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Accepted Manuscript Impact of yoga on psychopathologies and QoLin persons with HIV: A randomized controlled study Asha Kiloor, Sonykumari, Kashinath Metri PII: DOI: Reference: To appear in: S1360-8592(18)30446-7 https://doi.org/10.1016/j.jbmt.2018.10.005 YJBMT 1733 Journal of Bodywork & Movement Therapies Received Date: 22 June 2017 Revised Date: 12 March 2018 Accepted Date: 28 July 2018 Please cite this article as: Kiloor, A., Sonykumari, Metri, K., Impact of yoga on psychopathologies and QoLin persons with HIV: A randomized controlled study, Journal of Bodywork & Movement Therapies, https://doi.org/10.1016/j.jbmt.2018.10.005. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. 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ACCEPTED MANUSCRIPT Title: Impact of yoga on psychopathologies and QoLin persons with HIV: A randomized controlled study Authors: MANUSCRIPTACCEPTED Asha Kiloor1, Msc (Yoga) Yoga Therapist, SVYASA University, Bengaluru Dr Sonykumari1, PhD Associate Professor, SVYASA University, Bengaluru *Dr Kashinath Metri1, MD, PhD Assistant Professor, SVYASA University, Bengaluru *Corresponding author: Dr Kashinath G Metri Email: kgmhetre@gmail.com Mobile: +01 9035257626 1Affiliation: Division of Yoga and Life Sciences, Sami Vivekananda Yoga Anusandhana Samsthan (SVYASA – A deemed to be a University), # 1 Eknath Bhavan Gavipuram Circle K G Nagar, Bengaluru-560019, India. 1 ACCEPTED MANUSCRIPT ABSTRACT Background: Evidence suggests that individuals with human immunodeficiency virus (HIV) positive, often exhibit poor physical and mental health, which contributes to a reduced Quality of Life (QoL). Yoga is a form of alternative MANUSCRIPTACCEPTED therapy that has positive influences on general health and QoL. Objectives: This study examined the effects of yoga on i) anxiety, depression and psychological well-being, and ii) Quality of Life (QoL), among individual with HIV positive. Methodology: Sixty individuals with HIV-positive (aged30–50 years) from rehabilitation centres across Bangalore were randomly assigned to the yoga intervention group (n=30; 11 men) or the wait-listed control group (n=30; 10 men). Participants in the yoga group underwent 8 weeks of intense yoga practice, performed an hour a day, for 5 days a week. The yoga practice consisted of physical postures, breathing practices, relaxation techniques, and meditation. Participants in the wait-listed control group followed their normal routine. Anxiety, fatigue, depression, and QoL were assessed twice for all subjects in each group – once at the start of the study to establish a baseline and once more at the end of the2month study period to assess any changes. Data analysis was performed on the assessments using SPSS software version 10. Results: In the yoga group, a significant reduction in anxiety (p<0.001), depression (p<0.001), and fatigue (p<0.001) was observed, associated with significant improvements in well-being (p<0.001) and all domains of QoL (p<0.001). However, in the control group, an increase in anxiety, fatigue, and depression was observed, associated with a significant decrease in well-being and QoL. Conclusion: This study clearly indicates that yoga intervention improves the psychological health and QoL of individuals with HIV-positive. Therefore, based 2 ACCEPTED MANUSCRIPT MANUSCRIPTACCEPTED on these findings, yoga is strongly recommended as a complementary therapy to enhance conventional HIV care. Keywords: HIV, Yoga, Fatigue, Anxiety, Depression, Quality of Life. 3 ACCEPTED MANUSCRIPT INTRODUCTION Approximately, 40 million people worldwide are living with human immunodeficiency virus (HIV) infection (Alter et al 2006). Country-wise, India records the second-highest number of HIV-infected persons, approximately 3–4 MANUSCRIPTACCEPTED million (Go et al 2004). HIV is an infectious disease that affects an individual’s immunity, thus increasing vulnerability to various opportunistic infections. Pharmacological treatments such as Anti-Retroviral Therapy (ART) are presently used to increase life expectancy and control HIV progression. But, the ART intervention is frequently associated with various side effects (Antoni et al 2002; Hartmann et al 2006). However, despite ART intervention, several psychological issues associated with HIV, continue to persist among persons with HIV-positive (Green & Smith 2004; Rodger et al 2013; Rosenfield et al 1996). Additionally, individuals with HIV-positive experience social stigmas, feelings of guilt, uncertainty about the future, feelings of isolation, lack of social reinforcement, and worry about frequent infections, thus making them prone to chronic psychological problems such as anxiety disorder and depression (Bogart LM et al 2000; Vogl et al 1999). Several cross-sectional studies have demonstrated a high prevalence of anxiety disorder and depression among individuals HIV-positive, with the risk of depression being four times more as compared to normal individual. The prevalence rate of depression among HIV- infected individuals ranges from 5% to 45%, and the prevalence rate of anxiety disorder is up to 38% (Bogart LM et al 2000; Elliott A et al 1998). Also, individuals with HIV positive have depression have higher suicidal tendency than non-HIV depressed individuals (Chandra P et al 1998; Cluver et al 2007; Penzak et al 2000). 4 ACCEPTED MANUSCRIPT Further studies have shown that the presence of depression in HIV-infected individuals is associated with a decreased CD4 cell count, an increased viral load, and reduced compliance with ART (Yun LW et al 2005). Apart from frequent infections, weight loss and fatigue are observed MANUSCRIPTACCEPTED prominently among individuals with HIV-positive. Such symptoms affect daily work and lead to more disability and dependency in the persons with HIV (Cleary PD et al 1993; Low et al 2011; Ferrando et al 1998; Breitbart et al 1998). Collectively, these issues such as anxiety, depression, poor immunity, and HIV- associated symptoms lead to reduced psychological well-being and significantly affect quality of life (QoL) among individuals with HIV-positive people (Adewuya et al 2008; AminiLari et al 2013; Aranda et al 2004). Non-drug interventions such as yoga, meditation, tai chi, or Cognitive Behavioural Therapy (CBT) have been found to be effective in improving several physical and psychological symptoms associated with chronic health conditions, including HIV (Antoni et al 2002; Naoroibam et al 2016; Bhargav et al 2016; Ferrando et al 2004; Taylor et al 1995). Yoga Yoga is a form of mind–body intervention consisting of physical practices, breathing techniques, and meditation. The science of Yoga is considered to be approximately more than 5000 years old (Keley et al 2010). Spiritually, the practise of yoga aims to achieve the highest goal of life called Moksha, which refers to liberation (Siddiqui et al 2016). Scientific investigations have noted the many physiological and psychological benefits of yoga practice in both clinical and nonclinical populations (Yang et al 2007; Raju et al 1986). The practise of yoga has disease preventive effects and beneficial effects on wellness. Scientific evidences have confirmed the various wellness benefits of 5 ACCEPTED MANUSCRIPT yoga for various health conditions, such as diabetes mellitus (Hemmer et al 2008; Mahapure et al 2008), cardiovascular disease (Ashish et al 2015), neurological disorders (Sharma, 2015), gastrointestinal disorders (Kaswal et al 2013; ), and many psychological troubles. A significant portion of yoga research has focused MANUSCRIPTACCEPTED on studying its impact on psychological health and well-being. Yoga and meditation intervention studies show reduction in anger (Bhushan & Sinha 2001), anxiety (Eppley et al 1989), and depression (Krishnamurthy & Telles 2007; Woolery et al 2004), as well as increase in well-being (Netz & Lidor 2003). The potential of yoga to increase psychological well-being, including improved energy, and overall QoL has been demonstrated in older adults (Oken B et al 2006).Yoga practice reduces depression symptoms in pregnant woman (Mitchell, 2012).Yoga can be considered an ancillary treatment option for people with depressive disorders and individuals with elevated levels of depression (Cramer & Langhorst 2013).Yoga practice results in a significant decrease in anxiety levels and a positive change in subjective well-being among students (Jadhav & Havalappanavar 2009).Yoga practice reduces anxiety and blood pressure and improves QoL more significantly than physical exercise (Marefat & Peymanzad2011). Hence, the present study intended to assess the impact of a 2-month integrated yoga intervention on psychological health, QoL, and well-being among HIV- infected persons, when compared with a matched wait-list control group. Methods and materials Participants HIV-infected people aged 30–50 years on ART were recruited in this study.We considered the participants within this age range because, after the age of 50, people with HIV usually experience severe weight loss, and co- morbid conditions such as tuberculosis, hepatitis B, fatigue syndrome etc. 6 ACCEPTED MANUSCRIPT rendering them unable to perform yoga. Also, the lower age limit is chosen as 30, as any HIV person below 30 years of age is usually in less advanced stages of disease. We approached two HIV rehabilitation centres located in Bengaluru city, India. MANUSCRIPTACCEPTED A total of 88 participants was approached for participation, and they were screened for eligibility criteria. Among 88 participants, 63 were found to be eligible for the study. Of 63 potential participants, 2 declined to participate in the study. Finally, we selected 60 potential participants for the study. For the equal distribution of subjects across both groups, we did not consider the data of one subject from yoga group, although he received IY (See Flow Chant 1). None of the participants had CD4 count<300 indicating AIDS. Randomization Participants’ names were fixed up in alphabetical order and then listed in serial order from 1 to 60. Using a computer-based random number generator, two groups were formed. The groups were named 'A' and 'B'. Group A was selected as intervention group and B as a wait-list group using tossing method. 7 ACCEPTED MANUSCRIPT Flow Chart 1 MANUSCRIPTACCEPTED Subjects screened = 88 Eligible subjects = 63 Drop outs=2 Due personal reasons 60 subjects Yoga group = 30 subjects Pre assessment n=30 2 Months yoga + ART Post assessment n=30 Control group = 30 subjects Pre assessment n=30 ART only Post assessment n=30 Figure 1: Participant recruitment 8 ACCEPTED MANUSCRIPT Inclusion criteria MANUSCRIPTACCEPTED · HIV-positive and within the age range of30–50 years · Willing to participate in the study · Participants of Both genders Exclusion criteria · Prior exposure to yoga · Physical handicap or Severe disability · Recent surgery · Acute respiratory infections · History of psychiatric illness or usage of antipsychotic medication · Drug addiction Ethical consideration Participants were informed about the study protocol in their respective mother tongue, and written informed consent was obtained before the commencement of the study. This study was approved by an Institutional Review Board (IRB) of Directorate of Distance Education, SVYASA University, Bengaluru, India. Intervention All subjects in the yoga group performed2 months of yoga practice consisting of loosening practices, Suryanamaskara, breathing practices, Asanas, Pranayama, meditation, and relaxation techniques (See Table:1), which were performed daily for 1hour, 5 days a week. The subjects in the control group followed their 9 ACCEPTED MANUSCRIPT normal routine activity. Regular attendance was monitored by maintaining an attendance register and subjects who attended <70% of the sessions were excluded from analysis. A total of 95% of the subjects attended all sessions, none of the subjects had attendance less than 70%. MANUSCRIPTACCEPTED The yoga module used in the study by Rosy et al (2015) was applied in this study. (Please add Table 1 Here) Table 1: List of practices performed by the yoga group Sl.No. Name of Practices Starting Prayer Shithilikarana practices 1 Forward and backward bending Number of rounds 5 rounds Duration 2 min 2 min 2 Twisting 3 Side bending 5 rounds 2 min 5 rounds 2 min Suryanamaskara Quick Relaxation Technique Breathing Practices 6 rounds 8 min 3 min 1 Hands in and out breathing 2 Ankle stretch breathing 3 Bhujangasanabreathing 4 Straight leg- raise breathing Asanas 1 Ardhakatichakrasana 2 Ushtrasana 3 Paschimothanasana 4 Bhujangasana 5 Shalabhasana 6 Setubandasana 5 rounds 2 min 5 rounds 2 min 5 rounds 2 min 5 rounds 2 min 1 round 2min 1 round 1 min 1 round 1 min 1 round 1 min 1 round 1 min 1 round 1min 7 Vipareetakarani Quick Relaxation Technique Pranayama 1 round 2 min 3 min 1 Kapalabhati 2 Sectional Breathing 3 Nadishudhi 60–80 rounds/min 2 min 5 rounds 5 min 10 rounds 5 min 10 ACCEPTED MANUSCRIPT 4 Seetkari/Seetali/Sadanta 5 Bhramari 5 rounds 2 min 10 rounds 5 min Meditation 1 Nadanusandhana Deep Relaxation Technique MANUSCRIPTACCEPTED Closing Prayer 9 ×4 5 min 10 min 2 min Assessments and tools Primary outcome measures WHO Quality of Life- HIV Brief (WHOQOL-HIV BREF) Both groups were administered WHOQOL-HIV BREF before and after 2 months of (Hsiung PC et al 2011). The WHOQOL-HIV BREF is considered to be a valid &a reliable tool to assess different domains of QoL among HIV infected persons. It comprises of 31 items, each using a 5-point Likert scale ( 5 most 1 least?). The 31 items are distributed across six domains. The six domains of QoL are as follows: physical health, psychological health, level of independence, social relationships, environment, and spirituality/religion/personal beliefs. The physical health domain measures pain and discomfort, energy and fatigue, and sleep and rest. The psychological health domain measures positive feelings, thinking, learning, memory and concentration, self-esteem, body image and appearance, and negative feelings. The level of independence domain measures mobility, daily life activities, dependence on medications or treatments, and work capacity. The social relationships domain includes personal relationships, social support, and 11 ACCEPTED MANUSCRIPT sexual activity. The environment domain measures physical safety and security, home environment, financial resources, health and social care, accessibility and quality, opportunities for acquiring new information and skills, participation in MANUSCRIPTACCEPTED and opportunities for recreation and leisure activities, and physical environment (pollution, noise, traffic, climate, and transport) (Fatiregun, 2009). Secondary outcome measures Hospital Anxiety and Depression Scale Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale. The Hospital Anxiety and Depression Scale (HADS) is a valid tool to assess symptom severity and anxiety disorders and depression in both individuals under somatic, psychiatric, and primary care as well as those in the general population. The scale contains a total of 14 items, of which 7 items assess subjective anxiety and 7 assess depressions. (Zigmond AS; Snaith et al RP 1983) Fatigue For both groups, subjective fatigue was assessed using the Fatigue Severity Scale (FSS) before and after 2 months. Fatigue Severity Scale The FSS is a valid tool to assess subjective fatigue. For both groups, the FSS was administered before and after 2 months. The FSS is a method of evaluating the impact of fatigue (Valko P et al 2008). 12 ACCEPTED MANUSCRIPT WHO (Five) Well-Being Index (1998 version) Both groups were administered WHO (Five) Well-Being Index (1998 version) before and after 2 months of the yoga intervention (Huen & Bonsiqnore M 2001). MANUSCRIPTACCEPTED It is a valid &reliable tool to assess the subjective well-being of individual (Saipanish, 2009; Heun et al 2001). Data analysis Data analysis was performed using SPSS version 10 (IBM, Chicago, USA). Data was subjected tothe Shapiro–Wilk test normality test and all variables were found to be normally distributed. Descriptive statistics were presented as mean and standard deviation. Paired sample t test and the independent sample t test were used to compare the characteristics within-group and between-group, respectively. P value (significance) more than 0.05 was considered to depict a statistically significant change. Results Demographic characteristics of participants did not differ between the two groups; hence, the groups were comparable at baseline (Table 2). Table 2: Comparison of demographics between the groups at baseline Variable Yoga group, (n=30; 10 men; 20 women) Control group, p value (n=30; 11 men; 19 women) [Mean±SD] [Mean±SD] 13 ACCEPTED MANUSCRIPT Age (years) History of HIV infection (years) MANUSCRIPTACCEPTED Fatigue Psychological well- being Anxiety Depression Physical QoL Psychological QoL Overall QoL &General health Social relations Environmental Spirituality 41.90±7.02 6.82±1.83 47.87±4.47 11.26±3.52 11.29±2.15 9.16±2.15 10.71±1.16 10.27±0.85 12.39 ± 1.41 9.58 ± 0.81 11.58 ± 0.98 11.68 ± 1.25 42.1±7.32 0.13 6.65±1.36 0.15 48.42±1.18 0.51 9.87±1.54 0.51 11.45±2.17 0.71 9.19±2.04 0.92 10.77±1.15 0.81 10.01±1.01 0.50 12.32 ± 1.17 0.81 9.48 ± 0.63 0.60 11.47 ± 0.89 0.84 11.26 ± 1.12 0.17 The yoga group consisted of 30 participants (11 men and 19 women), and the wait-listed control group consisted of 30 participants (10 men and 20 women). The intervention was found to be feasible, which is evidenced by a regular attendance rate ofmore than 90%. Shapiro-Wilk Test: Data was subjected to Shapiro-Wilk test and all the variables found to be normally distributed with p value more than 0.05. Hence we used 14 ACCEPTED MANUSCRIPT the paired sample t-test to assess the changes within each group before and after 2 months and the independent sample t-test were used to compare the differences between the groups. Yoga group (Table 3) MANUSCRIPTACCEPTED In the yoga group, we noted significant improvement in depression (p <0.001), anxiety (p <0.001), psychological well-being (p <0.001), fatigue (p <0.001), and all domains of QoL after2 months of yoga intervention when compared with those at baseline (Table 3). Control group (Table 3) In contrast to the yoga group, we observed a significant increase in anxiety (p <0.001), depression (p <0.001), and fatigue (p <0.005), along with asignificant decrease in all domains of QoL and well-being (p <0.001), after 2 months compared with those at baseline in the control group (See Table 3). Table 3: Pre–post comparison of variables of yoga and wait-listed control groups Group Yoga group Control group Pre M ± SD Post M ± SD p % value change Pre M ± SD Post M ± SD p value Between- % group change compariso n p value Fatigue Well-being Anxiety Depression 47.87 ± 4.47 11.26 ± 3.52 11.29 ± 2.15 9.16 ± 2.15 22.77 ± 2.51 <0.001 19.03 ± 1.97 <0.001 5.45 ± 1.34 <0.001 4.74 ± 1.12 <0.001 −52 48.42 ± 1.18 69 9.87 ± 1.54 −52 11.45 ± 2.17 −48 9.19 ± 2.04 49 ± 35 0.005 2 <0.001 8.61 ± 2.56 0.001 −13 <0.001 12.48 ± 2.20 <0.001 9 < 0.001 10.23 ± 1.93 <0.001 11 <0.001 QOL PH 10.71 ± 1.16 15.77 ± 1.12 <0.001 47 10.77 ± 1.15 9.84 ± 1.1 <0.001 −9 <0.001 15 ACCEPTED MANUSCRIPT Psy 10.27 ± 0.85 LOInd 12.39±1.41 SRln 9.58±0.81 MANUSCRIPTACCEPTED Envmt 11.58±0.98 PBlfs 11.68±1.25 14.94 ± 0.84 <0.001 45 15.68±1.17 <0.001 27 13.29±0.59 <0.001 39 15.71±0.57 <0.001 36 <0.001 15.94±0.96 36 10.01±1.01 12.32±1.17 9.48±0.63 11.47±0.89 11.26±1.12 9.08±0.91 <0.001 −9 <0.001 10.97±1.49 <0.001 −11 <0.001 9.26±0.58 0.03 −2 <0.001 10.87±0.67 0.002 −5 <0.001 10.84±1.07 0.11 −4 <0.001 Abbreviations: “<” values are p values’ Fatg, Fatigue;WBng, Well-being;Anx, Anxiety;Dpr, Depression;QOL Ph, QOL Physical;QOLPsy, QOL Psychological. QOL LOInd, QOL Level of Independence;QOL SRln, QOL Social Relation;QOL Envmt, QOL Environment; QOL PBlfs, QOL Personal Beliefs Between-group comparison The yoga group showed a higher improvement in anxiety (p <0.001), depression (p <0.001), fatigue (p <0.001), psychological well-being (p <0.001), and all domains of QoL. Thus, we found significant differences between theyoga and control groups (Table 3). Discussion In this study, we found a significant improvement in depression, anxiety, fatigue, well-being, and QoL following 2 months of the yoga intervention in HIV-infected participants. In contrast to the yoga group, a significant increase in depression, anxiety, and fatigue and the deterioration of QoL and well-being were observed in the control group. Worsening of the control group characteristics may be attributed to the progression of the disease. Previously ssurveys have shown that the natural advancement of disease involves worsening of anxiety and depression symptoms along with reduction of CD4 counts in HIV patients. Both these factors are known to have are reciprocities spiraling effect on each other, resulting in a vicious cycle. Addition of yoga may break this cycle by preventing or retarding progression of psychopathology (Marry et al 2002). Rosy 16 ACCEPTED MANUSCRIPT et al 2016 also observed that there was an increase in anxiety and depression in HIV positive patients on ART after one month of routine conventional treatment as compared to the baseline. This study suggests that yoga practice enhances the mental health by improving MANUSCRIPTACCEPTED the well-being and reducing anxiety, depression and fatigue. Further, these findings suggest the importance of yoga as an alternative intervention in conventional HIV care. This study also showed the significance of the yoga intervention as an add-on therapy to ART in HIV care. Few studies have shown the potential use of the yoga intervention in HIV- infected persons. Another randomized controlled trial by Mawar et al 2015 reported significant improvement in the health related QoL domains (12% in physical health; 9% in level of independence; 11% in psychological health) (Mawar et al 2015) In a randomized controlled trial, Rosy et al (2016) reported significant improvement in depression scores (p=0.04, −13.39%) and a non-significant reduction in anxiety scores (p=0.13, −8.2%) following 1 month of an integrated yoga intervention in persons with HIV; in contrast to the yoga group, the control group showed a significant increase in anxiety and depression over the same period. The findings of our study are consistent with this previous study by Rosy et al (2016) with a notable difference being the longer duration of 2 months. The longer duration in our study may explain the comparatively higher improvement in depression (48%) and anxiety (52%) in the yoga intervention group. Similarly, asignificant increase in anxiety and depression in the control group was observed at post-assessment; which may be attributed to HIV-associated depression and anxiety. 17 ACCEPTED MANUSCRIPT In another randomized controlled trial, Ram et al (2016) reported significant improvement in QoL domains following 4 months of the yoga intervention in HIV persons with cocaine addiction (Agarwal et al 2015). Consistent with this study, our study also found significant improvement in QoL domains following 2 months MANUSCRIPTACCEPTED of yoga intervention. However, the frequency of the yoga intervention in our study was 5 days per week, as compared to 1 session per week in the previous study. Also the type of yoga module differed from the previous study. These variations could explain the greater improvement in QoL domains observed in our study, Our findings are also supported by a pilot RCT study by Menon et al 2013 in which significant improvement in physical health, psychological well-being and CD4 count following 10 weeks of yoga intervention among the adolescents with HIV positive (Menon et al 2013). The exact mechanism action of yoga is not known. However, based on earlier findings, we can hypothesize that yoga practice leads to decreased stress response through down-regulation of the HPA (hypothalamus-pituitary-adrenal axis) (Ross et al 2009), which could have contributed to a reduction in anxiety. Most of the yoga postures involve active stretching, which might have contributed to increased parasympathetic activity and enhanced secretion of positive Neuro-hormones such as serotonin, oxytocin which have anti- depressant action (Sharma et al 2005). Decreased anxiety and depression is shown to improve QoL (Chandwani et al 2009). This study has a few limitations such as a small sample size, with no sample size calculation done prior to the study. Additionally, the control-group has not had any type of intervention, while the yoga group is a short term intervention. Conclusion 18 ACCEPTED MANUSCRIPT This study clearly indicates that yoga intervention improves the psychological health and QoL of individuals infected with HIV. Therefore, based on these findings, yoga is strongly recommended as a complementary therapy to enhance conventional HIV care. MANUSCRIPTACCEPTED 19 ACCEPTED MANUSCRIPT Conflict of Interest Authors declare no conflict of interest. Acknowledgement We are grateful for the constant support we received from the HIV Centres MANUSCRIPTACCEPTED throughout the study. 20 ACCEPTED MANUSCRIPT Reference · Adewuya, A. O., Afolabi, M. O., Ola, B. A., Ogundele, O. A., Ajibare, A. O., Oladipo, B. F., & Fakande, I. (2008). 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