Feasibility Of Randomized Trial Research Articles

Randomized feasibility trial for evaluating the impact of primary nursing on delirium duration during intensive care unit stay

ObjectiveWe tested the feasibility of a randomized controlled trial for comparing primary nursing with standard care. Research MethodologyElective cardiac surgical patients were eligible for inclusion. Patients with an intensive care unit stay of ≥ 3 days were followed up until intensive care unit discharge. Recruitment period was one year. SettingTwo intensive care units at a university hospital specialized in cardiovascular and diabetic diseases. Main Outcome MeasuresPrimary outcomes were recruitment and delivery rate. Primary clinical outcome was duration of delirium, as assessed by the Confusion Assessment Method for Intensive Care Units. Secondary outcomes included the incidence of delirium, anxiety (10-point Numeric Rating Scale), and the satisfaction of patient relatives (validated questionnaire). ResultsOf 369 patients screened, 269 could be allocated to primary nursing (n = 134) or standard care (n = 135), of whom 46 patients and 48 patients, respectively, underwent an intensive care unit stay ≥ 3 days. Thus, recruitment and delivery rates were 73 and 26 %, respectively. During primary nursing and standard care, 18 and 24 patients developed a delirium, with a median duration of 32 (IQR: 14–96) and 24 (IQR: 8–44) hours (P = 0.10). The risk difference of delirium for primary nursing versus standard care was 11 % and the relative risk was 0.65 (95 % CI: 0.28–1.46; P = 0.29). The extent of anxiety was similar between groups (P = 0.13). Satisfaction could be assessed in 73.5 % of relatives, without substantial differences between groups. ConclusionData demonstrate that a trial for comparing primary nursing with standard care is generally feasible. However, the incidence of delirium may be a better primary outcome parameter than delirium duration, both in terms of long-term patient outcome and robustness of data quality. Implications for clinical practiceA randomized clinical trial regarding nursing organization during intensive care unit stay requires detailed planning of patient recruitment, data evaluation, and power calculation.

The Effect of Oral Nutritional Supplement on Muscle Strength in Older Hip Fracture Patients (NUTRI-MUSCLES) – a Randomized Feasibility Trial for a Parallel RCT

The Effect of Oral Nutritional Supplement on Muscle Strength in Older Hip Fracture Patients (NUTRI-MUSCLES) – a Randomized Feasibility Trial for a Parallel RCT

Proactive review for people with diabetes in hospital: a cluster randomised feasibility trial with process evaluation, protocol V3.1

BackgroundDiabetes inpatient specialist services vary across the country, with limited evidence to guide service delivery. Currently, referrals to diabetes inpatient specialists are usually ‘reactive’ after diabetes-related events have taken place, which are associated with an increased risk of morbidity/mortality and increased length of hospital stay. We propose that a proactive diabetes review model of care, delivered by diabetes inpatient specialist nurses, may contribute to the prevention of such diabetes-related events and result in a reduction in the risk of harm.MethodWe will conduct a cluster randomised feasibility study with process evaluation. The proactive diabetes review model (PDRM) is a complex intervention that focuses on the prevention of potentially modifiable diabetes-related harms. All eligible patients will receive a comprehensive, structured diabetes review that aims to identify and prevent potentially modifiable diabetes-related harms through utilising a standardised review structure. Reviews are undertaken by a diabetes inpatient specialist nurse within one working day of admission. This differs from usual care where patients are often only seen after diabetes-related harms have taken place. The trial duration will be approximately 32 weeks, with intervention delivery throughout. There will be an initial 8-week run-in phase, followed by a 24-week data collection phase. Eight wards will be equally randomised to either PDRM or usual care. Adult patients with a known diagnosis of diabetes admitted to an included ward will be eligible. Data collection will be limited to that typically collected as part of usual care. Data collected will include descriptive data at both the ward and patient level and glucose measures, such as frequency and results of capillary glucose testing, ketonaemia and hypoglycaemic events. The analysis aims to determine the fidelity and acceptability of the intervention and the feasibility of a future definitive trial. Whilst this study is primarily about trial feasibility, the findings of the process evaluation may lead to changes to both trial processes and modifications to the intervention. A qualitative process evaluation will be conducted in parallel to the trial. A minimum of 22 patients, nurses, doctors, and managers will be recruited with methods including direct non-participant observation and semi-structured interviews. The feasibility of a future definitive trial will be assessed by evaluating recruitment and randomisation processes, staffing resources and quality of available data.DiscussionThe aim of this cluster randomised feasibility trial with a process evaluation is to explore the feasibility of a definitive trial and identify appropriate outcome measures. If a trial is feasible and the effectiveness of PDRM can be evaluated, this could inform the future development of inpatient diabetes services nationally.Trial registrationUK Clinical Research Network, 51,167. ISRCTN, ISRCTN70402110. Registered on 21 February 2022.

Move for Life an intervention for inactive adults aged 50 years and older: a cluster randomised feasibility trial.

Move for Life (MFL) is a theory-informed intervention that was developed to augment established physical activity (PA) programmes and enable inactive adults aged 50 years and older to be more active. This study examined the feasibility of MFL and sought to provide evidence of its potential for improving PA and associated health outcomes. A 3-arm cluster randomised feasibility trial compared MFL intervention, usual provision (UP) and control (CON) groups at baseline (T0), post-intervention (T1, at 8, 10 or 12- weeks) and 6-month follow up (T2). We used purposive sampling strategies to recruit participants according to characteristics of interest. Feasibility outcomes assessed recruitment, fidelity, adherence, retention and data completion rates based on pre-set criteria. Primary outcomes were accelerometer-based moderate-to-vigorous intensity PA (MVPA) and self-reported compliance with physical activity guidelines (PAGL). Secondary outcomes included light intensity PA (LiPA), standing time, sedentary time, body composition (adiposity), physical function and psychological well-being. We used linear mixed models (continuous outcomes) or generalized estimated equations (categorical outcomes) to estimate group differences over time in the study outcomes. Progression criteria for feasibility outcomes were met, and 733 individuals were recruited. Considering a 6-month period (T0-T2), while self-reported compliance with PAGL increased in MFL relative to UP and CON and in UP relative to CON, standing time decreased in MFL relative to CON and sedentary time increased in the latter compared to UP. Waist circumference decreased in MFL relative to UP and CON. MFL outperformed UP in the Timed Up and Go Test while MFL and UP increased the distance covered in the Six-Minute Walk Test compared to CON. Psychological well-being increased in MFL relative to CON (all p < 0.05). Findings show that MFL is feasible, while data are promising with regards to the potential of improving community PA programmes for adults aged 50 or more years. https://www.isrctn.com/Registration#ISRCTN11235176.

Physiologic Determinants of Near-Infrared Spectroscopy-Derived Cerebral and Tissue Oxygen Saturation Measurements in Critically Ill Patients.

Near-infrared spectroscopy (NIRS) is a potentially valuable modality to monitor the adequacy of oxygen delivery to the brain and other tissues in critically ill patients, but little is known about the physiologic determinants of NIRS-derived tissue oxygen saturations. The purpose of this study was to assess the contribution of routinely measured physiologic parameters to tissue oxygen saturation measured by NIRS. An observational sub-study of patients enrolled in the Role of Active Deresuscitation After Resuscitation-2 (RADAR-2) randomized feasibility trial. Two ICUs in the United Kingdom. Patients were recruited for the RADAR-2 study, which compared a conservative approach to fluid therapy and deresuscitation with usual care. Those included in this sub-study underwent continuous NIRS monitoring of cerebral oxygen saturations (SctO2) and quadriceps muscle tissue saturations (SmtO2). Synchronized and continuous mean arterial pressure (MAP), heart rate (HR), and pulse oximetry (oxygen saturation, Spo2) measurements were recorded alongside NIRS data. Arterial Paco2, Pao2, and hemoglobin concentration were recorded 12 hourly. Linear mixed effect models were used to investigate the association between these physiologic variables and cerebral and muscle tissue oxygen saturations. Sixty-six patients were included in the analysis. Linear mixed models demonstrated that Paco2, Spo2, MAP, and HR were weakly associated with SctO2 but only explained 7.1% of the total variation. Spo2 and MAP were associated with SmtO2, but together only explained 0.8% of its total variation. The remaining variability was predominantly accounted for by between-subject differences. Our findings demonstrated that only a small proportion of variability in NIRS-derived cerebral and tissue oximetry measurements could be explained by routinely measured physiologic variables. We conclude that for NIRS to be a useful monitoring modality in critical care, considerable further research is required to understand physiologic determinants and prognostic significance.

Improving foot self-care in people with diabetes in Ghana: A development and feasibility randomised trial of a context appropriate, family-orientated diabetic footcare intervention.

Africa presents a higher diabetic foot ulcer prevalence estimate of 7.2% against global figures of 6.3%. Engaging family members in self-care education interventions has been shown to be effective at preventing diabetes-related foot ulcers. This study culturally adapted and tested the feasibility and acceptability of an evidence-based footcare family intervention in Ghana. The initial phase of the study involved stakeholder engagement, comprising Patient Public Involvement activities and interviews with key informant nurses and people with diabetes (N = 15). In the second phase, adults at risk of diabetes-related foot ulcers and nominated caregivers (N = 50 dyads) participated in an individually randomised feasibility trial of the adapted intervention (N = 25) compared to usual care (N = 25). The study aimed to assess feasibility outcomes and to identify efficacy signals on clinical outcomes at 12 weeks post randomisation. Patient reported outcomes were foot care behaviour, foot self-care efficacy, diabetes knowledge and caregiver diabetes distress. Adjustments were made to the evidence-based intervention to reflect the literacy, information needs and preferences of stakeholders and to develop a context appropriate diabetic foot self-care intervention. A feasibility trial was then conducted which met all recruitment, retention, data quality and randomisation progression criteria. At 12 weeks post randomisation, efficacy signals favoured the intervention group on improved footcare behaviour, foot self-care efficacy, diabetes knowledge and reduced diabetes distress. Future implementation issues to consider include the staff resources needed to deliver the intervention, family members availability to attend in-person sessions and consideration of remote intervention delivery. A contextual family-oriented foot self-care education intervention is feasible, acceptable, and may improve knowledge and self-care with the potential to decrease diabetes-related complications. The education intervention is a strategic approach to improving diabetes care and prevention of foot disease, especially in settings with limited diabetes care resources. Future research will investigate the possibility of remote delivery to better meet patient and staff needs. Pan African Clinical Trials Registry (PACTR) - PACTR202201708421484: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=19363 or pactr.samrc.ac.za/Search.aspx.

'ThinkCancer!': randomised feasibility trial of a novel practice-based early cancer diagnosis intervention.

UK cancer deaths remain high; primary care is key for earlier cancer diagnosis as half of avoidable delays occur here. Improvement is possible through lower referral thresholds, better guideline adherence, and better safety-netting systems. Few interventions target whole practice teams. We developed a novel whole-practice team intervention to address this. To test the feasibility and acceptability of a novel, complex behavioural intervention, 'ThinkCancer!', for assessment in a subsequent Phase III trial. Pragmatic, superiority pilot randomised controlled trial (RCT) with an embedded process evaluation and feasibility economic analysis in Welsh general practices. Clinical outcome data were collected from practices (the unit of randomisation). Practice characteristics and cancer safety-netting systems were assessed. Individual practice staff completed evaluation and feedback forms and qualitative interviews. The intervention was adapted and refined. Trial recruitment and workshop deliveries took place between March 2020 and May 2021. Trial progression criteria for recruitment, intervention fidelity, and routine data collection were met. Staff-level fidelity, retention, and individual level data collection processes were reviewed and amended. Interviews highlighted positive participant views on all aspects of the intervention. All practices set out to liberalise referral thresholds appropriately, implement guidelines, and address safety-netting plans in detail. 'ThinkCancer!' appears feasible and acceptable. The new iteration of the workshops was completed and the Phase III trial has been funded to assess the effectiveness and cost-effectiveness of this novel professional behaviour change intervention. Delivery at scale to multiple practices will likely improve fidelity and reach.

Anti-TNF (adalimumab) injection for the treatment of pain-predominant early-stage frozen shoulder: the Anti-Freaze-Feasibility randomised controlled trial

ObjectiveThe Anti-Freaze-F (AFF) trial assessed the feasibility of conducting a definitive trial to determine whether intra-articular injection of adalimumab can reduce pain and improve function in people with pain-predominant early-stage...

Feasibility and acceptability of a tailored health coaching intervention to improve type 2 diabetes self-management in Saudi Arabia: a mixed-methods randomised feasibility trial

BackgroundAround one-third of the population of Saudi Arabia have been diagnosed with type 2 diabetes, a condition often requiring lifestyle changes. Personalised health coaching, a strategy developed to assist individuals...

Randomized Feasibility Pilot of an Executive Functioning Intervention Adapted for Children's Mental Health Settings.

The critical role of executive functioning in autism as well as the co-occurring mental health challenges common among autistic youth support to the immense value of interventions targeting executive functioning for enhancing mental health services for autistic children. The goal of the present study was to conduct a randomized feasibility trial of Unstuck and On Target, an executive functioning intervention, adapted for delivery in children's community mental health setting. Mental health therapists (n = 26) enrolled with participating autistic clients (n = 32) were randomized to receive training in and deliver the adapted Unstuck intervention or to deliver care as usual. We completed masked observational measures of Unstuck strategy use (fidelity) during recorded sessions of participating therapist-client dyads and collected measures of acceptability from participating clients and their caregivers. We also collected measures of pre-post changes in executive functioning and mental health symptoms. Therapists trained in Unstuck demonstrated significantly higher use of Unstuck strategies compared to usual care therapists. Caregivers and autistic clients perceive adapted Unstuck as highly acceptability and helpful. Autistic clients whose therapists were trained in adapted Unstuck demonstrated larger pre-post changes in executive functioning compared to usual care. Across all participating clients, changes in executive functioning were significantly related to changes in mental health symptoms. Finally, clients of therapists trained in adapted Unstuck demonstrated moderate improvements in overall mental health symptoms. The current study provides preliminary evidence of the feasibility and impact of Unstuck and On Target for children's community mental health settings.

Mellow Babies: A Randomised Feasibility Trial of an Intervention to Improve the Quality of Parent-Infant Interactions and Parental Mental Wellbeing.

Mellow Babies aims to improve mothers' mental wellbeing and the quality of their interactions with their baby. The feasibility of a definitive trial of Mellow Babies was assessed using a waiting-list randomised pilot trial (Clinicaltrials.gov: NCT02277301). Mothers with substantial health/social care needs and a child aged <13 months were randomly allocated either to a 14-week Mellow Babies programme or to receive usual care whilst on a waiting list for the intervention. Rates of recruitment and retention as well as participants' views of their experience in this study were recorded. Outcomes were parenting behaviour, assessed by the blind-rated Mellow Parenting Observation System (primary) and self-report maternal wellbeing pre- and post-intervention/waiting period. We recruited 38 eligible participants: 36 (95%; 18 intervention, 18 control) completed baseline measures, and 28 (74%; 15 intervention, 13 control) provided post-intervention data. Two practitioners took part in feedback interviews. Intervention participants had significantly more positive interactions with their babies at post-intervention compared to those in the control group (p = 0.019), adjusted for pre-intervention scores. There was no significant improvement in mothers' mental wellbeing on any measure. A definitive trial of Mellow Babies is feasible and should include longer follow up of mothers and the opportunity for fathers to take part.

Home-based Circuit Training and Community Walking for Intermittent Claudication

ObjectiveSupervised exercise training is recommended for people with peripheral artery disease (PAD), yet it remains underutilised. Home-based exercise programmes are a potential alternative. The aim of this study was to assess the feasibility of conducting a full scale trial of a 12-week home-based exercise programme (HBEP) for people living with symptomatic PAD. MethodsIn a randomised feasibility trial, patients with intermittent claudication (IC) were allocated to either a HBEP or a non-exercise control. The HBEP group were given a Fitbit to use during a 12-week exercise programme comprising of personalised step goals and a resistance-based circuit to be undertaken at home twice weekly. The primary outcome was feasibility, assessed via eligibility, recruitment, attrition, tolerability, and adherence. Acceptability was assessed via semi-structured interviews. Secondary analysis was undertaken to determine the feasibility of collecting clinical outcome data. Results188 people were screened, 133 were eligible (70.7%), 30 were recruited (22.6%) and one withdrew (3.33%). Mean adherence to the daily step goal was 53.5% (range=29.8–90.5%), and 58.6% of prescribed circuits were completed of which 56.4% were at the desired intensity. Six adverse events were recorded, three of which were related to study involvement. No significant differences were observed in exploratory outcomes. Small clinically important differences were seen in walking speed and pain-free treadmill walking distance which should be confirmed or refuted in a larger trial. ConclusionThe HBEP was feasible and well tolerated, with successful recruitment and minimal attrition. The intervention was acceptable, with walking seen as more enjoyable than circuit exercise. The WALKSTRONG programme may be suitable for those who will not, or cannot, take part in supervised exercise outside of the home.

A randomized feasibility trial of medium chain triglyceride-supplemented ketogenic diet in people with Parkinson's disease

BackgroundA ketogenic diet (KD) may benefit people with neurodegenerative disorders marked by mitochondrial depolarization/insufficiency, including Parkinson’s disease (PD).ObjectiveEvaluate whether a KD supplemented by medium chain triglyceride (MCT-KD) oil is feasible and acceptable for PD patients. Furthermore, we explored the effects of MCT-KD on blood ketone levels, metabolic parameters, levodopa absorption, mobility, nonmotor symptoms, simple motor and cognitive tests, autonomic function, and resting-state electroencephalography (rsEEG).MethodsA one-week in-hospital, double-blind, randomized, placebo-controlled diet (MCT-KD vs. standard diet (SD)), followed by an at-home two-week open-label extension. The primary outcome was KD feasibility and acceptability. The secondary outcome was the change in Timed Up & Go (TUG) on day 7 of the diet intervention. Additional exploratory outcomes included the N-Back task, Unified Parkinson’s Disease Rating Scale, Non-Motor Symptom Scale, and rsEEG connectivity.ResultsA total of 15/16 subjects completed the study. The mean acceptability was 2.3/3, indicating willingness to continue the KD. Day 7 TUG time was not significantly different between the SD and KD groups. The nonmotor symptom severity score was reduced at the week 3 visit and to a greater extent in the KD group. UPDRS, 3-back, and rsEEG measures were not significantly different between groups. Blood ketosis was attained by day 4 in the KD group and to a greater extent at week 3 than in the SD group. The plasma levodopa metabolites DOPAC and dopamine both showed nonsignificant increasing trends over 3 days in the KD vs. SD groups.ConclusionsAn MCT-supplemented KD is feasible and acceptable to PD patients but requires further study to understand its effects on symptoms and disease.Trial RegistrationTrial Registration Number NCT04584346, registration dates were Oct 14, 2020 – Sept 13, 2022.

Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM): protocol for a randomised feasibility trial

IntroductionPersonalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM) is a research programme that seeks to develop and evaluate a comprehensive exercise-based rehabilitation intervention designed for people with multimorbidity, the...

O126: Non-invasive vagus nerve stimulation to reduce ileus after colorectal surgery: randomised feasibility trial and efficacy assessment

Abstract Objective Ileus is characterised by intestinal dysmotility after surgery. In preclinical models, vagus nerve stimulation reduces intestinal inflammation, preventing smooth muscle dysfunction and accelerating the return of gut function. This study explored the efficacy and feasibility of a definitive trial and implementation of non-invasive, electrical, vagus nerve stimulation (nVNS). Design A participant-blinded, multi-centre, feasibility trial of self-administered nVNS was performed. Patients undergoing colorectal surgery were randomised to four groups of pre- and post-operative treatment (A: nVNS/nVNS; B: nVNS/Sham; C: Sham/nVNS; D: Sham/Sham). Feasibility outcomes were participant recruitment, compliance, and blinding. Clinical outcomes were intestinal function and adverse events. Interviews with patients and clinicians explored barriers to feasibility and implementation. In an independent cohort, the effects of nVNS on serum IL-1b, IL-6, and TNFa were quantified at baseline, 24-hours, and 72-hours after surgery. Results Ninety-seven out of 125 (77.6%) eligible patients took part. The median compliance was 19 out of 20 stimulations (IQR: 17-20). The median time to pass stool was 4 (3-5), 3 (2-4), 2.5 (2-3.5), and 3 (2-4) days for groups A-D, respectively. The incidence of adverse events was similar across groups. Trends toward reduced pro-inflammatory mediators were observed after nVNS. Interviews with patients (n=19) demonstrated their motivation to contribute actively to their recovery and interviews with clinicians (n=10) revealed strong reciprocal support. Conclusion This study confirms the safety, feasibility, and support for nVNS after surgery. Research on nVNS should progress from its current focus on pre-clinical models to powered, dedicated assessments of clinical effectiveness.

The HIV Empowering Adults’ Decisions to Share: UK/Uganda (HEADS-UP) Study—A Randomised Feasibility Trial of an HIV Disclosure Intervention for Young Adults with Perinatally Acquired HIV

Young adults with perinatally acquired HIV (PAH) face numerous challenges, including antiretroviral therapy (ART) adherence, managing onward HIV transmission risks and maintaining wellbeing. Sharing one’s HIV status with others (onward HIV disclosure) may assist with these challenges but this is difficult. We developed and tested the feasibility of an intervention to help HIV status sharing decision-making for young adults with PAH. The study used a randomised parallel group feasibility design with 18–25-year-olds in Uganda and 18–29 year-olds in the UK. Participants were randomly assigned to intervention or standard of care (SOC) condition. The intervention consisted of four sessions (3 group, 1 individual) with follow-up support, delivered in person in Uganda and remotely in the UK. Assessments were carried out at: Pre-intervention /baseline; Post-intervention (intervention group only); Six-month follow-up. 142 participants were recruited (94 Uganda, 48 UK; 89 female, 53 male). At six-month follow-up, 92/94 (98%) participants were retained in Uganda, 25/48 (52%) in the UK. Multivariate analysis of combined data from both countries, showed a non-significant effect of intervention condition on HIV disclosure cognitions and affect (p = 0.08) and HIV disclosure intention (p = 0.09). There was a significant intervention effect on well-being (p = 0.005). This study addressed important gaps in understanding acceptable and feasible ways of delivering HIV status sharing support for young people living with PAH across two very different settings. The intervention was acceptable in both countries and feasible in Uganda. In the UK, retention may have been affected by its remote delivery.Trial registration: ISRCTN Registry, ISRCTN31852047, Registered on 21 January 2019.

A randomized feasibility trial of the modified Atkins diet in older adults with mild cognitive impairment due to Alzheimer's disease.

Alzheimer's disease (AD) is increasing in prevalence, but effective treatments for its cognitive impairment remain severely limited. This study investigates the impact of ketone body production through dietary manipulation on memory in persons with mild cognitive impairment due to early AD and explores potential mechanisms of action. We conducted a 12-week, parallel-group, controlled feasibility trial of a ketogenic diet, the modified Atkins diet (MAD), compared to a control diet in patients with cognitive impairments attributed to AD. We administered neuropsychological assessments, including memory tests, and collected blood samples at baseline and after 12 weeks of intervention. We performed untargeted lipidomic and targeted metabolomic analyses on plasma samples to detect changes over time. A total of 839 individuals were screened to yield 38 randomized participants, with 20 assigned to receive MAD and 18 assigned to receive a control diet. Due to attrition, only 13 in the MAD arm and nine in the control arm were assessed for the primary endpoint, with two participants meeting ketosis levels used to define MAD adherence criteria. The average change from baseline in the Memory Composite Score was 1.37 (95% CI: -0.87, 4.90) points higher in the MAD group compared to the control group. The effect size of the intervention on baseline MAD change was moderate (Cohen's D = 0.57, 95% CI: -0.67, 1.33). In the 15 participants (nine MAD, six control) assessed for lipidomic and metabolomic-lipidomics and metabolomics, 13 metabolites and 10 lipids showed significant changes from baseline to 12 weeks, including triacylglycerols (TAGs, 50:5, 52:5, and 52:6), sphingomyelins (SM, 44:3, 46:0, 46:3, and 48:1), acetoacetate, fatty acylcarnitines, glycerol-3-phosphate, and hydroxy fatty acids. Attrition was greatest between baseline and week 6. All participants retained at week 6 completed the study. Despite low rates of adherence by criteria defined a priori, lipidomic and metabolomic analyses indicate significant changes from baseline in circulating lipids and metabolites between MAD and control participants at 12-week postrandomization, and MAD participants showed greater, albeit nonsignificant, improvement in memory.

Enhancing social functioning in older veterans with PTSD: Rationale and design of an intervention and initial RCT

BackgroundOlder Veterans with Posttraumatic Stress Disorder (PTSD) are often socially isolated and have complex comorbid physical health problems. Aging-related stressors can exacerbate PTSD symptoms. These factors contribute to greater impairment in social functioning and decreased quality of life (QoL). Evidence-based psychotherapies for PTSD often address these issues, but not all older Veterans with PTSD seek help for these challenges, some don't want to engage in trauma-focused treatment, some drop out prematurely, and some still have residual symptoms upon completion. Thus, additional interventions that directly target social functioning among older Veterans with PTSD are needed. MethodsIn this paper we describe the development of and feasibility evaluation plan for, “Enhancing Social Functioning for older Veterans with PTSD (ESVP),” a social functioning group intervention for older (>60 years) Veterans with PTSD. This project involved four phases of work: 1) Intervention development, 2) Review of intervention and potential modifications using focus groups, 3) Intervention pilot testing and modification, and 4) A randomized feasibility trial comparing the intervention with a support group control. Intervention modules address interpersonal relationships, effective communication, anger management, social skills, social support/activities, and behavioral activation. ConclusionThis project details the iterative process used to develop the ESVP intervention designed to enhance social functioning in older Veterans with PTSD, and to evaluate feasibility. Analyses are underway to examine feasibility of conducting ESVP with a sample of older Veterans with PTSD. Findings from the final project phase, the randomized feasibly trial, will inform the design and implementation of a future trial.Clinicaltrials.gov Identifier: NCT02803125

Feasibility and preliminary efficacy of metacognitive therapy for health anxiety: A pilot RCT

BackgroundHealth anxiety is a pervasive mental health condition, in which people worry about having or developing a serious illness or disease. Cognitive behavioural therapy (CBT) is currently considered the most researched psychological treatment for health anxiety, although several systematic reviews and meta-analysis have shown mixed findings for its efficacy. More efficacious interventions that can be easily integrated within services are required. An alternative to CBT, that has proven more effective in some other disorders, is metacognitive therapy (MCT). The aim was to evaluate the feasibility of delivering MCT for health anxiety and to collect pilot data on the treatment's preliminary efficacy. MethodTwenty participants with health anxiety were recruited to an open randomized feasibility trial and randomized to MCT or waitlist control. Acceptability and feasibility of MCT was based on recruitment rates, withdrawal, and drop-out, number of MCT sessions attended, completion of questionnaires, and any adverse reactions observed. The study was also used to evaluate initial treatment effects. ResultsMCT was found to be feasible and acceptable for individuals with health anxiety. Recruitment and retention of all participants was high, and no adverse events were observed in either group. Pre to post between group effect sizes on the primary outcome measure The Whiteley Index (Pilowsky, 1967) were large (Hedges’ g = 3.18-Mdiff= 26.2, [95 % CI=18.7–33.6]) in favour of MCT. Clinically significant recovery rates were 80 % at post treatment and follow up. ConclusionThe results suggest that a trial of MCT was acceptable and feasible in individuals with health anxiety and the treatment effects were statistically significant in comparison to the waiting list. Based upon the design used in this study MCT should be compared with active treatments such as medication, treatment as usual or specific cognitive behaviour therapy protocols in a future definitive randomised trial.

Cardiac rehabilitation for children and young people (CardioActive): protocol for a single-blind randomised feasibility and acceptability study of a centre-based cardiac rehabilitation programme versus usual care in 11–16 years with heart conditions

BackgroundCongenital heart conditions are among the most common non-communicable diseases in children and young people (CYP), affecting 13.9 million CYP globally. While survival rates are increasing, support for young people...