Two-way associations between relationship quality and uptake of couples health screening including HIV testing and counselling together: quantitative analysis of a couples cohort in rural South Africa.

In the context of a couples cohort established to evaluate an optimised couples-focused behavioural intervention in rural South Africa, we examined: (1) Is couples' relationship quality (RQ) associated with couples HIV testing and counselling (CHTC) uptake? (2) Does CHTC uptake or the intervention components uptake improve subsequent RQ? Enrolled couples, (n = 218), previously naïve to couples HIV testing, were invited to two group sessions and offered four couples counselling sessions (CS1-CS4), as part of the intervention and administered a questionnaire individually at baseline, four weeks, and four months, which included item-scales to measure RQ: satisfaction, intimacy, dyadic trust, conflict, and mutual constructive communication. Logistic models indicated that no baseline RQ measures were significantly associated with CHTC uptake. Linear regression models showed that CHTC uptake before four weeks assessment significantly improved couples' satisfaction and trust at four weeks, and intimacy at four months. Attending at least one CS was associated with increased satisfaction, intimacy, and decreased conflict within couples at four weeks; the improvement in intimacy was sustained at four months. Consistent with the theoretical interdependence model, our findings suggest that CHTC and CS seemed to strengthen aspects of relationship quality, possibly leading to further collaboration in managing lifestyle changes and treatment adherence.

Adolescents' self-reported experiences following a person-centred, theory-based educational intervention versus conventional education for improved oral hygiene: Analysis of secondary outcomes of a randomized field study.

AIM: To analyse adolescents' self-reported experiences and behavioural outcomes of a person-centred, theory-based intervention in comparison with conventional information/instruction for improved oral hygiene. MATERIALS AND METHODS: Data were derived from a prospective, multi-centred, two-arm, quasi-randomized field study focusing on the effectiveness of educational interventions for improved oral hygiene. Dental hygienists working within the Public Dental Service, Västra Götaland, Sweden, provided treatments, and adolescents with poor oral hygiene conditions were eligible for participation. The person-centred test intervention was based on social cognitive constructs, and motivational interviewing was used as an approach in communication. The control intervention included conventional information/instructions. Clinical examinations were performed, and questionnaires were distributed at baseline and at 6 months. Three-hundred and twelve patients were enrolled, and data from 276 patients, following treatment per protocol, were analysed. RESULTS: The test group was more satisfied with the education about gingivitis (very good: 61% vs. 37%) and communication during therapy (very good: 69% vs. 50%) and reported to a larger extent that they were much more careful regarding their oral hygiene after the treatment (30% vs. 15%) and had higher confidence about keeping up healthy gingival conditions, in comparison with the control group (all p < .01). CONCLUSIONS: The person-centred, theory-based intervention was superior in terms of adolescents' experiences of education and communication during therapy and self-reported oral hygiene behavioural outcomes at 6 months, in comparison with conventional information/instruction.

Developing the PEAK mood, mind, and marks program to support university students' mental and cognitive health through physical exercise: a qualitative study using the Behaviour Change Wheel.

BACKGROUND: Concerns about mental and cognitive health are common among university students. Engaging in regular physical exercise has been shown to enhance both mental health and cognitive performance, yet most students are not participating in the level of exercise required to obtain these benefits. The Behaviour Change Wheel (BCW) provides a framework for developing behavioural interventions that are informed by theory, evidence, and stakeholder perspectives. The current study aimed to apply the BCW to develop the PEAK Mood, Mind, and Marks program (i.e., PEAK), a behaviour change intervention designed to increase university students' exercise engagement for the benefit of their mental and cognitive health. METHODS: PEAK was developed across three stages of the BCW: (1) understand the target behaviour, (2) identify intervention options, and (3) identify intervention content and delivery mode. Development was informed by triangulated data from a systematic literature review, co-design consultations with key stakeholders, and knowledge of relevant experts. Consultations with stakeholders involved focus groups with 25 university students and individual interviews with 10 university leaders and staff to identify barriers and facilitators to students' exercise engagement and the adoption and implementation of PEAK by universities. Template analysis was used to code transcripts to the capability, opportunity, and motivation (COM-B) model of behaviour. The BCW was applied to identify the most appropriate intervention types and behaviour change techniques (BCTs). RESULTS: Thirty-one barriers and facilitators were identified and mapped to seven intervention types (Education; Modelling; Persuasion; Environmental Restructuring; Incentivisation; Training; and Enablement) and 26 BCTs, which were delivered across digital channels and in-person. The final intervention consisted of multiple components targeting students' capability (e.g., increasing knowledge about the mental and cognitive health benefits of exercise), opportunity (e.g., providing a flexible range of accessible exercise options and social support), and motivation (e.g., increasing the perceived importance of exercise) to exercise. CONCLUSIONS: University students and staff describe a need and appetite for more empowering, scalable solutions to support students' mental and cognitive health. Exercise-based approaches that are informed by behaviour change frameworks, evidence, and stakeholder perspectives, such as PEAK, have the potential to address this need. Current findings will inform a pilot of PEAK to evaluate its efficacy and implementation.

Promoting healthy sleep in 0-2-year-old infants: a study protocol for the development and mixed method evaluation of a sleep health program tailored to Dutch youth healthcare regions.

BACKGROUND: Sleep problems are common among infants and can have a serious impact on the health and wellbeing of both child and parents. To sustainably promote infant sleep on a population level, it is necessary to develop evidence-based programs that can be implemented on a large scale. The Youth Health Care setting, with its focus on prevention, child health promotion and services widely available for parents, can be a suitable setting to do so. Currently however, sleep health promotion in this setting seems to be suboptimal. To promote healthy infant sleep on a population level, programs need to be accessible and comprehensible for all parents, including parents with limited (health) literacy. Therefore, this study aims to develop, implement and evaluate a program called 'Sleep on number 1', that is tailored to Dutch Youth Health Care, to sustainably promote healthy sleep in 0-2-year-old infants. METHODS: The program was developed based on co-creation with parents and Youth Health Care professionals, evidence-based behaviour change theories and sleep health promotion methods. Program effectiveness is investigated with a quasi-experimental study design comparing the program group with the care as usual control group. Participants consist of parents of 0-2-year-old children. Primary outcome is infant sleep quality at the age of 10 weeks and 6, 9, 14 and 24 months, measured with a sleep diary. The primary data analysis focuses on night awakenings at 9 months. Secondary outcomes focus on parental behaviour regarding infant sleep, related behavioural determinants and parental satisfaction with Youth Health Care sleep advice. Program effectiveness is analysed using a linear mixed-model in case of data clustering, and an independent samples T-test or linear regression in case no substantial clustering effects are found. A mixed methods process evaluation is performed with parents and Youth Health Care professionals, assessing program reach, adoption, implementation, maintenance and working mechanisms. DISCUSSION: The 'Sleep on number 1' program is an evidence-based sleep health program for 0-2-year-old children, tailored to Dutch Youth Health Care. If effective, this program has the potential to improve infant sleep on a population level. TRIAL REGISTRATION: ISRCTN, ISRCTN27246394, registered on 10/03/2023. https://www.isrctn.com/ISRCTN27246394 .

Testing a family system-based intervention (ENTREN-F Programme) for a paediatric obesity sample by a randomized controlled trial.

This study evaluated the effectiveness of 'ENTREN-F' -a multi-component, family system-based intervention-for managing paediatric obesity at National Health Primary Care. A 3-arm, parallel-design, single-blinded randomized controlled trial (RCT), 165 families were randomized: Arm 1) ENTREN-F(n = 62) is a 12-week cognitive-behavioural intervention (CBT) family system-based programme, addressing lifestyle changes, children's emotional and social development and the family system, Arm 2) 'ENTREN' (n = 52) is a CBT family-based programme for children and parents, not addressing the family system, and Arm 3) Control group (CG) (n = 51) covers individual behavioural monitoring. All children were clinical interviewed to assess a diagnosis. Their effectiveness was assessed against six-month changes in children's body mass index (BMI) z-score, children's psychological well-being, levels of expressed maternal emotion, depression symptoms, parental feeding practices, levels of physical activity and sedentary lifestyles. The maintenance of the changes was evaluated for two years. High-attendance rates for ENTREN-F (72.6% vs. 66% vs. 33%, respectively) indicated its greater acceptance. After programme completion, the BMI z-score reduced by .5 points in almost 50% ENTREN-F (n = 22/45), 21.9% ENTREN (n = 7/32) and 11.8% (n = 2/17) CG participants. There were no significant differences between the three trial arms for anthropometric, psychological, or family-related measures. At the two-year follow-up, both ENTREN-F and ENTREN showed similar long-term effectiveness without between-group differences, and weight trajectories were favourable. ENTREN-F appears effective for childhood obesity management; however, the COVID-19 pandemic limited the sample size. Also, the tendency towards multiple differences in child and family outcomes could not be statistically shown. It also provides further evidence of the role of psychological and family-related factors that may underlie the origin and maintenance of weight gain.

Behavioural interventions to increase adherence to palivizumab prophylaxis in children with CHD.

OBJECTIVES: Adherence to palivizumab prophylaxis programmes is crucial to protect infants with CHD against respiratory syncytial virus infections. We analysed the effectiveness of two nudge interventions in increasing adherence. METHODS: Our study included 229 infants, and their caregivers, from five centers in Turkey in the 2020-2021 respiratory syncytial virus season. We randomly allocated caregivers to a control and two intervention groups. Caregivers in all groups were informed about the prophylaxis programme and provided a schedule. Additionally, caregivers in Intervention 1 were called two days before appointments (default bias) and were asked to plan the appointment day (implementation intention), whereas caregivers in Intervention 2 received biweekly text messages informing them about the programme's benefits (availability bias) and current adherence rate (social norm). RESULTS: Caregivers in Intervention 1 had a significantly higher adherence rate than Control (97.3% versus 90.9%) (p = 0.014). Both interventions had a significant effect on participants in their first prophylaxis season (p = 0.031, p = 0.037). Families where the father was employed had a 14.2% higher adherence rate (p = 0.001). Every additional child was associated with a 2.2% decrease in adherence rate (p = 0.02). In control, ICU admission history was associated with an 18.8% lower adherence rate (p = 0.0001), but this association disappeared in intervention groups. CONCLUSION: This is the first prospective interventional study which, in the context of palivizumab prophylaxis, analyses the effectiveness of nudge interventions based on established cognitive biases by comparing randomly generated intervention and control groups. We found that default bias and implementation intention have significant effects on adherence.Clinical trial, in the name and number "Adherence of palivizumab prophylaxis, NCT05778240" registered retrospectively. https://clinicaltrials.gov/ct2/show/NCT05778240.

Pepea Pamoja:† Applying the Ecological Validity Framework to co-develop a wellbeing and behavioural training program for caregivers of young children with autism in low-resource settings of Kenya and the United States.

BACKGROUND: Autism is a complex neurodevelopmental disability with global prevalence of one in 100 individuals. Poor access to interventions in both under-resourced regions of high-income countries and low- and middle-income countries has deleterious effects on the health and wellbeing of individuals with autism and their families. Our objective was to utilize a reciprocal innovation framework and participatory methods to adapt and co-develop a culturally grounded group-based wellbeing and naturalistic developmental behavioural intervention (NDBI) training program for caregivers of young children with autism to be implemented in Kenya and rural Indiana. METHODS: This study was conducted within the Academic Model Providing Access to Healthcare (AMPATH) program. An evidence-informed Naturalistic Developmental Behavioral Intervention (NDBI) previously utilized in Indiana was adapted and iteratively refined using the Ecological Validity Framework (EVF) by a team of US and Kenyan disability experts. Key adaptations to the program were made across the EVF domains of language, persons, metaphors/content, concepts, goals, methods, and context. RESULTS: Substantial cultural adaptations were made to the NDBI following the EVF model, including the addition of traditional Kenyan cultural practices, use of narrative principles, and focus on daily routines over play. Pepea, the adapted program, involves 10 group sessions covering content in basic education on autism, positive caregiver coping strategies, and behavioural skills training to promote child communication and reduce challenging behaviour. Key adaptations for Pepea were integrated back into a US NDBI caregiver training program. CONCLUSIONS: This study fills a critical gap by detailing the adaptation process of a caregiver wellbeing and naturalistic developmental behavioural training program for caregivers of children with autism in low-resource settings. Our next steps are to report on mixed-methods outcomes from pilot implementation. Our long-term goal is to apply these insights to advance sustainable and scalable autism intervention services across the globe.

Enhancing self-esteem in adults with body dysmorphic symptoms: experimental testing and initial evaluation of a brief internet-based training.

BACKGROUND: Low self-esteem is an important factor associated with body dysmorphic concerns. In treatment, self-esteem cannot always be adequately addressed. Internet-based interventions offer a low-threshold and cost-efficient possibility for treating body dysmorphic disorder (BDD). AIMS: For this reason, we conducted two studies to explore the effectiveness of an internet-based intervention targeting improving self-esteem in adults with BDD symptoms. METHOD: The first study investigated the differential effects of a 1-week self-esteem training compared with a 1-week attention-focus training. Two hundred twenty adults with elevated body dysmorphic symptoms were randomly assigned to one of the two trainings. Our second study (n = 58 adults with body dysmorphic symptoms) evaluated an extended 2-week stand-alone self-esteem training. RESULTS: In the first study, self-esteem in different domains (appearance, performance and social), self-focused attention, and BDD symptom severity improved in both groups. Other-focused attention only increased in the attention training group. Participants' overall adherence was high. In the second study we observed significant improvements in self-esteem, BDD symptom severity, and other secondary outcomes, with additional improvements in most outcomes in the second week. Adherence was again high. CONCLUSIONS: Together, these findings show that a brief internet-based intervention may be a highly accepted and effective way of improving self-esteem in people suffering from BDD symptoms.

Outcomes for children with autism spectrum disorder and their families after two years of school based early intensive behavioural intervention.

The effectiveness of a school based Early Intensive Behavioural Intervention (EIBI) program was assessed over a two-year period for a cohort of 16 pre-school children with autism spectrum disorder (ASD) and their families. Children with a mean age of 40 months, were assessed prior to intervention, after 1 year of intervention, and again after 2 years. Significant improvements were observed on measures of adaptive behaviour, communication ability and challenging behaviour. Parents of children attending the program also reported increased familial quality of life, specifically improved emotional and physical well-being and increased parenting capacity over the duration of the program. The current study suggests that EIBI for young children with ASD can be effective in facilitating improvements in communication ability, reducing challenging behaviours and improving quality of life for families. Children's pre-intervention adaptive skills appeared to be the strongest predictor of post intervention gains as initial level of adaptive ability was positively related to improved post-intervention outcomes.

Changing from disease-centred to person-centred - Swedish dental hygienists' views on a theory-based behavioural intervention for improved oral hygiene among adolescents.

OBJECTIVES: To explore dental hygienists' (DHs') views on (i) a person-centred, theory-based, behavioural intervention for improving oral hygiene among adolescents and (ii) professional and organizational factors to consider in the implementation of such an intervention in daily dental practice. METHODS: Semi-structured interviews were conducted with 13 DHs who had applied the person-centred, theory-based, behavioural intervention directed at adolescents with poor oral hygiene in a field study within the Public Dental Service, Region Västra Götaland, Sweden. The interviews were audio-taped, transcribed verbatim and analysed using qualitative content analysis. RESULTS: The main theme 'From individual experts to partners - DHs changing direction from a disease-centred towards a person-centred approach' illustrated a changed professional approach among DHs, from exerting their roles as experts to encouraging partnership in treatment by supporting the adolescents in taking health behavioural decisions and responsibility for their oral health. The DHs considered the changed approach as challenging, but also more enjoyable, compared to conventional information/instruction. Adequate knowledge and skills, personal interest and willingness for a change as well as support from colleagues and clinic management were identified as prerequisites for implementing the person-centred, theory-based, behavioural intervention in daily practice, while the expenditure of time needed in relation to economic demands in care were seen as barriers. CONCLUSIONS: The findings elucidate that DHs considered the application of a person-centred, theory-based, behavioural intervention to be challenging but also enjoyable. For such an intervention to be implemented in daily practice, prerequisites and barriers need to be considered on both personal/professional and organizational levels.

Five-year follow-up of a clinic-based sleep intervention for paediatric epilepsy: A randomized clinical trial.

Sleep disturbances in children with epilepsy are prevalent, and are associated with substantial adverse medical and psychosocial consequences. This study is a 5-year follow-up of a clinic-based sleep intervention study that randomized 100 toddlers and preschool-age children with epilepsy to a usual care group or a sleep intervention group. The intervention group received standard paediatric neurology care plus three education sessions during the child's routine clinic visit. The outcomes measured were: (1) child sleep by actigraphy and parental report; and (2) maternal sleep and depression. We aimed to evaluate the long-term benefits of a clinic-based sleep intervention for paediatric epilepsy. In total, 42 families (42.0%) participated. The average child's age at follow-up was 9.55 years. Thirty-eight (90.5%) children were not obtaining sufficient sleep at baseline, and 40 (95.2%) at the 5-year follow-up. The numbers of children with clinically significant sleep disturbances were 40 (95.2%) at baseline and 36 (85.7%) at the 5-year follow-up. Fourteen mothers (33.3%) had poor sleep quality and high depressive symptoms at both assessment time points. There were no differences (P > 0.05) in the child and maternal outcomes between the two trial arms. Overall, there was no evidence that a clinic-based sleep intervention that effectively improved multiple aspects of sleep in toddlers and preschool-age children with epilepsy had long-lasting beneficial effects. Our findings suggest that sleep interventions for families of children with epilepsy require ongoing reinforcement and monitoring during routine paediatric neurology care to prevent sleep problems from persisting or recurring.

Increased physical activity reduces sleep disturbances in asthma: A randomized controlled trial.

BACKGROUND AND OBJECTIVE: Individuals with asthma are more likely to develop sleep-disordered breathing. Exercise training improves sleep; however, the effect of physical activity (PA) on improving sleep quality remains unknown. This study had two objectives: (i) to evaluate the effect of a behavioural intervention to increase physical activity in daily living (PADL) on sleep quality in adults with asthma; (ii) to verify the association between a change in sleep quality, quality of life, anxiety, depression and asthma symptoms. METHODS: This randomized controlled clinical trial included adults physically inactive with asthma. Participants were randomized into the control (CG; n = 25) and intervention groups (IG; n = 24). IG was submitted to a behavioural intervention to increase PADL, and CG received the usual care. Pre- and post-intervention assessments of sleep quality (by actigraphy and questionnaire), PADL level (by accelerometry), asthma control, health-related quality of life and anxiety and depression levels were conducted. RESULTS: Both groups were similar at baseline. After the intervention, IG increased daily steps and moderate to vigorous PA levels. IG also improved sleep efficiency and latency as well as increased asthma-symptom-free days compared to CG. In addition, a greater proportion of participants in the IG had improved sleep quality after the intervention. Lastly, IG presented clinical improvement in the asthma-related quality of life questionnaire and a reduction in anxiety symptoms. CONCLUSION: Our results demonstrate that a behavioural intervention can increase PA, enhance behavioural sleep quality, efficiency and quality of life and reduce asthma and anxiety symptoms.

Behavioural interventions for swallowing in subjects with Parkinson's disease: A mixed methods systematic review.

BACKGROUND: Dysphagia is prevalent in subjects with Parkinson's disease (PD). Swallowing intervention to improve or maintain swallowing function is of major importance as dysphagia may considerably impact physical and psycho-social health. AIMS: A mixed methods systematic review was conducted to summarize and appraise literature reporting (1) effects of behavioural interventions for swallowing in individuals with PD; and (2) participants' perspectives of swallowing interventions. METHODS & PROCEDURES: Electronic databases were searched systematically in July 2020 for articles published between 2014 and 2020. In addition, studies published between 2000 and 2014 were identified non-systematically through previous reviews. Peer-reviewed quantitative and qualitative research in English or German documenting behavioural interventions for swallowing in individuals with a diagnosis of PD was eligible for inclusion. Participants at all disease stages were included. Behavioural interventions included rehabilitative and compensatory strategies. Studies reporting swallowing outcomes with and without a comparative group were included. For each study, the National Health and Medical Research Council level of evidence was defined. Included studies were critically appraised using the Standard Quality Assessment Criteria for Evaluating Primary Research Papers from a Variety of Fields. An integrated synthesis was performed after separate analysis of effect data and data reflecting participants' experiences. This review was conducted based on published JBI methodology and the guideline from the Preferred Reporting Items for Systematic Reviews and Meta-Analysis system was followed. MAIN CONTRIBUTION: A total of 33 studies published in English met the inclusion criteria. Thirty-one studies reported quantitative data, one was qualitative and one was mixed methods. Intervention effects on swallowing function, swallowing safety and swallowing-related quality of life were reported for various treatment approaches. Three studies explored how participants perceived the intervention. Overriding themes including subjects' views regarding treatment schedules and levels of effort or comfort associated with the intervention were identified across these studies. Combining evidence of intervention effects and subjects' experiences was possible for one rehabilitative and one compensatory intervention. CONCLUSIONS & IMPLICATIONS: Beneficial effects of swallowing interventions have been reported; however, most experiments were case studies of variable methodological quality. Randomized-controlled trials with robust methodology to explore treatment effects in larger samples is needed to guide clinical practice. Research reporting subjects' views is scarce. More studies exploring how individuals perceive behavioural interventions for swallowing are necessary to inform clinical decision-making. WHAT THIS PAPER ADDS: What is already known on the subject Dysphagia is common in individuals with PD. Swallowing intervention is of major importance as dysphagia may negatively affect physical and psycho-social health of subjects with PD. What this study adds Beneficial effects of behavioural interventions for swallowing, including rehabilitative and compensatory strategies, have been reported; however, available data are mostly based on case studies of variable quality. Data on how participants perceive specific behavioural interventions are lacking. Based on the available data, integration of efficacy data and individuals' experiences is limited. What are the clinical implications of this work? Given the current evidence of intervention effects and individuals' views on behavioural treatment strategies, interventions implemented into clinical practice require careful evaluation on a case-by-case basis. More high-quality research is needed to examine interventions' short- and long-term effects in larger samples to guide clinical practice. In addition to studies evaluating intervention effects, research exploring participants' experiences with interventions is required as a foundation for clinical decision-making.

Impact of cognitive behavioural intervention on caregiver burden in mothers of children diagnosed with cancer.

Background: Mothers of children diagnosed with cancer are found to have coping difficulties in various studies. Most of the studies were done on parents after their child has been newly diagnosed with malignancy, and very few studies were done on coping skills intervention. Hence, this study has been done to assess the impact of cognitive behavioural intervention on caregiver burden in mothers of children diagnosed with cancer. Methods: Twenty mothers coming to the outpatient department of paediatric oncology from 01 September 2018 to 30 April 2019 were enrolled for the study. The participants were administered General Health Questionnaire, Brief Coping Operation Preference Enquiry Scale, Zung Self-Rating Anxiety Scale, and Coping Inventory for Stressful Situations-21 (CISS-21) Scale. Sixteen sessions of cognitive behavioural intervention were given over 8 weeks to all the participants. Reassessment was done after 3 months by use of the above mentioned scales. Results: Participants' mean anxiety score was 49.40 (standard deviation [SD] ±8.89). They used adaptive (active coping and positive reframing) more than the maladaptive (denial and self-blame) coping strategies. Task- and emotion-focused coping mean score on CISS-21 revealed 19.25 (SD ±6.20) and 18.90 (SD ±5.76), respectively. Reassessment after cognitive behavioural intervention revealed statistically significant improvement in maladaptive coping styles, mean anxiety index score, avoidance, and emotion-focused coping. Conclusion: The study has revealed mild to moderate anxiety and the use of both adaptive and maladaptive coping strategies by participants. There is statistically significant improvement in anxiety, maladaptive coping strategies with cognitive behavioural intervention.

Smartphone-based virtual agents and insomnia management: A proof-of-concept study for new methods of autonomous screening and management of insomnia symptoms in the general population.

Insomnia is the most frequent sleep disorder, and the COVID-19 crisis has massively increased its prevalence in the population, due to psychosocial stress or direct viral contamination. KANOPEE_2 is a smartphone-based application that provides interactions with a virtual agent to autonomously screen and alleviate insomnia symptoms through an intervention programme giving personalized advices regarding sleep hygiene, relaxation techniques and stimulus-control. In this proof-of-concept study, we tested the effects of KANOPEE_2 among users from all over the country (France) who downloaded the app between 1 June and 26 October 2020 (to focus on effects after the end of COVID-19 confinement). Outcome measures include insomnia severity (Insomnia Severity Index) and sleep/wake schedules measured by a sleep diary. One-thousand and thirty-four users answered the screening interview (Mage  = 43.76 years; SD = 13.14), and 108 completed the two-step programme (Mage  = 46.64 years; SD = 13.63). Of those who answered the screening, 42.8% did not report sleep complaints, while 57.2% presented mild-to-severe insomnia symptoms. At the end of the intervention, users reported significantly fewer sleep complaints compared with the beginning of the intervention (Insomnia Severity Indexbeginning  = 13.58; Insomnia Severity Indexend  = 11.30; p < 0.001), and significantly increased their sleep efficiency (sleep efficiencybeginning  = 76.46%; sleep efficiencyend  = 80.17%; p = 0.013). KANOPEE_2 is a promising solution both to provide autonomous evaluation of individuals' sleep hygiene and reduce insomnia symptoms over a brief and simple intervention. These results are very encouraging for addressing the issue of insomnia management in people exposed to major psychosocial stress and the consequences of COVID-19 infection.

Behavioural intervention in medication overuse headache: A concealed double-blind randomized controlled trial.

BACKGROUND AND PURPOSE: Medication overuse headache is a prevalent disorder, with a strong biobehavioural component. Hence, behavioural interventions might effectuate reduction of the overused medication. We assessed in a double-blind manner the efficacy of a behavioural intervention during medication withdrawal therapy. METHODS: In this concealed, double-blind, randomized controlled trial in medication overuse headache, conducted at the Leiden University Medical Centre, we compared the effect of maximal versus minimal behavioural intervention by a headache nurse during withdrawal therapy. Maximal intervention consisted of an intensive contact schedule, comprising education, motivational interviewing, and value-based activity planning during 12 weeks of withdrawal therapy. Minimal intervention consisted of a short contact only. Patients were unaware of the existence of these treatment arms, as the trial was concealed in another trial investigating botulinum toxin A. Endpoints were successful withdrawal and monthly days of acute medication use after the withdrawal period. RESULTS: We enrolled 179 patients (90 maximal, 89 minimal intervention). At Week 12, most patients achieved withdrawal in both groups (82/90 [93%] maximal intervention vs. 75/89 [86%] minimal intervention, odds ratio = 2.44, 95% confidence interval [CI] = 0.83-7.23, p = 0.107). At Week 24, patients in the maximal intervention group had fewer medication days (mean difference = -2.23, 95% CI = -3.76 to -0.70, p = 0.005). This difference receded over time. Change in monthly migraine days did not differ between groups (-6.75 vs. -6.22). CONCLUSIONS: This trial suggests modest benefit of behavioural intervention by a headache nurse during withdrawal therapy for medication overuse headache, to reduce acute medication use during and shortly after intervention, but extension seems warranted for a prolonged effect.

A person-centred, theory-based, behavioural intervention programme for improved oral hygiene in adolescents: A randomized clinical field study.

AIM: To test the effectiveness of a person-centred and theory-based educational intervention to increase adolescents' adherence to adequate oral hygiene behaviour, that is, self-performed periodontal infection control. MATERIALS AND METHODS: Data were derived from a prospective, multi-centred, two-arm, quasi-randomized field study in which treatment was performed by dental hygienists (DHs) within the Public Dental Service, Västra Götaland, Sweden. Adolescents with poor oral hygiene conditions were invited to participate. The test intervention was based on cognitive behavioural theory and principles, and the DHs used a collaborative communicative approach, inspired by motivational interviewing. The control intervention consisted of conventional information/instruction. Clinical assessments and oral hygiene behaviours were evaluated at 6 months. RESULTS: Three-hundred and twelve adolescents were enrolled, of whom 274 followed the treatment to 6-month follow-up. There were significant improvements in gingival bleeding and plaque scores for both treatment groups at 6 months, with significantly greater improvements in the test group. Adolescents in the test group brushed their teeth and used interdental cleaning aids more frequently compared to participants in the control group at 6 months. CONCLUSION: A person-centred and theory-based oral health education programme is more effective than conventional oral health education in improving adolescents' oral hygiene behaviour and periodontal infection control. CLINICALTRIALS: gov (NCT02906098).

School-based cognitive behavioural intervention programme for addressing anxiety in 10- to 11-year-olds using short classroom activities in Japan: a quasi-experimental study.

BACKGROUND: Although several school-based cognitive behavioural intervention programmes have been developed in Japan to prevent and improve children's anxiety disorders, the substantial time required for their completion remains a problem. METHODS: A brief version of the cognitive behavioural programme called 'Journey of the Brave', developed for Japanese children was conducted among 90 children aged 10‒11 years using 20-min short classroom activities, and its effectiveness was examined. The children were divided into two groups: the intervention (n = 31) and control groups (n = 59). The control group did not attend any programme sessions and followed regular school curriculum. We conducted 14 weekly programme sessions and assessed children at pre-intervention, post-intervention, and 2-month follow-up (6 months after the beginning). The primary and secondary outcome measures were the Spence Children's Anxiety Scale (SCAS) to assess children's anxiety symptoms and the Strengths and Difficulties Questionnaire (SDQ) to measure behaviour problems, respectively. RESULTS: A statistically significant reduction in the SCAS score in the intervention group was found at 2-month follow-up compared with the control group. A significant reduction was also observed in the SDQ score. CONCLUSIONS: Our findings suggested that the 'Journey of the Brave' programme, which requires only 5 h of short classroom activities, demonstrates promising results compared with previous programmes. A larger randomised control trial would be desirable. TRIAL REGISTRATION: UMIN, UMIN000009021, Registered 10 March 2012.

Using health economic modelling to inform the design and development of an intervention: estimating the justifiable cost of weight loss maintenance in the UK.

BACKGROUND: There is a need to develop cost-effective weight loss maintenance interventions to prolong the positive impact of weight loss on health outcomes. Conducting pre-trial health economic modelling is recommended to inform the design and development of behavioural interventions. We aimed to use health economic modelling to estimate the maximum cost per-person (justifiable cost) of a cost-effective behavioural weight loss maintenance intervention, given an estimated intervention effect for individuals with: i) a Body Mass Index (BMI) of 28 kg/m2 or above without diabetes and ii) a diagnosis of type 2 diabetes prescribed a single non-insulin diabetes medication. METHODS: The School for Public Health Research Diabetes prevention model was used to estimate the lifetime Quality-adjusted life year (QALY) gains, healthcare costs, and maximum justifiable cost associated with a weight loss maintenance intervention. Based on a meta-analysis, the estimated effect of a weight loss maintenance intervention following a 9 kg weight loss, was a regain of 1.33 kg and 4.38 kg in years one and two respectively compared to greater regain of 2.84 kg and 5.6 kg in the control group. Sensitivity analysis was conducted around the rate of regain, duration of effect and initial weight loss. RESULTS: The justifiable cost for a weight loss maintenance intervention at an ICER of £20,000 per QALY was £104.64 for an individual with a BMI of 28 or over and £88.14 for an individual with type 2 diabetes. Within sensitivity analysis, this varied from £36.42 to £203.77 for the former, and between £29.98 and £173.05 for the latter. CONCLUSIONS: Researchers developing a weight loss maintenance intervention should consider these maximum justifiable cost estimates and the potential impact of the duration of effect and initial weight loss when designing intervention content and deciding target populations. Future research should consider using the methods demonstrated in this study to use health economic modelling to inform the design and budgetary decisions in the development of a behavioural interventions.

A process evaluation of 'We Can Quit': a community-based smoking cessation intervention targeting women from areas of socio-disadvantage in Ireland.

BACKGROUND: Smoking poses a serious risk of early preventable death and disease especially for women living with socio-economic disadvantage (SED). A smoking cessation programme, 'We Can Quit', was developed in Ireland tailored to SED women. This includes group-based support delivered by trained lay local community facilitators (CFs) and free nicotine replacement therapy (NRT). The intervention was pilot tested in a cluster randomised controlled trial, 'We Can Quit 2'. This paper reports on the WCQ2 process evaluation which assessed feasibility and acceptability of the programme and trial processes. METHODS: Embedded qualitative design using the UK Medical Research Council's process evaluation framework. Semi-structured interviews with trial participants (N = 21) and CFs (N = 8). Thematic analysis was utilised. RESULTS: Peer-modelling, a non-judgemental environment, CFs facilitation of group support were viewed as acceptable programme related factors. Some participants expressed concerns about NRT side effects. Provision of free NRT was welcomed and accepted by participants, although structural barriers made access challenging. Pharmacists took on a role that became larger than originally envisaged - and the majority provided additional support to women in their quit attempts between group meetings which augmented and supplemented the intervention sessions provided by the CFs. Participants reported good acceptance of repeated measures for data collection, but mixed acceptability of provision of saliva samples. Low literacy affected the feasibility of some women to fully engage with programme and trial-related materials. This was despite efforts made by intervention developers and the trial team to make materials (e.g., participant intervention booklet; consent forms and participant information leaflets) accessible while also meeting requirements under 2018 European General Data Protection Regulation legislation. Hypothetical scenarios of direct (e.g., researcher present during programme delivery) and indirect (e.g., audio recordings of programme sessions) observational fidelity assessments for a future definitive trial (DT) were acceptable. CONCLUSIONS: Intervention and trial-related processes were generally feasible and acceptable to participants and CFs. Any future DT will need to take further steps to mitigate structural barriers to accessing free NRT; and the established problem of low literacy and low educational attainment in SED areas, while continuing to comply within the contemporary legislative research environment. TRIAL REGISTRATION: WCQ2 pilot trial ( ISRCTN74721694 ).