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1.  New Modified English and Hindi Oswestry Disability Index in Low Back Pain Patients Treated Conservatively in Indian Population 
Asian Spine Journal  2014;8(5):632-638.
Study Design
Prospective cohort study along with questionnaire.
To measure the correlation of the visual analogue score (VAS), with (Oswestry disability Index [ODI], version 2.1a) in English, and modified ODI (English and Hindi version). To validate translated version of the modified ODI in English version to Hindi.
Overview of Literature
Conflicting evidence in literature regarding the ability for existing ODI score to accurately measure the pain associated disability.
One hundred and three patients conservatively treated for low back pain were enrolled in the study. The Pearson correlation coefficient for VAS and ODI along with the Cronbach α and test-retest reliability for Hindi version using the intraclass correlation coefficient was recorded. The new proposed translated Hindi version of ODI was carried out with established guidelines.
The mean age in English and Hindi version of ODI was 53.5 years and 58.5 years, respectively. The gender ration was 21:24 in the English version and 35:23 in the Hindi version. The mean follow-up in English and Hindi version of ODI was 3.4 months and 50.27 months, respectively. The Cronbach coefficient α=0.7541 for English ODI and 0.9913 for Hindi ODI was recorded for the both modified versions.
The new modified ODI is time saving and accurate, and it avoids the need to measure other scores and has stronger correlation with VAS score compared to the previous scores. We recommend this version for both English and Hindi speaking population as an assessment tool to measure the disability related to pain.
PMCID: PMC4206813  PMID: 25346816
Back pain; Oswestry disability index; Outcome measures; Validity; Reliability; Indian population
2.  Validation of Hindi Translation of SRPB Facets of WHOQOL-SRPB Scale 
World Health Organization's Quality of Life – Spirituality, Religiousness and Personal Beliefs Scale (WHOQOL SRPB) is a valuable instrument for assessing spirituality and religiousness. The absence of this self-administered instrument in Hindi, which is a major language in India, is an important limitation in using this scale.
To translate the English version of the SRPB facets of WHOQOL-SRPB scale to Hindi and evaluate its psychometric properties.
Materials and Methods:
The SRPB facets were translated into Hindi using the World Health Organisation's translation methodology. The translated Hindi version was evaluated for cross-language equivalence, test-retest reliability, internal consistency, and split half reliability.
Hindi version was found to have good cross-language equivalence and test-retest reliability at the level of facets. Twenty-six of the 32 items and 30 of the 32 items had a significant correlation (ρ<0.001) in cross language concordance and test-retest reliability data, respectively. The Cronbach's alpha was 0.93, and the Spearman-Brown Sphericity value was 0.91 for the Hindi version of SRPB.
The present study shows that cross-language equivalence, internal consistency, split-half reliability, and test-retest reliability of the Hindi version of SRPB (of WHOQOL-SRPB) are excellent. Thus, the Hindi version of WHOQOL-SRPB as translated in this study is a valid instrument.
PMCID: PMC3868086  PMID: 24379495
Hindi translation; religiousness; spirituality; WHOQOL-SRPB
3.  Primary headaches in restless legs syndrome patients 
Annals of Indian Academy of Neurology  2012;15(Suppl 1):S104-S108.
Earlier studies conducted among migraineurs have shown an association between migraine and restless legs syndrome (RLS). We chose RLS patients and looked for migraine to exclude sample bias.
Materials and Methods:
99 consecutive subjects of idiopathic RLS were recruited from the sleep clinic during four months period. Physician diagnosis of headache and depressive disorder was made with the help of ICHD-2 and DSM-IV-TR criteria, respectively. Sleep history was gathered. Severity of RLS and insomnia was measured using IRLS (Hindi version) and insomnia severity index Hindi version, respectively. Chi-square test, one way ANOVA and t-test were applied to find out the significance.
Primary headache was seen in 51.5% cases of RLS. Migraine was reported by 44.4% subjects and other types of ‘primary headaches’ were reported by 7.1% subjects. Subjects were divided into- RLS; RLS with migraine and RLS with other headache. Females outnumbered in migraine subgroup (χ2=16.46, P<0.001). Prevalence of depression (χ2=3.12, P=0.21) and family history of RLS (χ2=2.65, P=0.26) were not different among groups. Severity of RLS (P=0.22) or insomnia (P=0.43) were also similar.
Migraine is frequently found in RLS patients in clinic based samples. Females with RLS are prone to develop migraine. Depression and severity of RLS or insomnia do not affect development of headache.
PMCID: PMC3444227  PMID: 23024558
Migraine; primary headache; restless legs syndrome
4.  Validation of a Korean Version of the Insomnia Severity Index 
Background and Purpose
The purposes of this study were to standardize and validate a Korean version of the Insomnia Severity Index (ISI-K), and to evaluate its clinical usefulness.
We translated the ISI into Korean and then translated it back into English to check its accuracy. The 614 patients with sleep disorders who were enrolled in this study comprised 169 with primary insomnia, 133 with comorbid insomnia, and 312 with obstructive sleep apnea. All subjects underwent one night of polysomnography (PSG) and completed the Korean versions of both the Pittsburgh Sleep Quality Index (PSQI-K) and the Epworth Sleepiness Scale, as well as the ISI-K. The ISI-K was compared to these sleep scales and various PSG sleep parameters.
The internal consistency the ISI-K total score was confirmed by a Cronbach's alpha of 0.92, and the item-to-total-score correlations (item-total correlations) ranged from 0.65 to 0.84, suggesting adequate reliability. The correlation between the ISI-K total score and PSQI-K was 0.84, which suggested adequate convergent validity. Low-to-moderate correlations were obtained between the ISI-K total score and PSG-defined sleep parameters: 0.22 for sleep onset latency, 0.38 for wake after sleep onset, and 0.46 for sleep efficiency. A cutoff score of 15.5 on the ISI-K was optimal for discriminating patients with insomnia. The test-retest scores over a 4-week interval with 34 subjects yielded a correlation coefficient of 0.86, suggesting excellent temporal stability.
The findings of this study show that the ISI-K is a reliable and valid instrument for assessing the severity of insomnia in a Korean population.
PMCID: PMC4101097  PMID: 25045373
sleep; insomnia; reliability; validity
5.  Validity and Reliability of the Iranian Version of the Insomnia Severity Index 
The Insomnia Severity Index (ISI) is a short subjective questionnaire which helps physicians in making decisions about patients suffering from insomnia. The present study was an attempt to test the reliability and validity of the Iranian version of the ISI and to measure the correlation between ISI items and polysomnography results in chronic insomnia patients.
Two groups responded to the Persian translation of four questionnaires; ISI, Pittsburg Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and General Health Questionnaire (GHQ). The first group consisted of 135 patients diagnosed with chronic insomnia, and the second group was comprised of 55 normal people. After completing the questionnaires, the insomniac patients underwent standard overnight polysomnography.
The internal consistency demonstrated by Cronbach’s alpha coefficient was above 0.8 for both groups. The Intra-class correlation coefficient was above 0.7 after two weeks for both groups. The correlations between ISI, PSQI, ESS, and GHQ were high. In addition, close correlations were found between scores obtained from the ISI questionnaire items in insomniac patients with corresponding polysomnographic variables.
The Iranian version of the ISI is a reliable and valid instrument. It is a valuable short and first-line questionnaire for insomnia research and clinical work.
PMCID: PMC3629678  PMID: 23613647
insomnia; Insomnia Severity Index; Iran; reliability; validity
6.  Translation and validation of International Restless Leg Syndrome Study Group rating scale in Hindi language 
The objective of this study is to translate and validate the International Restless Leg Syndrome Study Group rating scale (IRLS) in Hindi language.
Materials and Methods:
Thirty one consecutive patients diagnosed of Restless Leg Syndrome (RLS) were included in the study. Control group comprised of 31 subjects not having any symptom of RLS. The scale was procured from MAPI research trust; and, permission for the translation was sought. The translation was done according to the guidelines provided by the publisher. After translation, final version of the scale was applied in both the groups to find out the reliability and clinical validity.
RLS group had a predominance of females, and they were younger than the male counterparts (Age=36.80 ± 10.46 years vs 45.18 ± 8.34 years; t=2.28; P=0.03). There was no difference in the mean age between groups (RLS=39.77 ± 10.44 years vs Non RLS=38.29 ± 11.29 years; t=-0.53; P=0.59). IRLS scores were significantly different between both groups on all items (P<0.001). Translated version showed high reliability (Cronbach's alpha=0.86). IRLS scores were significantly different between both groups on all items (P<0.001).
Hindi version of IRLS is reliable and a clinically valid tool that can be applied in Hindi speaking population.
PMCID: PMC3271463  PMID: 22346013
Hindi translation; International Restless Leg Syndrome Study Group rating scale; Restless Leg Syndrome; translation; validation
7.  BIS-11A -Hindi version: A preliminary study of impulsivity in rural and urban Indian adolescents 
Indian Journal of Psychiatry  2008;50(2):96-99.
Despite of there being a pressing need to gauge impulsivity scores, there is no behavioral instrument in India to assess the impulsivity in adolescents. No earlier studies have been done in India to access impulsivity in adolescents. Even in western countries, no study has been done in rural setting to access impulsivity, although segment of rural population is small in western nations with major population residing in urban areas.
To translate BIS-11A into Hindi from English in a culturally sensitive manner and to do preliminary study in rural and urban areas.
Settings and Design:
First translation of BIS-11 (as it is meant for adults) and cultural substitution resulted in Hindi adult version. Adolescent version was derived from adult version by replacing adult activities with adolescent activities.
Materials and Methods:
BIS-11 English version was translated into Hindi and a back translation was made. As BIS-11 was developed for adults, answering some of the questions poses challenges for adolescents, so to be used with adolescents, questions that do not fit into adolescent age group were substituted keeping in view the activities of adolescents. Besides, questions that were not suitable as per the Indian culture were modified. Initially, these changes were made hypothetically by discussion among the authors and later a group of 48 school students were interviewed about the questions. Based on the interviews of students a final version was prepared. Translation, back translation, cultural substitution -hypothetically, and in school by discussion were carried out. The questionnaire was given to 120 urban high school students (in Jaipur, northern India) and 50 rural students (at Kanota, 25 km from Jaipur, northern India) and the scores were calculated as per the scoring method provided with original BIS-11.
Statistical Analysis:
T-test (two-tailed, two sample unequal variance, i.e., type 3) was used.
T-test (two-tailed, two sample unequal variance, i.e., type 3) found no significant difference between impulsivity scores of adolescents of urban and rural areas t 0.05(2)1 = 0.57, |t| < t 0.05(2)1, P > 0.05, P = 12.706. There were no gender related differences either.
As impulsivity can lead to suicide and is implicated for substance abuse in disorders like Schizophrenia, it is important that culturally sensitive impulsivity studies are done in India on a large scale keeping in view the large size of population. Standardization of the BIS11-A Hindi version is being taken up. The work on Hindi version also generates necessity for other tasks if BIS-11(Hindi version) is to be used widely. Work on psychometric properties of Hindi version of BIS-11 A is being taken up. There is a need to devise a quick way to calculate impulsivity scores keeping in view the large population of India (1 billion out of which at least 33% is Hindi speaking, Census Survey of India, 2001). Besides, BIS-11A needs to be developed for other regional languages in India as there is a high-linguistic diversity in India.
PMCID: PMC2738344  PMID: 19742223
Adolescent; BIS-11 A; Hindi; rural; urban
8.  Insomnia Associated with Depressive Disorder: Primary, Secondary, or Mixed? 
Insomnia is a common problem that is known to occur during depression. However, literature still debates whether insomnia is part of depression or a separate entity.
Materials and Methods:
Subjects presenting with depressive disorder according to DSM-IV-Text Revision criteria were recruited after seeking informed consent. Clinical interview was performed with the help of Mini International Neuropsychiatric Interview Plus. Their demographic data and depression related history were recorded. Depression severity was assessed by using Hamilton Rating Scale for Depression. Diagnosis of insomnia was made with the help of International Classification of Sleep Disorders-2 criteria. Type of insomnia, its duration, and its relationship with depressive illness were specifically asked. If any subject fulfilled criteria for more than one type of insomnia, both were recorded. Statistical analysis was done with the help of statistical package for social sciences (SPSS) version 17.0. χ2 test, independent sample t test, and Pearson's correlation were performed.
A total of 54 subjects were enrolled in this study. Primary insomnia was seen in 40.7% cases and secondary insomnia in 58.8% cases; 27.3% subjects did not experience insomnia along with depressive disorder. In the primary insomnia category, adjustment insomnia was most prevalent (63.6%), and in secondary insomnia group, insomnia due to depressive disorder was most frequent (59.3%). Interestingly, primary insomnia often followed an onset of depressive illness (P=0.04), while secondary insomnia preceded it (c2 =11.1; P=0.004). The presence of either type of insomnias was not influenced by duration of depressive illness, number of depressive episodes, and duration of current depressive episode. On the other hand, duration of insomnia was positively correlated with total duration of depressive illness (P=0.003), number of episodes (P=0.04), and duration of current depressive episode (P<0.001).
Primary insomnia is common in subjects with depression, and it usually follows depressive illness. On the other hand, secondary insomnia often precedes the onset of depressive illness. Duration of insomnia positively correlates with duration and frequency of depressive episodes.
PMCID: PMC3271484  PMID: 22345834
Major depressive disorder; primary insomnia; secondary insomnia
9.  Hindi translation and validation of dysfunctional beliefs and attitudes about sleep (DBAS - 16) 
Industrial Psychiatry Journal  2013;22(1):80-85.
The objective of this study is to translate and validate the Dysfunctional Beliefs and Attitudes about Sleep Brief Version (DBAS-16)) in Hindi language.
Materials and Methods:
The scale was obtained online, and the permission for translation was obtained from the author. The translation of the scale was carried out following back translation method. The scale was applied on 63 participants attending the adult psychiatry OPD who were included in the study.
Thirty-two patients were having insomnia, and 31 patients were controls without insomnia. The results show that the translated version had good reliability with internal consistency (Chronbach alpha = 0.901).
The Hindi translation of DBAS-16 is a reliable tool for assessing the dysfunctional beliefs and attitude about sleep.
PMCID: PMC3895320  PMID: 24459381
Attitudes; dysfunctional beliefs; sleep; translation
10.  New assessment tools that measure sleep vital signs: the SleepMed Insomnia Index and the Sleep Matrix 
Insomnia is the leading sleep disorder in the US; however, diagnosis is often problematic. This pilot study assessed the clinical value of a novel diagnostic insomnia questionnaire. The SleepMed Insomnia Index (SMI) was administered to 543 consecutive patients and 50 normal control subjects during a pilot study. Mean SMI scores were assessed based on subsequent sleep-related diagnoses. The SMI scores for patients with sleep-related disorders were significantly higher than those for the control group (p < 0.001) and highest for the 90 patients comprising the insomnia group. Analysis of the SMI scores from the 90 insomnia patients indicates a high degree of reliability (Cronbach’s alpha: 0.7). These data support our clinical experience with this diagnostic tool which indicates a strong likelihood of disrupted nighttime sleep in patients with high SMI scores. Following further validation, the SMI may prove to be a valuable tool for evaluating sleep disorders, specifically as an aid in the diagnosis of insomnia. The Sleep Matrix is a visual tool that quantifies a sleep complaint by combining scores from the Epworth Sleepiness Scale (ESS) and the SMI. The SMI measures an insomnia component while the ESS is an accepted measure of daytime sleepiness. The Sleep Matrix visually displays the complexity of the sleep complaint in an effort to differentiate insomnia with differing etiologies from other sleep disorders and measure treatment outcomes. To pilot test the Sleep Matrix, the tool was administered to 90 patients with insomnia and to 22 normal controls. Plots from the insomnia patients were concentrated into the “insomnia zone” while scores from the normal controls were located in the “normal zone” located in the lower left quadrant. Additional research using the Sleep Matrix could provide data that the tool could be utilized to visually aid the clinician in the diagnosis of unknown sleep complaints.
PMCID: PMC2655088  PMID: 19300579
insomnia; diagnosis; sleep disorders; tools
11.  Psychometric Analysis of the Pittsburgh Insomnia Rating Scale among University Population of Poor Sleepers in India 
Pittsburgh insomnia rating scale is a 65 item self administered open source questionnaire. The scale is widely used in clinical practice but its psychometric properties are not well established. Therefore keeping in mind this lacuna the current study was designed for university population of poor sleepers in India.
The purpose of this study was to establish the Pittsburgh sleep Quality Index test- retest reliability, validity and internal consistency of Pittsburgh insomnia rating scale.
Materials and Methods:
Twenty five subjects were randomly chosen from the screened population of poor sleepers. Pittsburgh insomnia rating scale, Pittsburgh sleep quality index and Insomnia severity index were administered on test day. Retest was administered after one week.
Eight males and seventeen females with mean age 24 + 7.04 were recruited. The test retest reliability for Pittsburgh insomnia rating scale total score showed excellent reliability (ICC2,1-0.93). The results also show that the total score is moderately correlated with Pittsburgh sleep Quality Index (r-0.31) and moderately correlated with Insomnia severity index (r-0.49). Internal consistency for the test was excellent (Cronbach's alpha- 0.930)
The study findings suggest that Pittsburgh insomnia rating scale has excellent internal consistency, test-retest reliability and good validity for university population of poor sleepers in India. It is an important first line of assessment scale for screening of sleep problems.
PMCID: PMC4024582  PMID: 24843848
Insomnia; Insomnia severity index; Pittsburgh insomnia rating scale; Pittsburgh sleep quality index; Poor sleepers
12.  Factors Associated with Clinically Significant Insomnia Among Pregnant Low-Income Latinas 
Journal of Women's Health  2013;22(8):694-701.
Poor sleep, common during pregnancy, is associated with negative health risks. The study aimed to identify predictors of clinically significant insomnia among pregnant Latinas.
A total of 1289 pregnant Latinas recruited from obstetric clinics completed the Insomnia Severity Index (ISI) and questions about demographics and sleep.
Clinically significant insomnia (ISI≥10) was present among 17% of participants. Significant correlates of clinically significant insomnia were higher scores on the Edinburgh Postnatal Depression Scale (EPDS) after removing the sleep item (47% of women with EPDS≥9 and 9% with EPDS<9), completing measures in English (rather than Spanish: 26% versus 13%), and income but not pregnancy week, age, highest education level, or marital status. The highest percentage of clinically significant insomnia (59%) was experienced by women with EPDS≥9 who completed measures in English. The lowest percentage of clinically significant insomnia (6.2%) was experienced by women with EPDS<9 who completed measures in Spanish.
In this sample of low-income, mostly Spanish-speaking pregnant Latinas, rates of clinically significant insomnia appear to be higher than rates among nonpregnant Latinas. Rates of clinically significant insomnia are particularly high among Latinas with elevated depressive symptom severity, a known risk for insomnia. Acculturation, as indicated by completing measures in English, may be another risk specific to Latinas, possibly owing to loss of some ethnicity-specific protective factors (e.g., social support, strong family ties, and group identity). It will be important to directly test this explanation in future research.
PMCID: PMC3736643  PMID: 23863074
13.  Daytime symptom patterns in insomnia sufferers: is there evidence for subtyping insomnia? 
Journal of sleep research  2011;20(3):425-433.
The type and severity of daytime symptoms reported by insomnia sufferers may vary markedly. Whether distinctive daytime symptom profiles are related to different insomnia diagnoses has not been studied previously. Using profile analysis via multidimensional scaling, we investigated the concurrent validity of ICSD-2 insomnia diagnoses by analysing the relationship of prototypical profiles of daytime symptoms with a subset of ICSD-2 diagnoses, including insomnia associated to a mental disorder, psychophisiological insomnia, paradoxical insomnia, inadequate sleep hygiene, idiopathic insomnia, obstructive sleep apnea and restless legs syndrome. In a sample of 332 individuals meeting research diagnostic criteria for insomnia (221 women, Mage=46 yrs.), the profile analysis identified four prototypical patterns of daytime features. Pearson correlation coefficients indicated that the diagnoses of insomnia associated to a mental disorder and idiopathic insomnia were associated with a daytime profile characterized by mood disturbance and low sleepiness; whereas the diagnoses of psychophysiological insomnia and inadequate sleep hygiene were related to a profile marked by poor sleep hygiene, daytime tension and low fatigue. Furthermore, whereas paradoxical insomnia was consistently associated to lower daytime impairment, insomnia associated to a mental disorder was related to the most severe daytime impairment. This classification of insomnia sufferers along multiple defining dimensions provides initial validation for two basic insomnia subtypes, with a presumably distinct aetiology: insomnia characterized mainly by an “internal” component, and a “learned” insomnia. Research to determine which dimensions are critical for inclusion or differential weighting for defining a general typological system for insomnia sufferers is warranted.
PMCID: PMC3135706  PMID: 21205038
Insomnia; ICSD-2; Daytime symptoms; Concurrent validity
14.  Relationship between insomnia and headache in community-based middle-aged Hong Kong Chinese women 
The Journal of Headache and Pain  2010;11(3):187-195.
Limited studies have investigated the prevalence of insomnia symptoms among individuals with different headache diagnoses and the association between insomnia and headache in subjects with comorbid anxiety and depression. A total of 310 community-dwelling Hong Kong Chinese women aged 40–60 years completed a self-administered questionnaire on headache, sleep difficulties, mood disturbances, and functional impairment. About 31% of the sample complained of recurrent headache unrelated to influenza and the common cold in the past 12 months. The percentages of women diagnosed to have migraine, tension-type headache (TTH), and headache unspecified were 8.4, 15.5 and 7.1%, respectively. The most frequent insomnia complaint was “problem waking up too early” (29.4%), followed by “difficulty staying asleep” (28.0%) and “difficulty falling asleep” (24.4%). Women with headaches were significantly more likely to report insomnia symptoms than those without headaches. There were no significant differences among women with migraine, TTH, and headache unspecified in the prevalence of insomnia symptoms. Logistic regression analysis showed that women with insomnia disorder as defined by an insomnia severity index total score ≥8 had 2.2-fold increased risk of reporting recurrent headache, 3.2-fold increased risk of migraine, and 2.3-fold increased risk of TTH, after adjusting for anxiety and depression. Individual insomnia symptoms were not independent predictors. The association between insomnia and headache was stronger in subjects with more frequent headaches. Our findings suggest that insomnia and the associated distress, but not insomnia symptoms alone, is an independent risk factor for recurrent headache in middle-aged women with mixed anxiety, depression and sleep disturbances.
PMCID: PMC3451911  PMID: 20186559
Anxiety; Depression; Headache; Insomnia; Migraine; Tension-type headache
15.  Effect of acupuncture on patients with insomnia: study protocol for a randomized controlled trial 
Trials  2014;15(1):403.
Hypnotic drugs tend to be the dominant form of treatment of insomnia, but these come with a number of reported side effects. Acupuncture has been studied as an alternative, resulting in a rising need for methodological research towards verifying its efficacy as insomnia treatment.
We describe a proposal for a single-center, patient-assessor-blinded, randomized controlled trial with two parallel arms. A total of 38 patients complete screening tests at the first visit, are registered into the clinical trial, and then randomly assigned to the experimental or sham control groups (19 patients for each group). All subjects are clinical insomnia patients who score a 6 or above on the Pittsburgh Sleep Quality Index (PSQI) and meet all inclusion criteria. All subjects are treated with acupuncture and intradermal acupuncture (IDA) three times during the first week. Five sham acupoints are used in the control group. In the experimental group, five real acupoints (PC6, SP6, HT7, KI6, and BL62) are used unilaterally in turn. Sham acupoints are over 1 cm away from each real acupoint.
The primary outcomes are the scores on the Insomnia Severity Index (ISI) and PSQI. Secondary outcomes are the sleep log, the Beck Depression Inventory (BDI), the State-Trait Anxiety Inventory (STAI), the World Health Organization Quality of Life Abbreviated Version (WHOQOL-BREF), the Korean-Auditory Verbal Learning Test (K-AVLT), the Digit Span Test (DS), Event Related Potentials (ERPs) and heart rate variability (HRV) to assess emotional states, sleep quality, cognitive functioning, and electro-physiological changes.
Subjects are assessed at three time points: baseline, post-treatment and follow-up. The duration of the clinical trial is 18 days.
To study the enhancement of the effectiveness of acupuncture for insomnia, we test the intradermal acupuncture method, which is performed continuously on the subject’s skin and stimulated at home by the subject every night. In the trial, objective measurements including ERPs and HRV are used to evaluate states of cognition and autonomic nervous system functioning and subjective self-report questionnaires assess insomnia symptoms.
'Sham’ acupuncture points provided by STRICTA are used for the control group.
Trial registration NCT01956760, registered 5 September 2013.
PMCID: PMC4213556  PMID: 25342100
Insomnia; Acupuncture; Intradermal acupuncture; Clinical trial
16.  The Interplay of Stress and Sleep Impacts BDNF Level 
PLoS ONE  2013;8(10):e76050.
Sleep plays a pivotal role in normal biological functions. Sleep loss results in higher stress vulnerability and is often found in mental disorders. There is evidence that brain-derived neurotrophic factor (BDNF) could be a central player in this relationship. Recently, we could demonstrate that subjects suffering from current symptoms of insomnia exhibited significantly decreased serum BDNF levels compared with sleep-healthy controls. In accordance with the paradigm indicating a link between sleep and BDNF, we aimed to investigate if the stress system influences the association between sleep and BDNF.
Methodology/Principal Findings
Participants with current symptoms of insomnia plus a former diagnosis of Restless Legs Syndrome (RLS) and/or Periodic Limb Movement (PLM) and sleep healthy controls were included in the study. They completed questionnaires on sleep (ISI, Insomnia Severity Index) and stress (PSS, Perceived Stress Scale) and provided a blood sample for determination of serum BDNF. We found a significant interaction between stress and insomnia with an impact on serum BDNF levels. Moreover, insomnia severity groups and score on the PSS each revealed a significant main effect on serum BDNF levels. Insomnia severity was associated with increased stress experience affecting serum BDNF levels. Of note, the association between stress and BDNF was only observed in subjects without insomnia. Using a mediation model, sleep was revealed as a mediator of the association between stress experience and serum BDNF levels.
This is the first study to show that the interplay between stress and sleep impacts BDNF levels, suggesting an important role of this relationship in the pathogenesis of stress-associated mental disorders. Hence, we suggest sleep as a key mediator at the connection between stress and BDNF. Whether sleep is maintained or disturbed might explain why some individuals are able to handle a certain stress load while others develop a mental disorder.
PMCID: PMC3797810  PMID: 24146812
17.  The Global Mental Health Assessment Tool-validation in Hindi: A validity and feasibility study 
Indian Journal of Psychiatry  2010;52(4):316-319.
A computer-assisted interview, the Global Mental Health Assessment Tool-validation (GMHAT/PC) has been developed to assist general practitioners and other health professionals to make a quick, convenient, yet reasonably comprehensive standardized mental health assessment. GMHAT/PC has been translated into various languages including Hindi. This is the first study conducted in India, using the Hindi version GMHAT/PC of the series of studies assessing its validity in different cultures.
The study aims to assess the feasibility of using a computer assisted diagnostic interview by health professionals and to examine the level of agreement between the Hindi version GMHAT/PC diagnosis and psychiatrists’ ICD-10 based clinical diagnosis.
Cross-sectional validation study.
Psychiatric clinic of a General Hospital and an out patient (Neurology) clinic in the Teaching General Hospital in Jaipur, India.
Materials and Methods:
All consecutive patients attending the psychiatric out patient clinic were interviewed using GMHAT/PC and psychiatrists made a diagnosis applying ICD-10 criteria for a period of six weeks. A small sample of subjects was interviewed in a similar way in a Neurology clinic for four weeks.
The mean duration of interview was under 17 minutes. Most patients were pleased that they were asked about every aspect of their mental health. The agreement between psychologists’ GMHAT/PC interview diagnoses and psychiatrists’ clinical diagnoses was excellent (Kappa 0.96, sensitivity 1.00, and specificity 0.94).
GMHAT/PC Hindi version detected mental disorders accurately and it was feasible to use GMHAT/PC in Indian settings.
PMCID: PMC3025156  PMID: 21267364
GMHAT; mental health assessment; primary care mental health; psychiatric diagnosis
18.  Insomnia with Short Sleep Duration: Nosological, Diagnostic, and Treatment Implications 
Sleep medicine clinics  2013;8(3):309-322.
The diagnosis of insomnia is based solely on subjective complaints. This has contributed to the low reliability and validity of the current nosology of insomnia as well as to its lack of firm association with clinically relevant outcomes such as cardiometabolic and neurocognitive morbidity. We review evidence that insomnia with objective short sleep duration is associated with physiological hyperarousal, higher risk for hypertension, diabetes, neurocognitive impairment, and mortality as well as with a persistent course. It also appears that objective short sleep duration in poor sleepers is a biological marker of genetic predisposition to chronic insomnia. In contrast, insomnia with objective normal sleep duration is associated with cognitive-emotional and cortical arousal and sleep misperception but not with signs of physiological hyperarousal or medical complications. Thus, short sleep duration in insomnia may be a reliable marker of the biological severity and medical impact of the disorder. We propose that (a) objective measures of sleep be included in the diagnosis of insomnia and its subtypes, (b) objective measures of sleep obtained in the home environment of the patient would become part of the routine assessment and diagnosis of insomnia in a clinician’s office setting, and (c) insomnia with short sleep duration may respond better to biological treatments, whereas insomnia with normal sleep duration may respond primarily to psychological therapies.
PMCID: PMC3780422  PMID: 24072989
Insomnia; short sleep duration; cardiometabolic; neurocognitive; physiological hyperarousal; morbidity; mortality
19.  Development, Translation and Validation of Enhanced Asian Rome III Questionnaires for Diagnosis of Functional Bowel Diseases in Major Asian Languages: A Rome Foundation-Asian Neurogastroenterology and Motility Association Working Team Report 
The development-processes by regional socio-cultural adaptation of an Enhanced Asian Rome III questionnaire (EAR3Q), a cultural adaptation of the Rome III diagnostic questionnaire (R3DQ), and its translation-validation in Asian languages are presented. As English is not the first language for most Asians, translation-validation of EAR3Q is essential. Hence, we aimed to culturally adapt the R3DQ to develop EAR3Q and linguistically validate it to show that the EAR3Q is able to allocate diagnosis according to Rome III criteria.
After EAR3Q was developed by Asian experts by consensus, it was translated into Chinese, Hindi-Telugu, Indonesian, Korean, and Thai, following Rome Foundation guidelines; these were then validated on native subjects (healthy [n = 60], and patients with irritable bowel syndrome [n = 59], functional dyspepsia [n = 53] and functional constipation [n = 61]) diagnosed by clinicians using Rome III criteria, negative alarm features and investigations.
Experts noted words for constipation, bloating, fullness and heartburn, posed difficulty. The English back-translated questionnaires demonstrated concordance with the original EAR3Q. Sensitivity and specificity of the questionnaires were high enough to diagnose respective functional gastrointestinal disorders (gold standard: clinical diagnoses) in most except Korean and Indonesian languages. Questionnaires often uncovered overlapping functional gastrointestinal disorders. Test-retest agreement (kappa) values of the translated questionnaires were high (0.700–1.000) except in Korean (0.300–0.500) and Indonesian (0.100–0.400) languages at the initial and 2-week follow-up visit.
Though Chinese, Hindi and Telugu translations were performed well, Korean and Indonesian versions were not. Questionnaires often uncovered overlapping FGIDs, which were quite common.
PMCID: PMC4288097  PMID: 25537673
Asia; Gastrointestinal diseases; Rome III criteria; Translations; Validation
20.  Reliability and validity of Hindi translation of the migraine disability assessment and headache impact test-6 questionnaires 
The objective of the study was to assess the reliability and validity of the Hindi translation of the Migraine Disability Assessment (MIDAS) and Headache Impact Test-6 (HIT-6) questionnaires.
Materials and Methods:
The study was conducted on the migraine patients. For test–retest reliability, the respondents filled the MIDAS and HIT-6 questionnaires twice, at an interval of three weeks. For validity, the same population of patients filled the headache diary for three months. After three months they filled the MIDAS and HIT-6 questionnaires again. The patients were subgrouped according to their occupation and level of education. The test–retest reliability and validity were calculated by the Pearson correlation coefficient. Internal consistency was calculated using the Cronbach alpha.
A total of 236 migraine patients were screened. Seventy-nine patients fulfilled the inclusion criteria. A total of 69 patients completed the study. The HIT-6 questionnaire was applicable to all the subgroups of patients and had better comprehensibility than the MIDAS. Housewives missed out on the first two questions of the MIDAS and had lower mean MIDAS scores than HIT-6. The test–retest correlation coefficients for the total MIDAS and HIT-6 scores were 0.94 and 0.81, respectively. The correlation coefficients between the total score in the headache diary equivalent and the MIDAS and HIT-6 total score were 0.91 and 0.77, respectively. Cronbach alpha, a measure of internal consistency for the MIDAS questionnaire was > 0.90 at all the compilations. For the HIT-6 questionnaire, it ranged from 0.67 to 0.79.
The Hindi versions of MIDAS and HIT-6 questionnaires were reliable and valid, but could not be interchanged. HIT-6 had better comprehensibility.
PMCID: PMC3021931  PMID: 21264136
Headache Disability; HIT-6; migraine disability assessment; migraine; reliability; validity
21.  Clinical Significance of night-to-night sleep variability in insomnia 
Sleep medicine  2012;13(5):469-475.
Study Objectives
To evaluate the clinical relevance of night-to-night variability of sleep schedules and insomnia symptoms.
The sample consisted of 455 patients (193 men, mean age=48) seeking treatment for insomnia in a sleep medicine clinic. All participants received group cognitive behavioral therapy for insomnia (CBTI). Variability in sleep parameters was assessed using sleep diary data. Two composite scores were computed, a behavioral schedule composite score (BCS) and insomnia symptom composite score (ICS). The Insomnia Severity Index, the Beck Depression Inventory, and the Morningness-Eveningness Composite Scale were administered at baseline and post-treatment.
Results revealed that greater BCS scores were significantly associated with younger age, eveningness chronotype, and greater depression severity (p<.001). Both depression severity and eveningness chronotype independently predicted variability in sleep schedules (p<.001). Finally, CBTI resulted in reduced sleep variability for all sleep diary variables, except bedtime. Post-treatment symptom reductions in depression severity were greater among those with high versus low baseline BCS scores (p<.001).
Results suggest that variability in sleep schedules predict reduction in insomnia and depressive severity following group CBTI. Schedule variability may be particularly important to assess and address among patients with high depression symptoms and those with evening chronotype.
PMCID: PMC4086618  PMID: 22357064
insomnia; sleep variability; depression; chronotype; CBTI; circadian rhythm
22.  The effect of magnesium supplementation on primary insomnia in elderly: A double-blind placebo-controlled clinical trial 
Nearly 50% of older adults have insomnia, with difficulty in getting to sleep, early awakening, or feeling unrefreshed on waking. With aging, several changes occur that can place one at risk for insomnia, including age-related changes in various circadian rhythms, environmental and lifestyle changes, and decreased nutrients intake, absorption, retention, and utilization. The natural N-methyl-D-aspartic acid (NMDA) antagonist and GABA agonist, Mg2+, seems to play a key role in the regulation of sleep. The objective of this study was to determine the efficacy of magnesium supplementation to improve insomnia in elderly.
Materials and Methods:
A double-blind randomized clinical trial was conducted in 46 elderly subjects, randomly allocated into the magnesium or the placebo group and received 500 mg magnesium or placebo daily for 8 weeks. Questionnaires of insomnia severity index (ISI), physical activity, and sleep log were completed at baseline and after the intervention period. Anthropometric confounding factors, daily intake of magnesium, calcium, potassium, caffeine, calories form carbohydrates, and total calorie intake, were obtained using 24-h recall for 3 days. Blood samples were taken at baseline and after the intervention period for analysis of serum magnesium, renin, melatonin, and cortisol. Statistical analyses were performed using SPSS19 and P values < 0.05 were considered as statistically significant.
No significant differences were observed in assessed variables between the two groups at the baseline. As compared to the placebo group, in the experimental group, dietary magnesium supplementation brought about statistically significant increases in sleep time (P = 0.002), sleep efficiency (P = 0.03), concentration of serum renin (P < 0.001), and melatonin (P = 0.007), and also resulted in significant decrease of ISI score (P = 0.006), sleep onset latency (P = 0.02) and serum cortisol concentration (P = 0.008). Supplementation also resulted in marginally between-group significant reduction in early morning awakening (P = 0.08) and serum magnesium concentration (P = 0.06). Although total sleep time (P = 0.37) did not show any significant between-group differences.
Supplementation of magnesium appears to improve subjective measures of insomnia such as ISI score, sleep efficiency, sleep time and sleep onset latency, early morning awakening, and likewise, insomnia objective measures such as concentration of serum renin, melatonin, and serum cortisol, in elderly people.
PMCID: PMC3703169  PMID: 23853635
Dietary supplementation; elderly; insomnia; magnesium
Indian Journal of Psychiatry  1997;39(3):196-199.
The psychometric properties and factor structure of the 12 item General Health Questionnaire used in a sample of women of ethnic Indian origin living in the United Kingdom is described. The Cronbach's alpha was 0.89 and the split half reliability was 0.91. Principal component analysis revealed 2 significant components which accounted for 75.2% of variance. The psychometric properties and factor structure of the Hindi and English versions were similar.The psychometric properties and factor structure of the 12 item General Health Questionnaire used in a sample of women of ethnic Indian origin living in the United Kingdom is described. The Cronbach's alpha was 0.89 and the split half reliability was 0.91. Principal component analysis revealed 2 significant components which accounted for 75.2% of variance. The psychometric properties and factor structure of the Hindi and English versions were similar.
PMCID: PMC2967114  PMID: 21584074
GHQ; ethnic Indian; women
24.  Ayurvedic Therapy (Shirodhara) for Insomnia: A Case Series 
Insomnia is one of the most common complaints faced by primary care practitioners after pain. Non-pharmacological management of Insomnia that is noninvasive is gaining interest among patients with insomnia.
To determine the feasibility of recruiting and retaining participants in a clinical trial on shirodhara, Ayurvedic oil dripping therapy, for insomnia in the United States and also to investigate the therapeutic usefulness of Shirodhara for insomnia using standardized outcome measures.
Case series.
Study Intervention and Data Collection:
Shirodhara with Brahmi oil was done for 45 minutes on each participant for 5 consecutive days. Insomnia Severity Index (ISI) was used to evaluate the severity of insomnia as well as to determine the response to Shirodhara therapy. Data were collected at baseline, end of the treatment (day 5) and 1 week after the treatment ended (follow-up).
Two males and eight females with a mean age of 40 years (range 23 to 72), SD ± 14.2, were enrolled in the study. One dropped out of the study, but all remaining nine participants experienced improvement at the end of treatment. The percentage of improvement range varied from 3.85% to 69.57%. At follow-up, most participants continued to improve. Comparison of means between baseline and day 5 indicated an overall significant improvement (P < .005), but in a comparison of baseline vs 1 week posttreatment the improvement was not significant (P < .089). No adverse events were reported during the study.
Shirodhara with Brahmi oil may be beneficial for moderate to severe insomnia. It is feasible to recruit and retain participants for such therapies in the United States. It is important to validate these findings and investigate the mechanism of action using a larger sample and rigorous research design.
PMCID: PMC3921608  PMID: 24753997
Shirodhara; oil dripping therapy; insomnia; Ayurveda; case series
25.  Chronic Insomnia and Its Negative Consequences for Health and Functioning of Adolescents: A 12-Month Prospective Study 
To estimate prevalence and chronicity of insomnia and the impact of chronic insomnia on health and functioning of adolescents.
Data were collected from 4175 youths 11–17 at baseline and 3134 a year later sampled from managed care groups in a large metropolitan area. Insomnia was assessed by youth reported DSM-IV symptom criteria. Outcomes are three measures of somatic health, three measures of mental health, two measures of substance use, three measures of interpersonal problems, and three of daily activities.
Over one-fourth reported one or more symptoms of insomnia at baseline and about 5% met diagnostic criteria for insomnia. Almost 46% of those who reported 1 or more symptoms of insomnia in Wave 1 continued to be cases at Wave 2 and 24% met DSM-IV symptom criteria for chronic insomnia (cases in Wave 1 were also cases in Wave 2). Multivariate analyses found chronic insomnia increased subsequent risk for somatic health problems, interpersonal problems, psychological problems, and daily activities. Significant odds (p<.05) ranged from 1.6 to 5.6 for poor outcomes. These results are the first reported on chronic insomnia among youths and corroborate, using prospective data, previous findings on correlates of disturbed sleep based on cross-sectional studies.
Insomnia is both common and chronic among adolescents. The data indicate that the burden of insomnia is comparable to that of other psychiatric disorders such as mood, anxiety, disruptive and substance use disorders. Chronic insomnia severely impacts future health and functioning of youths. Those with chronic insomnia are more likely to seek medical care. These data suggest primary care settings might provide a venue for screening and early intervention for adolescent insomnia.
PMCID: PMC2488408  PMID: 18295138
insomnia; prevalence; persistence; outcomes; adolescents

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