Low-intensity Intervention Research Articles

A remotely delivered intervention targeting adults with persisting mild-to-moderate post-concussion symptoms (GAIN Lite): a study protocol for a parallel group randomised trial

BackgroundWorldwide, mild traumatic brain injury, synonymous with concussion, affects more than 30–50 million each year. The incidence of concussion in Denmark is estimated to be about 20,000 yearly. Although complete resolution normally occurs within a few weeks, up to a third develop persistent post-concussion symptoms (PPCS) beyond 3 months. Evidence for effective treatment strategies is scarce. The objective of this study is to evaluate the efficacy of the novel intervention GAIN Lite added to enhanced usual care (EUC) for adults with mild-to-moderate PPCS compared to EUC only.MethodsAn open-label, parallel-group, two-arm randomised controlled superiority trial (RCT) with 1:1 allocation ratio. Potential participants will be identified through the hospital’s Business Intelligence portal of the Central Denmark Region or referred by general practitioners within 2–4 months post-concussion. Participants with mild-to-moderate PPCS will be randomly assigned to either (1) EUC or (2) GAIN Lite added to EUC. GAIN Lite is characterised as a complex intervention and has been developed, feasibility-tested and process evaluated before effect evaluation in the RCT. GAIN Lite contains an initial remote interview, self-administrated e-learning videos and voluntary remote counselling with an allocated occupational- or physiotherapist. Sixty-six participants will be recruited to each group. Primary outcomes are mean changes in PPCS and limitations in daily life from baseline to 24 weeks after baseline.DiscussionGAIN Lite is a low-intensity intervention for adults with mild-to-moderate PPCS. Offering a remote intervention may improve access to rehabilitation and prevent chronification for individuals with mild-to-moderate PPCS. Moreover, GAIN Lite will facilitate access to healthcare, especially for those with transportation barriers. Overall, GAIN Lite may provide an accessible, flexible and convenient way to receive treatment based on sound theories and previous evidence of effective interventions for adults with mild-to-moderate PPCS.Trial registrationClinicalTrials.gov NCT05233475. Registered on February 10, 2022.

Comparative efficacy of PsyPills and OCAT mobile psychological interventions in reducing depressive, anxiety and stress symptoms: A blinded randomized clinical trial

BackgroundDigital applications, such as in smartphone apps format, have shown high suggestive evidence for their efficacy in reducing general distress, but rigorous studies of their efficacy in symptom change and the mechanisms involved are still needed. MethodsIn the current multi-arm parallel-group randomized trial, participants aged 18–65 with smartphone access were recruited through social media. They were randomly assigned to two app interventions (PsyPills and OCAT) or an active placebo group (shamOCAT). The primary outcome was psychological distress measured up to one month. ResultsA total of 229 participants from diverse regional and demographic groups of the general population of Romania were randomly allocated into the three groups (PsyPills n = 80; OCAT n = 70; shamOCAT n = 79) and included in intention-to-treat analyses. Both the PsyPills (MD = −522; 95%CI = −10.00 to −0.44; d = 0.48) and OCAT (MD = −6.30; 95%CI = −11.39 to −1.21; d = 0.58) reduced significantly, with medium effect sizes, the psychological distress levels compared with the control group at follow-up. For the separate outcomes, only PsyPills showed significant medium reduction effects for anxiety symptoms (MD = −2.17; 95%CI = −3.83 to −0.50; d = −0.60), while OCAT showed reduction effects of small size for depression (MD = −1.50 (95%CI = −3.53 to 0.54, d = −0.34), that was however statistically nonsignificant. LimitationsWe registered high attrition and low adherence rates. Also, lower-than-planned effects might have been statistically underpowered to detect. ConclusionThe results support the high potential of both apps as scalable tools to provide low-intensity self-guided interventions for common psychological problems in the general population and expand opportunities for further research (e.g., confirm and capitulate on the differential effects).

HED-Start: A Brief Positive Psychology Cluster-Randomized Controlled Trial to Improve Psychological Adjustment in Patients New on Hemodialysis.

Initiation onto hemodialysis marks a critical transition with intense psychosocial demands. Interventions using cognitive-behavioral therapy to improve distress have been variably effective but require trained staff and are typically delivered only to those who screen positive for clinically significant distress. Interventions guided by positive psychology are lacking. To investigate the effectiveness of a brief positive-skills RCT in improving psychological adjustment in new hemodialysis patients. Using a parallel (2:1) design, blinded cluster-randomized controlled trial (cRCT) design, incident patients (<6 months at NKF dialysis centers) undergoing hemodialysis were randomized to intervention or usual care (UC). HED-Start intervention comprised four group sessions delivered by healthcare staff on positive emotions, acceptance, and life-orientated goal setting. Measures were taken at baseline (pre-randomization) and at 12 weeks: distress/mood (HADS; SPANE); quality of life (KDQOL-SF, WHOQOL-BREF); benefit-finding (BFS, BIPQ); life-oriented skills (HEIQ, CD-RISC-2); self-efficacy (CD-SES). A total of 147 participants enrolled in the trial (response rate, 51.0%; retention [assessment], 90.5%). Study arms were comparable on all baseline and outcome variables except for age, diabetic nephropathy, and hypertensive nephrosclerosis which were subsequently controlled for. Repeated measures ANCOVAs (intention to treat) were used. HED-Start yielded significant reductions over time in depression, and increased quality of life, self-efficacy, benefit finding, and skills relative to UC (moderate effect sizes). Rates of clinically significant depression significantly decreased in HED-Start (p < .001) and increased in UC (p = .002). The significant positive effects of HED-Start, a low-intensity and cost intervention, on several adjustment indices, suggest that programs focusing on positive life skills can value add to existing renal care services.

Effectiveness of community-based Baduanjin exercise intervention for older adults with varying frailty status: a randomized controlled trial

BackgroundDue to poorer exercise tolerance, it may be challenging for frail older adults to engage in moderate- or vigorous-intensity exercise. While low-intensity exercise interventions may be more feasible, its effectiveness for such population group remains unclear. We examined the effectiveness and implementation of community-based Baduanjin Qigong, a low-intensity exercise program in older adults with varying frailty status.MethodsA two-arm, multicenter assessor-blind parallel group randomized controlled trial was conducted at three local senior activity centers. Fifty-six community-dwelling older adults with low handgrip strength were randomly allocated to either the intervention (IG) or wait-list control (CG) group. The IG underwent a supervised 16-week Baduanjin exercise program at a frequency of 2–3 × 60 min sessions/week. The CG was instructed to maintain their usual activity and received a monthly health education talk. The primary outcome measures were knee extension strength, vital exhaustion, and fear of falling. Secondary outcome measures include physiological falls risk, handgrip strength, gait speed, timed up and go test, 30-second sit-to-stand, quality of life, depression, and frailty. All outcome measures were assessed at baseline and 4-month follow-up.ResultsOverall, there were no statistically significant differences in all outcome measures between CG and IG at 4-month follow-up. However, in exploratory compliance analysis, a statistically significant group x time interaction was found for vital exhaustion (B = -3.65, 95% CI [-7.13, -0.16], p = .047) among participants with at least 75% attendance. In post-hoc within-group comparisons, IG showed improved vital exhaustion by 4.31 points (95% CI [1.41, 7.20], d = 0.60). The average participant attendance rate was 81.3%. No major adverse events occurred, and all participants reported positive experiences with the exercise intervention.ConclusionsOur study demonstrated that Baduanjin is a safe, feasible, and acceptable exercise program that can be successfully implemented in community settings for older adults with varying frailty status. With good adherence, Baduanjin exercise could potentially be effective in alleviating vital exhaustion. However, the effectiveness of Baduanjin on physical performance, psychological measures and frailty in community-dwelling older adults remains equivocal.Trial registrationClinicalTrials.gov NCT04549103. Registered September 16, 2020.

Biometrically measured sleep in medical students as a predictor of psychological health and academic experiences in the preclinical years

ABSTRACT Background Student wellness is of increasing concern in medical education. Increased rates of burnout, sleep disturbances, and psychological concerns in medical students are well documented. These concerns lead to impacts on current educational goals and may set students on a path for long-term health consequences. Methods Undergraduate medical students were recruited to participate in a novel longitudinal wellness tracking project. This project utilized validated wellness surveys to assess emotional health, sleep health, and burnout at multiple timepoints. Biometric information was collected from participant Fitbit devices that tracked longitudinal sleep patterns. Results Eighty-one students from three cohorts were assessed during the first semester of their M1 preclinical curriculum. Biometric data showed that nearly 30% of the students had frequent short sleep episodes (<6 hours of sleep for at least 30% of recorded days), and nearly 68% of students had at least one episode of three or more consecutive days of short sleep. Students that had consecutive short sleep episodes had higher rates of stress (8.3%) and depression (5.4%) symptoms and decreased academic efficiency (1.72%). Conclusions Biometric data were shown to significantly predict psychological health and academic experiences in medical students. Biometrically assessed sleep is poor in medical students, and consecutive days of short sleep duration are particularly impactful as it relates to other measures of wellness. Longitudinal, biometric data tracking is feasible and can provide students the ability to self-monitor health behaviors and allow for low-intensity health interventions.

Recovery at your fingertips: pilot study of an mHealth intervention for work-related stress among nursing students

BackgroundWork-related stress is detrimental to individual health and incurs substantial social costs. Interventions to tackle this problem are urgently needed, with mHealth solutions being a promising way of delivering accessible and standardized interventions on a wide scale. This study pilot tests a low-intensive mHealth intervention designed to mitigate the negative consequences of stress through promoting recovery strategies.MethodsNursing school students (N = 16) used the intervention for a month. Data were collected immediately before, immediately after, and one month after the end of the intervention. Additionally, intensive longitudinal data were collected daily during the time of the intervention. Primary outcome measures include recruitment and retention rates, engagement with and acceptability of the intervention, as well as evaluating the quality of measurement instruments.ResultsRecruitment and retention rates provide a benchmark that we need to invite 10–12 times the intended target sample size. Engagement and acceptability metrics are promising overall, showing key areas that need to be adapted to improve the intervention. Measurement quality is acceptable with instruments mostly functioning as intended.ConclusionResults show that the intervention and study protocol are feasible for conducting a randomized controlled trial given a few adjustments. The randomization algorithm needs to match the sample size in order to allocate evenly distributed experimental groups. Acceptability of the intervention may be improved through adapting the recommended recovery strategies. Some additional outcome measures are suggested to provide a more comprehensive picture of intervention effects.Trial registrationNCT06228495. Registered retrospectively 01/10/2024.

Skill Enactment Among University Students Using a Brief Video-Based Mental Health Intervention: Mixed Methods Study Within a Randomized Controlled Trial.

Mental health problems are common among university students, yet many students do not seek professional help. Digital mental health interventions can increase students' access to support and have been shown to be effective in preventing and treating mental health problems. However, little is known about the extent to which students implement therapeutic skills from these programs in everyday life (ie, skill enactment) or about the impact of skill enactment on outcomes. This study aims to assess the effects of a low-intensity video-based intervention, Uni Virtual Clinic Lite (UVC-Lite), in improving skill enactment relative to an attention-control program (primary aim) and examine whether skill enactment influences symptoms of depression and anxiety (secondary aim). The study also qualitatively explored participants' experiences of, and motivations for, engaging with the therapeutic techniques. We analyzed data from a randomized controlled trial testing the effectiveness of UVC-Lite for symptoms of depression and anxiety among university students with mild to moderate levels of psychological distress. Participants were recruited from universities across Australia and randomly assigned to 6 weeks of self-guided use of UVC-Lite (243/487, 49.9%) or an attention-control program (244/487, 50.1%). Quantitative data on skill enactment, depression, and anxiety were collected through baseline, postintervention, and 3- and 6-month follow-up surveys. Qualitative data were obtained from 29 intervention-group participants through open-ended questions during postintervention surveys (n=17, 59%) and semistructured interviews (n=12, 41%) after the intervention period concluded. Mixed model repeated measures ANOVA demonstrated that the intervention did not significantly improve skill enactment (F3,215.36=0.50; P=.68). Skill enactment was also not found to influence change in symptoms of depression (F3,241.10=1.69; P=.17) or anxiety (F3,233.71=1.11; P=.35). However, higher levels of skill enactment were associated with lower symptom levels among both intervention and control group participants across time points (depression: F1,541.87=134.61; P<.001; anxiety: F1,535.11=73.08; P<.001). Inductive content analysis confirmed low levels of skill enactment among intervention group participants. Participants were motivated to use techniques and skills that were perceived to be personally relevant, easily integrated into daily life, and that were novel or had worked for them in the past. The intervention did not improve skill enactment or mental health among students with mild to moderate psychological distress. Low adherence impacted our ability to draw robust conclusions regarding the intervention's impact on outcomes. Factors influencing skill enactment differed across individuals, suggesting that it may be necessary to tailor therapeutic skills and engagement strategies to the individual user. Theoretically informed research involving collaboration with end users is needed to understand the processes underlying skill enactment in digital mental health interventions. Australian New Zealand Clinical Trials Registry ACTRN12621000375853; https://tinyurl.com/7b9ar54r.

The clinical effectiveness of the Mind/Body Program for Infertility on wellbeing and assisted reproduction outcomes: a randomized controlled trial in search for active ingredients.

Does the Mind/Body Program for Infertility (MBPI) perform better, due to certain distinctive elements, than a partly matched support group in improving the wellbeing and medically assisted reproduction (MAR) outcomes of women with elevated distress levels in a clinical setting? While robust enhancements occurred in the wellbeing overall, the cognitive behavioural and formalized stress management elements of the MBPI allowed a significantly stronger improvement in trait anxiety, but not in other mental health and MAR outcomes, compared with a support group. Mind-body psychological programmes adjacent to MAR have been found to improve women's mental states and possibly increase chances of pregnancy. However, not enough is known about the programme's effectiveness among patients with elevated distress levels in routine clinical settings, nor is it clear which of its particular ingredients are specifically effective. A pre-post design, single-centre, randomized controlled trial was performed between December 2019 and October 2022 (start and end of recruitment, respectively). The sample size (n = 168) was calculated to detect superiority of the MBPI in improving fertility-related quality of life. Randomization was computer-based, with random numbers concealing identities of patients until after allocation. The trial was conducted at a large university teaching hospital. A total of 168 patients were randomly assigned to the mind-body (MBPI) group (n = 84) and the fertility support (FS) control group (n = 84). Patients received a 10-week, 135-min/week group intervention, with the FS group following the same format as the MBPI group, but with a less restricted and systematic content, and without the presumed effective factors. The number of patients analysed was n = 74 (MBPI) and n = 68 (FS) for post-intervention psychological outcomes, and n = 54 (MBPI) and n = 56 (FS) for pregnancy outcomes at a 30-month follow-up. Significant improvements occurred in both groups in all psychological domains (adjusted P < 0.001), except for treatment-related quality of life. Linear mixed-model regression analysis did not reveal significantly greater pre-post improvements in the MBPI group than in the FS group in fertility-related quality of life (difference in differences (DD) = 4.11 [0.42, 7.80], d = 0.32, adjusted P = 0.124), treatment-related quality of life (DD = -3.08 [-7.72, 1.55], d = -0.20, adjusted P = 0.582), infertility-specific stress (DD = -2.54 [-4.68, 0.41], d = -0.36, adjusted P = 0.105), depression (DD = -1.16 [3.61, 1.29], d = -0.13, adjusted P = 0.708), and general stress (DD = -0.62 [-1.91, 0.68], d = -0.13, adjusted P = 0.708), but it did show a significantly larger improvement in trait anxiety (DD = -3.60 [-6.16, -1.04], d = -0.32, adjusted P = 0.042). Logistic regression showed no group effect on MAR pregnancies, spontaneous pregnancies, or live births. The follow-up only covered MAR-related medical outcomes and no psychological variables, and their rates were not equal in the two groups. Biological factors other than age, aetiology, and duration of infertility may have confounded the study results. Loss to follow-up was between 5% and 10%, which may have led to some bias. The psychologically and medically heterogeneous sample, the normal clinical setting and the low attrition rate all raise the external validity and generalizability of our study. The MBPI works not only in controlled conditions, but also in routine MAR practice, where it can be introduced as a cost-effective, low-intensity psychological intervention, within the framework of stepped care. More studies are needed to further identify its active ingredients. The authors received no financial support for the research, authorship, and/or publication of this article. The authors have no conflict of interest to disclose. ClinicalTrials.gov NCT04151485. 5 November 2019. 15 December 2019.

A pediatric primary care practice-based obesity intervention to support families: a cluster-randomized clinical trial.

The American Academy of Pediatrics recommends that pediatric practices help families make lifestyle changes to improve BMI, but provider time and access to treatment are limited. This study compared the effectiveness of two pediatric practice-based referral interventions in reducing BMI. In this cluster-randomized clinical trial, 20 pediatric primary care practices were randomized to telephonic coaching (Fitline Coaching) or mailed workbook (Fitline Workbook). Parents and their 8- to 12-year-old children with BMI ≥ 85th percentile completed assessments at baseline and at6 and 12 months post baseline. Primary outcomes were 12-month BMI percentile and z score. A total of 501 children and their parents received Fitline Coaching (n = 243) or Fitline Workbook (n = 258); 26.8% had overweight, 55.4% had obesity, and 17.8% had severe obesity. Mean (SD) age was 10.5 (1.4), and 47.5% were female. BMI percentile improved in both groups; 12-month decline in continuous BMI z score was not statistically significant in either group. However, 20.8% of telephonic coaching participants and 12.4% of workbook participants achieved a clinically significant reduction of at least 0.25 in BMI z score, a significant between-group difference (p = 0.0415). Both low-intensity interventions were acceptable and produced modest improvements in BMI percentile. One in five children in the telephonic coaching condition achieved clinically meaningful BMI z score improvements. However, more research is needed before such a program could be recommended for pediatric primary care practice.

Online, group, low-intensity psychological intervention for adults, children, and parents with food allergy

BackgroundFood allergy (FA) impairs psychological wellbeing because of constant vigilance, planning and preparation, dietary and social restrictions, and fear of accidental ingestion, though psychological interventions are sparse. ObjectiveTo examine online, group, low-intensity psychological interventions for adults, children, young people (CYP), and parents with food allergies. MethodsThe randomized controlled trials assessed the feasibility and signal of the efficacy of a psychological intervention for adults, CYP, and parents with FA. Participants were randomized to receive the psychological intervention or treatment as usual. The intervention consisted of two, 3-hour manualized online sessions spaced 1 week apart. All participants completed relevant Food Allergy Quality of Life Questionnaires (FAQLQ) and worry (Penn State Worry Questionnaires), in addition to exploratory outcomes, at baseline, 1 month, and 3 months. ResultsA total of 129 participants (n = 44 adults, n = 52 CYP, and n = 33 parents) were recruited and randomized; 95 (74%) (n = 36 adults, n = 35 CYP, and n = 24 parents) were retained at 3 months. Owing to baseline differences, mean change was used for parent and CYP outcomes. The psychological intervention demonstrated large FAQLQ benefits across adults (g = −1.12, 95% CI −0.41 to −1.28), CYP (g = 1.23, 95% CI 0.51-1.95), and parents (g = 1.43, 95% CI 0.54-2.30) compared with controls at 3-months. ConclusionThis study provides encouraging findings regarding the feasibility of online, group, low-intensity psychological interventions, in terms of recruitment and retention as well as a signal of efficacy on FAQLQ. A definitive trial including health economic analysis and FA-specific psychological measures with consideration of best routes to implementation, is warranted. Trial RegistrationClinicaltrials.gov Identifiers: NCT04763889 (adults), NCT04770727 (CYP), and NCT04774796 (parents).

The feasibility and acceptability of delivering a group trauma-focused intervention to children in care.

Young people in care (i.e., in the child welfare system) are a group who have often experienced very high rates of potentially traumatic events, including maltreatment. It is well-documented that they have high rates of trauma-related mental health difficulties, such as posttraumatic stress. To address the needs of the large number of young people who may benefit from support, scalable interventions are crucial. But also important is that they are effective and deliverable - particularly given the complexity of this group and services. We assessed a five-session group CBT-based intervention for PTSD. The primary goal was to understand core procedural and protocol uncertainties to address prior to a definitive trial. Participants were 34 10-17 year olds in care, with moderate to severe posttraumatic stress symptoms, and their caregiver. We ran seven groups (four online), delivered in social care and NHS-based mental health teams. Data were collected via pre-, post-, 3-month follow-up questionnaires and qualitative interviews. Of the 34 participants allocated to the intervention, 27 (80%) attended at least three of the five sessions (most attended all). Caregiver attendance was lower (50%). There was generally good completion of assessment measures. Qualitatively, most participants were positive about the intervention, and many reported improvements in areas such as coping, sleep, and willingness to talk about experiences. However, there were important concerns about the lack of ongoing support, given this was a low-intensity intervention for a group who often had complex needs. The intervention and research protocols were acceptable to most young people and carers. With modifications, a future definitive trial would likely be possible. However, key considerations include: how (and whether) to screen for PTSD; the trial design; and the option to embed high-intensity support (e.g., via assessing a stepped-care model).

Digital Interventions for Self-Management of Type 2 Diabetes Mellitus: Systematic Literature Review and Meta-Analysis.

The proliferation of digital technology has the potential to transform diabetes management. One of the critical aspects of modern diabetes management remains the achievement of glycemic targets to avoid acute and long-term complications. This study aims to describe the landscape of evidence pertaining to the relative effectiveness or efficacy and safety of various digital interventions for the self-management of type 2 diabetes mellitus (T2DM), with a primary focus on reducing glycated hemoglobin A1c (HbA1c) levels. A systematic literature review (SLR) was conducted by searching Embase, MEDLINE, and CENTRAL on April 5, 2022. Study selection, data extraction, and quality assessment were performed by 2 independent reviewers. Eligibility criteria for the SLR included randomized controlled trials (RCTs) and comparative observational studies evaluating interventions containing both human (eg, coaching) and digital components (eg, glucose meter) in adult patients with T2DM. The primary meta-analysis was restricted to studies that reported laboratory-measured HbA1c. In secondary analyses, meta-regression was performed with the intensity of coaching in the digital intervention as a categorical covariate. In total, 28 studies were included in this analysis. Most studies (23/28, 82%) used the reduction of HbA1c levels as the primary end point, either directly or as a part of a multicomponent outcome. In total, 21 studies reported statistically significant results with this primary end point. When stratified into 3 intervention categories by the intensity of the intervention supporting the digital health technology (analyzing all 28 studies), the success rate appeared to be proportional to the coaching intensity (ie, higher-intensity studies reported higher success rates). When the analysis was restricted to RCTs using the comparative improvement of HbA1c levels, the effectiveness of the interventions was less clear. Only half (12/23, 52%) of the included RCTs reported statistically significant results. The meta-analyses were broadly aligned with the results of the SLR. The primary analysis estimated a greater reduction in HbA1c associated with digital interventions compared with usual care (-0.31%, 95% CI -0.45% to -0.16%; P<.001). Meta-regression estimated reductions of -0.45% (95% CI -0.81% to -0.09%; P=.02), -0.29% (95% CI -0.48% to -0.11%; P=.003), and -0.28% (95% CI -0.65% to 0.09%; P=.20) associated with high-, medium-, and low-intensity interventions, respectively. These findings suggest that reducing HbA1c levels in individuals with T2DM with the help of digital interventions is feasible, effective, and acceptable. One common feature of effective digital health interventions was the availability of timely and responsive personalized coaching by a dedicated health care professional.

Administrative regulation-informed analysis of the developmental path of national volume-based procurement to improve drug accessibility in China.

The procurement of medicines via China's national volume-based procurement (NVBP) necessitates collaboration among various entities. This paper highlights the legal significance of the engagement of pharmaceutical companies, hospitals, and the National Healthcare Security Administration (NHSA) in improving drug accessibility. We conducted a numerical simulation using MATLAB to develop an evolutionary game model involving these three participants in NVBP. Our findings indicate that the final evolutionary stabilization strategies are pharmaceutical companies actively participating, hospitals using bid-winning medicines, and the NHSA implementing a low-intensity intervention. The study reveals that the evolutionary outcomes for hospitals and pharmaceutical companies are significantly affected by factors such as NHSA's subsidy level and pharmaceutical companies' level of participation. However, NHSA's decision-making process is less influenced by these factors. From a legal perspective, the successful implementation of NVBP, ensuring fairness and legality, requires adherence to relevant policies and regulations. The NHSA should employ statutory incentives and regulatory methods in formulating and adjusting NVBP policy to enable pharmaceutical companies, hospitals, and the NHSA to exercise their rights rationally within the legal framework of the game process.

A Pilot Study of BRAIN BOOTCAMP, a Low-Intensity Intervention on Diet, Exercise, Cognitive Activity, and Social Interaction to Improve Older Adults’ Dementia Risk Scores

BackgroundLittle is known about the impact of short, low-intensity multidomain dementia risk reduction interventions in older adults.ObjectivesTo examine the effectiveness and feasibility of a low-intensity multidomain lifestyle intervention on dementia risk and dementia literacy in Australian older adults.DesignSingle-group pre-post design.SettingCommunity-dwelling.ParticipantsA total of 853 older Australians (Mean age=73.3 years, SD=6.1) recruited from the community.InterventionA 3-month dementia risk reduction program, BRAIN BOOTCAMP, including education, personalised risk information, physical cues for healthier choices and goal setting and planning to target four modifiable risk factors of diet, exercise, cognitive activity and social interaction in older adults.MeasurementsThe ‘LIfestyle for BRAin health’ (LIBRA) index was used to assess participants’ modifiable dementia risk based on 12 factors, with higher scores indicating greater risk. Dementia literacy was measured using a modified questionnaire derived from Dutch and British surveys, encompassing knowledge, risk reduction, and awareness aspects. Paired t-tests were used to compare dementia risk scores and dementia literacy before and after the program. Multivariate regressions were performed to identify sociodemographic and psychological factors associated with change in the LIBRA index.ResultsProgram attrition was high (58.3%). Participants who completed the program had decreased dementia risk scores (Cohen’s d=0.59, p<0.001), increased dementia literacy and awareness (Cohen’s d=0.64, p<0.001) and increased motivation to change lifestyle behaviors (Cohen’s d=0.25–0.52, p<0.016). Participants with higher motivational beliefs had greater dementia risk reduction.ConclusionsImproving older adults’ motivation and knowledge may help modify lifestyle behaviors to reduce dementia risk. However, program attrition remains a challenge, suggesting the need for strategies to enhance participant engagement and retention in such interventions.

A multidomain lifestyle intervention to maintain optimal cognitive functioning in Dutch older adults—study design and baseline characteristics of the FINGER-NL randomized controlled trial

BackgroundEvidence on the effectiveness of multidomain lifestyle interventions to prevent cognitive decline in older people without dementia is mixed. Embedded in the World-Wide FINGERS initiative, FINGER-NL aims to investigate the effectiveness of a 2-year multidomain lifestyle intervention on cognitive functioning in older Dutch at risk individuals.MethodsMulti-center, randomized, controlled, multidomain lifestyle intervention trial with a duration of 24 months. 1210 adults between 60–79 years old with presence of ≥ 2 modifiable risk factors and ≥ 1 non-modifiable risk factor for cognitive decline were recruited between January 2022 and May 2023 via the Dutch Brain Research Registry and across five study sites in the Netherlands. Participants were randomized to either a high-intensity or a low-intensity intervention group. The multidomain intervention comprises a combination of 7 lifestyle components (physical activity, cognitive training, cardiovascular risk factor management, nutritional counseling, sleep counseling, stress management, and social activities) and 1 nutritional product (Souvenaid®) that could help maintain cognitive functioning. The high-intensity intervention group receives a personalized, supervised and hybrid intervention consisting of group meetings (on-site and online) and individual sessions guided by a trained lifestyle coach, and access to a digital intervention platform that provides custom-made training materials and selected lifestyle apps. The low-intensity intervention group receives bi-monthly online lifestyle-related health advice via the digital intervention platform. Primary outcome is 2-year change on a cognitive composite score covering processing speed, executive function, and memory.ResultsWithin 17 months, participant recruitment has been successfully completed (N = 1210; mean age: 67.7 years (SD: 4.6); 64% female). Modifiable risk factors commonly present at baseline were physical inactivity (89%), low mental/cognitive activity (50%), low social engagement (39%), hypertension (39%) and high alcohol consumption (39%). The mean body mass index of participants was 28.3 (SD: 4.2) and the total serum cholesterol was 5.4 mmol/L (SD: 1.2).ConclusionsBaseline lifestyle and clinical measurements showed successful recruitment of participants with sufficient potential for prevention. Results of FINGER-NL will provide further insight into the efficacy of a multidomain lifestyle intervention to prevent cognitive decline in older adults.Trial registrationClinicalTrials.gov (ID: NCT05256199)/2022–01-11.

Results from a Pilot Randomized Controlled Trial of a Single-Session Growth-Mindset Intervention for Internalizing Symptoms in Autistic Youth.

Autistic youth experience elevated rates of co-occurring internalizing symptoms. Interventions to treat internalizing symptoms in autistic youth are almost uniformly costly and time-intensive, blunting dissemination of intervention and highlighting the need for scalable solutions. One promising option is a relatively new class of evidence-based treatments, single-session interventions (SSIs), however, no study has examined SSIs for depression symptoms in autistic youth. Participants included 40 autistic adolescents ranging in age from 11 to 16 (Mage = 14.22, Nmale = 32). Eligible youth who agreed to participate were randomized to either the active intervention (Project Personality), or an active control designed to mimic supportive therapy. Participants and their caregiver completed questionnaires immediately before, after, and three months post intervention. All participants completed the intervention independently and largely reported enjoying it. The intervention was delivered with 100% fidelity. Findings demonstrated improvements in perceived primary control, malleability of personality, and social competence relative to the active control group immediately post-intervention. Further, results revealed improvements in self-reported depression symptoms and parent reported emotional regulation at 3-month follow up. This study was the first to assess a GM-SSI designed to treat depression symptoms in autistic adolescents. Results indicated improvements in perceived control immediately post-intervention and downstream improvements in depression. Nonetheless, we did not find improvements in symptoms of anxiety, suggesting that autistic adolescents may require modifications to the intervention to maximize benefit. Findings demonstrate the utility of GM-SSI for internalizing symptoms for autistic youth and hold considerable promise as a low-intensity and scalable intervention.

Novel medications for problematic alcohol use.

Alcohol-related harm, a major cause of disease burden globally, affects people along a spectrum of use. When a harmful pattern of drinking is present in the absence of significant behavioral pathology, low-intensity brief interventions that provide information about health consequences of continued use provide large health benefits. At the other end of the spectrum, profound behavioral pathology, including continued use despite knowledge of potentially fatal consequences, warrants a medical diagnosis, and treatment is strongly indicated. Available behavioral and pharmacological treatments are supported by scientific evidence but are vastly underutilized. Discovery of additional medications, with a favorable balance of efficacy versus safety and tolerability can improve clinical uptake of treatment, allow personalized treatment, and improve outcomes. Here, we delineate the clinical conditions when pharmacotherapy should be considered in relation to the main diagnostic systems in use and discuss clinical endpoints that represent meaningful clinical benefits. We then review specific developments in three categories of targets that show promise for expanding the treatment toolkit. GPCRs remain the largest category of successful drug targets across contemporary medicine, and several GPCR targets are currently pursued for alcohol-related indications. Endocrine systems are another established category, and several promising targets have emerged for alcohol indications. Finally, immune modulators have revolutionized treatment of multiple medical conditions, and they may also hold potential to produce benefits in patients with alcohol problems.

Interventions to increase vaccination in vulnerable groups: rapid overview of reviews

ObjectiveGroups which are marginalised, disadvantaged or otherwise vulnerable have lower uptake of vaccinations. This differential has been amplified in COVID-19 vaccination compared to (e.g.) influenza vaccination. This overview assessed the effectiveness of interventions to increase vaccination in underserved, minority or vulnerable groups.MethodsIn November 2022 we searched four databases for systematic reviews that included RCTs evaluating any intervention to increase vaccination in underserved, minority or vulnerable groups; our primary outcome was vaccination. We used rapid review methods to screen, extract data and assess risk of bias in identified reviews. We undertook narrative synthesis using an approach modified from SWiM guidance. We categorised interventions as being high, medium or low intensity, and as targeting vaccine demand, access, or providers.ResultsWe included 23 systematic reviews, including studies in high and low or middle income countries, focused on children, adolescents and adults. Groups were vulnerable based on socioeconomic status, minority ethnicity, migrant/refugee status, age, location or LGBTQ identity. Pregnancy/maternity sometimes intersected with vulnerabilities. Evidence supported interventions including: home visits to communicate/educate and to vaccinate, and facilitator visits to practices (high intensity); telephone calls to communicate/educate, remind/book appointments (medium intensity); letters, postcards or text messages to communicate/educate, remind/book appointments and reminder/recall interventions for practices (low intensity). Many studies used multiple interventions or components.ConclusionThere was considerable evidence supporting the effectiveness of communication in person, by phone or in writing to increase vaccination. Both high and low intensity interventions targeting providers showed effectiveness. Limited evidence assessed additional clinics or targeted services for increasing access; only home visits had higher confidence evidence showing effectiveness. There was no evidence for interventions for some communities, such as religious minorities which may intersect with gaps in evidence for additional services. None of the evidence related to COVID-19 vaccination where inequalities of outcome are exacerbated.Prospero registrationCRD42021293355

Clinical effectiveness and cost-effectiveness of Structured Psychological Support for people with probable personality disorder in mental health services in England: study protocol for a randomised controlled trial

IntroductionEvidence-based psychological treatments for people with personality disorder usually involve attending group-based sessions over many months. Low-intensity psychological interventions of less than 6 months duration have been developed, but their...

Data-Driven Exploration of National Health Service Talking Therapies Care Pathways Using Process Mining: Retrospective Cohort Study.

The National Health Service (NHS) Talking Therapies program treats people with common mental health problems in England according to "stepped care," in which lower-intensity interventions are offered in the first instance, where clinically appropriate. Limited resources and pressure to achieve service standards mean that program providers are exploring all opportunities to evaluate and improve the flow of patients through their service. Existing research has found variation in clinical performance and stepped care implementation across sites and has identified associations between service delivery and patient outcomes. Process mining offers a data-driven approach to analyzing and evaluating health care processes and systems, enabling comparison of presumed models of service delivery and their actual implementation in practice. The value and utility of applying process mining to NHS Talking Therapies data for the analysis of care pathways have not been studied. A better understanding of systems of service delivery will support improvements and planned program expansion. Therefore, this study aims to demonstrate the value and utility of applying process mining to NHS Talking Therapies care pathways using electronic health records. Routine collection of a wide variety of data regarding activity and patient outcomes underpins the Talking Therapies program. In our study, anonymized individual patient referral records from two sites over a 2-year period were analyzed using process mining to visualize the care pathway process by mapping the care pathway and identifying common pathway routes. Process mining enabled the identification and visualization of patient flows directly from routinely collected data. These visualizations illustrated waiting periods and identified potential bottlenecks, such as the wait for higher-intensity cognitive behavioral therapy (CBT) at site 1. Furthermore, we observed that patients discharged from treatment waiting lists appeared to experience longer wait durations than those who started treatment. Process mining allowed analysis of treatment pathways, showing that patients commonly experienced treatment routes that involved either low- or high-intensity interventions alone. Of the most common routes, >5 times as many patients experienced direct access to high-intensity treatment rather than stepped care. Overall, 3.32% (site 1: 1507/45,401) and 4.19% (site 2: 527/12,590) of all patients experienced stepped care. Our findings demonstrate how process mining can be applied to Talking Therapies care pathways to evaluate pathway performance, explore relationships among performance issues, and highlight systemic issues, such as stepped care being relatively uncommon within a stepped care system. Integration of process mining capability into routine monitoring will enable NHS Talking Therapies service stakeholders to explore such issues from a process perspective. These insights will provide value to services by identifying areas for service improvement, providing evidence for capacity planning decisions, and facilitating better quality analysis into how health systems can affect patient outcomes.