior group therapy experience. The intervention included interpersonal, self-awareness, and interpretive approaches (Tuck, 2004). The intervention builds on the definition of spirituality as “the essence of an individual and is expressed in the outward manifestations of thoughts, feelings, and behaviors that allows meaning making, peace, hope and connectedness with self, others, nature, and God or higher power” (Tuck, 1998, p. 1). The theoretical underpinning of the spiritual intervention is an integrative framework that is based on the premises and assumptions of symbolic interactionism (Blumer, 1969), phenomenology (Husserl, 1970; Schultz, 1962, 1964, 1970), existentialism (Sartre, 1953), and social learning theory (Bandura, 1977; Grusec, 1992). The 11 assumptions for the intervention derived from these frameworks focus on exploring, apprehending, sharing, appreciating, and connecting with spirituality (Tuck, 2004).
  7. 7. Tuck 717 The intervention was designed for participants to share personal and communal views of spirituality in a group format and supports both secular and religious views. The participants meet weekly for 90 minutes, which includes 20 minutes for reflection and 70 minutes for structured activities designed to facilitate understanding and appreciation of spirituality. The reflection time is accompanied by selections of music. The members are asked to focus their attention on the “here and now” experience of being present in the group while monitoring their breathing and limiting their thoughts. After a brief discussion, the group participates in an activity designed to explore their spirituality. For instance, participants are asked to respond to spiritual readings, watch video clips, and engage in creative activities that allow the expression of spirituality. The session is concluded with the discussion of the activity that allows sharing with others. The participants are encouraged to acknowledge and clarify their insights. The facilitator follows the written protocols and an instruction manual that details the specific activities for each session and critical points regarding group process (Tuck, 2005). Testing of the Spiritual Intervention Whittemore and Grey (2002) discussed the four phases of clinical trials identified by the U.S. National Institutes of Health (NIH) and linked these phases to the development of nursing interventions. They suggested that Phase I trials are designed to test the effectiveness and feasibility of the intervention. The first phase also includes the conceptual development of the intervention and the definition of clinical problems. Phase II pilot studies use larger samples to test the efficacy of the intervention, determine the effect size, and refine the protocol. Phase III includes prospective randomized clinical trials with well-designed experimental designs with large samples, and in this phase, the research protocol is highly defined. Internal and external validity of the intervention is refined in this stage. Phase IV allows the intervention to be tested in actual practice and includes the consideration of the generalizability of the intervention to practice situations. These NIH guidelines imply a positivistic approach to research. Whittemore and Grey (2002) added the interpretative qualitative paradigm in their conceptualization of intervention development. These NIH guidelines will be used to structure this report of testing the intervention. SPIRIT© has been implemented with 29 groups of participants of varying sizes. Three versions of SPIRIT© intervention, 6, 8, and 10 weeks, have been tested for feasibility and acceptability (Tuck, Alleyne, & Thinganjana, 2006; Tuck, McCain, & Elswick, 2001; Tuck, McCain, Elswick, & Baliko, 2002). The initial version of 8 weeks was expanded to 10 weeks based on the
  8. 8. 718 Western Journal of Nursing Research 34(6) qualitative findings and later, a 6-week intervention was developed as a health promotion and stress management activity for healthy community dwelling adults. The author’s work began with preliminary pilot studies as proposed in the NIH model and advanced to Phase III clinical trials to test the effectiveness of this intervention. The protocols for conducting SPIRIT-6©, -8, and -10 are identical. Essentially, there is one intervention that ranges from 6 to 10 sessions. The differences in the number of sessions offer variations in the “dosage” of spirituality. Four additional sessions serve as booster sessions in longitudinal studies. The choice for the length of the intervention is based on the preference of the investigator, the design of the study, or consideration of the population being studied. Detailed findings of these studies have been previously reported elsewhere (Tuck et al., 2002; Tuck, McCain, et al., 2001; Tuck, McCain et al., 2008). However, a brief synopsis and selected findings from these studies illustrate the NIH classification scheme. Phase I Preliminary Trial and Descriptive Pilots Consistent with the intent of Phase I trials, the initial study was designed to determine the acceptability and feasibility of the intervention with a sample of persons living with HIV disease (N = 28). A subset of participants from a larger study (NIH No. R01 NR04395, McCain, PI; McCain et al., 2008) who were randomly assigned to the CBSM, social support, and the control groups were matched with newly recruited participants enrolled in SPIRIT-8© as a third intervention group. Pre- and posttest measures were administered to participants in the four groups following a standard research protocol. This limited sample yielded evidence of trends in the direction of significant effects for the spirituality group on psychosocial measures although there were no apparent effects noted on the physiological measures (Tuck, 2004; Tuck et al., 2002). The acceptability of the spiritual intervention was confirmed by participants’ statements that they enjoyed being in the group and desired additional sessions to further develop their spirituality. A cross-sectional study was conducted to determine the appropriate measures to use in future longitudinal studies. Secondary analysis of pretest data in a sample of 52 persons living with HIV explored the relationships among spirituality and selected psychosocial measures. Spirituality was measured with three instruments: Spiritual Perspective Scale (SpS), Spiritual Health Inventory (SHI), and Spiritual Well-Being Scale (SWBS). Tuck, McCain, et al. (2001) found a strong positive relationship between SWBS and social support, appraisal focused coping (effective coping strategy), emotional, social, physical, and functional well-being, and total quality of life. There
  9. 9. Tuck 719 was an inverse relationship between spirituality and perceived stress, uncertainty, psychological distress, and emotion-focused coping. The results of these analyses provided data essential to selecting spirituality instruments and health outcome measures for subsequent studies. Of the three instruments, only the SWBS had significant results. A Phase II Clinical Trial SPIRIT-6© was studied as a stress reduction intervention with a convenience sample of adults from three local Protestant churches (two predominantly Caucasian and one African American). The study allowed for the refinement of the intervention protocol, explored the relationship among study variables, and tested the efficacy of the intervention using a pre- and posttest design with follow-up booster sessions over 12 months (Tuck et al., 2006). Participants completed three measures, SpS, SWBS, and Perceived Stress Scale (PSS), at the start of the 6-week intervention (T1), at 6 weeks (T2), 12 weeks (T3), 6 months (T4), and 1 year (T5). The findings indicated a significant decrease in participants’ levels of perceived stress from Time 1 to Time 3, F(2, 34) = 4.21, p < .05, and a significant increase in participants’ levels of spirituality from Time 1 to Time 3, as measured by the SpS, F(2, 34) = 3.60, p < .05, suggesting a significant effect for the intervention. There was a significant negative correlation between the measure of perceived stress and spiritual well-being at Time 1 (r = −.613, p < .01), Time 2 (r = −.638, p < .01), and Time 3 (r = −.855, p < .01; Tuck, McCain, et al., 2005). Due to small sample size, analysis were unavailable for Times 4 and 5. Phase III Randomized Clinical Trials Phase III studies are prospective randomized clinical trials with welldesigned experimental designs with large samples. Data from the preliminary studies warranted the inclusion of the intervention in this level of research. The first of two studies was a randomized clinical trial grounded in the psychoneuroimmunology (PNI) theoretical framework. The clinical trial included three interventions: (a) CBSM, (b) SPIRIT-10©, and (c) a 10-week version focused Tai Chi and a wait-control group of persons living with HIV disease. The study, conducted by a multidisciplinary team (NIH No. R01 AT000331, McCain, PI), used multiple PNI indicators to measure the three outcomes of psychosocial functioning, quality of life, and physical health along with neuroendocrine mediation and immune function. Details of the study aims, design and procedures, and study findings are beyond the
  10. 10. 720 Western Journal of Nursing Research 34(6) scope of this article and are reported elsewhere (McCain et al., 2008), and only the results of spiritual growth group are reported here. A total of 66 participants completed the SPIRIT-10© intervention group with complete data sets. Using paired t tests, the pre- to postintervention comparisons indicated that the spiritual subgroup had higher overall quality of life (p ≤ 0.01), largely accounted for by higher emotional well-being (p ≤ 0.01) and higher physical well-being (p ≤ 0.01) upon completion of the intervention. They also had lower perceptions of social support on the dimension of allegiance (p ≤ 0.05) at postintervention. There were no significant changes in the spiritual well-being measures. Control group participants (n = 57) reported significantly higher perceived stress levels (p ≤ .01), but no other psychosocial–spiritual changes over the 10-week period. Thus, these data indicate that the SPIRIT-10© intervention may account for clinically meaningful improvements in psychosocial functioning. A second Phase III clinical trial used two interventions, focused Tai Chi and SPIRIT-10©, and a wait-control group in a sample of women diagnosed with early stage breast cancer. The women were undergoing chemotherapy and/or radiation. The study explored the effects of these two mind–body– spirit interventions and psychobehavioral and neuroimmunological factors (endorphins, urinary cortisol, NK cell cytotoxicity, and cytokine production) on adaptational outcomes. Preliminary data indicated no treatment or group effects noted for the spirituality group. An interesting finding was at pretest (Time 1), all participants reported moderately high spiritual perspective scores (M = 4.9, SD = 0.9, no group differences noted) and low spiritual well-being scores (M = 42.6, SD = 16.2). No interaction effects were noted between the spirituality scales and selected study variables. Data from this study are currently being analyzed and when completed, findings of the entire study will be disseminated by the research team. Exploring the Scientific Rigor of the Spiritual Intervention Determining Internal Validity of the Intervention Internal validity of the intervention is determined by the study designs and strength of the intervention, protocol delivery, and treatment integrity. These studies were designed and sequenced in a manner consistent with the corresponding phases of research. Multiple designs were used to explore the efficacy and effectiveness of the intervention. Studies used experimental and quasi-experimental designs in an effort to create controlled conditions, that is,
  11. 11. Tuck 721 random assignment and statistical controls for covariance. The studies were longitudinal in nature using repeated measures with most requiring participant enrollment for 1 year. Data were collected with valid and reliable measures. Evidence of the strength of the intervention is best found in the qualitative responses elicited in the final session of the intervention. Participants respond to open-ended questions regarding the value of the intervention and the responses were overwhelmingly positive. In addition, open-ended questions were added to the recent clinical trial to gather data regarding religion to more fully understand the religious dimensions. A subsample of participants was randomly selected for qualitative interviews by an independent researcher to ascertain responses to the intervention free of the facilitator’s involvement. The transcriptions of the interviews are currently being analyzed independently of the interventionists. These studies did confirm that the intervention protocol is replicable across settings and populations and facilitator training is feasible. The detailed intervention operation manual facilitates the ease of delivery and describes approaches to intervention dose (participants were required to participate in 80% of the intervention, including booster sessions when available). Treatment integrity was consistently monitored across studies using a variety of techniques, including videotaping randomly selected sessions. An independent audit of those videotaped sessions indicated compliance with the written protocol. Human subject protection was granted for each study and adverse events were monitored but none were reported. The appropriate time to enroll for the best effect of the intervention is yet to be determined. The most recent study with women undergoing breast cancer treatment was proposed to determine its effectiveness as an early treatment intervention. Determining External Validity of the Intervention External validity of an intervention is determined by recruitment, sampling methods, retention rates, and the effective measurement of outcomes. This group intervention is best suited for 10 to 12 members at a time. Although the format limits the overall sample size, the use of repeated measures in longitudinal studies somewhat buffers this limitation. Random assignment to intervention groups strengthens the findings as well. Aggressive strategies to recruit and retain participants over time are necessary. Efforts were made to recruit samples for these studies from diverse backgrounds although race and ethnicity were primarily limited to African Americans and Caucasians. The following examples illustrate the team’s efforts to recruit and enroll diverse samples with a particular focus on underserved populations. The convenience sample of healthy participants ranged in age between
  12. 12. 722 Western Journal of Nursing Research 34(6) 20 and 77 years (mean age was 52 years); 14 (51%) were African American and 24 participants were female and reported at least 14 years of education. The sample of 66 participants who completed the SPIRIT-10© intervention in the first clinical trial consisted of 26 females and 40 males and was predominantly African American (79%; 52/66). The average age of the sample was 43.0 years. Brief descriptions of other samples are found in Table 2. Retention of participants is critical in longitudinal studies. There was some attrition noted in these studies. For instance, only 11 of the healthy adults had complete data available at 12 months (retention rate of 41%). The volunteer nature of this convenience sample without the benefit of incentives may have contributed to the attrition rate. A limitation of this intervention as well as other nursing and social science interventions is that it is offered in community settings and not in the controlled conditions of clinical laboratories. Group interventions in longitudinal studies raise pragmatic issues of the cost of the intervention, participant recruitment and retention, and covariance questions due to time and subject maturation even with control groups. There are a variety of instruments used to measure spirituality and psychosocial variables in these studies. Participant burden in the studies ranged from 15 to 40 min. Efforts were made in the pilot studies to determine the appropriate spirituality instruments to use. As previously discussed, three instruments were initially used to measure spirituality: SpS, a measure of the significance of spirituality in one’s life and the extent to which one engages in spiritually related interactions; SWBS, a general measure of spiritual wellbeing; and SHI, a measure of healthy aspects of spirituality. The SHI, which added minimally to the study findings, was used only in the first pilot intervention study testing SPIRIT-8©. In the subsequent studies, the SpS was used as a measure of the intensity of engagement in the SPIRIT© group. The scores reflect the frequency of expressing spiritually oriented thoughts or behaviors. Likewise, efforts were made to select other suitable measures. The psychosocial instruments used to measure health/illness outcomes were the Mishel Uncertainty in Illness Scale (MUIS), Dealing With Illness Scale (DIS), Social Provisions Scale (SPS), Impact of Events Scale (IES), Functional Assessment of HIV Infection Scale (FAHI), Revised Ways of Coping Checklist (COPE), PSS, and Depression Scale (CES-D). The PSS is an example of an appropriate scale for these samples as it is widely used to measure stress, does not require a clinical population for its use, and was selected due to its length. This scale was designed for use with community samples with at least a junior high school education (Cohen, Kamarck, & Mermelstein, 1983) and therefore was well suited for the study with healthy adults. These scales were used in various combinations in these studies and
  13. 13. 723 Perceived Stress Scale (PSS) Spiritual Health Inventory (SHI) Uncertainty in Illness Scale (MUIS) Spiritual WellBeing Scale (SWBS) Spiritual Perspective Scale (SpS) Instrument Name (continued) SpS is a 10-item, Likert-type scale developed to measure the significance of spirituality in one’s life and the extent to which one engages in spiritually related interactions. The SpS is scored by calculating the arithmetic mean. Total scores range from 1.0 to 6.0. Reliability of the scale has been documented by a Cronbach’s alpha of .90; criterion-related validity and discriminate validity have been previously demonstrated (Reed, 1986, 1987). SWBS is a 20-item Likert-type scale consisting of 11 positively worded items and 9 negatively worded items. It was developed by Paloutzian and Ellison (1982) as a general measure of spiritual well-being. Possible scores range from 20 to 120. Subscale scores are derived for religious well-being and existential well-being, with higher scores indicating greater well-being. The scale has been used with persons with HIV disease as a predictor of hardiness (Carson & Green, 1992; Carson, Soeken, & Belcher, 1991). Reliability has ranged from alpha = .78 to .96. Construct validity is suggested by the examination of item content, as well as theoretically meaningful interrelationships among the existential well-being subscale scores and scores of other psychosocial measures (Paloutzian & Ellison, 1982). Subscale scores are derived for religious well-being and existential well-being, with higher scores indicating greater well-being. SHI was developed by Highfield (1992) and has been used primarily to study patients with cancer. The patient’s version of the instrument is a self-report of spiritual health that includes positive and negative expressions. The 31-item Likert-type scale measures three factors: selfacceptance, relationships, and hope. Total scores range from 31 to 155. Cronbach’s alpha for the SHI has been reported at .77. Content and construct validity have been supported by literature review, expert panel, and factor analysis (Highfield, 1992). The MUIS is a well-validated, reliable measure of uncertainty associated with illness (Mishel, 1981, 1984). Higher scores on this 33-item scale indicate higher uncertainty in the areas of symptomatology, diagnosis, treatment, relationships with caregivers, and prognosis (Mishel, 1990). The MUIS has been shown to be reliable in research with individuals living with HIV (McCain & Cella, 1995; McCain, Zeller, Cella, Urbanski, & Novak, 1996). The PSS is a 14-item measure that measures the degree to which one appraises situations in one’s life as stressful. This scale was designed for use with community samples with at least a junior high school education (Cohen, Kamarck, & Mermelstein, 1983). It is composed of 7 positive items (e.g., In the past month, how often have you dealt successfully with irritating life hassles?) and 7 negative items (e.g., In the past month, how often have you been upset because of something that happened unexpectedly?). Scores for this scale are obtained by reversing the scores on the positive items and then summing across all 14 items, so that higher scores indicate higher levels of perceived stress. Description of Instruments and Psychometric Properties Table1. Selected Instruments Used in Studies Testing SPIRIT© Intervention
  14. 14. 724 Dealing With Illness Scale (DIS) Functional Assessment of HIV Infection Scale (FAHI) Version 3 FAHI Version 4 Impact of Events Scale (IES) Instrument Name Description of Instruments and Psychometric Properties Health-related quality of life is defined as the impact of illness experiences on physical, psychological, social, and spiritual or existential well-being. The FAHI is a multidimensional measure of quality of life in people with HIV infection (Cella, 1994; Cella et al., 1996; Peterman, Mo, Cella, & McCain, 1997). The FAHI has demonstrated excellent psychometric performance (α = 0.85-0.92), including sensitivity to stage of illness and to intervention in the previous studies (McCain et al., 1996, McCain et al., 1998), as well as other studies (Cella et al., 1996; Peterman et al., 1997). The HIV-specific FAHI has been revised to the current (version 4) format and is expected to provide more sensitive data for the dimension of HIV-specific quality of life. The 44 items of the current FAHI are grouped into subscales of physical, functional and global, and social well-being; emotional well-being/living with HIV; and cognitive functioning. Thus, the scale reflects both general health-related and HIV-specific quality of life, with higher scores indicating greater quality of life (Peterman et al., 1997). The DIS is comprised of 20 items reflecting negative emotions, positive interpersonal experiences, negative life changes, and loss of control (McCain & Gramling, 1992) as revised in 1994 and 1999. The DIS was qualitatively derived with persons with HIV disease. The DIS is comprised of Stress and Coping subscales. Modeled after the Life Experiences Survey (LES; Sarason, Johnson, & Siegel, 1978), the format for the Stress subscale captures the process of cognitive appraisal by enabling respondents to indicate the desirability or undesirability and the personal impact of experienced events (perceived stress). Participants indicate perceived stress specifically related to HIV disease for two time periods: since the time of their diagnoses and within the past month. Positive and Negative Stress subscale scores are derived by separately summing the items indicated as having a positive or negative personal impact. Previous psychometric analyses indicated that the 20 items of the 1994 version of the subscale comprised 4 factors involving negative emotions, positive interpersonal experiences, negative life changes, and loss of control. IES is a 15-item instrument with response options that indicate how frequently within the past 7 days each distressing thought has occurred. Using the IES, psychological distress specific to living with HIV disease has been previously documented in the form of avoidant and/or intrusive thoughts related to the illness (Horowitz, Wilner, & Alvarez, 1979; Ironson et al., 1990; McCain & Cella, 1995; McCain, Zeller, Cella, Urbanski, & Novak, 1996; Perry, Fishman, Jacobsberg, & Frances, 1992). The IES has excellent psychometric properties, is not confounded with physical symptoms, and yields an index of illness-related psychological distress. Higher scores on the subscales of Intrusive and Avoidant thinking indicate higher psychological distress. The FAHI scale is a disease-specific extension of the general version of the Functional Assessment of Cancer Therapy (FACT-G) scale (Cella & Tulsky, 1993), measuring the quality of life in people with HIV infection. The 55-item revised FAHI (version 3) includes subscales of physical, social/family, emotional, and functional well-being; relationship with physician; and additional concerns specific to HIV infection. Higher scores indicate greater quality of life. The FAHI has demonstrated excellent psychometric performance, including sensitivity to stage of illness and to intervention in previous studies (Cella, McCain, Peterman, Mo, & Wolen, 1996; McCain et al., 1996). Table 1. (continued)
  15. 15. 725 The revised 24-item SPS is a measure of six social provisions or components of social support including reliable alliance, attachment, guidance, nurturance of others, social integration, and reassurance of worth. The SPS has demonstrated excellent construct validity and internal consistency in other populations (Cutrona & Russell, 1987). Higher scores indicate a higher level of social support. Social Provisions Scale (SPS) Description of Instruments and Psychometric Properties The revised 40-item Coping subscale was modeled on the Revised Ways of Coping Checklist (Vitaliano, Maiuro, Russo, & Becker, 1985). For these 40 of the original 60 items, psychometric analyses revealed 3 empirical factors related to maintaining a positive attitude, adapting to illness, and withholding, with items approximately equally distributed across the original, theoretical dimensions of problem-focused, emotion-focused, and appraisal-focused coping. Scoring schemes for the coping subscale enable assessment of both the theoretical foci of coping and the factor-analytically derived coping methods. Higher scores reflect more frequent use of the various coping strategies. The reliability (Stress subscale α = .83, Coping subscale α = .80-.87) and validity of the DIS for the study population have consistently been supported (Cella et al., 1996; McCain & Cella, 1995; McCain et al., 1996; McCain et al., 1998). Ways of Coping Scale (WOC) Instrument Name Table 1. (continued)
  16. 16. 726 Western Journal of Nursing Research 34(6) had demonstrated high validity and reliability in previous studies. See Table 1 for a list of selected measures used and the psychometric properties as available. Table 2 indicates the specific instruments that were used in each study. Whittemore and Grey (2002) suggested that the systematic development of a nursing intervention includes the following: (a) a well-defined problem, (b) a strong theoretical base, (c) a research approach to establish the content, strength, and timing of innovative and pragmatic interventions, (d) refinement of the intervention, (e) determination of clinical efficacy, and (f) determination of clinical effectiveness. (p. 116) The spiritual intervention was designed and tested according to these criteria across various phases of research. The intervention has been offered to clinical and nonclinical populations of adults. Treatment integrity has been well documented. Studies have used a way array of spiritual, psychosocial, and physiological measures. The psychosocial measures have sought to determine positive and negative outcomes, including benefit finding, quality of life, depression, and perceived stress. Early findings were significant for the SPIRIT© intervention on a number of psychosocial measures in the hypothesized directions. The phase II trial studies have indicated trends in findings in the expected directions. However, findings from the recent clinical trials were inconclusive. Few significant findings were noted in the randomized clinical trials. There are several strengths of the intervention. One strength is the multimodal approach that allows for the expression of spiritual views and religious doctrine, a choice left to the individual. Another is the clear evidence that the intervention can be replicated and reproduced with other populations. Treatment integrity is also maintained by adhering to the intervention protocol. Additional measures particularly related to health and well-being can be added or substituted in future research studies. What might explain why a well-designed and tested intervention is found to have little significant treatment effect? What explains the inconsistent findings of spirituality with other measures of mind–body–spirit outcomes? A number of possible explanations are offered for consideration. First of all, there was limited variance in spirituality scores between groups. In general, the participants’ spirituality scores were moderately high at pretest. One possible explanation for these scores is that having the lived experience of lifealtering illnesses such as cancer and HIV disease may raise spiritual or religious concerns in everyone in an existential way. If this is true, there is a
  17. 17. 727  52 Quasiexperimental, pretest–posttest, control group, nonrandom assignment Cross-sectional, correlational Longitudinal, onegroup repeated measures Phase I Pilot SPIRIT-8© Intervention Study Descriptive Exploratory Study Phase II Pilot SPIRIT-6© Intervention Study  27  28 Study Designs Type of Study Total Number of Participants in the Study Table 2. Summary of Spirituality Intervention Studies 27 NA  7 Number of Participants Enrolled in SPIRIT© Intervention Healthy adults Adult males living with HIV disease Adult males living with HIV disease Type of Population 24 Females, 3 Males All males All males Gender of Participants in SPIRIT© Intervention SpS SHI SWBS DIS SPS IES MUIS FAHI SpS SHI SWBS DIS SPS IES MUIS FAHI SpS SWBS PSS (continued) Psychosocial and Spiritual Measures Used
  18. 18. 728 Experimental with repeated measures; control group and random assignment Experimental with repeated measures; control group and random assignment Phase III Randomized Clinical Trial SPIRIT-10© Intervention Phase III Randomized Clinical Trial SPIRIT-10© Intervention 145 298 Total Number of Participants in the Study 38 66 Number of Participants Enrolled in SPIRIT© Intervention Women diagnosed with early stage breast cancer Adults living with HIV disease Type of Population 38 Females 26 Females, 40 males Gender of Participants in SPIRIT© Intervention SpS SWBS IES PSS SPS FACT-B WOC CES-D SpS SWBS DIS IES SPS FAHI Psychosocial and Spiritual Measures Used Note: SpS = Spiritual Perspective Scale; SHI = Spiritual Health Inventory; SWBS = Spiritual Well-Being Scale; DIS = Dealing With Illness Scale; SPS = Social Provisions Scale; IES = Impact of Events Scale; MUIS = Mishel Uncertainty in Illness Scale; FAHI = Functional Assessment of HIV Infection Scale; PSS = Perceived Stress Scale; FACT-B = Functional Assessment of Cancer Therapy; WOC = Ways of Coping Scale; CES-D = Depression Scale. Study Designs Type of Study Table 2. (continued)
  19. 19. Tuck 729 need for spiritual measures that discriminate change over time in this heightened state of popular spirituality. Second, although the intervention is well grounded theoretically, in efforts to be sensitive to a pluralistic culture, the intervention might dilute the influence of spiritual or religious views and may instead elicit commonly shared humanistic worldviews. Third, the amount of time spent in the intervention on a weekly basis may not be sufficient to capture the essence of the experience. Assignments during the week and daily practice may be required to reinforce spirituality. The strongest effects were reported retrospectively or when the participants were further away from the illness experience; possibly suggesting new methods of data collection. As investigators, we must refine the phenomenon of interest. Many studies continue to link spirituality and religion as one construct and then measure it as religion. A recent example, a longitudinal study by Gall, Kristjansson, Charbonneau, and Florack (2009), examined the role of spirituality in women with breast cancer. Although the focus of the study was on spirituality, they measured religion/spirituality as religious salience, the level of participation in religion, and the strength of religious views. They also explored positive and negative views of God as a study variable. Other studies too numerous to cite here have likewise combined the two constructs. The question remains whether these are distinct ideas or have been artificially separated. Efforts made to solicit definitions directly from participants have value and may help clarify these terms (Tuck & Thinganjana, 2007). The mechanism for spirituality remains unclear as to whether there are direct or indirect effects. Gall et al. (2009) found no support for Pargament’s (1997) spiritual mobilization hypothesis during illness or that religion served as a protective factor. They found that distress increases over time and proposed that the strength of religious beliefs was only protective if they were strong beliefs prior to the illness and that mobilization of these beliefs in absence of a strong base during the crises promoted distress instead. Research is needed to explain the recurring strength of the relationships between measures in cross-sectional studies and the relative lack of effect noted in some longitudinal studies. In a recent cross-sectional study, Kandasamy, Chaturvedi, and Desai (2011) found the strong positive relationships between spirituality and quality of life and inverse relationships with depression and anxiety. They also reported highly significant negative relationships between spiritual well-being and distress, fatigue, memory disturbances, and loss of appetite. Shah et al. (2010) in another cross-sectional study reported that the strengths of the spiritual beliefs were positive contributors to coping. In an attempt to understand the mechanism, it is noted
  20. 20. 730 Western Journal of Nursing Research 34(6) that the numerous studies, including those previously reported by the author, demonstrate strong relationships with a wide range of variables but provide limited support for causality and treatment effect. It is likely that the strength of one’s beliefs and whether the strongly held views are spiritual or religious in nature will both have implications for future testing of the SPIRIT© intervention. Tate (2011) in an integrative review of 13 studies found that spirituality or belief in God was an integral part of the cultural identity of African American women with breast cancer suggesting that there is a contextual feature. Pargament (1997) proposed that the spirituality needed to be integrated in a sense of the person. A key feature of the SPIRIT© intervention was to help participants become increasingly aware of the relevance of spirituality to their everyday lives; however, reflection and insight may not be sufficient to promote physiological and immunological changes. The overreliance on spirituality and religion to significantly influence negative outcomes might be counter to its mechanisms of action. Perhaps, paper-and-pencil tests and logical samples might not be direct measures of the effects. The development and testing of the SPIRIT© spirituality intervention has taken more than a decade. This spirituality intervention has met the criteria suggested by Whittemore and Grey (2002): the spirituality intervention was linked with the available literature and clinical problems, the content of the intervention was described, the strengths were identified, and finally, it was tested for efficacy and effectiveness. The components of the intervention are readily available, transferable, and implemented in many holistic nursing practices. According to the interpretation of the NIH guidelines described by Whittemore and Grey (2002), Phase III clinical trials are viewed as pivotal to support the value of the intervention. Phase IV trials allow the intervention to be tested in actual practice and examines clinical utility and cost effectiveness. Studies at this level often are clinical trials with two or more interventions. In reality, Phases III and IV may not be as distinct in studies with human subjects as in bench science. Nursing studies must also offer some benefit (some degree of effectiveness) or at least cause no harm whenever they are offered and often clinical implications are discussed even after pilot studies are conducted. The application of nursing research occurs with the translation of the findings to practice across multiple settings and in welldeveloped standards of practice. The intervention can benefit from recent research and refinements made before clinical implementation. The intervention requires more definitive testing over time.
  21. 21. Tuck 731 Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Funding The author disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The author received financial support for the series of research studies cited in this manuscript. Intramural funding was provided by the A. W. Williams Foundation at Virginia Commonwealth University and the Department of Integrative Systems, School of Nursing, Virginia Commonwealth University. The first clinical trial was funded by the National Institutes of Health’s National Center for Complementary and Alternative Medicine Grant 5R01 AT000331 to Nancy L. McCain, Principal Investigator, and facilitated by the General Clinical Research Center, Virginia Commonwealth University Health System (5M01 RR000065; J.N. Clore, Director). The second clinical trial was funded by the National Institutes of Health’s National Cancer Institute grant 5R01 CA114718 to Nancy L. McCain, Principal Investigator, and facilitated by the General Clinical Research Center, Virginia Commonwealth University Health System (5M01 RR000065; J. N. Clore, Director). References Anandarajah, G., & Hight, E. (2001). Spirituality and medical practice: Using the HOPE questions as a practical tool for spiritual assessment. American Family Physician, 63, 81-89. Astin, J. A. (1997). Stress reduction through mindfulness meditation: Effects on psychological symptomatology, sense of control and spiritual experiences. Psychotherapy and Psychosomatics, 66, 97-106. Bandura, A. (1977). Social learning theory. Englewood Cliffs, NJ: Prentice Hall. Blumer, H. (1969). Symbolic interactionism: Perspective and method. Englewood Cliffs, NJ: Prentice Hall. Burkhardt, M. (1989). Spirituality: An analysis of the concept. Holistic Nursing Practice, 3, 69-77. Carson, V. B., & Green, H. (1992). Spiritual well-being: A predictor of hardiness in patients with acquired immunodeficiency syndrome. Journal of Professional Nursing, 8, 209-220. Carson, V. B., Soeken, K. L., & Belcher, A. (1991). Spiritual well-being, hardiness, and ego strength in persons with AIDS. Journal of Christian Healing, 13, 21. Cella, D. F. (1994). Quality of life: Concepts and definition. Journal of Pain and Symptom Management, 9, 186-192.
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