A cardiac-rehab behaviour intervention to reduce sedentary time in coronary artery disease patients: the SIT LESS randomized controlled trial.

BACKGROUND: High sedentary times (ST) is highly prevalent in patients with coronary artery disease (CAD), highlighting the need for behavioural change interventions that effectively reduce ST. We examined the immediate and medium-term effect of the SIT LESS intervention on changes in ST among CAD patients enrolled in cardiac rehabilitation (CR). METHODS: CAD patients participating in CR at 2 regional hospitals were included in this randomized controlled trial (1:1, stratified for gender and hospital). The control group received CR, whereas SIT LESS participants additionally received a 12-week hybrid behaviour change intervention. The primary outcome was the change in accelerometer-derived ST from pre-CR to post-CR and 3 months post-CR. Secondary outcomes included changes in ST and physical activity characteristics, subjective outcomes, and cardiovascular risk factors. A baseline constrained linear mixed-model was used. RESULTS: Participants (23% female; SIT LESS: n = 108, control: n = 104) were 63 ± 10 years. Greater ST reductions were found for SIT LESS compared to control post-CR (-1.7 (95% confidence interval (CI): -2.0; -1.4) versus - 1.1 (95% CI: -1.4; -0.8) h/day, pinteraction=0.009), but not at 3 months post-CR (pinteraction=0.61). Besides, larger light-intensity physical activity (LIPA) increases were found for SIT LESS compared to control post-CR (+ 1.4 (95% CI: +1.2; +1.6) versus + 1.0 (95% CI: +0.8; +1.3) h/day, pinteraction=0.020). Changes in other secondary outcomes did not differ among groups. CONCLUSION: SIT LESS transiently reduced ST and increased LIPA, but group differences were no longer significant 3 months post-CR. These findings highlight the challenge to induce sustainable behaviour changes in CAD patients without any continued support. TRIAL REGISTRATION: Netherlands Trial Register: NL9263. Registration Date: 24 February 2021.

Behavior Change Techniques Within Digital Interventions for the Treatment of Eating Disorders: Systematic Review and Meta-Analysis.

BACKGROUND: Previous systematic reviews of digital eating disorder interventions have demonstrated effectiveness at improving symptoms of eating disorders; however, our understanding of how these interventions work and what contributes to their effectiveness is limited. Understanding the behavior change techniques (BCTs) that are most commonly included within effective interventions may provide valuable information for researchers and developers. Establishing whether these techniques have been informed by theory will identify whether they target those mechanisms of action that have been identified as core to changing eating disorder behaviors. It will also evaluate the importance of a theoretical approach to digital intervention design. OBJECTIVE: This study aims to define the BCTs within digital self-management interventions or minimally guided self-help interventions for adults with eating disorders that have been evaluated within randomized controlled trials. It also assessed which of the digital interventions were grounded in theory and the range of modes of delivery included. METHODS: A literature search identified randomized controlled trials of digital intervention for the treatment of adults with eating disorders with minimal therapist support. Each digital intervention was coded for BCTs using the established BCT Taxonomy v1; for the application of theory using an adapted version of the theory coding scheme (TCS); and for modes of delivery using the Mode of Delivery Ontology. A meta-analysis evaluated the evidence that any individual BCT moderated effect size or that other potential factors such as the application of theory or number of modes of delivery had an effect on eating disorder outcomes. RESULTS: Digital interventions included an average of 14 (SD 2.6; range 9-18) BCTs. Self-monitoring of behavior was included in all effective interventions, with Problem-solving, Information about antecedents, Feedback on behavior, Self-monitoring of outcomes of behavior, and Action planning identified in >75% (13/17) of effective interventions. Social support and Information about health consequences were more evident in effective interventions at follow-up compared with postintervention measurement. The mean number of modes of delivery was 4 (SD 1.6; range 2-7) out of 12 possible modes, with most interventions (15/17, 88%) being web based. Digital interventions that had a higher score on the TCS had a greater effect size than those with a lower TCS score (subgroup differences: χ21=9.7; P=.002; I²=89.7%) within the meta-analysis. No other subgroup analyses had statistically significant results. CONCLUSIONS: There was a high level of consistency in terms of the most common BCTs within effective interventions; however, there was no evidence that any specific BCT contributed to intervention efficacy. The interventions that were more strongly informed by theory demonstrated greater improvements in eating disorder outcomes compared to waitlist or treatment-as-usual controls. These results can be used to inform the development of future digital eating disorder interventions. TRIAL REGISTRATION: PROSPERO CRD42023410060; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=410060.

[Behavioral treatment of functional anejaculation and factors influencing the therapeutic effect].

OBJECTIVE: To study the effect of a modified behavioral treatment (MBT) on functional anejaculation and analyze the factors influencing the therapeutic efficacy. METHODS: We enrolled in this study 59 men aged 24－45 years visiting the Andrology Clinic of Shanghai First Maternity and Infant Hospital from August 2019 to May 2021 and complaining of aejaculation in sexual intercourse but normally ejaculating during masturbation. Thirty-nine of the patients underwent conventional behavioral treatment (the CBT group) and the other 20 received MBT, namely, changing the masturbation method combined with audiovisual stimulation during sexual intercourse (the MBT group). We compared the therapeutic effects between the two groups of patients, and analyzed the correlation of the outcomes of MBT with age, abstinence duration, use of audiovisual stimulation, change of the sexual position, mean bilateral testis volume and sex hormone levels. RESULTS: After treatment, 22 (37.29%) of the patients achieved successful ejaculation at least once in sexual intercourse, 11 (55.00%) in the MBT group, and the other 11 (28.21) in the CBT group, with a significantly higher effectiveness rate in the former than in the latter (P<0.05). The effectiveness rate was significantly correlated to the method of standing-position masturbation plus sexual intercourse and reduction in the frequency of masturbation among various strategies of behavioral treatment (P<0.05). CONCLUSION: MBT has a certain effect on functional anejaculation, and targeting the previous events of the patient is the key to the therapeutic efficacy. Further exploration of more effective strategies of behavioral treatment will become the trend of development in the management of functional anejaculation.

Using the behaviour change wheel to develop a tailored intervention to overcome general practitioners' perceived barriers to referring insomnia patients to digital therapeutic sleepio.

BACKGROUND: Digital therapeutic Sleepio has proven effective in improving sleep quality and decreasing symptoms of anxiety. The National Institute for Health and Care Excellence (NICE) guidance recommends Sleepio as an alternative treatment to usual sleep hygiene education and hypnotic medications. General practitioners (GPs) play a critical role in the adoption of digital therapeutics in patient care. Previous interventions did not adopt theoretical frameworks to systematically understand GPs behaviour toward referring patients to digital therapeutics. OBJECTIVES: This study aimed to report the systematic and comprehensive development of an intervention to encourage GPs to refer insomnia patients to Sleepio, using the Behaviour Change Wheel (BCW). METHODS: The eight steps outlined in the BCW were followed to develop an intervention. The Capability Opportunity Motivation-Behaviour Self-Evaluation Questionnaire (COM-B-Qv1) was adopted to understand GPs perceived facilitators and barriers to refer insomnia patients to Sleepio. The Behaviour Change Technique Taxonomy Version 1 (BCTv1) was thereafter used to identify possible strategies that could be used to facilitate changes in GPs' behaviour in relation to Sleepio. RESULTS: The BCW design process resulted in the identification of five intervention functions, three policy categories and five behaviour change techniques (BCTs) as potential active components for an intervention. The intervention includes providing GPs with an orientation about using Sleepio to improve their knowledge and confidence, sending visual reminders to GPs to recommend Sleepio to their patients, providing ongoing technical support. CONCLUSION: The BCW can be successfully applied through a systematic process to understand the drivers of GPs' behaviour and to develop an intervention that can encourage them to refer insomnia patients to Sleepio.

Evaluating the Efficacy of Psycho-Behavioral Interventions for Cardiovascular Risk among People Living with HIV: A Systematic Review and Meta-Synthesis of Randomized Controlled Trials.

People with HIV (PWH) are disproportionately affected by cardiovascular disease (CVD). Psycho-behavioral therapies are capable of targeting the pathophysiology underlying HIV-CVD comorbidity. This study synthesized findings from randomized controlled trials (RCTs) of psycho-behavioral therapies for reducing CVD risk among PWH following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Inclusion criteria were: (1) utilized an RCT design, (2) evaluated a cognitive-behavioral or mindfulness-based therapy, (3) sampled adults (age ≥18 years) with HIV, (4) measured a behavioral (e.g., diet) or biological (e.g., immune functioning) CVD risk factor, and (5) published in an English-language peer-reviewed journal. Electronic searches were conducted in six databases (e.g., MEDLINE) using controlled vocabulary and free-text synonyms for HIV, psycho-behavioral therapy, and CVD risk. Data were independently extracted with consensus reached. Outcomes were immune activation, tobacco-smoking, stress, inflammation, and physical activity from 33 studies. There were stronger effects for psycho-behavioral interventions compared to controls on CD4 (Hedge's g=0.262, 95% Confidence Interval [CI]=0.127, 0.396) and tobacco-smoking abstinence (Hedge's g=0.537, 95% CI=0.215, 0.86). There were no differences or insufficient data for stress, inflammation, or physical activity. No eligible studies examined psycho-behavioral interventions on blood pressure, lipids, or weight in PWH. There is increasing importance to further invest in broader CVD risk reduction effort for PWH that include psycho-behavioral intervention strategies.

The utility of behavioral activation therapy in addressing emotional problems of two depressed students with borderline intellectual disability: A case study.

PURPOSE: Intellectual disability is one of the neurodevelopmental disorders. Studies indicated that depression and anxiety are the most prevalent emotional problems among the people with intellectual disability. The aim of this study was to investigate the utility of behavioral activation therapy in addressing emotional problems of two depressed students with borderline intellectual disability. METHOD: This study is a single-subject design with multiple baseline and one month follow-up. Two students with borderline intelligence underwent behavioral activation therapy for 12 sessions. Beck Depression Inventory-Second Edition, Beck Anxiety Inventory, Oxford Happiness Inventory and Rosenberg Self-Esteem Scale were used. Data were analyzed using visual inspection of graphed data, changes in trends, improvement percentage and effect size. FINDINGS: The findings of this study support the utility of behavioral activation therapy in addressing the emotional problems of two depressed students with borderline intellectual disability. CONCLUSION: Behavioral activation therapy has had favorable outcomes in reducing depression and anxiety in depressed students with borderline intellectual disabilities.

The effectiveness of internet-based group behavioural interventions on lifestyle modifications: A systematic review.

OBJECTIVES: To examine the effectiveness of internet-based group interventions incorporating social support elements in addressing behaviours related to smoking, nutrition, alcohol consumption, physical activity, and obesity. METHODS: A literature search was undertaken in six databases from inception to April 2024. Articles were eligible if they reported on group-based online interventions targeting smoking, nutrition, alcohol consumption, physical activity, and obesity, and included interactive features aimed at promoting social engagement and support. Two reviewers independently screened and assessed the quality of articles using Joanna Briggs Institute Critical Appraisal tools. A narrative analysis was used to synthesize and interpret the data to understand the effects of online interventions on lifestyle modifications. RESULTS: A total of 4063 citations underwent screening, resulting in 32 articles being deemed eligible and included in this review. Most studies examined physical activity (n = 14), followed by obesity (n = 7) and smoking (n = 6), Most studies were conducted in the USA (n = 14) and Australia (n = 11). Websites were the most utilised mode of intervention delivery (n = 11), followed by Facebook (n = 7) and mobile apps (n = 5). Group-based internet interventions were effective in improving smoking cessation, increasing physical activity and addressing obesity. However, there is insufficient data to determine their effect on promoting healthy nutrition and reducing alcohol intake. CONCLUSION: Group-based interventions delivered on the internet are effective in changing various health behaviours. This approach can offer large scale and cost-effective means to deliver behavioural interventions. However, the long-term effects and strategies for maintaining the behaviour changes are lacking, underscoring the need for further research.

Data Collection and Management of mHealth, Wearables, and Internet of Things in Digital Behavioral Health Interventions With the Awesome Data Acquisition Method (ADAM): Development of a Novel Informatics Architecture.

Unlabelled: The integration of health and activity data from various wearable devices into research studies presents technical and operational challenges. The Awesome Data Acquisition Method (ADAM) is a versatile, web-based system that was designed for integrating data from various sources and managing a large-scale multiphase research study. As a data collecting system, ADAM allows real-time data collection from wearable devices through the device's application programmable interface and the mobile app's adaptive real-time questionnaires. As a clinical trial management system, ADAM integrates clinical trial management processes and efficiently supports recruitment, screening, randomization, data tracking, data reporting, and data analysis during the entire research study process. We used a behavioral weight-loss intervention study (SMARTER trial) as a test case to evaluate the ADAM system. SMARTER was a randomized controlled trial that screened 1741 participants and enrolled 502 adults. As a result, the ADAM system was efficiently and successfully deployed to organize and manage the SMARTER trial. Moreover, with its versatile integration capability, the ADAM system made the necessary switch to fully remote assessments and tracking that are performed seamlessly and promptly when the COVID-19 pandemic ceased in-person contact. The remote-native features afforded by the ADAM system minimized the effects of the COVID-19 lockdown on the SMARTER trial. The success of SMARTER proved the comprehensiveness and efficiency of the ADAM system. Moreover, ADAM was designed to be generalizable and scalable to fit other studies with minimal editing, redevelopment, and customization. The ADAM system can benefit various behavioral interventions and different populations.

Motivation toward physical activity in patients with chronic musculoskeletal disorders: a meta-analysis of the efficacy of behavioural interventions.

Musculoskeletal disorders (MDs) represent a global health issue, which can lead to disability. Physical activity (PA) reduces pain and increases physical function among patients with MDs. To promote behavioural changes, it seems important to focus on modifiable factors, such as motivation. Thus, this review aims to assess effects of interventions targeting PA on motivation towards PA. Searches used terms referring to "physical activity", "motivation" and "chronic musculoskeletal disorders" on the databases PubMed, PsychINFO, MEDLINE, EMBASE, PEDro and Web of Science. All types of intervention-including but not limited to RCTs-were eligible for inclusion. Risk of bias was assessed with the Quality Assessment Tool for Studies with Diverse Designs (QATSDD). Among 6 489 abstracts identified, there were 387 eligible studies and 19 were included, reporting in total 34 effect sizes. The meta-analysis concerned 1 869 patients and indicated a small effect of interventions on change in motivation towards PA (d = 0.34; 95% CI [0.15; 0.54]; p < .01; k = 33). Behavioural interventions positively impact PA motivation in patients with MDs. In the literature, most studies focused on intervention's effect on fear of movement. Future research should assess other explicit motivational constructs, as well as implicit processes.

Behavioral KSA Intervention Class to Boost Positive Airway Pressure Adherence Among Active Duty Military Personnel With Obstructive Sleep Apnea.

INTRODUCTION: Obstructive sleep apnea (OSA) is a treatable cause of daytime sleepiness and associated medical problems that can negatively impact soldier readiness and performance. This study examined adherence to positive airway pressure (PAP) by soldiers who were newly diagnosed with OSA and prescribed PAP therapy and participated in a Knowledge, Skills, and Attitudes (KSA) behavioral intervention class. MATERIALS AND METHODS: The KSA was a one-time, interactive 90-minute class attended by up to 10 patients per class. PAP adherence was examined using Medicare standard at 30-, 60-, 90-, and 180 days post class. The analytic sample comprised 379 active duty patients (93% men; mean age 40.21 ± 8.06) categorized into 3 groups: KSA (n = 235), did not show (DNS; n = 61), and mandatory education class (MEC; n = 83). The MEC group comprised patients from an education class in a previous year. RESULTS: Baseline scores on the apnea hypopnea index, body mass index, sleepiness, insomnia severity, and age were non-significant among the 3 groups. At 30 days, significantly more patients in KSA (48%) and MEC (51%) were adherent than the DNS group (16%). At 60 days, the adherence rates for the KSA, DNS, and MEC were significantly different at 39%, 22%, and 27%, respectively. At 90- and 180 days, the adherence rates among the KSA, DNS, and MEC groups did not differ significantly at 34%, 17%, and 26% (90 days) and 34%, 27%, and 25% (180 days), respectively. Consistently, more patients in KSA were adherent than those in DNS and MEC, except at 30 days. Additionally, adherence rates for KSA intervention declined more gradually over the 6 month period. The mean PAP usage on nights used was 4.6 hours that computed to a 34% non-use rate based on an optimal 7-hour/night sleep time. CONCLUSION: KSA could be a behavioral intervention that enhances PAP adherence with a booster session implemented at the 90 days mark.

[Treatment of emotion regulation problems in people with neurofibromatosis type 1]. / Behandeling van emotieregulatieproblemen bij mensen met neurofibromatose type 1.

Individuals with the genetic disorder neurofibromatosis type 1 (NF1) are typically diagnosed in a medical hospital setting strongly relying on the presence of well-defined physical symptoms such as neurofibromas or pigmentary spots (known as café-au-lait spots). In mental health care settings, however, aside from a few highly specialized centres, the diagnosis and treatment of individuals with NF1 receives little attention, while the need for psychological treatment is increasingly identified, both in clinical practice and in the scientific literature. Occasional referrals of individuals with NF1 to the mental health services are often only targeted at psychological assessment. Subsequent treatment, however, is usually lacking. We describe two individuals with NF1 for whom by means of specialized clinical neuropsychological assessment, participation in a tailored dialectical behavior therapy (DBT) skills training was indicated. We exposit how they were able to develop their skills and how they themselves and their significant others experienced the treatment.

Obesity in Adults.

This JAMA Patient Page defines obesity in adults and describes the health effects of obesity, the treatment options available, and the health benefits of weight loss.

Behavioral change interventions, theories, and techniques to reduce physical inactivity and sedentary behavior in the general population: a scoping review.

BACKGROUND: Worldwide, physical inactivity (PIA) and sedentary behavior (SB) are recognized as significant challenges hindering the achievement of the United Nations (UN) sustainable development goals (SDGs). PIA and SB are responsible for 1.6 million deaths attributed to non-communicable diseases (NCDs). The World Health Organization (WHO) has urged governments to implement interventions informed by behavioral theories aimed at reducing PIA and SB. However, limited attention has been given to the range of theories, techniques, and contextual conditions underlying the design of behavioral theories. To this end, we set out to map these interventions, their levels of action, their mode of delivery, and how extensively they apply behavioral theories, constructs, and techniques. METHODS: Following the scoping review methodology of Arksey and O'Malley (2005), we included peer-reviewed articles on behavioral theories interventions centered on PIA and SB, published between 2010 and 2023 in Arabic, French, and English in four databases (Scopus, Web of Science [WoS], PubMed, and Google Scholar). We adopted a framework thematic analysis based on the upper-level ontology of behavior theories interventions, Behavioral theories taxonomies, and the first version (V1) taxonomy of behavior change techniques(BCTs). RESULTS: We included 29 studies out of 1,173 that were initially screened/searched. The majority of interventions were individually focused (n = 15). Few studies have addressed interpersonal levels (n = 6) or organizational levels (n = 6). Only two interventions can be described as systemic (i.e., addressing the individual, interpersonal, organizational, and institutional factors)(n = 2). Most behavior change interventions use four theories: The Social cognitive theory (SCT), the socioecological model (SEM), SDT, and the transtheoretical model (TTM). Most behavior change interventions (BCIS) involve goal setting, social support, and action planning with various degrees of theoretical use (intensive [n = 15], moderate [n = 11], or low [n = 3]). DISCUSSION AND CONCLUSION: Our review suggests the need to develop systemic and complementary interventions that entail the micro-, meso- and macro-level barriers to behavioral changes. Theory informed BCI need to integrate synergistic BCTs into models that use micro-, meso- and macro-level theories to determine behavioral change. Future interventions need to appropriately use a mix of behavioral theories and BCTs to address the systemic nature of behavioral change as well as the heterogeneity of contexts and targeted populations.

Brief behavioral intervention for chronic pain in integrated primary care: What are we waiting for?

Despite high rates of pain-related concerns among primary care patients and associated increases in health care costs (Gore et al., 2012; Mills et al., 2016), psychological or behavioral treatments that are well suited for use in integrated primary care (IPC) settings remain sparsely implemented. Psychological treatment for chronic pain has been recommended for many years (Darnall, 2021; Institute of Medicine (US) Committee on Advancing Pain Research, Care and Education, 2011; Kligler et al., 2018), and the emphasis on the application of nonpharmacological treatment has intensified following concerns about opioid safety. There is abundant empirical support for the use of psychological treatment for chronic pain, such as cognitive behavioral therapy (CBT) in specialty settings (Williams et al., 2021). The evidence to support the use of "brief treatments" in IPC is in a comparatively early stage. The limited state of the research might suggest that brief behavioral intervention for chronic pain is years away from being ready for translation to everyday clinical practice. But why wait? We therefore conducted a focused narrative review of peer-reviewed research on brief psychotherapy for chronic pain in adults that could be feasibly employed in IPC settings through more widely adopted models, such as primary care behavioral health. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Optimising a digitally delivered behavioural weight loss programme: study protocol for a factorial cluster randomised controlled trial.

BACKGROUND: Digitally delivered weight loss programmes can provide a convenient, potentially cheaper, and scalable treatment option for people who may need to lose weight. However, outcomes are often inferior to in-person interventions in the long-term. This trial will use principles from the Multiphase Optimisation Strategy (MOST) framework to test whether it can enhance the effectiveness of a commercial digital behavioural weight loss programme. This trial aims to identify an optimised combination of four intervention components to enhance weight loss over a 24-week period. We will also explore which components contribute to improvements in participant retention and engagement with the programme. METHODS: Approximately 1400 adults with a BMI > 21 kg/m2 will be enrolled and randomised to one of 16 experimental conditions in a 24 factorial cluster design. The trial will test four intervention components: an introductory video call with the health coach, drop-in webchat sessions with the health coach, goal setting statements, and food diary review and feedback. All participants will receive the core digital behavioural weight loss programme and up to four new intervention components. Participation in the trial will last for 24 weeks. The primary outcome will be weight change at 16 weeks. Other outcomes, measured at 4, 16, and 24 weeks, include programme drop-out and engagement (number of interactions with the three main app functions). Fidelity and acceptability will be assessed using data on component adherence and self-report questionnaires. Decision-making for the enhanced programme will be based on components that contribute to at least a minimal improvement in weight loss, defined as ≥ 0.75kg, alone or in combination with other components. DISCUSSION: The factorial design is an efficient way to test the efficacy of behavioural components alone, or in combination, to improve the effectiveness of digital weight loss programmes. This trial will test the implementation of the MOST framework in an industry setting, using routinely collected data, which may provide a better way to refine and evaluate these types of interventions in a model of continuous service improvement. TRIAL REGISTRATION: Trial registration: ISRCTN, ISRCTN14407868. Registered 5 January 2024, 10.1186/ISRCTN14407868.

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.

The Effectiveness of Dialectical Behavior Therapy Compared to Schema Therapy for Borderline Personality Disorder: A Randomized Clinical Trial.

INTRODUCTION: In the treatment of borderline personality disorder (BPD), there is empirical support for both dialectical behavior therapy (DBT) and schema therapy (ST); these treatments have never been compared directly. This study examines whether either of them is more effective than the other in treating patients with BPD. METHODS: In this randomized, parallel-group, rater-blind clinical trial, outpatients aged between 18 and 65 years with a primary diagnosis of BPD were recruited in a tertiary outpatient treatment center (Lübeck, Germany). Participants were randomized to DBT or ST with one individual and one group session per week over 1.5 years. The primary outcome was the BPD symptom severity assessed with the mean score of the Borderline Personality Disorder Severity Index at 1-year naturalistic follow-up. RESULTS: Between November 26, 2014, and December 14, 2018, we enrolled 164 patients (mean age = 33.7 [SD = 10.61] years). Of these, 81 (49.4%) were treated with ST and 83 (50.6%) with DBT, overall, 130 (79.3%) were female. Intention-to-treat analysis with generalized linear mixed models did not show a significant difference at 1-year naturalistic follow-up between DBT and ST for the BPDSI total score (mean difference 3.32 [95% CI: -0.58-7.22], p = 0.094, d = -24 [-0.69; 0.20]) with lower scores for DBT. Pre-to-follow-up effect sizes were large in both groups (DBT: d = 2.45 [1.88-3.02], ST: d = 1.78 [1.26-2.29]). CONCLUSION: Patients in both treatment groups showed substantial improvements indicating that even severely affected patients with BPD and various comorbid disorders can be treated successfully with DBT and ST. An additional non-inferiority trial is needed to show if both treatments are equally effective. The trial was retrospectively registered on the German Clinical Trials Register, DRKS00011534 without protocol changes.

Reduction in substance use stigma following a peer-recovery specialist behavioral activation intervention.

BACKGROUND: Patients' perceptions and experiences of stigma related to substance use and methadone treatment are barriers to successful treatment of opioid use disorder, particularly among low-income and medically underserved populations. Interventions led by peer recovery specialists (PRSs) may shift stigma-related barriers. This study sought to evaluate shifts in substance use and methadone treatment stigma in the context of an evidence-based behavioral intervention adapted for PRS delivery to support methadone treatment outcomes. METHODS: We recruited patients who had recently started methadone treatment or demonstrated difficulty with adherence from a community-based program (N = 37) for an open-label pilot study of a 12-session behavioral activation intervention led by a PRS interventionist. Participants completed substance use and methadone treatment stigma assessments and the SIP-R, a brief measure of problems related to substance use, at baseline, mid-point (approximately six weeks), and post-treatment (approximately 12 weeks). Generalized estimating equations assessed change in total stigma scores between baseline and post-treatment as well as change in stigma scores associated with change in SIP-R responses. RESULTS: There was a statistically significant decrease in substance use stigma (b(SE)=-0.0304 (0.0149); p = 0.042) from baseline to post-treatment, but not methadone treatment stigma (b(SE)=-0.00531 (0.0131); p = 0.68). Decreases in both substance use stigma (b(SE)=0.5564 (0.0842); p < 0.001) and methadone treatment stigma (b(SE)=0.3744 (0.1098); p < 0.001) were associated with a decrease in SIP-R scores. CONCLUSIONS: PRS-led interventions have potential to shift substance use stigma, which may be associated with decrease in problems related to substance use, and therefore merit further testing in the context of randomized controlled trials.

Nasal sprays and behavioural interventions compared with usual care for acute respiratory illness in primary care: a randomised, controlled, open-label, parallel-group trial.

BACKGROUND: A small amount of evidence suggests that nasal sprays, or physical activity and stress management, could shorten the duration of respiratory infections. This study aimed to assess the effect of nasal sprays or a behavioural intervention promoting physical activity and stress management on respiratory illnesses, compared with usual care. METHODS: This randomised, controlled, open-label, parallel-group trial was done at 332 general practitioner practices in the UK. Eligible adults (aged ≥18 years) had at least one comorbidity or risk factor increasing their risk of adverse outcomes due to respiratory illness (eg, immune compromise due to serious illness or medication; heart disease; asthma or lung disease; diabetes; mild hepatic impairment; stroke or severe neurological problem; obesity [BMI ≥30 kg/m2]; or age ≥65 years) or at least three self-reported respiratory tract infections in a normal year (ie, any year before the COVID-19 pandemic). Participants were randomly assigned (1:1:1:1) using a computerised system to: usual care (brief advice about managing illness); gel-based spray (two sprays per nostril at the first sign of an infection or after potential exposure to infection, up to 6 times per day); saline spray (two sprays per nostril at the first sign of an infection or after potential exposure to infection, up to 6 times per day); or a brief behavioural intervention in which participants were given access to a website promoting physical activity and stress management. The study was partially masked: neither investigators nor medical staff were aware of treatment allocation, and investigators who did the statistical analysis were unaware of treatment allocation. The sprays were relabelled to maintain participant masking. Outcomes were assessed using data from participants' completed monthly surveys and a survey at 6 months. The primary outcome was total number of days of illness due to self-reported respiratory tract illnesses (coughs, colds, sore throat, sinus or ear infections, influenza, or COVID-19) in the previous 6 months, assessed in the modified intention-to-treat population, which included all randomly assigned participants who had primary outcome data available. Key secondary outcomes were possible harms, including headache or facial pain, and antibiotic use, assessed in all randomly assigned participants. This trial was registered with ISRCTN, 17936080, and is closed to recruitment. FINDINGS: Between Dec 12, 2020, and April 7, 2023, of 19 475 individuals screened for eligibility, 13 799 participants were randomly assigned to usual care (n=3451), gel-based nasal spray (n=3448), saline nasal spray (n=3450), or the digital intervention promoting physical activity and stress management (n=3450). 11 612 participants had complete data for the primary outcome and were included in the primary outcome analysis (usual care group, n=2983; gel-based spray group, n=2935; saline spray group, n=2967; behavioural website group, n=2727). Compared with participants in the usual care group, who had a mean of 8·2 (SD 16·1) days of illness, the number of days of illness was significantly lower in the gel-based spray group (mean 6·5 days [SD 12·8]; adjusted incidence rate ratio [IRR] 0·82 [99% CI 0·76-0·90]; p<0·0001) and the saline spray group (6·4 days [12·4]; 0·81 [0·74-0·88]; p<0·0001), but not in the group allocated to the behavioural website (7·4 days [14·7]; 0·97 [0·89-1·06]; p=0·46). The most common adverse event was headache or sinus pain in the gel-based group: 123 (4·8%) of 2556 participants in the usual care group; 199 (7·8%) of 2498 participants in the gel-based group (risk ratio 1·61 [95% CI 1·30-1·99]; p<0·0001); 101 (4·5%) of 2377 participants in the saline group (0·81 [0·63-1·05]; p=0·11); and 101 (4·5%) of 2091 participants in the behavioural intervention group (0·95 [0·74-1·22]; p=0·69). Compared with usual care, antibiotic use was lower for all interventions: IRR 0·65 (95% CI 0·50-0·84; p=0·001) for the gel-based spray group; 0·69 (0·45-0·88; p=0·003) for the saline spray group; and 0·74 (0·57-0·94; p=0·02) for the behavioural website group. INTERPRETATION: Advice to use either nasal spray reduced illness duration and both sprays and the behavioural website reduced antibiotic use. Future research should aim to address the impact of the widespread implementation of these simple interventions. FUNDING: National Institute for Health and Care Research.