To Treatment As Usual Research Articles

Cost-utility analysis of adapted problem adaptation therapy for depression in mild-to-moderate dementia caused by Alzheimer's disease: PATHFINDER randomised controlled trial.

Depression is common in people with dementia, and negatively affects quality of life. This paper aims to evaluate the cost-effectiveness of an intervention for depression in mild and moderate dementia caused by Alzheimer's disease over 12 months (PATHFINDER trial), from both the health and social care and societal perspectives. A total of 336 participants were randomised to receive the adapted PATH intervention in addition to treatment as usual (TAU) (n = 168) or TAU alone (n = 168). Health and social care resource use were collected with the Client Service Receipt Inventory and health-related quality-of-life data with the EQ-5D-5L instrument at baseline and 3-, 6- and 12-month follow-up points. Principal analysis comprised quality-adjusted life-years (QALYs) calculated from the participant responses to the EQ-5D-5L instrument. The mean cost of the adapted PATH intervention was estimated at £1141 per PATHFINDER participant. From a health and social care perspective, the mean difference in costs between the adapted PATH and control arm at 12 months was -£74 (95% CI -£1942 to £1793), and from the societal perspective was -£671 (95% CI -£9144 to £7801). The mean difference in QALYs was 0.027 (95% CI -0.004 to 0.059). At £20 000 per QALY gained threshold, there were 74 and 68% probabilities of adapted PATH being cost-effective from the health and social care and societal perspective, respectively. The addition of the adapted PATH intervention to TAU for people with dementia and depression generated cost savings alongside a higher quality of life compared with TAU alone; however, the improvements in costs and QALYs were not statistically significant.

Executive functioning and nonverbal cognitive factors associated with response to technology-assisted language intervention

ObjectiveTo explore potential differences in the relationship between executive function (EF) skills and language development when integrating augmentative and alternative communication technology into speech-language therapy for deaf/hard of hearing (DHH) children. MethodRandomized trial data were analysed to investigate this relationship among children who participated in a Technology-Assisted Language Intervention (TALI) compared to treatment as usual (TAU). Language samples were assessed for pre-post-intervention changes, including mean length of utterance in morphemes (MLU), mean turn length (MTL), and number of different words spoken (NDW). EF skills were measured with standardized parent-report assessment. ResultsThirty-seven DHH children were included (TALI n = 19 and TAU n = 18). Results of regression models indicated that higher EF skills were significantly (p < 0.05) associated with improvements in MLU, MTL, and NDW among children who received TAU. No significant associations between EF skills and any of the measures (MLU, MTL, NDW) were seen in children who received TALI. ConclusionThese results suggest that TALI may offer language learning support, particularly for DHH children with EF difficulties. Future research should investigate the direct relationship between EF measurements and language outcomes in TALI recipients. Establishing baseline EF measurements in DHH children could inform personalized strategies within language interventions and therapy.

The effectiveness and cost-effectiveness of attachment-based family therapy for young adults with high suicidal ideation: protocol of a randomized controlled trial

BackgroundYoung adult suicidality is worldwide a prevalent mental health problem and the number one cause of death, with devastating consequences for individuals and their families, and substantial economic costs. However, psychological and pharmacological treatments currently recommended in guidelines for treatment of high-risk youth for fatal suicide have limited effect. In line with the World Health Organization’s (WHO) recommendation to involve the family in treatment of these youth, attachment-based family therapy (ABFT) was developed, a 16-week attachment and emotion-focused treatment, implemented in mental health care settings across various European countries in the past years, and becoming increasingly popular among therapists. However, the (cost-)effectiveness of ABFT has not been studied in emerging adults. In the proposed pragmatic randomized controlled trial (RCT), we aim to evaluate the effectiveness and cost-effectiveness of ABFT compared to treatment as usual (TAU) on suicidality, as delivered in daily practice.MethodsThis pragmatic multicenter study in the Netherlands and Belgium includes 13 participating sites. Participants are suicidal young adults (≥ 31 SIQ-JR score) between 16 and 30 years old who seek mental health treatment (n = 142) and their caregivers. The primary outcome is suicidality (SIQ-JR), with assessments at baseline, post-intervention (5 months after baseline), 3, 6, and 12 months after intervention. We predict that, compared to TAU, ABFT will lead to a stronger reduction in suicidality and will be more cost-effective, over the course of all time points. We also expect stronger decreases in depressive symptoms, given that suicidality is very common in individuals with depressive disorder, as well as more improvement in family functioning, autonomy, entrapment, and young adult attachment, in the ABFT condition.DiscussionThis study can contribute to improving the care for suicidal youngsters with high mortality risk. Treatment of suicidal emerging adults is understudied. The results will inform clinical guidelines and policy makers and improve treatment of suicidal emerging adults.Trial registrationThis trial is registered on ClinicalTrials.gov (NCT05965622, first posted on July 28, 2023).

Peer-led recovery groups for people with psychosis in South Africa (PRIZE): Results of a randomized controlled feasibility trial.

The aims of this feasibility trial were to assess the acceptability and feasibility of peer-led recovery groups for people with psychosis in a low-resource South African setting, to assess the feasibility of trial methods, and to determine key parameters in preparation for a definitive trial. The design was an individually randomised feasibility trial comparing recovery groups in addition to treatment as usual (TAU) with TAU alone. Ninety-two isiXhosa-speaking people with psychosis and forty-seven linked caregivers were recruited from primary care clinics and randomly allocated to trial arms in a 1:1 allocation ratio. TAU comprised anti-psychotic medication delivered in primary care. The intervention arm comprised six recovery groups including service users and caregivers. Two-hour recovery group sessions were delivered weekly in a 2-month auxiliary social worker (ASW)-led phase, then a 3-month peer-led phase. To explore acceptability and feasibility, a mixed methods process evaluation included 25 in-depth interviews and 2 focus group discussions at 5months with service users, caregivers and implementers, and quantitative data collection including attendance and facilitator competence. To explore potential effectiveness, quantitative outcome data (functioning, relapse, unmet needs, personal recovery, stigma, health service use, medication adherence and caregiver burden) were collected at baseline, 2months and 5months post randomisation. Trial registration: PACTR202202482587686. Qualitative interviews revealed that recovery groups were broadly acceptable with most participants finding groups to be an enjoyable opportunity for social interaction, and joint problem-solving. Peer facilitation was a positive experience; however a minority of participants did not value expertise by lived experience to the same degree as expertise of professional facilitators. Attendance was moderate in the ASW-led phase (participants attended 59% sessions on average) and decreased in the peer-led phase (41% on average). Participants desired a greater focus on productive activities and financial security. Recovery groups appeared to positively impact on relapse. Relapse occurred in 1 (2.2%) of 46 participants in the recovery group arm compared to 8 (17.4%) of 46 participants in the control arm (risk difference -0.15 [95% CI: -0.26; -0.05]). Recovery groups also impacted on the number of days in the last month totally unable to work (mean 1.4days recovery groups vs 7.7days control; adjusted mean difference -6.3 [95%CI: -12.2; -0.3]). There were no effects on other outcomes. Peer-led recovery groups for people with psychosis in South Africa are potentially acceptable, feasible and effective. A larger trial, incorporating amendments such as increased support for peer facilitators, is needed to demonstrate intervention effectiveness definitively.

Evaluation of the Effectiveness of a Group CBT-Based Intervention Aiming to Reduce Self-Stigma and Improve Recovery-Related Outcomes in People with Severe Mental Disorders: Randomised Controlled Trial.

Self-stigma is a major barrier to personal and clinical recovery in people with mental illness. Although psychosocial interventions have been developed to reduce self-stigma, the exploration of group CBT-based interventions for hospitalised patients are less represented. The purpose of this trial is to investigate the effectiveness of a group CBT-based intervention aiming to reduce self-stigma and improve recovery-related outcomes such as self-esteem, stigma resistance and sense of coherence, which comes down to saying, "I am what I am". A total of 104 patients admitted to the inpatient therapy were recruited to participate in a randomised controlled clinical trial, and 77 participants (46 in the intervention group and 31 in the control group) completed the trial. Constructs of interest were measured before and after the intervention. The results showed that the evaluated intervention was effective in improving sense of coherence and stigma resistance, compared to treatment as usual (TAU). The level of self-stigma significantly decreased in both the intervention and control groups, but no statistically significant difference was observed between the groups. The limitations of the study include: the lack of assessment of the sustainability of the effects of therapy (follow-up), the presence of intensive interventions of the ward's programme and patients pre-qualified for the ward based on admission criteria. The intervention "I am what I am," has proven to be effective, especially in increasing the level of personal resources needed to build clinical and personal recovery and to counteract the negative consequences of self-stigma.

Efficacy of a Culturally Adapted Emotion Recognition Training Program in Improving Facial Emotion Recognition in Persons with Schizophrenia

Background: Facial emotion recognition (FER) deficits are being considered as core features of social cognitive deficits in schizophrenia, associated with socio-occupational dysfunction. Social cognition intervention programs have been shown to improve these deficits; however, there are no such intervention strategies in India. In this study, we aim to examine the efficacy of Training of Affect Recognition – Indian Version (TAR-IV) to enhance the FER abilities of people with schizophrenia. Methods: In an open-label experimental design, 36 participants with schizophrenia underwent 12 sessions of TAR-IV as an add-on to treatment as usual (TAU), while 29 participants with schizophrenia continued TAU (pharmacological treatment with or without occupational therapy and vocational rehabilitation services). Clinical and functional assessments were done using the positive and negative syndrome scale (PANSS) and socio-occupational functioning scale. Emotion recognition abilities were assessed on the tool for recognition of emotions in neuropsychiatric disorders at baseline, post-intervention, and follow-up (two to three months post-intervention). Results: The intervention group showed significant improvements in FER ( P = .001) and socio-occupational functioning ( P = .008) after receiving the TAR-IV, which remained significant at two months follow-up. A lower age of onset and poorer neurocognitive function at baseline predicted greater changes in emotion recognition ability following the intervention. Conclusions: This study demonstrated the efficacy of TAR-IV, the Indian adaptation of social cognition intervention, in improving emotion recognition abilities and socio-occupational functioning in patients with schizophrenia. These findings need to be replicated in randomized controlled trials.

Early Intervention after Rape to prevent post-traumatic stress symptoms (the EIR-study): an internal pilot study of a randomized controlled trial

BackgroundRape is one of the trauma incidents with the highest risk of subsequent post-traumatic stress disorder. Early interventions, such as prolonged exposure therapy (PE), have shown promise in preventing PTSD following a sexual assault. The primary objective of this internal pilot trial was to examine the feasibility of the EIR study protocol, which used modified prolonged exposure therapy (mPE) as a preventive intervention after rape.MethodsThis parallel two-arm clinical pilot study involved three sexual assault centers (SACs) in Trondheim, Oslo, and Vestfold, with data collected between June 2022 and March 2023. Women seeking assistance at one of these three SACs within 72 h after rape or attempted rape received acute medical treatment and forensic examinations. Women who wanted further psychosocial treatment were, if eligible and consenting, recruited to complete baseline assessments and a clinical interview before being randomized to one of two study arms. The intervention group prescribed up to five sessions of modified PE (mPE) in addition to treatment as usual (TAU), starting within the first 14 days after the rape incident, followed by weekly sessions. The other group received TAU.The present pilot evaluation is based on 22 participants, i.e., nine mPE + TAU and 13 TAU alone. Primary outcomes were predefined progression criteria regarding recruitment, retention, intervention implementation, a harm reporting system, and applying biological measurements and actigraphy.ResultsDuring the 6-month recruitment period, 235 women visited the three SACs. After eligibility screening and consent, 22 (9.4%) women were randomized. Three months later, 14 (63.6%) participants completed the final assessments. Intervention implementation was successful using trained SAC personnel to deliver mPE. The harm reporting system was used according to the study’s plan, and adverse and serious adverse events were detected during the trial. The biological measurements and actigraphy had substantial missing data but were still considered usable for statistical analyses.ConclusionIt may be feasible to conduct a full-scale RCT of early intervention after rape by comparing mPE + TAU to TAU alone. Minor design refinements were made to the protocol to enhance the main study outcome.Trial registrationClinicalTrials.gov Identifier: NCT05489133. Registered on 15 July 2022, retrospectively.

Addressing depression and comorbid health conditions through solution-focused brief therapy in an integrated care setting: a randomized clinical trial

BackgroundCo-occurring physical and mental health conditions are common, but effective and sustainable interventions are needed for primary care settings.PurposeOur paper analyzes the effectiveness of a Solution-Focused Brief Therapy (SFBT) intervention for treating depression and co-occurring health conditions in primary care. We hypothesized that individuals receiving the SFBT intervention would have statistically significant reductions in depressive and anxiety symptoms, systolic blood pressure (SBP), hemoglobin A1C (HbA1c), and body mass index (BMI) when compared to those in the control group. Additionally, we hypothesized that the SFBT group would have increased well-being scores compared to the control group.MethodsA randomized clinical trial was conducted at a rural federally qualified health center. Eligible participants scored ≥ 10 on the Patient Health Questionnaire (PHQ-9) and met criteria for co-occurring health conditions (hypertension, obesity, diabetes) evidenced by chart review. SFBT participants (n = 40) received three SFBT interventions over three weeks in addition to treatment as usual (TAU). The control group (n = 40) received TAU over three weeks. Measures included depression (PHQ-9) and anxiety (GAD-7), well-being (Human Flourishing Index), and SFBT scores, along with physical health outcomes (blood pressure, body mass index, and hemoglobin A1c).ResultsOf 80 consented participants, 69 completed all measures and were included in the final analysis. 80% identified as female and the mean age was 38.1 years (SD = 14.5). Most participants were white (72%) followed by Hispanic (15%) and Black (13%). When compared to TAU, SFBT intervention participants had significantly greater reductions in depression (baseline: M = 18.17, SD = 3.97, outcome: M = 9.71, SD = 3.71) and anxiety (baseline: M = 14.69, SD = 4.9, outcome: M = 8.43, SD = 3.79). SFBT intervention participants also had significantly increased well-being scores (baseline: M = 58.37, SD = 16.36, outcome: M = 73.43, SD = 14.70) when compared to TAU. Changes in BMI and blood pressure were not statistically significant.ConclusionThe SFBT intervention demonstrated efficacy in reducing depressive and anxiety symptoms and increasing well-being but did not affect cardio-metabolic parameters over a short period of intervention.Trial RegistrationThe study was pre-registered at ClinicalTrials.gov Identifier: NCT05838222 on 4/20/2023. *M = Mean, SD = Standard deviation.

Reducing Distress from Auditory Verbal Hallucinations: A Multicenter, Parallel, Single-Blind, Randomized Controlled Feasibility Trial of Relating Therapy

Introduction: There is a significant demand for interventions that reduce distress related to auditory verbal hallucinations (AVHs). AVH distress is associated with the way voice hearers relate with AVHs. We aimed to establish the feasibility of a randomized controlled trial to demonstrate that adding “Relating Therapy” (RT) to treatment as usual (TAU) is superior to TAU in reducing AVH distress. Methods: We conducted a multicenter, parallel, single-blind, randomized controlled feasibility trial in five mental health centers in Germany. Participants were ≥19 years of age, had persistent and distressing AVHs, and had a diagnosis of a schizophrenia-spectrum disorder. RT was delivered over a maximum of 16 sessions within 5 months. Blind assessments were conducted at baseline and at 5 and 9 months. Feasibility outcomes were the number of patients recruited and retained, and safety and therapist adherence. The primary endpoint was the distress factor score of the AVH subscale of the Psychotic Symptoms Rating Scales at 9 months. Results: Eighty-five of 177 enrolled participants were randomized into RT + TAU (n = 43) or TAU (n = 42). Feasibility was excellent with 87% retention at 9 months, 86% reaching treatment uptake criteria, 98% therapist adherence, and no unexpected serious adverse reactions. Compared to TAU, RT + TAU showed nonsignificant trends toward less AVH distress (b = −2.40, SE = 1.52, p = 0.121, 90% CI (−4.94 to 0.15) and stronger improvement on all but one of the secondary outcomes. Conclusion: A randomized controlled trial of RT is feasible, safe, and well accepted. Our results provide an encouraging basis to further test the efficacy of RT in a definitive multicenter trial.

Yoga and Physical Therapy for Chronic Pain and Opioid Use Disorder Onsite in an Opioid Treatment Program: A Randomized Controlled Trial.

There is a lack of integrated treatment for chronic pain and opioid use disorder (OUD). Yoga and physical therapy (PT) may improve pain and physical function of people living with (PLW) chronic low back pain (CLBP) and may also reduce opioid craving and use, but PLW with OUD face barriers to accessing these interventions. We hypothesize that compared to treatment as usual (TAU), providing yoga and PT onsite at opioid treatment programs (OTPs) will be effective at improving pain, opioid use, and quality of life among people with CLBP and OUD, and will be cost-effective. In this hybrid type-1 effectiveness-implementation study, we will randomly assign 345 PLW CLBP and OUD from OTPs in the Bronx, NY, to 12 weeks of onsite yoga, onsite PT, or TAU. Primary outcomes are pain intensity, opioid use, and cost-effectiveness. Secondary outcomes include physical function and overall well-being. This trial tests an innovative, patient-centered approach to combined management for pain and OUD in real-world settings. We rigorously examine the efficacy of yoga and PT onsite at OTPs as nonpharmacologic, cost-effective treatments among people with CLBP and OUD who face barriers to integrated care.

Embodied Spatial Navigation Training in Mild Cognitive Impairment: A Proof-of-Concept Trial.

Egocentric and allocentric spatial memory impairments affect the navigation abilities of older adults with mild cognitive impairment (MCI). Embodied cognition research hints that specific aids can be implemented into virtual reality (VR) training to enhance spatial memory. In this study, we preliminarily tested 'ANTaging', an embodied-based immersive VR training for egocentric and allocentric memory, compared to treatment as usual (TAU) spatial training in MCI. MCI patients were recruited for this controlled trial. A cognitive battery was administered at pre-test, after ten sessions of ANTaging or TAU intervention, and at 3-month follow-up (FU). The primary outcomes were spatial cognition tests (Corsi supra-span, CSS; Manikin test, MT). VR egocentric and allocentric performance was also collected. We found that ANTaging significantly improved MT scores at FU compared to TAU. CSS slightly improved in both groups. Concerning secondary outcomes, auditory-verbal forgetting significantly improved at post-test in the ANTaging but not TAU group and significantly declined at FU in the TAU but not in the ANTaging group. Global cognition significantly improved at FU for TAU and remained stable for ANTaging. Other tests showed no improvement or deterioration. Clinical significance showed that ANTaging is effective for CSS. Virtual egocentric and allocentric memory performance improved across ANTaging sessions. ANTaging holds the potential to be superior for improving spatial cognition in MCI compared to TAU. Embodied cognition research provides insights for designing effective spatial navigation rehabilitation in aging.

Reducing intrusive suicidal mental images in patients with depressive symptoms through a dual-task add-on module: Results of a multicenter randomized clinical trial.

To examine the safety and efficacy of a brief cognitive dual-task (using eye movements) add-on module to treatment as usual (TAU) in reducing the severity and frequency of intrusive suicidal mental images and suicidal ideation. We conducted a single-blind, parallel multicenter randomized trial (No. NTR7563) among adult psychiatric outpatients (N = 91; Mage = 34.4, SD = 13.54; 68% female) with elevated depressive symptoms and experiencing distressing suicidal intrusions in the Netherlands. Primary outcome was the severity (Suicidal Intrusions Attributes Scale) and frequency (Clinical Interview for Suicidal Intrusions) of suicidal mental imagery intrusions at 1-week posttreatment and 3-month follow-up. Primary analysis was intention-to-treat. Between November 27, 2018 and September 13, 2021, 91 patients were included and randomly assigned to intervention group (Cognitive Dual Task Add-on + TAU) (n = 46) or TAU-only (n = 45). Cognitive Dual Task Add-on + TAU had greater reductions in severity (mean difference, -15.50, 95% CI [23.81, -7.19]; p < .001, d = 0.60), and frequency (geometric mean difference, 0.47, 95% CI [0.29, 0.79]; p = .004) of suicidal intrusions over time than TAU-alone. Cognitive Dual Task Add-on + TAU patients also showed lower suicidal ideation over time (p = .008, d = 0.42). There were no significant group differences in reductions in depressive symptoms, rumination, or hopelessness. Four serious adverse events occurred (three Cognitive Dual Task Add-on + TAU; one TAU-only); all unlikely attributable to intervention/trial. Findings provide support for the effectiveness of adding a cognitive dual-task module to the treatment of psychiatric outpatients with elevated depressive symptoms in reducing suicidal intrusions and ideation and can be executed safely. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Study protocol for an adaptive, multi-arm, multi-stage (MAMS) randomised controlled trial of brief remotely delivered psychosocial interventions for people with serious mental health problems who have experienced a recent suicidal crisis: Remote Approaches to Psychosocial Intervention Delivery (RAPID)

BackgroundPeople with serious mental health problems (SMHP) are more likely to be admitted to psychiatric hospital following contact with crisis services. Admissions can have significant personal costs, be traumatic and are the most expensive form of mental health care. There is an urgent need for treatments to reduce suicidal thoughts and behaviours and reduce avoidable psychiatric admissions.MethodsA multi-stage, multi-arm (MAMS) randomised controlled trial (RCT) with four arms conducted over two stages to determine the clinical and cost effectiveness of three psychosocial treatments, compared to treatment as usual (TAU), for people with SMHP who have had recent suicidal crisis. Primary outcome is any psychiatric hospital admissions over a 6-month period. We will assess the impact on suicidal thoughts and behaviour, hope, recovery, anxiety and depression. The remote treatments delivered over 3 months are structured peer support (PREVAIL); a safety planning approach (SAFETEL) delivered by assistant psychologists; and a CBT-based suicide prevention app accessed via a smartphone (BrighterSide). Recruitment is at five UK sites. Stage 1 includes an internal pilot with a priori progression criteria. In stage 1, the randomisation ratio was 1:1:1:2 in favour of TAU. This has been amended to 2:2:3 in favour of TAU following an unplanned change to remove the BrighterSide arm following the release of efficacy data from an independent RCT. Randomisation is via an independent remote web-based randomisation system using randomly permuted blocks, stratified by site. An interim analysis will be performed using data from the first 385 participants from PREVAIL, SAFETEL and TAU with outcome data at 6 months. If one arm is dropped for lack of benefit in stage 2, the allocation ratio of future participants will be 1:1. The expected total sample size is 1064 participants (1118 inclusive of BrighterSide participants).DiscussionThere is a need for evidence-based interventions to reduce psychiatric admissions, via reduction of suicidality. Our focus on remote delivery of established brief psychosocial interventions, utilisation of different modalities of delivery that can provide sustainable and scalable solutions, which are also suitable for a pandemic or national crisis context, will significantly advance treatment options.Trial registrationISRCTN33079589. Registered on June 20, 2022.

Randomised pilot study comparing a coach to SMARTPhone reminders to aid the management of heart failure (HF) patients: humans or machines

Ambulatory management of congestive heart failure (HF) continues to be a challenging clinical problem. Recent studies have focused on the role of HF clinics, nurse practitioners and disease management programmes...

The cost effectiveness of early assessment and intervention by a dedicated health and social care professional team for older adults in the emergency department compared to treatment-as-usual: Economic evaluation of the OPTI-MEND trial.

Over 65s are frequent attenders to the Emergency Department (ED) and more than half are admitted for overnight stays. Early assessment and intervention by a dedicated ED-based Health and Social Care Professionals (HSCP) team reduces ED length of stay and the risk of hospital admissions among older adults while improving patient health-related quality-of-life and satisfaction with care. This study aims to evaluate whether augmenting the treatment as usual for older adults admitted to ED is cost-effective. Cost-effectiveness analysis (CEA), conducted alongside the OPTI-MEND randomised controlled trial of 353 patients aged ≥65 with lower urgency complaints compared the effectiveness of early assessment and intervention by a dedicated HSCP team in the ED to treatment as usual (TAU). An economic analysis estimated the average cost per older adults randomised to the HSCP team, and compared to TAU, how contact with HSCP team changed health care use, and associated total costs, and estimated the effect of HSCP on Quality-Adjusted Life Years (QALYs). Within the OPTI-MEND trial, the average cost of a contact with the HSCP team during ED attendance is estimated to be €801 per patient. Compared to TAU, the incremental QALY of intervention is 0.053 (95% CI: 0.023 to 0.0826, p<0.0001). Accounting for cost savings because of contact with HSCP team, the average incremental saving in the total cost, compared to TAU, is -€6,128 (95% CI: -€9,217 to -€3,038, p<0.0001). Given the incremental health gains and significant cost savings, bootstrapped cost CEA suggests that dedicated HSCP care dominates over TAU for low urgency older adults attending the ED. A dedicated HSCP team in the ED significantly improves overall health for lower acuity older adults and, by reducing inpatient length of stay, results in staggering cost savings. This economic evaluation conducted on the OPTI-MEND trial provides convincing evidence that HSCP should be adopted as part of treatment as usual in Irish EDs. ClinicalTrials.gov, NCT03739515; registered on 12th November 2018. https://classic.clinicaltrials.gov/ct2/show/NCT03739515.

Strategies, processes, outcomes, and costs of implementing experience sampling-based monitoring in routine mental health care in four European countries: study protocol for the IMMERSE effectiveness-implementation study

BackgroundRecent years have seen a growing interest in the use of digital tools for delivering person-centred mental health care. Experience Sampling Methodology (ESM), a structured diary technique for capturing moment-to-moment variation in experience and behaviour in service users’ daily life, reflects a particularly promising avenue for implementing a person-centred approach. While there is evidence on the effectiveness of ESM-based monitoring, uptake in routine mental health care remains limited. The overarching aim of this hybrid effectiveness-implementation study is to investigate, in detail, reach, effectiveness, adoption, implementation, and maintenance as well as contextual factors, processes, and costs of implementing ESM-based monitoring, reporting, and feedback into routine mental health care in four European countries (i.e., Belgium, Germany, Scotland, Slovakia).MethodsIn this hybrid effectiveness-implementation study, a parallel-group, assessor-blind, multi-centre cluster randomized controlled trial (cRCT) will be conducted, combined with a process and economic evaluation. In the cRCT, 24 clinical units (as the cluster and unit of randomization) at eight sites in four European countries will be randomly allocated using an unbalanced 2:1 ratio to one of two conditions: (a) the experimental condition, in which participants receive a Digital Mobile Mental Health intervention (DMMH) and other implementation strategies in addition to treatment as usual (TAU) or (b) the control condition, in which service users are provided with TAU. Outcome data in service users and clinicians will be collected at four time points: at baseline (t0), 2-month post-baseline (t1), 6-month post-baseline (t2), and 12-month post-baseline (t3). The primary outcome will be patient-reported service engagement assessed with the service attachment questionnaire at 2-month post-baseline. The process and economic evaluation will provide in-depth insights into in-vivo context-mechanism-outcome configurations and economic costs of the DMMH and other implementation strategies in routine care, respectively.DiscussionIf this trial provides evidence on reach, effectiveness, adoption, implementation and maintenance of implementing ESM-based monitoring, reporting, and feedback, it will form the basis for establishing its public health impact and has significant potential to bridge the research-to-practice gap and contribute to swifter ecological translation of digital innovations to real-world delivery in routine mental health care.Trial registrationISRCTN15109760 (ISRCTN registry, date: 03/08/2022).

Reducing disparities in behavioral health treatment in pediatric primary care: a randomized controlled trial comparing Partnering to Achieve School Success (PASS) to usual ADHD care for children ages 5 to 11 – study protocol

BackgroundIntegrating behavioral health services into pediatric primary care can improve access to care, especially for children marginalized by poverty and racial/ethnic minority status. In primary care, a common presenting concern is attention-deficit/hyperactivity disorder (ADHD). Services in primary care for marginalized children with ADHD typically include medication alone; therapy to improve skills and build relationships is less available. This study evaluates the effectiveness of a behavioral intervention offered through primary care for marginalized families coping with ADHD (Partnering to Achieve School Success, PASS) compared to treatment as usual (TAU).MethodThree hundred participants will be randomly assigned to PASS or TAU. Participants include children ages 5 to 11 who have ADHD and are from economically marginalized families. PASS is a personalized, enhanced behavioral intervention that includes evidence-based behavior therapy strategies and enhancements to promote family engagement, increase caregiver distress tolerance, and provide team-based care to improve academic and behavioral functioning. TAU includes services offered by primary care providers and referral for integrated behavioral health or community mental health services. Outcomes will be assessed at mid-treatment (8 weeks after baseline), post-treatment (16 weeks), and follow-up (32 weeks) using parent- and teacher-report measures of service use, child academic, behavioral, and social functioning, parenting practices, family empowerment, and team-based care. Mixed effects models will examine between-group differences at post-treatment and follow-up. Analyses will examine the mediating role of parenting practices, family empowerment, and team-based care. Subgroup analyses will examine differential effects of intervention by child clinical characteristics and socioeconomic factors.DiscussionThis study is unique in targeting a population of children with ADHD marginalized by low socioeconomic resources and examining an intervention designed to address the challenges of families coping with chronic stress related to poverty.Trial registrationThis study was registered on clinicaltrials.gov (NCT04082234) on September 5, 2019, prior to enrollment of the first participant. The current version of the protocol and IRB approval date is October 4, 2023. Results will be submitted to ClinicalTrials.gov no later than 30 days prior to the due date for the submission of the draft of the final research report to the Patient-Centered Outcomes Research Institute.

Online acceptance and commitment therapy (iACT) for adults with persistent physical symptoms – 3-month follow-up study of a randomized controlled trial

ObjectivePersistent physical symptoms (PPS) represent a major health problem affecting daily functioning. This RCT aimed to examine whether a guided Internet-based treatment based on acceptance and commitment therapy (ACT) provided additional benefits compared to Treatment as Usual (TAU) in reducing somatic complaints and psychological distress in adults with PPS. MethodsA total of 103 adults with PPS related to indoor environments, chronic fatigue or both conditions were assigned to receive either either a 14-week intervention (video-based case conceptualization + Internet-based ACT) combined with TAU (iACT + TAU; n = 50) or TAU alone (n = 53). Somatic symptoms, depression, anxiety, insomnia, and psychological flexibility were assessed from pre-intervention to a 3-month follow-up. Additionally, the association between changes in psychological flexibility from pre- to post-intervention and changes in symptoms from pre to 3-month follow-up was explored. Analyses were conducted using a multigroup method with full information maximum likelihood estimator. ResultsThe results revealed a significant interaction effect, indicating reductions in somatic symptoms and symptoms of depression and anxiety with moderate to large between-group effects (d = 0.71–1.09). No significant interaction effect was observed in insomnia and measures of psychological flexibility. ConclusionInternet-based ACT, when combined with Treatment as Usual, demonstrated efficacy for individuals with PPS associated with indoor environments and chronic fatigue. These findings are pertinent for primary healthcare providers, suggesting that the current treatment model could serve as a low-threshold first-line treatment option.The clinical trial registration number: NCT04532827

MANCAN2: A multicentre randomised controlled trial of self-help cognitive behavioural therapy (CBT) to manage hot flush and night sweats (HFNS) symptoms in patients with prostate cancer receiving androgen deprivation therapy (ADT).

LBA5004 Background: Up to 80% of patients receiving ADT suffer HFNS which impacts quality of life (QOL) and potentially ADT compliance. Mitigation options are limited. Prior research has found self-help CBT, with minimal guidance, reduced HFNS due to ADT at 6 weeks. We tested the longer term impact of self-help CBT, guided and delivered by prostate Cancer Nurse Specialist (CNS) teams. Methods: MANCAN2 is a multicentre randomised controlled trial and process evaluation within UK prostate cancer units. Eligibility: localised/advanced prostate cancer; on ADT with ≥ 6 months further planned; HFNS Problem Rating Scale ≥ 2. Patients were randomised (1:1) in groups of 6 to 8 to treatment as usual (TAU) or CBT + TAU, by permuted block, stratified by site, cohort and treatment intent. CBT was a 4-week self-help intervention (booklet and relaxation audio) with pre- and post-intervention group workshops by the prostate CNS team. Primary objective: does adding CBT to TAU reduce 6 month HFNS Problem Rating Scale versus baseline (mixed linear regression). Secondary endpoints: 6 week HFNS Problem Rating Scale, HFNS frequency, HFNS beliefs and behaviours, QOL (EORTC QLQ-C30, symptoms (rating scales for anxiety, depression, mood and sleep) by mixed logistic regression), ADT compliance (chi-squared test). A 6 month mean HFNS Problem Rating Scale difference of ≥ 1.5 points was deemed clinically relevant, and required data from 111 patients (90% power, 5% type 1 error, 6 to 8 patients per group, intra-class correlation 0.01, anticipating 26% patient loss). Results: 162 patients were randomly assigned (81/arm) and 117 returned 6 month HFNS Problem Rating Scale data. Baseline characteristics were balanced. Mean CBT delivery adherence was 85%. 6 month mean HFNS Problem Rating Scale score was not significantly different for the TAU alone versus CBT + TAU (mean 4.08 vs 4.04, 95% CI for difference: -0.89, 0.80; p=0.97), although a difference was observed at 6 weeks (mean 4.47 vs 3.79, 95% CI: -1.26, -0.09; p=0.03). At 6 weeks, CBT patients had higher weekly HFNS frequency (median 54.2 vs 59.4, 95% CI: 0.22, 10.19; p=0.04), lower depression score (median 7.19 vs 6.19, 95% CI: -1.88, -0.12; p=0.03) and lower anxiety score (median 4.25 vs 3.39, 95% CI: -1.64, -0.08; p=0.03). CBT patients had more positive beliefs about openness and humour scores at 6 months (median 4.92 vs 4.59, 95% CI: -0.63, -0.03; p=0.03). There was no significant difference for other measures of HFNS beliefs and behaviours, quality of life, anxiety, mood, sleep quality and treatment compliance. Conclusions: Adding CBT to TAU in prostate cancer patients receiving ADT improved short-term HFNS severity but was not maintained at 6 months. Future research should investigate whether initial CBT benefit could be made sustainable in this setting. Clinical trial information: 58720120.

Clinical effectiveness and safety of adding a self-harm prevention app (BlueIce) to specialist mental health care for adolescents who repeatedly self-harm: A single blind randomised controlled trial (the BASH study)

No randomised controlled trials have evaluated whether the addition of a smartphone app to usual child and adolescent mental health care (CAMHS) can reduce self-harm in adolescents (<18 years) with repeated self-harm. We enrolled 170 participants aged 12–17, receiving CAMHS treatment who had self-harmed ≥2 in the past 12 months. Participants were randomised via an independent web-based system (1:1, minimised for gender, age, self-harm frequency, and depression severity) to treatment as usual (TAU) or treatment as usual plus BlueIce (TAU+BI). BlueIce is a self-harm prevention app that includes techniques from CBT and DBT that was co-designed with adolescents who self-harm. The primary outcome was change from baseline to 12-weeks on the self-harm scale of the Risk Taking and Self-Harm Inventory for Adolescents (RTSHIA), analysed by intention to treat (ITT). Emergency department attendances or admissions for self-harm were assessed over 6-months via a review of clinical records. Both groups improved but there were no statistically significant between group differences at 12 weeks or 6 months on the self-harm scale of the RTSHIA. There were fewer emergency department attendances and admissions in those who received the app, a finding that approached statistical significance. BlueIce can be helpful in some important aspects by contributing to fewer emergency department admissions and attendances. Trial registrationTrial registration number ISRCTN10541045.