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1.
Eat Weight Disord ; 29(1): 7, 2024 Jan 12.
Artículo en Inglés | MEDLINE | ID: mdl-38214807

RESUMEN

BACKGROUND: Research suggests that food choices, preferences, and tastes change after bariatric surgery, but evidence regarding changes in food cravings is mixed. OBJECTIVES: The primary aim of this cohort study was to compare food cravings during the first year following bariatric surgery in patients who had undergone sleeve gastrectomy (SG) versus Roux-en-Y gastric bypass (RYGB). SETTING: Integrated multispecialty health system, United States. METHODS: Patients aged ≥ 18 years seen between May 2017 and July 2019, provided informed consent, completed the Food Craving Inventory (FCI), and had ≥ 1 year of follow-up after undergoing primary SG or RYGB were included in the study. Secondary data captured included psychological and behavioral measures. Preoperative and postoperative (3, 6, 9, and 12 months) FCI scores of patients who underwent SG and RYGB were compared. RESULTS: Some attrition occurred postoperatively (N = 187 at baseline, 141 at 3 months, 108 at 6 months, 89 at 9 months, and 84 at 12 months). No significant relationship between pre- or postoperative food cravings and surgery type was found except on the carbohydrate subscale. Patients with higher preoperative food addiction symptoms were not more likely to experience an earlier reoccurrence of food cravings during the first 12 months after surgery. Likewise, patients with higher levels of preoperative depression and anxiety were not more likely to have early reoccurrence of food cravings during the first 12 months after surgery; however, those with higher PHQ9 scores at baseline had uniformly higher food craving scores at all timepoints (pre-surgery, 3 m, 6 m, 9 m, and 12 m). CONCLUSIONS: Results suggest that food cravings in the year after bariatric surgery are equivalent by surgery type and do not appear to be related to preoperative psychological factors or eating behaviors. LEVEL OF EVIDENCE: Level III: Evidence obtained from well-designed cohort.


Asunto(s)
Cirugía Bariátrica , Derivación Gástrica , Laparoscopía , Obesidad Mórbida , Humanos , Estados Unidos , Derivación Gástrica/métodos , Ansia , Obesidad Mórbida/cirugía , Obesidad Mórbida/psicología , Estudios de Cohortes , Gastrectomía/métodos , Estudios Retrospectivos , Resultado del Tratamiento
2.
Can J Public Health ; 114(5): 755-773, 2023 10.
Artículo en Inglés | MEDLINE | ID: mdl-37668893

RESUMEN

OBJECTIVE: Assess the association between prenatal mental health during the COVID-19 pandemic and preterm birth (PTB; delivery < 37 weeks gestation) and low birth weight (LBW; < 2500 g). METHODS: Pregnant individuals, > 18 years, were recruited in Canada and provided data through a web-based questionnaire. We analyzed data on persons recruited between 06/2020 and 08/2021 who completed questionnaires while pregnant and 2 months post-partum. Data on maternal sociodemographics, comorbidities, medication use, mental health (Edinburgh Postnatal Depression Scale, General Anxiety Disorder-7, stress), pandemic hardship (CONCEPTION-Assessment of Stress from COVID-19), and on gestational age at delivery and birth weight were self-reported. Crude and adjusted odds ratios (aOR) with 95% confidence interval (95%CI) were calculated to quantify the association between PTB/LBW and maternal mental health. RESULTS: A total of 1265 and 1233 participants were included in the analyses of PTB and LBW, respectively. No associations were observed between PTB and prenatal mental health (depression [aOR 1.01, 95%CI 0.91-1.11], anxiety [aOR 1.04, 95%CI 0.93-1.17], stress [aOR 0.88, 95%CI 0.71-1.10], or hardship [aOR 1.00, 95%CI 0.96-1.04]) after adjusting for potential confounders. The risk of PTB was increased with non-white ethnicity/race (aOR 3.85, 95%CI 1.35-11.00), consistent with the literature. Similar findings were observed for LBW (depression [aOR 1.03, 95%CI 0.96-1.13], anxiety [aOR 1.05, 95%CI 0.95-1.17], COVID stress [aOR 0.92, 95%CI 0.77-1.09], or overall hardship [aOR 0.97, 95%CI 0.94-1.01]). CONCLUSION: No association was found between prenatal mental health nor hardship during the COVID-19 pandemic and the risk of PTB or LBW. However, it is imperative to continue the follow-up of mothers and their offspring to detect long-term health problems early.


RéSUMé: OBJECTIF: Évaluer l'association entre la santé mentale prénatale pendant la pandémie de COVID-19 et les naissances prématurées (accouchement < 37 semaines de gestation) et les faibles poids à la naissance (< 2 500 g). MéTHODES: Des personnes enceintes de plus de 18 ans ont été recrutées au Canada et ont fourni des données prénatales via un questionnaire en ligne. Nous avons analysé les données des personnes recrutées entre 06/2020 et 08/2021, ayant rempli deux questionnaires dont un pendant la grossesse et un 2 mois post-partum. Les données sur les caractéristiques sociodémographiques maternelles, les comorbidités, l'utilisation de médicaments, la santé mentale (Échelle de dépression postnatale d'Édimbourg [EPDS], trouble anxieux généralisé-7 [GAD-7], stress), les difficultés liées à la pandémie (CONCEPTION­Évaluation du stress lié à la COVID-19) ainsi que l'âge gestationnel à l'accouchement et le poids à la naissance ont été auto-déclarées. Les rapports de cotes bruts et ajustés (aRC) avec un intervalle de confiance à 95% (IC 95%) ont été calculés pour quantifier l'association entre la prématurité/petit poids à la naissance et la santé mentale maternelle. RéSULTATS: Un total de 1 265 et 1 233 participants ont été inclus dans les analyses de NP et de FPN, respectivement. Aucune association n'a été observée entre la prématurité et la santé mentale prénatale (dépression [aRC 1,01, IC 95% 0,91­1,11], anxiété [aOR 1,04, IC 95% 0,93­1,17], stress [aRC 0,88, IC 95% 0,71­1,10], ni difficultés liées à la COVID-19 [aOR 1,00, IC 95% 0,96­1,04]) après ajustement pour les facteurs de confusion potentiels. Le risque de prématurité était plus élevé chez les personnes d'ethnie/race non blanche (aRC 3,85, IC 95% 1,35­11,00), en accord avec la littérature. Des résultats similaires ont été observés pour le faible poids à la naissance (dépression [aRC 1,03, IC 95% 0,96­1,13], anxiété [aRC 1,05, IC 95% 0,95­1,17], stress lié à la COVID [aRC 0,92, IC 95% 0,77­1,09], ou difficultés en lien avec la COVID-19 [aRC 0,97, IC 95% 0,94­1,01]). CONCLUSION: Aucune association n'a été trouvée entre la santé mentale prénatale ni les difficultés pendant la pandémie de COVID-19 et le risque de prématurité ou de petit poids à la naissance. Cependant, il est impératif de poursuivre le suivi des mères et de leurs enfants pour détecter précocement d'éventuels problèmes de santé à long terme.


Asunto(s)
COVID-19 , Nacimiento Prematuro , Recién Nacido , Femenino , Embarazo , Humanos , Salud Mental , Pandemias , COVID-19/epidemiología , Nacimiento Prematuro/epidemiología , Estudios de Casos y Controles , Madres
3.
JMIR Res Protoc ; 12: e50316, 2023 Aug 22.
Artículo en Inglés | MEDLINE | ID: mdl-37606989

RESUMEN

BACKGROUND: The high academic demands experienced by students will often have an impact on the quality of their mental and physical health. The most common health problems reported are gastrointestinal disorders. This condition tends to manifest in the emergence of generalized anxiety disorders (GADs) and reduces the quality of life and productivity. The population that experiences this disorder the most is female adolescents, and this condition occurs in both South African and Indonesian populations. The use of drugs, especially benzodiazepines, often causes psychological conditions as side effects. For this reason, it is necessary to have a solution in the form of a targeted and efficient approach to reduce psychological symptoms that arise from functional gastrointestinal disorders (FGIDs) in the form of anxiety. OBJECTIVE: The purpose of this study is to produce and implement a counseling intervention model to assist female students with GADs caused by FGID factors using an approach combining cognitive behavioral therapy (CBT), web-based counseling, and local wisdom in Indonesian and South African populations. METHODS: The research subjects will comprise 118 female adolescent students from Indonesia and 118 female adolescent students from South Africa, making a total sample of 236 participants, and the study will use a prospective, parallel randomized controlled trial design. The recruitment process will begin in July 2023, and the trial will begin in August 2023. The posttest assessment data gathering will take place by November 2023. Questionnaires that will be used in this study include the Functional Gastrointestinal Disorder Checklist (FGI-Checklist) to collect data related to FGIDs and the Generalized Anxiety Disorder 7-item (GAD-7) to measure the anxiety conditions experienced by respondents. RESULTS: By adopting the intention-to-treat principle, there will be significant mean changes in GAD scores and FGID scores after exposure to this combined approach in the Indonesian and South African populations. Implementing this comprehensive intervention will improve the students' psychological symptoms related to FGIDs and ultimately enhance their overall well-being. CONCLUSIONS: This study will develop and implement a model of counseling intervention for female students with GADs obtained from FGIDs using a combination approach to CBT, web-based counseling, and local wisdom in both the Indonesian and South African populations. The trial findings will contribute to our understanding of the effects of CBT combined with local wisdom and web-based counseling approaches that mental health counselors can use to treat GAD-affected adolescent girls who have FGIDs. TRIAL REGISTRATION: UMIN Clinical Trial Registry UMIN000051386; https://tinyurl.com/yjwz8kht. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/50316.

4.
Cereb Cortex ; 33(10): 6354-6365, 2023 05 09.
Artículo en Inglés | MEDLINE | ID: mdl-36627243

RESUMEN

Generalized anxiety disorder (GAD) is a common anxiety disorder experiencing psychological and somatic symptoms. Here, we explored the link between the individual variation in functional connectome and anxiety symptoms, especially psychological and somatic dimensions, which remains unknown. In a sample of 118 GAD patients and matched 85 healthy controls (HCs), we used multivariate distance-based matrix regression to examine the relationship between resting-state functional connectivity (FC) and the severity of anxiety. We identified multiple hub regions belonging to salience network (SN) and default mode network (DMN) where dysconnectivity associated with anxiety symptoms (P < 0.05, false discovery rate [FDR]-corrected). Follow-up analyses revealed that patient's psychological anxiety was dominated by the hyper-connectivity within DMN, whereas the somatic anxiety could be modulated by hyper-connectivity within SN and DMN. Moreover, hypo-connectivity between SN and DMN were related to both anxiety dimensions. Furthermore, GAD patients showed significant network-level FC changes compared with HCs (P < 0.01, FDR-corrected). Finally, we found the connectivity of DMN could predict the individual psychological symptom in an independent GAD sample. Together, our work emphasizes the potential dissociable roles of SN and DMN in the pathophysiology of GAD's anxiety symptoms, which may be crucial in providing a promising neuroimaging biomarker for novel personalized treatment strategies.


Asunto(s)
Conectoma , Humanos , Conectoma/métodos , Red en Modo Predeterminado , Imagen por Resonancia Magnética/métodos , Trastornos de Ansiedad/diagnóstico por imagen , Encéfalo/diagnóstico por imagen
5.
Artículo en Inglés | MEDLINE | ID: mdl-36231687

RESUMEN

The effect of the COVID-19 pandemic on maternal mental health has been described in Canada and China but no study has compared the two countries using the same standardized and validated instruments. In this study, we aimed to evaluate and compare the impact of COVID-19 public health policies on maternal mental health between Canada and China, as we hypothesize that geographical factors and different COVID-19 policies are likely to influence maternal mental health. Pregnant persons >18 years old were recruited in Canada and China using a web-based strategy. All participants recruited between 26 June 2020 and 16 February 2021 were analyzed. Self-reported data included sociodemographic variables, COVID-19 experience and maternal mental health assessments (Edinburgh Perinatal Depression Scale (EPDS), Generalized Anxiety Disorders (GAD-7) scale, stress and satisfaction with life). Analyses were stratified by recruitment cohort, namely: Canada 1 (26 June 2020-10 October 2020), Canada 2 and China (11 October 2020-16 February 2021). Overall, 2423 participants were recruited, with 1804 participants within Canada 1, 135 within Canada 2 and 484 in China. The mean EDPS scores were 8.1 (SD, 5.1) in Canada 1, 8.1 (SD, 5.2) in Canada 2 and 7.7 (SD, 4.9) in China (p-value Canada 2/China: p = 0.005). The mean GAD-7 scores were 2.6 (SD, 2.9) in China, 4.3 (SD, 3.8) in Canada 1 (p < 0.001) and 5.8 (SD, 5.2) in Canada 2 (p < 0.001). When adjusting for stress and anxiety, being part of the Chinese cohort significantly increased the chances of having maternal depression by over threefold (adjusted OR 3.20, 95%CI 1.77-5.78). Canadian and Chinese participants reported depressive scores nearly double those of other crises and non-pandemic periods. Lockdowns and reopening periods have an important impact on levels of depression and anxiety among pregnant persons.


Asunto(s)
COVID-19 , Adolescente , Ansiedad/epidemiología , COVID-19/epidemiología , Canadá/epidemiología , Control de Enfermedades Transmisibles , Depresión/epidemiología , Femenino , Humanos , Salud Mental , Pandemias , Embarazo , SARS-CoV-2
6.
Artículo en Inglés | MEDLINE | ID: mdl-35270623

RESUMEN

Introduction: We aimed to measure the impact of the COVID-19 pandemic on maternal mental health, stratifying on pregnancy status, trimester of gestation, and pandemic period/wave. Methods: Pregnant persons and persons who delivered in Canada during the pandemic, >18 years, were recruited, and data were collected using a web-based strategy. The current analysis includes data on persons enrolled between 06/2020−08/2021. Maternal sociodemographic indicators, mental health measures (Edinburgh Perinatal Depression Scale (EPDS), Generalized Anxiety Disorders (GAD-7), stress) were self-reported. Maternal mental health in pregnant women (stratified by trimester, and pandemic period/wave at recruitment) was compared with the mental health of women who had delivered; determinants of severe depression were identified with multivariate logistic regression models. Results: 2574 persons were pregnant and 626 had already delivered at recruitment. Participants who had delivered had significantly higher mean depressive symptom scores compared to those pregnant at recruitment (9.1 (SD, 5.7) vs. 8.4 (SD, 5.3), p = 0.009). Maternal anxiety (aOR 1.51; 95%CI 1.44−1.59) and stress (aOR 1.35; 95%CI 1.24−1.48) were the most significant predictors of severe maternal depression (EDPS ˃ 13) in pregnancy. Conclusion: The COVID-19 pandemic had a significant impact on maternal depression during pregnancy and in the post-partum period. Given that gestational depression/anxiety/stress has been associated with preterm birth and childhood cognitive problems, it is essential to continue following women/children, and develop strategies to reduce COVID-19's longer-term impact.


Asunto(s)
COVID-19 , Nacimiento Prematuro , COVID-19/epidemiología , Niño , Femenino , Humanos , Recién Nacido , Salud Mental , Pandemias , Embarazo , SARS-CoV-2
7.
Psychol Rep ; 125(5): 2709-2732, 2022 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-34047221

RESUMEN

This study determined the psychometric validation of the English version of the Fear of COVID-19 Scale (FCV-19S). Findings demonstrated robust psychometric properties for the FCV-19S. CFA results showed that the FCV-19S was a good model fit to the data in a sample of 608 university students. The FCV-19S also showed good concurrent validity, as it was significantly and positively related to the Preventive Behaviors related to COVID-19 Scale and the Generalized Anxiety Disorder Scale as well as significantly and negatively related to the Warwick-Edinburgh Mental Well-being Scale. The scale also showed good internal consistency reliability. Further, the association of age with FCV-19S indicated that younger students experienced greater fear of COVID-19. The analyses of mean differences revealed that women as compared to men, bachelor's and master's students as compared to post-master's students, and unemployed students as compared to employed students experienced greater fear of the outbreak. Also, those suffering from severe anxiety experienced greater fear of COVID-19 followed by those suffering from moderate, mild, and minimal anxiety. Moreover, knowing someone suffering from the coronavirus, being afraid that someone close might contract the virus, and believing that the current COVID-19 situation adversely affects academic performance were linked to higher levels of fear of the pandemic. Practice implications, limitations, and avenues for future research are also discussed.


Asunto(s)
COVID-19 , Miedo , Femenino , Humanos , Masculino , Pakistán , Reproducibilidad de los Resultados , Estudiantes , Universidades
8.
Phytother Res ; 33(6): 1604-1615, 2019 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-31006899

RESUMEN

This systematic review and meta-analysis aimed to study the efficacy and safety of chamomile for the treatment of state anxiety, generalized anxiety disorders (GADs), sleep quality, and insomnia in human. Eleven databases including PubMed, Science Direct, Cochrane Central, and Scopus were searched to retrieve relevant randomized control trials (RCTs), and 12 RCTs were included. Random effect meta-analysis was performed by meta package of R statistical software version 3.4.3 and RevMan version 5.3. Our meta-analysis of three RCTs did not show any difference in case of anxiety (standardized mean difference = -0.15, 95% CI [-0.46, 0.16], P = 0.4214). Moreover, there is only one RCT that evaluated the effect of chamomile on insomnia and it found no significant change in insomnia severity index (P > 0.05). By using HAM-A scale, there was a significant improvement in GAD after 2 and 4 weeks of treatment (mean difference = -1.43, 95% CI [-2.47, -0.39], P = 0.007), (MD = -1.79, 95% CI [-3.14, -0.43], P = 0.0097), respectively. Noteworthy, our meta-analysis showed a significant improvement in sleep quality after chamomile administration (standardized mean difference = -0.73, 95% CI [-1.23, -0.23], P < 0.005). Mild adverse events were only reported by three RCTs. Chamomile appears to be efficacious and safe for sleep quality and GAD. Little evidence is there to show its effect on anxiety and insomnia. Larger RCTs are needed to ascertain these findings.


Asunto(s)
Trastornos de Ansiedad/tratamiento farmacológico , Ansiedad/tratamiento farmacológico , Manzanilla/química , Extractos Vegetales/uso terapéutico , Trastornos del Inicio y del Mantenimiento del Sueño/tratamiento farmacológico , Sueño/efectos de los fármacos , Adulto , Anciano , Ansiedad/epidemiología , Trastornos de Ansiedad/epidemiología , Manzanilla/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Trastornos del Inicio y del Mantenimiento del Sueño/epidemiología , Resultado del Tratamiento
9.
J Anxiety Disord ; 64: 40-44, 2019 05.
Artículo en Inglés | MEDLINE | ID: mdl-30974236

RESUMEN

INTRODUCTION: Multivariable risk prediction algorithms are useful for making clinical decisions and health planning. While prediction algorithms for new onset of anxiety disorders in Europe and elsewhere have been developed, the performance of these algorithms in the Americas is not known. The objective of this study was to validate the PredictA algorithm for new onset of anxiety and/or panic disorders in the US general population. METHODS: Longitudinal study design was conducted with approximate 2-year follow-up data from a total of 24 626 individuals who participated in Wave 1 and 2 of the US National Epidemiologic Survey on Alcohol and Related Conditions (NESARC) and who did not have generalized anxiety disorder (GAD) and panic disorder in the past year at Wave 1. The PredictA algorithm was directly applied to the selected participants. RESULTS: Among the participants, 5.4% developed GAD and/or panic disorder over two years. The PredictA algorithm had a discriminative power (C-statistics = 0.62, 95%CI: 0.61; 0.64), but poor calibration (p < 0.001) with the NESARC data. The observed and the mean predicted risk of GAD and/or panic disorders in the NESARC were 5.3% and 3.6%, respectively. Particularly, the observed and predicted risks of GAD and/or panic disorders in the highest decile of risk score in the NESARC participants were 13.3% and 10.4%, respectively. CONCLUSION: The PredictA algorithm has acceptable discrimination, but the calibration with the NESARC data was poor. The PredictA algorithm is likely to underestimate the risk of GAD/panic disorders in the US population. Therefore, the use of PredictA in the US general population for predicting individual risk of GAD and/or panic disorders is not encouraged.


Asunto(s)
Algoritmos , Ansiedad/epidemiología , Trastorno de Pánico/epidemiología , Adolescente , Adulto , Anciano , Comorbilidad , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Síndrome , Estados Unidos/epidemiología , Adulto Joven
10.
Int Urogynecol J ; 29(8): 1147-1153, 2018 08.
Artículo en Inglés | MEDLINE | ID: mdl-29478112

RESUMEN

INTRODUCTION AND HYPOTHESIS: Our aim was to evaluate the impact of generalized anxiety disorders (GAD) on the effectiveness of pessary treatment for pelvic organ prolapse (POP) in postmenopausal women. METHODS: One-hundred and ten women with symptomatic POP who underwent pessary treatment were enrolled in this prospective study. Subjective evaluations of pelvic floor symptoms were assessed using the Pelvic Floor Distress Inventory (PFDI-20) and the Pelvic Floor Impact Questionnaire-7 (PFIQ-7), both at baseline and at the 3-month follow-up visit after pessary use. GAD was measured by the Generalized Anxiety Disorder-7 (GAD-7). Independent samples t tests, Mann-Whitney U test, chi-square test, Fisher's exact test, and Wilcoxon signed rank test were used to analyze data. RESULTS: Twenty-one patients (20.6%) had GAD at baseline. After 3 months of pessary use, PFIQ-7, PFDI-20, and GAD scores were significantly improved in all participants (P < 0.001). In the GAD-negative group, total PFIQ-7 and PFDI-20 scores, including all subscales scores, were significantly decreased from baseline to posttreatment (P < 0.05). However, in the GAD-positive group, both PFIQ-7 and PFDI-20 scores, including subscales, were also significantly decreased from baseline to posttreatment (P < 0.05), except for subscale Colorectal-Anal Impact Questionnaire (CRAIQ-7) of PFIQ-7 (P = 0.225), which represented the impact on quality of life (QoL) from bowel dysfunction. CONCLUSIONS: Both groups of women with or without GAD showed significant improvement in QoL scores after 3 months of pessary treatment. GAD had no influence on the success of pessary treatment for POP.


Asunto(s)
Trastornos de Ansiedad/diagnóstico , Trastornos de Ansiedad/psicología , Diafragma Pélvico/fisiopatología , Prolapso de Órgano Pélvico/terapia , Pesarios , Calidad de Vida , Trastornos de Ansiedad/complicaciones , Femenino , Humanos , Prolapso de Órgano Pélvico/psicología , Posmenopausia , Estudios Prospectivos , Reproducibilidad de los Resultados , Encuestas y Cuestionarios , Resultado del Tratamiento
11.
Curr Psychiatry Rep ; 19(12): 103, 2017 Nov 07.
Artículo en Inglés | MEDLINE | ID: mdl-29110139

RESUMEN

PURPOSE OF REVIEW: The purpose of this review was to assess and present the findings up to this date on the efficacy of antipsychotics in the treatment of generalized anxiety disorders (GAD), social anxiety disorders (SAD), panic disorders (PD), and obsessive-compulsive disorders (OCD), mostly based on published randomized controlled trials (RCTs) or on open-label studies when RCT were lacking. RECENT FINDINGS: Quetiapine could be recommended in patients with GAD. The efficacy of aripiprazole in two open-label studies on patients with antidepressant-refractory GAD should be assessed in RCTs. Despite preliminary positive results in open studies, there are currently no strong evidence for the effectiveness of antipsychotics in refractory SAD and in refractory PD. Conversely, risperidone and aripiprazole can be used for the treatment of refractory OCD as augmentation agents to antidepressants. Contrary to SAD and PD, this review found evidence for the use of second-generation antipsychotics in GAD and OCD. Otherwise, first-generation antipsychotics cannot be recommended in anxiety disorders and OCD.


Asunto(s)
Antipsicóticos/uso terapéutico , Trastornos de Ansiedad/tratamiento farmacológico , Humanos , Trastorno Obsesivo Compulsivo/tratamiento farmacológico , Resultado del Tratamiento
12.
Drug Des Devel Ther ; 9: 4329-40, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-26273194

RESUMEN

BACKGROUND: Anxiety disorders are among the most common psychiatric illnesses, with generalized anxiety disorder (GAD) being one of the most common. Sleep disturbances are highly prevalent in GAD patients. While treatment with pregabalin has been found to be associated with significant improvement in GAD-related sleep disturbance across many controlled clinical trials, mediational analysis has suggested that a substantial portion of this effect could be the result of a direct effect of pregabalin. Thus, the objective of this study was to model the longitudinal latent effect of pregabalin or usual care (UC) therapies on changes in sleep in outpatients with GAD under routine clinical practice. METHODS: Male and female GAD outpatients, aged 18 years or above, from a 6-month prospective noninterventional trial were analyzed. Direct and indirect effects of either pregabalin or UC changes in anxiety symptoms (assessed with Hamilton Anxiety Scale) and sleep disturbances (assessed with Medical Outcomes Study-Sleep Scale [MOS-S]) were estimated by a conditional latent curve model applying structural equation modeling. RESULTS: A total of 1,546 pregabalin-naïve patients were analyzed, 984 receiving pregabalin and 562 UC. Both symptoms of anxiety and sleep disturbances were significantly improved in both groups, with higher mean (95% confidence interval) score reductions in subjects receiving pregabalin: -15.9 (-15.2; -16.6) vs -14.5 (-13.5; -15.5), P=0.027, in Hamilton Anxiety Scale; and -29.7 (-28.1; -31.3) vs -24.0 (-21.6; -26.4), P<0.001, in MOS-S. The conditional latent curve model showed that the pregabalin effect on sleep disturbances was significant (γ =-3.99, P<0.001), after discounting the effect on reduction in anxiety symptoms. A mediation model showed that 70% of the direct effect of pregabalin on sleep remained after discounting the mediated effect of anxiety improvement. CONCLUSION: A substantial proportion of the incremental improvements in anxiety-related sleep disturbances with pregabalin vs UC were explained by its direct effect, not mediated by improvements in anxiety symptoms.


Asunto(s)
Ansiolíticos/uso terapéutico , Trastornos de Ansiedad/tratamiento farmacológico , Pregabalina/uso terapéutico , Trastornos del Sueño-Vigilia/tratamiento farmacológico , Adulto , Trastornos de Ansiedad/complicaciones , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Modelos Estadísticos , Pacientes Ambulatorios , Estudios Prospectivos , Escalas de Valoración Psiquiátrica , Trastornos del Sueño-Vigilia/etiología , Resultado del Tratamiento
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