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A multidomain intervention against cognitive decline in an at-risk-population in Germany: Results from the cluster-randomized AgeWell.de trial.
Zülke, AE, Pabst, A, Luppa, M, Roehr, S, Seidling, H, Oey, A, Cardona, MI, Blotenberg, I, Bauer, A, Weise, S, et al
Alzheimer's & dementia : the journal of the Alzheimer's Association. 2024;20(1):615-628
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Due to ageing populations, there is a rapid increase in people living with dementia. A number of modifiable risk factors have been identified, including obesity, excessive alcohol consumption, diabetes mellitus, depression, physical inactivity, smoking and social isolation. The aim of this cluster-randomised controlled trial, including 1030 participants at risk of developing dementia aged 60-77, was to evaluate the effectiveness of a multidomain intervention which included optimisation of nutrition and medication, and physical, social, and cognitive activity for two years compared to standard care. There was no benefit of the intervention for the primary outcome global cognitive performance. The intervention had a positive effect on the secondary outcome health-related quality of life but did not have any significant effect on quality of life, depressive symptoms, social inclusion, activities of daily living and instrumental activities of daily living. The study period coincided with the COVID-19 pandemic. Significantly more participants than controls reported perceived COVID-19-related restrictions with regards to nutrition, whilst there was no such differences between groups for physical, cognitive or social activity. Better adherence to the nutrition and social activity components of the programme were associated with better global cognitive performance, whilst there was no association with physical and cognitive activity.
Abstract
INTRODUCTION We investigated the effectiveness of a multidomain intervention to preserve cognitive function in older adults at risk for dementia in Germany in a cluster-randomized trial. METHODS Individuals with a Cardiovascular Risk Factors, Aging, and Dementia (CAIDE) risk score ≥ 9 aged 60 to 77 years were recruited. After randomization of their general practitioner (GP), patients received a multidomain intervention (including optimization of nutrition and medication, and physical, social, and cognitive activity) or general health advice and GP treatment as usual over 24 months. Primary outcome was global cognitive performance (composite z score, based on domain-specific neuropsychological tests). RESULTS Of 1030 participants at baseline, n = 819 completed the 24-month follow-up assessment. No differences regarding global cognitive performance (average marginal effect = 0.010, 95% confidence interval: -0.113, 0.133) were found between groups at follow-up. Perceived restrictions in intervention conduct by the COVID-19 pandemic did not impact intervention effectiveness. DISCUSSION The intervention did not improve global cognitive performance. HIGHLIGHTS Overall, no intervention effects on global cognitive performance were detected. The multidomain intervention improved health-related quality of life in the total sample. In women, the multidomain intervention reduced depressive symptoms. The intervention was completed during the COVID-19 pandemic.
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Efficacy of non-pharmacological interventions on executive functions in children and adolescents with ADHD: A systematic review and meta-analysis.
Qiu, H, Liang, X, Wang, P, Zhang, H, Shum, DHK
Asian journal of psychiatry. 2023;87:103692
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Attention-deficit/hyperactivity disorder (ADHD) symptoms are thought to reflect underlying executive function (EF) impairments. EFs are comprised of three core functions (viz., inhibitory control [IC], working memory [WM], and cognitive flexibility [CF]) and higher-level functions (reasoning, planning, and problem-solving). Children with ADHD commonly show developmental delays in core EFs (vs. typically developing peers) which can persist throughout individuals’ lifetimes if not treated. The aim of this study was to investigate the effects of non-pharmacological interventions on EFs in children and adolescents with ADHD. This study is a systematic review and meta-analysis of sixty-seven articles. Results showed that non-pharmacological interventions had positive moderate to large effects on overall EFs; small to moderate effects on CF, IC, WM, and planning; non-existent on reasoning skills. Authors conclude that their findings underpin the importance of non-pharmacological treatments for improving core EFs in this clinical population.
Abstract
OBJECTIVE Although front-line doctors recommend medications, this kind of treatment has limited efficacy in improving executive functions (EFs) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). This study explored the effects of non-pharmacological intervention on EFs in children and adolescents with ADHD. METHODS In accordance with the Preferred Reporting Items for Systematic Review and Meta-analyses guidelines, we searched seven electronic databases: APA PsycINFO, CINAHL Complete, EMBASE, ERIC, Medline, Pubmed, and Web of Science, from inception to March 2022. Two authors independently screened studies for eligibility, extracted data, and assessed bias risk using the Physiotherapy Evidence Database scale. Our analyses included randomized controlled trials and non-randomized comparison studies of non-pharmacological interventions and assessed EFs through neurocognitive tasks in children and adolescents between 5 and 18 years. RESULTS Sixty-seven studies with 3147 participants met the inclusion criteria. The final meta-analysis included 74 independent interventions categorized into six categories: cognitive training, EF-specific curriculum, game-based training, mindfulness practice, neurofeedback training, and physical exercise. Overall, non-pharmacological interventions (combined) produced significant moderate to large effects on overall EFs in children and adolescents with ADHD (g=0.673). Physical exercise had a large positive effect on domain-specific EFs, including inhibitory control (g=0.900) and cognitive flexibility (g=1.377). Cognitive training had a large training effect on working memory (g=0.907), and an EF-specific curriculum had a small to moderate beneficial effect on planning performance (g=0.532). CONCLUSION Non-pharmacological interventions, particularly physical exercise, cognitive training, and an EF-specific curriculum, appear to have beneficial effects on EFs in children and adolescents with ADHD.
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Effect of Health Promotion Interventions in Active Aging in the Elderly: A Randomized Controlled Trial.
Davodi, SR, Zendehtalab, H, Zare, M, Behnam Vashani, H
International journal of community based nursing and midwifery. 2023;11(1):34-43
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The change in global demographics, with an increase in the proportion of the elderly who take up a large proportion of healthcare resources, will become a major challenge for health systems. Active ageing is defined by the WHO as “the process of promoting health, social security, and social contribution of the elderly to promote their quality of life”. The aim of this Iranian 6-week randomised controlled trial, including 60 participants aged 60 years or over, was to evaluate the effectiveness of an active ageing programme. The weekly group sessions included the topics nutrition, physical activity, responsibility, stress management, communications and spiritual aspects. Outcome measures were various questionnaires. Compared to controls, patients undergoing the programme experienced significant improvements in active mind maintenance, physical-functional activity, social contacts, productive engagement, social-institutional participation, but not agent attitude. The authors conclude that training programmes at the level of health centres are effective in promoting active ageing in an elderly population.
Abstract
BACKGROUND Active aging has been the paradigm of the old-age lifestyle. Integrated aging care interventions in health centers primarily focus on diseases such as diabetes, hypertension, depression, and cardiovascular diseases, and there is no program or training regarding active aging. This study was carried out from September to December 2021 to determine the effectiveness of an intervention program to promote active aging in the elderly referred to Mashhad health centers. METHODS This randomized controlled clinical trial was conducted on 60 elderly individuals without disabling diseases and cognitive impairment who presented to the Daneshamooz health center in Mashhad in 2021. Through a simple block allocation scheme, those who met the inclusion criteria were randomly divided into the intervention and control groups. The intervention group received the health promotion program during 6 sessions (one session per week) about nutrition, physical activity, responsibility, stress management, communications, and spiritual aspects. The data were gathered using the active aging questionnaire and analyzed using the SPSS software version 25; independent and paired t-test, Wilcoxon, and Mann-Whitney U tests were utilized. P value< 0.05 was considered statistically significant. RESULTS The results of this study demonstrated that after the intervention, the total active aging score in the intervention group increased significantly (68.5±3 to 85±8.25) (P<0.001) and there was a significant difference between the control and intervention groups (68±3.25 to 85±8.25) (P<0.001). CONCLUSION According to the results, training based on a health-enhancement approach can effectively promote active aging in the elderly. Therefore, more attention should be paid to strategic planning for active aging in health centers.Trial Registration Number: IRCT20210308050639N.
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Sexual dysfunction worsens both the general and specific quality of life of women with irritable bowel syndrome. A cross-sectional study.
Camacho, S, Díaz, A, Pérez, P, Batalla, H, Flores, Y, Altamirano, E, Higuera-de la Tijera, MF, Murguía, D, Gómez-Laguna, L
BMC women's health. 2023;23(1):134
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Sexual dysfunction has been shown to be closely associated with irritable bowel syndrome (IBS). Individuals with these dysfunctions have been shown to have reduced quality of life (QoL), however further research is warranted. This cross-sectional study aimed to determine QoL in 51 women with IBS and sexual dysfunction compared to 54 women without these disorders. The results showed that the presence of IBS did not increase the occurrence of sexual dysfunction. However, the presence of both disorders did decrease QoL and affect physical function, general health, vitality, social function, emotion, and mental health. These effects were especially prominent in women who suffer from the constipation IBS subtype than the unclassified IBS subtype. It was concluded that sexual dysfunction affects the QoL of women with IBS. This study could be used by healthcare professionals to understand that women with IBS may need to be assessed for sexual dysfunction and if found may need additional support to improve their quality of life.
Abstract
BACKGROUND Irritable bowel syndrome (IBS) and sexual dysfunction (SxD) lowers quality of life (QOL) separately, but the effect of their overlap in unselected populations has not been studied. OBJECTIVE To evaluate the QOL of IBS women with and without SxD and compare it with controls. METHODS In this cross-sectional assessment, we studied 51 IBS women (Rome IV criteria) and 54 controls. SxD was determined using the female sexual function index questionnaire. QOL was evaluated by the Short Form 36 (SF-36) and IBS-QOL questionnaires. RESULTS SxD prevalence was similar between IBS women (39.22%) and controls (38.89%). Compared with other groups, IBS patients with SxD showed lower scores in all domains as well as in the physical, mental summaries of the SF-36 and almost all domains (except for body image, food avoidance, and social reaction compared with IBS patients without SxD) and the total score of IBS-QOL. CONCLUSIONS These findings show that SxD worsens both general and specific QOL of women with IBS. The consideration of SxD in patients with IBS will allow us to make a more effective diagnostic and therapeutic approach. Clinical trial registry in Mexico City General Hospital: DI/19/107/03/080. CLINICAL TRIALS REGISTRATION NCT04716738.
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The impact of Dietary Weight loss, Aerobic Exercise, and Daylong Movement on Social Cognitive Mediators of Long-term Weight loss.
Fanning, J, Nicklas, B, Furlipa, J, Rejeski, WJ
Journal of behavioral medicine. 2023;46(3):499-508
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Obesity in older adults predisposes individuals to physical disability, a host of chronic diseases, and premature mortality. A strong body of evidence indicates that well-designed structured exercise interventions increase older adults’ self-efficacy and satisfaction with their physical functioning, and these are important social cognitive outcomes closely linked with quality of life and health behaviour change. The main aim of this study was to investigate changes in walking self-efficacy and satisfaction after the 6-month intensive phase of the intervention. This study was a secondary analysis of the Empowered with Movement to Prevent Obesity and Weight Regain (EMPOWER) study, which was an 18-month, three-group, single-blind randomised trial. A total of 183 participants were randomly assigned to one of the three treatment arms: weight loss + structured exercise (WL+EX), WL+ sitting less and moving more across the day (SL), or WL+EX+SL. Results showed that: - participants demonstrated improvements in self-efficacy and satisfaction following the 6-month intervention weight loss and physical activity intervention. - participants who received an exercise intervention focused on sustained walking demonstrated significantly better self-efficacy for walking relative to those who did not (WL+SL). - both WL+EX and WL+EX+SL regressed to baseline levels of self-efficacy for walking by month 18, only WL+SL did not significantly decrease self-efficacy scores, sustaining a significant increase over baseline. Authors conclude that programs focused on daylong movement may contribute to improved self-efficacy and satisfaction. Thus, health promotion professionals should demonstrate flexibility in the ways in which physical activity is prescribed for older adults since not everyone resonates with traditional structured exercise.
Abstract
This report contrasts the impact of a dietary weight loss intervention (WL) paired with aerobic exercise (EX) and/or sitting less and moving throughout the day (SL) on self-efficacy for walking (hereafter walking self-efficacy) and satisfaction with physical functioning (hereafter satisfaction). Additional analyses examined dose-response associations between change in weight and changes in these key outcomes. Older adults (N = 112; age = 70.21[Formula: see text]4.43) were randomized to 6 months of WL+EX, WL+SL, or WL+EX+SL followed by a 12-month maintenance period. All groups reported increases in walking self-efficacy at month 6 with greater improvements in WL+EX and WL + EX+SL. Only WL+SL demonstrated improved walking self-efficacy at month 18. All conditions demonstrated improved satisfaction scores at both time points. Changes in walking self-efficacy and satisfaction were negatively associated with change in weight over the 6-month intervention and after the maintenance period. These results support the utility of WL + SL for improving key social cognitive outcomes in aging.
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Effectiveness of Therapeutic Patient Education Interventions in Obesity and Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Correia, JC, Waqas, A, Huat, TS, Gariani, K, Jornayvaz, FR, Golay, A, Pataky, Z
Nutrients. 2022;14(18)
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Obesity and diabetes mellitus (DM) account for the highest burden of non-communicable diseases. Obesity is also highly comorbid with type 2 DM with a prevalence of 8.5% among adults around the globe. The aims of this study were to present (a) a critical synthesis of the theoretical basis and development of therapeutic patient education (TPE) interventions for obesity and diabetes, and (b) quantitative evidence for the efficacy of these interventions across a range of biomedical, psychosocial and psychological outcomes. This study is a systematic review and meta-analysis of fifty-four randomised controlled trials. Results show that: - TPE interventions bring about significant improvements in biomedical outcomes among patients with DM and obesity. - there weren’t significant differences in the quality of life of participants undergoing TPE interventions (inconclusive as only data from two studies were considered). - interventions delivered through different media and delivery formats may be equally effective. Authors conclude that the use of electronic media such as short messaging services, website-based educational programs and animation media can be used to deliver TPE effectively.
Abstract
Diabetes mellitus (DM) and obesity account for the highest burden of non-communicable diseases. There is increasing evidence showing therapeutic patient education (TPE) as a clinically and cost-effective solution to improve biomedical and psychosocial outcomes among people with DM and obesity. The present systematic review and meta-analysis present a critical synthesis of the development of TPE interventions for DM and obesity and the efficacy of these interventions across a range of biomedical, psychosocial and psychological outcomes. A total of 54 of these RCTs were identified among patients with obesity and diabetes and were thus qualitatively synthesized. Out of these, 47 were included in the quantitative synthesis. There was substantial heterogeneity in the reporting of these outcomes (I2 = 88.35%, Q = 317.64), with a significant improvement noted in serum HbA1c levels (standardized mean difference (SMD) = 0.272, 95% CI: 0.118 to 0.525, n = 7360) and body weight (SMD = 0.526, 95% CI: 0.205 to 0.846, n = 1082) in the intervention group. The effect sizes were comparable across interventions delivered by different modes and delivery agents. These interventions can be delivered by allied health staff, doctors or electronically as self-help programs, with similar effectiveness (p < 0.001). These interventions should be implemented in healthcare and community settings to improve the health outcomes in patients suffering from obesity and DM.
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HOMEFOOD randomised trial - Six-month nutrition therapy improves quality of life, self-rated health, cognitive function, and depression in older adults after hospital discharge.
Blondal, BS, Geirsdottir, OG, Halldorsson, TI, Beck, AM, Jonsson, PV, Ramel, A
Clinical nutrition ESPEN. 2022;48:74-81
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It is well known that older people are at a higher risk for nutritional inadequacy which is accompanied by depression, impaired cognitive function, and poor overall health. In this secondary analysis of a randomised controlled assessor-blinded dietary intervention trial, the authors examined the effects of six months of nutritional therapy on quality of life, self-rated health, cognitive function, and depression in elderly patients aged 65 years and over. The participants in the intervention group received nutritional therapy (HOMEFOOD) education to overcome malnutrition, which included dietary recommendations to ensure an adequate nutritional intake of energy and protein through diet and additional supplemental protein and energy-rich foods. After six months of nutritional therapy, the intervention group showed improvement in cognitive function, self-rated health, depression score, and quality of life scores, as well as improvements in measures related to weight gain. Further studies need to be conducted in order to determine if nutritional therapy provides additional benefits to older people. However, healthcare professionals can use the results of this study to better understand how nutritional therapy can improve the quality of life and health of older people in comparison to standard care, so they can better advise their patients.
Abstract
BACKGROUND AND AIMS Malnutrition is common among older adults and is related to quality of life, cognitive function, and depression. To what extent nutrition interventions can improve these outcomes remains unclear. The aim of this study was to investigate the effect of nutrition therapy on health-related quality of life (EQ-5D), self-rated health, cognitive function, and depression in community dwelling older adults recently discharged from hospital. METHODS Participants (>65 years) were randomised into an intervention (n = 53) and a control group (n = 53). The intervention group received individualised nutrition therapy based on the nutrition care process including 5 home visits and 3 phone calls, in combination with freely delivered energy- and protein-rich foods and oral nutrition supplements for six months after hospital discharge. EQ-5D, self-rated health, Mini-Mental-State-Examination (MMSE), and the Centre for Epidemiologic Studies Depression - IOWA (CES-D) scale were measured at baseline and at endpoint. RESULTS Two subjects dropped out, one from each arm. The control group experienced an increase in depressive symptoms and a decrease in self-rated health during the study period, while the intervention group experienced increases in cognitive function, self-rated health, and EQ-5D resulting in significant endpoint differences between the groups: EQ-5D (0.102, P = 0.001); self-rated health: 15.876 (P < 0.001); MMSE 1.701 (P < 0.001); depressive symptoms: - 3.072 (P < 0.001); all in favour of the intervention group. Improvements during the intervention in MMSE, self-rated health, and CES-D were significantly related to body weight gain in a linear way. CONCLUSION Cognitive function and mental well-being worsen or stagnate in older adults who receive standard care after hospital discharge. However, a six-month nutrition therapy improves these outcomes leading to statistically and clinically significant endpoint differences between the groups. As improvements were related to body weight gain after hospital discharge, we conclude that the increase in dietary intake, with focus on energy and protein density, and changes in body weight might have contributed to better cognitive function and mental well-being in older adults after the intervention.
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Efficacy of mindfulness-based intervention for the treatment of chronic headaches: A systematic review and meta-analysis.
Aemaz Ur Rehman, M, Waseem, R, Habiba, U, Fahad Wasim, M, Alam Rehmani, S, Alam Rehmani, M, Abdullah, M, Khabir, Y, Rehan Hashmi, M, Almas, T, et al
Annals of medicine and surgery (2012). 2022;78:103862
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The International Headache Society defines chronic daily headache (CDH) as headaches occurring on 15 or more days in a month for at least three months. Many pharmacological treatments are available to minimize the functional disability caused by headaches. However, meditation-based mindfulness techniques have gained popularity in recent years. The main aim of this study was to determine the efficacy of mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction (MBSR) in improving headache frequency, duration, and intensity in patients suffering from chronic headaches. This study is an updated systematic review and meta-analysis which included 10 full-text articles (4 from previous meta-analysis and 6 recently published). Results provide limited evidence that MBSR/MBCT intervention may be effective in reducing the frequency, duration, and pain intensity of headaches, in patients with chronic headaches including tension-type and migraine compared with the usual care but it demonstrated a significant difference between groups in achieving mindfulness. Authors conclude that since their findings are inconclusive, MBSR/MBCT interventions for the treatment of migraine and/or tension-type headaches cannot be recommended.
Abstract
Background: Mindfulness-based stress reduction/cognitive therapy has attained popularity as an adjunctive treatment for a plethora of medical and psychiatric conditions, however, its impact on chronic headaches is inconclusive. This review aims to assess the impact of MBSR/MBCT in alleviating the symptoms of chronic headaches. Data sources and data selection: PubMed and Cochrane CENTRAL were searched from inception till 1st May 2021. Randomized Control Trials evaluating mindfulness-based stress reduction/cognitive therapy with either passive comparators (usual care) or active comparators (e.g., Health education or cognitive behavioral therapy) for chronic headaches (Migraine, Tension-type, or cluster headaches), which evaluated either headache frequency, pain intensity or headache duration as primary outcome were eligible for inclusion. The Risk of Bias was evaluated using the Cochrane Collaboration's Risk of Bias Tool. Results: A total of ten Randomized Controlled Trials (five on migraine; three on tension-type; two with mixed samples) were evaluated. In comparison to usual care, mindfulness-based stress reduction/cognitive therapy did not illustrate significant changes in headache frequency (MD = -0.14; 95% CI -1.26 to 0.97; P = 0.80; Moderate Certainty), headache duration (MD = -0.27; 95% CI -3.51 to 2.97, P = 0.87; Low Certainty) or pain intensity (MD = -0.19; 95% CI -0.46 to 0.07; P = 0.15; Moderate Certainty). Conclusion: The results found are insignificant for the three primary outcomes, which may be due to the low number of participants and often a high or unclear risk of bias in the randomized control trials included. Perhaps more aggressive clinical trials with a larger sample size effectively demonstrate differences in outcomes before and after therapy for MBSR/MBCT could provide a more significant change.
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Menstruation-Related Disorders-Dysmenorrhea and Heavy Bleeding-as Significant Epiphenomena in Women With Rheumatic Diseases.
Orlandi, M, Vannuccini, S, El Aoufy, K, Melis, MR, Lepri, G, Sambataro, G, Bellando-Randone, S, Guiducci, S, Cerinic, MM, Petraglia, F
Frontiers in pharmacology. 2022;13:807880
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Rheumatic diseases (RDs) affect significantly more women than men, and for this reason, gynaecological disorders may have an additional negative impact on women’s health. The aim of this study was to describe gynaecological symptoms among fertile age women with RDs and their impact on quality of life. This study is a monocentric, cross-sectional observational study. Results show that a large number of women with RDs report menstrual disorders. In fact, more than half of the population reported of having dysmenorrhea since adolescence. Similarly, during fertile age, menstrual pain was frequently reported, and in 72% of the cases, the intensity resulted to be moderate/severe. Additionally, heavy menstrual bleeding was found in 38% of the patients during adulthood and in 52% of patients during adolescence. Authors conclude that the management of female patients with RDs is a challenge for clinicians and should include an accurate evaluation of gynaecological aspects (menstruation, fertility, maternity, and sexuality) as well as manage an interdisciplinary teamwork approach (rheumatologist and gynaecologists).
Abstract
Background: In women with rheumatic diseases (RDs) menstruation-related disorders have never been investigated. The aim of this study was to evaluate gynecological symptoms/disorders in fertile age women with RDs. Materials and methods: All patients (n = 200) filled up a self-administered questionnaire on their gynecological history, menstrual cycle pattern, menstrual-related symptoms, and quality of life (QoL). The RD group was then compared to a control group of 305 age-matched fertile age women. Results: Among patients with RDs, 58% had arthritis, 40% connective tissue diseases (CTDs), and 1.5% systemic vasculitis. No differences were observed between CTDs and arthritis, except for a family history of HMB which was more common among women with CTDs (p < .01). When compared to controls, women with RDs reported more frequent heavy menstrual bleeding (HMB) during adolescence (51.7 and 25.4%, respectively; p = .0001) and adult life (37.7 and 25.9%, respectively; p = .0065). Also, dysmenorrhea in adolescence was significantly more common among cases (55.6 and 45.4%, respectively; p = .0338). Gynecological pain (dysmenorrhea, non-menstrual pelvic pain, dyspareunia, dysuria, and dyschezia) in patients with RDs was more frequent than in controls (p = .0001, .0001, .0001, .0001, .0002, respectively). Considering women who reported moderate and severe symptoms in RDs, dysmenorrhea and dyspareunia remain significantly more frequent in women with RDs than in controls (p = .0001; p = .0022; respectively). QoL scores were significantly reduced in women with RDs, either in physical (p = .0001) and mental domains (p = .0014) of short-form 12. Conclusion: Women affected by RDs frequently presented menstruation-related disorders; thus, female patients with RDs should be questioned about gynecological symptoms and referred to the gynecologist for an accurate evaluation.
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Effect of internet-based counselling with a cognitive-behavioural approach on premenstrual syndrome.
Borji-Navan, S, Mohammad-Alizadeh-Charandabi, S, Esmaeilpour, K, Mirghafourvand, M
BMC research notes. 2022;15(1):324
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About 20% of women of reproductive age suffer from premenstrual syndrome (PMS). The syndrome leads to various consequences, including physical, psychological, behavioural, and social complications. The aim of this study was to assess the effect of internet-based counselling with a cognitive-behavioural approach on symptom severity of women with PMS and their quality of life during the perimenstrual and late follicular phases of the menstrual cycle. This study is based on data that was gathered for a randomised controlled trial with two-parallel arms carried out on 92 female university students aged 18–35 years. Authors conclude that the results cannot be generalised to all women suffering from PMS since the study recruited only medical students. Furthermore, the long-term effectiveness of the intervention is unknown because the participants were only followed for two menstrual cycles after the end of the intervention.
Abstract
OBJECTIVES To assess the effect of internet-based counselling with a cognitive-behavioural approach on symptom severity of women with premenstrual syndrome (PMS) and their quality of life during the perimenstrual and late follicular phases of the menstrual cycle. Moreover, the PMS-related disability and attitude toward menstruation were investigated as secondary outcomes. DATA DESCRIPTION We provide data generated in a randomized controlled trial with two-parallel arms carried out on 92 female university students aged 18-35 years who had moderate to severe PMS, residing at halls of the Tabriz University of Medical Sciences. PMS severity was assessed during two menstrual cycles before intervention (baseline) and during two cycles just after ending the two-month intervention using Daily Record of Severity of Problems (DRSP) and the quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) on days 1-2 and 11-13 of the menstrual cycle at the baseline and post-intervention. Also, the PMS-related disability was assessed using Sheehan Disability Scale (SDS) and attitude toward menstruation using Menstrual Attitude Questionnaire (MAQ) at the baseline and post-intervention. Participant satisfaction and views on intervention effectiveness were also assessed using a single Likert question.