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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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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.
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Effectiveness of Health Coaching in Diabetes Control and Lifestyle Improvement: A Randomized-Controlled Trial.
Lin, CL, Huang, LC, Chang, YT, Chen, RY, Yang, SH
Nutrients. 2021;13(11)
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World Health Organization statistics indicate that over 400 million people worldwide have Type 2 Diabetes. Health coaching is an approach to diabetes management that empowers patients to make healthier choices by changing their behaviours. This two-arm randomised controlled trial evaluated the effectiveness of health coaching in reducing blood sugar levels and following a healthy diet among Type 2 diabetic patients. Patients with diabetes improved their HbA1c by 0.62% after six months of health coaching. Through health coaching, patients were also able to reduce their calorie intake significantly by reducing their consumption of whole grains, meat, proteins, fats and oils and increasing their intake of vegetables. In the intervention group, diet modifications were also associated with a decrease in HbA1c. The benefits of health coaching in Type 2 diabetes management needs to be confirmed in more robust studies. However, healthcare professionals can use the results of this study to understand how behaviour change in diabetic patients contributes to blood sugar management and healthy eating.
Abstract
BACKGROUND The study aimed to look into the effectiveness of a 6-month health coaching intervention for HbA1c and healthy diet in the treatment of patients with type 2 diabetes. METHODS The study was carried out via a two-armed, randomized controlled trial that included 114 diabetic patients at a medical center in Taiwan. During the 6-month period, the intervention group had health coaching and usual care for 6 months, and the control group had usual care only. The outcome variables were HbA1c level and healthy diet for follow-up measurement in the third and sixth month. RESULTS The study discovered a significant decrease in HbA1c and health diet improvement after the 6-month health coaching. Patients in the intervention group decreased their daily intake of whole grains, fruits, meats and protein, and fats and oils while increasing their vegetables intake. CONCLUSIONS Health coaching may be conducive to the blood sugar control and healthy diet of patients with type 2 diabetes. Further study on health coaching with higher-quality evidence is needed.
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Effect of commercial wearables and digital behaviour change resources on the physical activity of adolescents attending schools in socio-economically disadvantaged areas: the RAW-PA cluster-randomised controlled trial.
Ridgers, ND, Timperio, A, Ball, K, Lai, SK, Brown, H, Macfarlane, S, Salmon, J
The international journal of behavioral nutrition and physical activity. 2021;18(1):52
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Most adolescents do not engage in the recommended 60 minutes per day moderate to vigorous physical exercise, therefore there is a need to ensure that exercise targets are hit. The use of wearable activity trackers has recently become popular, however their exact effects on physical activity levels in adolescents is unclear. The aim of this randomised control trial was to determine the effects of wearing a digital activity tracker for 12 weeks on activity levels of 275 adolescents, and how this affects activity levels 6 months after the end of the trial. The results showed that the use of a digital activity tracker had no effect on moderate to vigorous physical activity (MVPA) immediately after the trial had finished. At 6 months less activity was seen amongst adolescents and males in particular engaged in less activity than those who did not have a digital activity device. It was concluded that the use of a wearable digital physical activity tracker had no effect on physical activity levels. This study could be used by healthcare professionals to understand that in adolescents wearable digital activity trackers may not be enough motivation and support to increase activity levels.
Abstract
BACKGROUND There has been increasing interest in using wearable activity trackers to promote physical activity in youth. This study examined the short- and longer-term effects of a wearable activity tracker combined with digital behaviour change resources on the physical activity of adolescents attending schools in socio-economically disadvantaged areas. METHODS The Raising Awareness of Physical Activity (RAW-PA) Study was a 12-week, multicomponent intervention that combined a Fitbit Flex (and accompanying app), and online digital behaviour change resources and weekly challenges delivered via Facebook. RAW-PA was evaluated using a cluster-randomised controlled trial with 275 adolescents (50.2% female; 13.7 ± 0.4 years) from 18 Melbourne secondary schools (intervention n = 9; wait-list control group n = 9). The primary outcome was moderate- to vigorous-intensity physical activity (MVPA), measured using hip-worn ActiGraph accelerometers. The secondary outcome was self-reported physical activity. Data were collected at baseline, 12-weeks (immediately post-intervention), and 6-months post-intervention (follow-up). Multilevel models were used to determine the effects of the intervention on daily MVPA over time, adjusting for covariates. RESULTS No significant differences were observed between intervention and wait-list control adolescents' device-assessed MVPA immediately post-intervention. At 6-months post-intervention, adolescents in the intervention group engaged in 5 min (95% CI: - 9.1 to - 1.0) less MVPA per day than those in the wait-list control group. Males in the intervention group engaged in 11 min (95% CI: - 17.6 to - 4.5) less MVPA than males in the wait-list control group at 6-months post-intervention. No significant differences were observed for females at either time point. For self-reported physical activity, no significant effects were found at 12-weeks and 6-months post-intervention. CONCLUSIONS Combining a wearable activity tracker with digital behaviour change resources and weekly challenges did not increase inactive adolescents' accelerometer-derived and self-reported physical activity levels immediately post-intervention. This contrasts previous research that has suggested wearable activity tracker may increase youth physical activity levels in the short-term. Lower engagement in MVPA 6-months post-intervention was observed for males but not for females, though it is unclear why this finding was observed. The results suggest wearable activity trackers, in combination with supporting materials, may not be effective for increasing physical activity levels in adolescents. TRIAL REGISTRATION ACTRN12616000899448 . Australian and New Zealand Clinical Trials Registry. Registered 7 July 2016.
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Influence of GDM Diagnosis and Treatment on Weight Gain, Dietary Intake and Physical Activity in Pregnant Women with Obesity: Secondary Analysis of the UPBEAT Study.
Atakora, L, Poston, L, Hayes, L, Flynn, AC, White, SL
Nutrients. 2020;12(2)
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Obesity during pregnancy increases the risk of development of gestational diabetes (GDM), which can develop into type 2 diabetes postnatally. The UK has guidelines on diet and exercise in place following a positive result for GDM, however it is unclear how results from a GDM test may affect behaviours and weight gain in women with obesity during pregnancy. This secondary analysis of a randomised control trial; the UK pregnancies better eating and activity trial (UPBEAT), aimed to assess how a negative or positive diagnosis of GDM affects the diet, physical activity levels and weight gain of pregnant women with obesity. 1031 pregnant women who were positively and negatively diagnosed with GDM were randomly split into two groups for eight weeks. The intervention group received additional appointments with a health coach as well as regular antenatal appointments. The results showed that women who received a negative result to GDM gained significantly more weight than those with a positive diagnosis regardless of which treatment group they were allocated. GDM status also affected dietary intake, however no changes in amount of physical activity were seen with either diagnosis. It was concluded that pregnant women with obesity gained more weight if they received a negative result to GDM and a positive GDM result is associated with lower weight gain and dietary changes. This highlights the need for additional diet and weight gain strategies for pregnant women with obesity who return a negative GDM result. Clinicians could use this study to stress the importance of healthy eating and exercise to pregnant women with obesity, even if a negative GDM test is received.
Abstract
Obesity during pregnancy is associated with the development of gestational diabetes (GDM). This study aimed to assess if the result of an oral glucose tolerance test (OGTT) for GDM influences health (diet and physical activity) behaviours of pregnant women with obesity. In total, 1031 women who participated in the UK Pregnancies Better Eating and Activity Trial (UPBEAT) of a lifestyle intervention from early pregnancy were included. Changes in weight gain, dietary intake and physical activity following an OGTT undertaken between 27+0 and 28+6 weeks' and 34 and 36 weeks' gestation were examined using linear regression with appropriate adjustment for confounders. Obese women without GDM (IADPSG criteria) gained 1.9 kg (95% CI -2.2, -1.5, p < 0.001) more weight than women with GDM. Women with GDM demonstrated greater reductions in energy (-142kcal, 95%CI -242.2, -41.9, p = 0.006), carbohydrate intake (-1.5%E 95%CI -2.8, -0.3, p = 0.016) and glycaemic load (-15.2, 95%CI -23.6, -6.7, p < 0.001) and a greater increase in protein intake (2%E, 95%CI 1.3, 2.7, p < 0.001), compared to women without GDM. Trial intervention allocation did not influence any associations observed. The findings emphasise the need for strategies to optimise the health behaviours of pregnant women with obesity, following a negative OGTT for GDM.
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Behaviour change, weight loss and remission of Type 2 diabetes: a community-based prospective cohort study.
Dambha-Miller, H, Day, AJ, Strelitz, J, Irving, G, Griffin, SJ
Diabetic medicine : a journal of the British Diabetic Association. 2020;37(4):681-688
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Type 2 Diabetes is considered a lifelong condition, but calorie restriction or weight loss can lead to complete remission. Patients newly diagnosed with Type 2 Diabetic may benefit from behavioural change over the long run. When Type 2 Diabetes is diagnosed early in the disease trajectory, it may increase the patient's motivation and make them more receptive to weight-loss interventions. This prospective cohort study included 865 newly diagnosed Type 2 diabetic patients from the ADDICTION Cambridge Trial, a pragmatic, parallel-group cluster randomised controlled trial. The study assessed the relationship between behaviour change and weight loss and the prospect of type 2 diabetes remission in the first year, following four years and after five years without intense dietary or lifestyle intervention in patients. 30% of the patients achieved diabetes remission at 5-year follow-up, with a significant likelihood of remission among those who achieved ≥ 10% weight loss in the first year of diagnosis. A self-reported change in intake of alcohol units was found to be the only consistent association between behaviour change and remission in this study. The role of behaviour change in the remission of diabetes requires further robust research. This study will help healthcare professionals understand the association between weight loss and remission in diabetic patients.
Abstract
AIM: To quantify the association between behaviour change and weight loss after diagnosis of Type 2 diabetes, and the likelihood of remission of diabetes at 5-year follow-up. METHOD We conducted a prospective cohort study in 867 people with newly diagnosed diabetes aged 40-69 years from the ADDITION-Cambridge trial. Participants were identified via stepwise screening between 2002 and 2006, and underwent assessment of weight change, physical activity (EPAQ2 questionnaire), diet (plasma vitamin C and self-report), and alcohol consumption (self-report) at baseline and 1 year after diagnosis. Remission was examined at 5 years after diabetes diagnosis via HbA1c level. We constructed log binomial regression models to quantify the association between change in behaviour and weight over both the first year after diagnosis and the subsequent 1-5 years, as well as remission at 5-year follow-up. RESULTS Diabetes remission was achieved in 257 participants (30%) at 5-year follow-up. Compared with people who maintained the same weight, those who achieved ≥ 10% weight loss in the first year after diagnosis had a significantly higher likelihood of remission [risk ratio 1.77 (95% CI 1.32 to 2.38; p<0.01)]. In the subsequent 1-5 years, achieving ≥10% weight loss was also associated with remission [risk ratio 2.43 (95% CI 1.78 to 3.31); p<0.01]. CONCLUSION In a population-based sample of adults with screen-detected Type 2 diabetes, weight loss of ≥10% early in the disease trajectory was associated with a doubling of the likelihood of remission at 5 years. This was achieved without intensive lifestyle interventions or extreme calorie restrictions. Greater attention should be paid to enabling people to achieve weight loss following diagnosis of Type 2 diabetes.
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Anxiety reduction through art therapy in women. Exploring stress regulation and executive functioning as underlying neurocognitive mechanisms.
Abbing, A, de Sonneville, L, Baars, E, Bourne, D, Swaab, H
PloS one. 2019;14(12):e0225200
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Anxiety treatments currently involve medication and changing an individual’s beliefs through cognitive behavioural therapy (CBT). Art therapy (AT) is often used as a CBT treatment strategy, although little is known about its effectiveness. This randomised control trial of 47 adult women with anxiety aimed to understand the role of AT in anxiety treatment over three months. The results showed improvements in self-reported measures of anxiety, the ability to control emotions, memory and the ability to manage tasks with AT, however subjects were just as susceptible to stress following treatment. It was concluded that anxiety reduction was related to improvements in emotions, memory and task management and this was as a result of AT. This study could be used by healthcare professionals to recommend AT to individuals with symptoms of anxiety as part of their treatment management plan.
Abstract
OBJECTIVES To explore possible working mechanisms of anxiety reduction in women with anxiety disorders, treated with art therapy (AT). METHODS A RCT comparing AT versus waiting list (WL) condition on aspects of self-regulation. Stress regulation (heart rate and heart rate variability) and executive functioning (daily behavioural and cognitive performance aspects of executive functioning (EF)) were evaluated in a pre-post design. Participants were women, aged 18-65 years with moderate to severe anxiety symptoms. RESULTS Effectiveness of AT compared to WL was demonstrated in a higher resting HRV post treatment, improvements in aspects of self-reported daily EF (emotion control, working memory, plan/organize and task monitor), but not in cognitive performance of EF, stress responsiveness and down regulation of stress. The decrease in anxiety level was associated with improvements in self-reported daily EF. CONCLUSIONS AT improves resting HRV and aspects of EF, the latter was associated with art therapy-related anxiety reduction.
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Changes in Anxiety and Depression Traits Induced by Energy Restriction: Predictive Value of the Baseline Status.
Rodriguez-Lozada, C, Cuervo, M, Cuevas-Sierra, A, Goni, L, Riezu-Boj, JI, Navas-Carretero, S, Milagro, FI, Martinez, JA
Nutrients. 2019;11(6)
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Anxiety and depression are among the most common mental health problems and are associated with obesity and other chronic illnesses. The number of these disorders has not been reduced despite the increased use of cognitive behavioural therapy and pharmacotherapy. Current evidence suggests diet quality as a modifiable risk factor for mental illnesses. Additional studies are required to investigate the effect of dietary patterns as well as weight loss on improving symptoms. The first aim of this study was to investigate the effect of weight loss on overweight and obese patients, using two calorie-restricted diets, on anxiety and depression symptoms. The second aim was to analyse the role of the baseline psychological features in predicting future weight loss. The study was a randomized, longitudinal, and controlled intervention trial which lasted for 16 weeks. The study indicates that weight loss via calorie-controlled diets could improve depression symptoms in obese and overweight patients. Participants that lost more weight showed a larger amelioration in depression symptoms. The study also suggests that greater anxiety symptoms at the beginning of the intervention could predict a higher weight loss. These results, in addition to the positive effect on body composition, show that weight loss could become part of a health improvement plan.
Abstract
Current evidence proposes diet quality as a modifiable risk factor for mental or emotional impairments. However, additional studies are required to investigate the effect of dietary patterns and weight loss on improving psychological symptoms. The aim of this investigation was to evaluate the effect of energy-restriction, prescribed to overweight and obese participants, on anxiety and depression symptoms, as well as the potential predictive value of some baseline psychological features on weight loss. Overweight and obese participants (n = 305) were randomly assigned for 16 weeks to two hypocaloric diets with different macronutrient distribution: a moderately high-protein (MHP) diet and a low-fat (LF) diet. Anthropometrical, clinical, psychological, and lifestyle characteristics were assessed at baseline and at the end of the intervention. The nutritional intervention evidenced that weight loss has a beneficial effect on trait anxiety score in women (β = 0.24, p = 0.03), depression score in all population (β = 0.15, p = 0.02), particularly in women (β = 0.22, p = 0.03) and in subjects who followed the LF diet (β = 0.22, p = 0.04). Moreover, weight loss could be predicted by anxiety status at baseline, mainly in women and in those who were prescribed a LF diet. This trial suggests that weight loss triggers an improvement in psychological traits, and that anxiety symptoms could predict those volunteers that benefit most from a balanced calorie-restricted intervention, which will contribute to individualized precision nutrition.
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Mediators of Lifestyle Behaviour Changes in Obese Pregnant Women. Secondary Analyses from the DALI Lifestyle Randomised Controlled Trial.
van Poppel, MN, Jelsma, JGM, Simmons, D, Devlieger, R, Jans, G, Galjaard, S, Corcoy, R, Adelantado, JM, Dunne, F, Harreiter, J, et al
Nutrients. 2019;11(2)
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Obesity in pregnancy is rising and is associated with increased risks for both mother and baby. In particular, obese women and women with excess weight gain during pregnancy are at an increased risk for developing gestational diabetes (GDM). A better understanding of what drives behaviour change in obese pregnant women is needed to improve the effectiveness of lifestyle interventions such as dietary changes. In this randomised controlled trial, researchers set out to assess what factors might support behaviour change in pregnant women at risk of GDM. A total of 436 women, with pre-pregnancy body mass index of ≥29 kg/m², without GDM, were split into four groups: three of them received counselling based on motivational interviewing (MI) on 1) healthy eating and physical activity, 2) healthy eating alone or 3) physical activity alone, whilst the fourth group received their usual care. Physical activity and food intake were measured at the start of the study, and at 24-28 and 35-37 weeks of pregnancy. Social and psychological factors such as outcome expectancy, risk perception, task self-efficacy (peoples’ confidence to succeed in a specific situation) and social support were measured at those same time points and considered as possible mediators of intervention effects on lifestyle. All three groups that received MI demonstrated an increased positive outcome expectancy for GDM reduction, perceived risk to the baby and increased task self-efficacy. Women with higher self-efficacy tended to be more physically active and consumed less sugary drinks and smaller portion sizes. The authors concluded that motivational interviewing was successful in increasing outcome expectancy and task self-efficacy, both of which were related to improvements in diet and physical activity.
Abstract
A better understanding of what drives behaviour change in obese pregnant overweight women is needed to improve the effectiveness of lifestyle interventions in this group at risk for gestational diabetes (GDM). Therefore, we assessed which factors mediated behaviour change in the Vitamin D and Lifestyle Intervention for GDM Prevention (DALI) Lifestyle Study. A total of 436 women, with pre-pregnancy body mass index ≥29 kg/m², ≤19 + 6 weeks of gestation and without GDM, were randomised for counselling based on motivational interviewing (MI) on healthy eating and physical activity, healthy eating alone, physical activity alone, or to a usual care group. Lifestyle was measured at baseline, and at 24⁻28 and 35⁻37 weeks of gestation. Outcome expectancy, risk perception, task self-efficacy and social support were measured at those same time points and considered as possible mediators of intervention effects on lifestyle. All three interventions resulted in increased positive outcome expectancy for GDM reduction, perceived risk to the baby and increased task self-efficacy. The latter mediated intervention effects on physical activity and reduced sugared drink consumption. In conclusion, our MI intervention was successful in increasing task self-efficacy, which was related to improved health behaviours.
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A mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial.
Galante, J, Dufour, G, Vainre, M, Wagner, AP, Stochl, J, Benton, A, Lathia, N, Howarth, E, Jones, PB
The Lancet. Public health. 2018;3(2):e72-e81
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There has been a recent increase in students accessing university counselling services, though the reasons for this are currently unclear. Mindfulness-based stress reduction has gained increased attention as evidence has shown mindfulness training can improve anxiety and depression. The aim of this trial was to therefore assess whether a mindfulness course, Mindfulness Skills for Students (MSS), would improve university students’ resilience to stress. Participants were randomly assigned to either enrol in the 8-week MSS course alongside mental health support or receive mental health support alone. A total of 449 participants completed the study and self-reported psychological distress was the primary outcome. Students enrolled in MSS showed reduced distress scores during the examination period compared with those receiving support as usual. Based on these results, the authors conclude that offering mindfulness training could be an effective, feasible component of a wider university mental health strategies. Further controlled studies are required to better understand preventative mental health interventions for students.
Abstract
BACKGROUND The rising number of young people going to university has led to concerns about an increasing demand for student mental health services. We aimed to assess whether provision of mindfulness courses to university students would improve their resilience to stress. METHODS We did this pragmatic randomised controlled trial at the University of Cambridge, UK. Students aged 18 years or older with no severe mental illness or crisis (self-assessed) were randomly assigned (1:1), via remote survey software using computer-generated random numbers, to receive either an 8 week mindfulness course adapted for university students (Mindfulness Skills for Students [MSS]) plus mental health support as usual, or mental health support as usual alone. Participants and the study management team were aware of group allocation, but allocation was concealed from the researchers, outcome assessors, and study statistician. The primary outcome was self-reported psychological distress during the examination period, as measured with the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), with higher scores indicating more distress. The primary analysis was by intention to treat. This trial is registered with the Australia and New Zealand Clinical Trials Registry, number ACTRN12615001160527. FINDINGS Between Sept 28, 2015, and Jan 15, 2016, we randomly assigned 616 students to the MSS group (n=309) or the support as usual group (n=307). 453 (74%) participants completed the CORE-OM during the examination period and 182 (59%) MSS participants completed at least half of the course. MSS reduced distress scores during the examination period compared with support as usual, with mean CORE-OM scores of 0·87 (SD 0·50) in 237 MSS participants versus 1·11 (0·57) in 216 support as usual participants (adjusted mean difference -0·14, 95% CI -0·22 to -0·06; p=0·001), showing a moderate effect size (β -0·44, 95% CI -0·60 to -0·29; p<0·0001). 123 (57%) of 214 participants in the support as usual group had distress scores above an accepted clinical threshold compared with 88 (37%) of 235 participants in the MSS group. On average, six students (95% CI four to ten) needed to be offered the MSS course to prevent one from experiencing clinical levels of distress. No participants had adverse reactions related to self-harm, suicidality, or harm to others. INTERPRETATION Our findings show that provision of mindfulness training could be an effective component of a wider student mental health strategy. Further comparative effectiveness research with inclusion of controls for non-specific effects is needed to define a range of additional, effective interventions to increase resilience to stress in university students. FUNDING University of Cambridge and National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care East of England.