One session treatment (OST) is equivalent to multi-session cognitive behavioral therapy (CBT) in children with specific phobias (ASPECT): results from a national non-inferiority randomized controlled trial.

BACKGROUND: 5%-10% children and young people (CYP) experience specific phobias that impact daily functioning. Cognitive Behaviour Therapy (CBT) is recommended but has limitations. One Session Treatment (OST), a briefer alternative incorporating CBT principles, has demonstrated efficacy. The Alleviating Specific Phobias Experienced by Children Trial (ASPECT) investigated the non-inferiority of OST compared to multi-session CBT for treating specific phobias in CYP. METHODS: ASPECT was a pragmatic, multi-center, non-inferiority randomized controlled trial in 26 CAMHS sites, three voluntary agency services, and one university-based CYP well-being service. CYP aged 7-16 years with specific phobia were randomized to receive OST or CBT. Clinical non-inferiority and a nested cost-effectiveness evaluation was assessed 6-months post-randomization using the Behavioural Avoidance Task (BAT). Secondary outcome measures included the Anxiety Disorder Interview Schedule, Child Anxiety Impact Scale, Revised Children's Anxiety Depression Scale, goal-based outcome measure, and EQ-5DY and CHU-9D, collected blind at baseline and six-months. RESULTS: 268 CYPs were randomized to OST (n = 134) or CBT (n = 134). Mean BAT scores at 6 months were similar across groups in both intention-to-treat (ITT) and per-protocol (PP) populations (CBT: 7.1 (ITT, n = 76), 7.4 (PP, n = 57), OST: 7.4 (ITT, n = 73), 7.6 (PP, n = 56), on the standardized scale-adjusted mean difference for CBT compared to OST -0.123, 95% CI -0.449 to 0.202 (ITT), mean difference -0.204, 95% CI -0.579 to 0.171 (PP)). These findings were wholly below the standardized non-inferiority limit of 0.4, suggesting that OST is non-inferior to CBT. No between-group differences were found on secondary outcomes. OST marginally decreased mean service use costs and maintained similar mean Quality Adjusted Life Years compared to CBT. CONCLUSIONS: One Session Treatment has similar clinical effectiveness to CBT for specific phobias in CYP and may be a cost-saving alternative.

Cost and effectiveness of one session treatment (OST) for children and young people with specific phobias compared to multi-session cognitive behavioural therapy (CBT): results from a randomised controlled trial.

BACKGROUND: In the UK, around 93,000 (0.8%) children and young people (CYP) are experiencing specific phobias that have a substantial impact on daily life. The current gold-standard treatment-multi-session cognitive behavioural therapy (CBT) - is effective at reducing specific phobia severity; however, CBT is time consuming, requires specialist CBT therapists, and is often at great cost and limited availability. A briefer variant of CBT called one session treatment (OST) has been found to offer similar clinical effectiveness for specific phobia as multi-session CBT. The aim of this study was to assess the cost-effectiveness of OST compared to multi-session CBT for CYP with specific phobias through the Alleviating Specific Phobias Experienced by Children Trial (ASPECT), a two-arm, pragmatic, multi-centre, non-inferiority randomised controlled trial. METHODS: CYP aged seven to 16 years with specific phobias were recruited nationally via Health and Social Care pathways, remotely randomised to the intervention group (OST) or the control group (CBT-based therapies) and analysed (n = 267). Resource use based on NHS and personal social services perspective and quality adjusted life years (QALYs) measured by EQ-5D-Y were collected at baseline and at six-month follow-up. Incremental cost-effectiveness ratio (ICER) was calculated, and non-parametric bootstrapping was conducted to capture the uncertainty around the ICER estimates. The results were presented on a cost-effectiveness acceptability curve (CEAC). A set of sensitivity analyses (including taking a societal perspective) were conducted to assess the robustness of the primary findings. RESULTS: After adjustment and bootstrapping, on average CYP in the OST group incurred less costs (incremental cost was -£302.96 (95% CI -£598.86 to -£28.61)) and maintained similar improvement in QALYs (QALYs gained 0.002 (95% CI - 0.004 to 0.008)). The CEAC shows that the probability of OST being cost-effective was over 95% across all the WTP thresholds. Results of a set of sensitivity analyses were consistent with the primary outcomes. CONCLUSION: Compared to CBT, OST produced a reduction in costs and maintained similar improvement in QALYs. Results from both primary and sensitivity analyses suggested that OST was highly likely to be cost saving. TRIAL REGISTRATION: ISRCTN19883421 (30/11/2016).

Mechanisms of Action of a Web-Based Intervention With Health Professional Support to Increase Adherence to Nebulizer Treatments in Adults With Cystic Fibrosis: Qualitative Interview Study.

BACKGROUND: Adherence to nebulizer treatments in adults with cystic fibrosis (CF) is often low. A new complex intervention to help adults with CF increase their adherence to nebulizer treatments was tested in a pilot randomized controlled trial (RCT) in 2 UK CF centers. Patients used a nebulizer with electronic monitoring capabilities that transferred data automatically to a digital platform (CFHealthHub) to monitor adherence over time and to a tailored website to display graphs of adherence data and educational and problem-solving information about adherence. A trained interventionist helped patients identify ways to increase their adherence. OBJECTIVE: This study aims to explore the mechanisms of action underpinning the intervention. METHODS: A qualitative interview study was conducted concurrently with a pilot RCT. In total, 25 semistructured interviews were conducted with 3 interventionists at 2 time points, 14 patients in the intervention arm of the trial, and 5 members of the multidisciplinary teams offering wider care to patients. A framework approach was used for the analysis. RESULTS: The intervention was informed by a theoretical framework of behavior change. There was evidence of the expected behavior change mechanisms of action. There was also evidence of additional mechanisms of action associated with effective telehealth interventions for self-management support: relationships, visibility, and fit. Patients described how building a relationship with the interventionist through face-to-face visits with someone who cared about them and their progress helped them to consider ways of increasing adherence to medication. Rather than seeing the visibility of adherence data to clinicians as problematic, patients found this motivating, particularly if they received praise about progress made. The intervention was tailored to individuals, but there were challenges in how the intervention fitted into some patients' busy lives when delivered through a desktop computer. CONCLUSIONS: The mechanisms of action associated with effective telehealth interventions for self-management operated within this new intervention. The intervention was modified to strengthen mechanisms of action based on these findings, for example, delivery through an app accessed via mobile phones and then tested in an RCT in 19 UK CF centers. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number 13076797; http://www.isrctn.com/ISRCTN13076797.

A comparative study of the nature and magnitude of problems sleeping in inflammatory bowel disease (IBD) compared to healthy controls.

Inflammatory Bowel Disease (IBD) is commonly associated with poor global sleep quality, and has been posited as a modifiable determinant of IBD related outcomes. However, there is little evidence on the specific types of problems sleeping (e.g., sleep apnea, insomnia etc.) that might characterize the poor sleep quality experienced by those with IBD. The present research aimed to investigate the severity of seven specific types of problems sleeping in those with IBD vs. a healthy control group. This cross sectional comparison study recruited N = 409 with IBD, and N = 377 healthy controls. The Sleep-50 questionnaire was used to assess the presence of seven type of problems sleeping. Multivariate Analysis of Covariance (MANCOVA) was used to compare the severity of sleep disturbances between the IBD and control groups. Those in the IBD group reported significantly more severe experiences of five of the seven domains of the sleep-50, including increased; sleep apnea, insomnia, narcolepsy, restless-legs, and nightmares. More research is needed to; (i) improve the identification and treatment of problems sleeping in routine care; (ii) understand the mechamism(s) of action that links problems sleeping to IBD realted outcomes; and (iii) develop adapted interventions to improve sleep in those with IBD.

Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study.

BACKGROUND: Preventative medication reduces hospitalisations in people with cystic fibrosis (PWCF) but adherence is poor. We assessed the feasibility of a randomised controlled trial of a complex intervention, which combines display of real time adherence data and behaviour change techniques. METHODS: Design: Pilot, open-label, parallel-group RCT with concurrent semi-structured interviews. PARTICIPANTS: PWCF at two Cystic Fibrosis (CF) units. Eligible: aged 16 or older; on the CF registry. Ineligible: post-lung transplant or on the active list; unable to consent; using dry powder inhalers. INTERVENTIONS: Central randomisation on a 1:1 allocation to: (1) intervention, linking nebuliser use with data recording and transfer capability to a software platform, and behavioural strategies to support self-management delivered by trained interventionists (n = 32); or, (2) control, typically face-to-face meetings every 3 months with CF team (n = 32). OUTCOMES: RCT feasibility defined as: recruitment of ≥ 48 participants (75% of target) in four months (pilot primary outcome); valid exacerbation data available for ≥ 85% of those randomised (future RCT primary outcome); change in % medication adherence; FEV1 percent predicted (key secondaries in future RCT); and perceptions of trial procedures, in semi-structured interviews with intervention (n = 14) and control (n = 5) participants, interventionists (n = 3) and CF team members (n = 5). RESULTS: The pilot trial recruited to target, randomising 33 to intervention and 31 to control in the four-month period, June-September 2016. At study completion (30th April 2017), 60 (94%; Intervention = 32, Control =28) participants contributed good quality exacerbation data (intervention: 35 exacerbations; control: 25 exacerbation). The mean change in adherence and baseline-adjusted FEV1 percent predicted were higher in the intervention arm by 10% (95% CI: -5.2 to 25.2) and 5% (95% CI -2 to 12%) respectively. Five serious adverse events occurred, none related to the intervention. The mean change in adherence was 10% (95% CI: -5.2 to 25.2), greater in the intervention arm. Interventionists delivered insufficient numbers of review sessions due to concentration on participant recruitment. This left interventionists insufficient time for key intervention procedures. A total of 10 key changes that were made to RCT procedures are summarised. CONCLUSIONS: With improved research processes and lower monthly participant recruitment targets, a full-scale trial is feasible. TRIAL REGISTRATION: ISRCTN13076797 . Prospectively registered on 07/06/2016.

QT interval prolongation in opioid agonist treatment: analysis of continuous 12-lead electrocardiogram recordings.

AIMS: Methadone is a widely used opioid agonist treatment associated with QT prolongation and torsades de pointes. We investigated the QT interval in patients treated with methadone or buprenorphine using continuous 12-lead Holter recordings. METHODS: We prospectively made 24-h Holter recordings in patients prescribed methadone or buprenorphine, compared to controls. After their normal dose a continuous 12-lead Holter recorder was attached for 24 h. Digital electrocardiograms were extracted hourly from the Holter recordings. The QT interval was measured automatically (H-scribe software, Mortara Pty Ltd) and checked manually. The QT interval was plotted against heart rate (HR) on the QT nomogram to determine abnormality. Demographics, dosing, medical history and laboratory investigations were recorded. RESULTS: There were 58 patients (19 methadone, 20 buprenorphine and 19 control); median age 35 years (20-56 years); 33 males. Baseline characteristics were similar. Median dose of methadone was 110 mg day-1 (70-170 mg day-1 ) and buprenorphine was 16 mg day-1 (12-32 mg day-1 ). Seven participants had abnormal QT intervals. There was a significant difference in the proportion of prescribed methadone with abnormal QT intervals, 7/19 (37%; 95% confidence interval: 17-61%), compared to controls 0/19 (0%; 95% confidence interval: 0-21%; P = 0.008), but no difference between buprenorphine and controls (0/20). QT vs. HR plots showed patients prescribed methadone had higher QT-HR pairs over 24 h compared to controls. There was no difference in dose for patients prescribed methadone with abnormal QT intervals and those without. CONCLUSIONS: Methadone is associated with prolonged QT intervals, but there was no association with dose. Buprenorphine did not prolong the QT interval. Twenty four-hour Holter recordings using the QT nomogram is a feasible method to assess the QT interval in patients prescribed methadone.

One-session treatment for specific phobias: Barriers, facilitators and acceptability as perceived by children & young people, parents, and clinicians.

Between 2015 and 2020 the Alleviating Specific Phobias Experienced by Children Trial (ASPECT) was conducted in the UK to examine the non-inferiority of One-Session Treatment in comparison to Cognitive Behavioural Therapy based interventions for children and young people with specific phobias. A nested qualitative evaluation was conducted as part of this trial to examine the acceptability of One-Session Treatment. Qualitative interviews were conducted with children and young people taking part in the trial, their parents/guardians, and clinicians delivering the intervention, about their experiences and the acceptability of One Session Treatment. Interviews were digitally recorded and transcribed verbatim. Analysis followed a qualitative framework approach, a widely used method of analysing primary qualitative data pertaining to healthcare practices with policy relevance. Stakeholder groups found One Session Treatment to be an acceptable intervention and barriers and facilitators for its implementation into services were also identified. Potential barriers included challenges to patient flow and treatment scepticism, whilst facilitators included adopting a child-centred approach, child readiness and suitability, opportunity for increased momentum, parental support and involvement, and proximal and distal gains. For One Session Treatment's successful implementation into services, consideration of these barriers is needed and suitability guidance for its use in this population should be developed. Further research exploring children and young people's experiences of receiving Cognitive Behavioural Therapy and its acceptability in comparison to One Session Treatment would be welcomed.

One-session treatment compared with multisession CBT in children aged 7-16 years with specific phobias: the ASPECT non-inferiority RCT.

BACKGROUND: Up to 10% of children and young people have a specific phobia that can significantly affect their mental health, development and daily functioning. Cognitive-behavioural therapy-based interventions remain the dominant treatment, but limitations to their provision warrant investigation into low-intensity alternatives. One-session treatment is one such alternative that shares cognitive-behavioural therapy principles but has a shorter treatment period. OBJECTIVE: This research investigated the non-inferiority of one-session treatment to cognitive-behavioural therapy for treating specific phobias in children and young people. The acceptability and cost-effectiveness of one-session treatment were examined. DESIGN: A pragmatic, multicentre, non-inferiority randomised controlled trial, with embedded economic and qualitative evaluations. SETTINGS: There were 26 sites, including 12 NHS trusts. PARTICIPANTS: Participants were aged 7-16 years and had a specific phobia defined in accordance with established international clinical criteria. INTERVENTIONS: Participants were randomised 1 : 1 to receive one-session treatment or usual-care cognitive-behavioural therapy, and were stratified according to age and phobia severity. Outcome assessors remained blind to treatment allocation. MAIN OUTCOME MEASURES: The primary outcome measure was the Behavioural Avoidance Task at 6 months' follow-up. Secondary outcomes included the Anxiety Disorder Interview Schedule, Child Anxiety Impact Scale, Revised Children's Anxiety and Depression Scale, a goal-based outcome measure, Child Health Utility 9D, EuroQol-5 Dimensions Youth version and resource usage. Treatment fidelity was assessed using the Cognitive Behaviour Therapy Scale for Children and Young People and the One-Session Treatment Rating Scale. RESULTS: A total of 274 participants were recruited, with 268 participants randomised to one-session treatment (n = 134) or cognitive-behavioural therapy (n = 134). A total of 197 participants contributed some data, with 149 participants in the intention-to-treat analysis and 113 in the per-protocol analysis. Mean Behavioural Avoidance Task scores at 6 months were similar across treatment groups when both intention-to-treat and per-protocol analyses were applied [cognitive-behavioural therapy: 7.1 (intention to treat), 7.4 (per protocol); one-session treatment: 7.4 (intention to treat), 7.6 (per protocol); on the standardised scale adjusted mean difference for cognitive-behavioural therapy compared with one-session treatment -0.123, 95% confidence interval -0.449 to 0.202 (intention to treat), mean difference -0.204, 95% confidence interval -0.579 to 0.171 (per protocol)]. These findings were wholly below the standardised non-inferiority limit of 0.4, which suggests that one-session treatment is non-inferior to cognitive-behavioural therapy. No between-group differences in secondary outcome measures were found. The health economics evaluation suggested that, compared with cognitive-behavioural therapy, one-session treatment marginally decreased the mean service use costs and maintained similar mean quality-adjusted life-year improvement. Nested qualitative evaluation found one-session treatment to be considered acceptable by those who received it, their parents/guardians and clinicians. No adverse events occurred as a result of phobia treatment. LIMITATIONS: The COVID-19 pandemic meant that 48 children and young people could not complete the primary outcome measure. Service waiting times resulted in some participants not starting therapy before follow-up. CONCLUSIONS: One-session treatment for specific phobia in UK-based child mental health treatment centres is as clinically effective as multisession cognitive-behavioural therapy and highly likely to be cost-saving. Future work could involve improving the implementation of one-session treatment through training and commissioning of improved care pathways. TRIAL REGISTRATION: This trial is registered as ISRCTN19883421. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 42. See the NIHR Journals Library website for further project information.

A phobia is an intense, ongoing fear of an everyday object or situation. The phobia causes distress and the person with the phobia avoids that object or situation. Many children and young people have phobias that affect their daily lives. Cognitive­behavioural therapy helps by changing what people do or think when they have a phobia and is the most common treatment approach. However, cognitive­behavioural therapy is expensive, takes time and is not always easy to get. Different treatments are needed to help children and young people with specific phobias. One such therapy is one-session treatment, which works in similar ways to cognitive­behavioural therapy but takes place over one main 3-hour session. Our study, called ASPECT (Alleviating Specific Phobias Experienced by Children Trial), compared these two treatments to examine whether or not one-session treatment is as effective as cognitive­behavioural therapy. Overall, 274 children and young people aged 7­16 years from 26 sites nationally helped with our research, of whom 268 received either cognitive­behavioural therapy or one-session treatment. The results at 6 months found that one-session treatment and cognitive­behavioural therapy worked as well as each other for treating phobias in children and young people. We also found evidence that one-session treatment is cheaper than cognitive­behavioural therapy. We spoke with children and young people, their parents/guardians and the therapists of the single-session treatment, and we found one-session treatment to be acceptable for their needs. Future research could explore how to make one-session treatment more easily available for children and young people with specific phobias because it can save time and money, and works just as well as cognitive­behavioural therapy.

Do specific types of sleep disturbances represent risk factors for poorer health-related quality of life in inflammatory bowel disease? A longitudinal cohort study.

OBJECTIVES: Poor global sleep quality is commonly reported in people with inflammatory bowel disease (IBD) and is linked to poorer health-related quality of life (HRQoL). However, understanding is currently limited by a lack of: (1) longitudinal research and (2) research investigating the impact of specific types of problems sleeping on IBD-related outcomes, particularly on HRQoL. DESIGN: Observational longitudinal cohort study. METHODS: N = 276 participants with IBD completed measures at baseline (T1) and 4 weeks later at T2. Four specific sleep disturbances associated with IBD including sleep apnoea, insomnia, restless legs, and nightmares were measured alongside depression, anxiety and stress, and HRQoL. RESULTS: After controlling for participant demographics and clinical characteristics, T1 depression, anxiety, stress, and T1 HRQoL, more severe symptom severity of sleep apnoea (B = -0.30, p < .05) and insomnia symptoms (B = -0.23, p < .05) at T1 significantly predicted poorer HRQoL at T2. However, the experience of restless legs (B = -0.03, p > .87) and nightmares (B = -0.14, p > .11) at T1 did not predict HRQoL. CONCLUSION: Symptoms synonymous with sleep apnoea and insomnia might represent modifiable risk factors that provide independent contributions to HRQoL over time in those with IBD. These findings suggest that interventions designed to improve sleep apnoea and insomnia could confer benefits to HRQoL in those with IBD. However, more longitudinal research is needed to understand the contribution of sleep disturbances over the longer term, as well as more randomized controlled trials testing the effect of improving sleep on IBD-related outcomes.

Improving sleep quality leads to better mental health: A meta-analysis of randomised controlled trials.

The extent to which sleep is causally related to mental health is unclear. One way to test the causal link is to evaluate the extent to which interventions that improve sleep quality also improve mental health. We conducted a meta-analysis of randomised controlled trials that reported the effects of an intervention that improved sleep on composite mental health, as well as on seven specific mental health difficulties. 65 trials comprising 72 interventions and N = 8608 participants were included. Improving sleep led to a significant medium-sized effect on composite mental health (g+ = -0.53), depression (g+ = -0.63), anxiety (g+ = -0.51), and rumination (g+ = -0.49), as well as significant small-to-medium sized effects on stress (g+ = -0.42), and finally small significant effects on positive psychosis symptoms (g+ = -0.26). We also found a dose response relationship, in that greater improvements in sleep quality led to greater improvements in mental health. Our findings suggest that sleep is causally related to the experience of mental health difficulties. Future research might consider how interventions that improve sleep could be incorporated into mental health services, as well as the mechanisms of action that explain how sleep exerts an effect on mental health.

Prehospital continuous positive airway pressure for acute respiratory failure: the ACUTE feasibility RCT.

BACKGROUND: Acute respiratory failure is a life-threatening emergency. Standard prehospital management involves controlled oxygen therapy. Continuous positive airway pressure is a potentially beneficial alternative treatment; however, it is uncertain whether or not this treatment could improve outcomes in NHS ambulance services. OBJECTIVES: To assess the feasibility of a large-scale pragmatic trial and to update an existing economic model to determine cost-effectiveness and the value of further research. DESIGN: (1) An open-label, individual patient randomised controlled external pilot trial. (2) Cost-effectiveness and value-of-information analyses, updating an existing economic model. (3) Ancillary substudies, comprising an acute respiratory failure incidence study, an acute respiratory failure diagnostic agreement study, clinicians perceptions of a continuous positive airway pressure mixed-methods study and an investigation of allocation concealment. SETTING: Four West Midlands Ambulance Service hubs, recruiting between August 2017 and July 2018. PARTICIPANTS: Adults with respiratory distress and peripheral oxygen saturations below the British Thoracic Society's target levels were included. Patients with limited potential to benefit from, or with contraindications to, continuous positive airway pressure were excluded. INTERVENTIONS: Prehospital continuous positive airway pressure (O-Two system, O-Two Medical Technologies Inc., Brampton, ON, Canada) was compared with standard oxygen therapy, titrated to the British Thoracic Society's peripheral oxygen saturation targets. Interventions were provided in identical sealed boxes. MAIN OUTCOME MEASURES: Feasibility objectives estimated the incidence of eligible patients, the proportion recruited and allocated to treatment appropriately, adherence to allocated treatment, and retention and data completeness. The primary clinical end point was 30-day mortality. RESULTS: Seventy-seven patients were enrolled (target 120 patients), including seven patients with a diagnosis for which continuous positive airway pressure could be ineffective or harmful. Continuous positive airway pressure was fully delivered to 74% of participants (target 75%). There were no major protocol violations/non-compliances. Full data were available for all key outcomes (target ≥ 90%). Thirty-day mortality was 27.3%. Of the 21 deceased participants, 14 (68%) either did not have a respiratory condition or had ceiling-of-treatment decision implemented that excluded hospital non-invasive ventilation and critical care. The base-case economic evaluation indicated that standard oxygen therapy was probably cost-effective (incremental cost-effectiveness ratio £5685 per quality-adjusted life-year), but there was considerable uncertainty (population expected value of perfect information of £16.5M). Expected value of partial perfect information analyses indicated that effectiveness of prehospital continuous positive airway pressure was the only important variable. The incidence rate of acute respiratory failure was 17.4 (95% confidence interval 16.3 to 18.5) per 100,000 persons per year. There was moderate agreement between the primary prehospital and final hospital diagnoses (Gwet's AC1 coefficient 0.56, 95% confidence interval 0.43 to 0.69). Lack of hospital awareness of the Ambulance continuous positive airway pressure (CPAP): Use, Treatment Effect and economics (ACUTE) trial, limited time to complete trial training and a desire to provide continuous positive airway pressure treatment were highlighted as key challenges by participating clinicians. LIMITATIONS: During week 10 of recruitment, the continuous positive airway pressure arm equipment boxes developed a 'rattle'. After repackaging and redistribution, no further concerns were noted. A total of 41.4% of ambulance service clinicians not participating in the ACUTE trial indicated a difference between the control and the intervention arm trial boxes (115/278); of these clinician 70.4% correctly identified box contents. CONCLUSIONS: Recruitment rate was below target and feasibility was not demonstrated. The economic evaluation results suggested that a definitive trial could represent value for money. However, limited compliance with continuous positive airway pressure and difficulty in identifying patients who could benefit from continuous positive airway pressure indicate that prehospital continuous positive airway pressure is unlikely to materially reduce mortality. FUTURE WORK: A definitive clinical effectiveness trial of continuous positive airway pressure in the NHS is not recommended. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12048261. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 7. See the NIHR Journals Library website for further project information.

Acute respiratory failure is a life-threatening medical emergency. It occurs when heart or lung disease suddenly develops, or deteriorates, and leads to the patient being unable to maintain oxygen levels in their blood. Continuous positive airway pressure is a potentially useful treatment that could be used by paramedics. It involves delivering oxygen under increased pressure through a tight-fitting face mask. However, it is uncertain whether or not it could work effectively in NHS ambulance services, or if it represents value for money. The Ambulance continuous positive airway pressure (CPAP): Use, Treatment Effect and economics (ACUTE) trial investigated whether or not it is possible and worthwhile to undertake a full-scale study comparing continuous positive airway pressure with normal paramedic treatment. Paramedics identified adults with acute respiratory failure when attending 999 emergency calls. Half were randomly assigned to receive continuous positive airway pressure, whereas the other half were treated normally. Patients were then followed up to see what happened to them. Fewer patients than expected were entered into the trial, but paramedics were able to provide treatment with continuous positive airway pressure, and most patients were successfully followed up. It therefore seems possible to do a full-scale trial. A cost-effectiveness model also showed that it is uncertain whether or not continuous positive airway pressure represents value for money for the NHS, so further research might be worthwhile, if continuous positive airway pressure is thought to be effective. However, examination of patients recruited to the trial uncovered important doubts about whether or not continuous positive airway pressure would help them. One-quarter of patients were not able to tolerate the tight continuous positive airway pressure mask. Some of the patients had conditions that are not usually treated by continuous positive airway pressure, or had severe underlying disease that could not be helped by this treatment. Others had collapsed lungs that could have been made worse by continuous positive airway pressure. This means that, although a full-scale trial may be possible, it is difficult to see how continuous positive airway pressure could save enough lives to make a trial worthwhile.

Prospective Study of Psychological Morbidity and Illness Perceptions in Young People With Inflammatory Bowel Disease.

BACKGROUND AND AIMS: Psychological morbidity is increased in young people with inflammatory bowel disease [IBD]. Illness perceptions may be an important factor. This study aimed to describe the prevalence and severity of psychological morbidity and to examine relationships between baseline illness perceptions and anxiety, depression, and health-related quality of life [HRQoL], at baseline and 12 months later, in 16-21 year olds with IBD. METHODS: IBD patients [n = 121] completed measures of anxiety, depression, HRQoL, and illness perceptions [IPQ-R] at baseline and follow-up [n = 100, 83%]. RESULTS: Among the 121 patients at baseline [median age 19.3 years, 40% female, 62% Crohn's disease, 73% in clinical remission], 55% reported elevated symptoms of anxiety/depression and 83% reported low HRQoL. Negative illness perceptions at baseline were significantly correlated with greater anxiety, depression, and lower HRQoL at baseline and follow-up. In regression analysis at baseline, the IPQ-R domain of greater perception of a cyclical nature of IBD was an independent predictor of anxiety, and a greater perceived emotional impact of IBD was an independent predictor of anxiety, depression, and HRQoL. Female gender and clinical relapse were also independent predictors of lower HRQoL. After controlling for baseline measures, clinical risk factors and illness perceptions did not explain additional variance in psychological morbidity at follow-up. CONCLUSIONS: A high prevalence of psychological morbidity, stable over 1 year, was demonstrated in young people with IBD. Having negative illness perceptions, being female, and having active disease predicted those at greatest risk of psychological morbidity. Illness perceptions may be an appropriate target for psychological interventions.

A cluster randomized controlled trial of a theory-based sleep hygiene intervention for adolescents.

Study Objectives: To use theory to design and evaluate an intervention to promote sleep hygiene and health among adolescents. Methods: The Theory of Planned Behavior (TPB) and the Health Action Process Approach (HAPA) were used to develop an intervention, which was then evaluated in a cluster randomized trial. Participants were high school students (N = 2,841, M age = 15.12, SD = 1.50). Adolescents in the intervention group received four face-to-face sessions providing behavior change techniques targeting the theoretical determinants of sleep hygiene. Adolescents in the control group only received educational material at the end of the study. The primary outcome was sleep hygiene measured at 1 and 6 months postintervention. A number of secondary outcomes were also measured, including beliefs about sleep, self-regulatory processes, and outcomes related to health and wellbeing. Results: Sleep hygiene was improved in the intervention group when compared with the control group at both follow-up points (coefficients = 0.16 and 0.19, 95% CIs = 0.12-0.20 and 0.15-0.23 at 1 and 6 months, respectively, for scores on the Adolescent Sleep Hygiene Scale), as were psychosocial and general aspects of health. Mediation analyses suggested that beliefs about sleep hygiene as specified by the TPB, along with self-regulatory processes from HAPA, both mediated the effect of the intervention on outcomes. In turn, the effects of the intervention on sleep hygiene mediated its impact on general health. Conclusions: Healthcare practitioners might consider intervention programs based on the TPB and the HAPA to improve sleep among adolescents. Clinical Trial Registration: Clinicaltrials.gov (NCT02551913) https://clinicaltrials.gov/ct2/show/NCT02551913.

Clinical and cost-effectiveness of one-session treatment (OST) versus multisession cognitive-behavioural therapy (CBT) for specific phobias in children: protocol for a non-inferiority randomised controlled trial.

INTRODUCTION: Specific phobias (intense, enduring fears of an object or situation that lead to avoidance and severe distress) are highly prevalent among children and young people. Cognitive-behavioural therapy (CBT) is a well-established, effective intervention, but it can be time consuming and costly because it is routinely delivered over multiple sessions during several months. Alternative methods of treating severe and debilitating phobias in children are needed, like one-session treatment (OST), to reduce time and cost, and to prevent therapeutic drift and help children recover quickly. Our study explores whether (1) outcomes with OST are 'no worse' than outcomes with multisession CBT, (2) OST is acceptable to children, their parents and the practitioners who use it and (3) OST offers good value for money to the National Health Service (NHS) and to society. METHOD: A pragmatic, non-inferiority, randomised controlled trial will compare OST with multisession CBT-based therapy on their clinical and cost-effectiveness. The primary clinical outcome is a standardised behavioural task of approaching the feared stimulus at 6 months postrandomisation. The outcomes for the within-trial cost-effectiveness analysis are quality-adjusted life years based on EQ-5D-Y, and individual-level costs based of the intervention and use of health and social service care. A nested qualitative evaluation will explore children's, parents' and practitioners' perceptions and experiences of OST. A total of 286 children, 7-16 years old, with DSM-IV diagnoses of specific phobia will be recruited via gatekeepers in the NHS, schools and voluntary youth services, and via public adverts. ETHICS AND DISSEMINATION: The trial received ethical approval from North East and York Research Ethics Committee (Reference: 17/NE/0012). Dissemination plans include publications in peer-reviewed journals, presentations in relevant research conferences, local research symposia and seminars for children and their families, and for professionals and service managers. TRIAL REGISTRATION NUMBER: ISRCTN19883421;Pre-results.

Does improving sleep lead to better mental health? A protocol for a meta-analytic review of randomised controlled trials.

INTRODUCTION: Sleep and mental health go hand-in-hand, with many, if not all, mental health problems being associated with problems sleeping. Although sleep has been traditionally conceptualised as a secondary consequence of mental health problems, contemporary views prescribe a more influential, causal role of sleep in the formation and maintenance of mental health problems. One way to evaluate this assertion is to examine the extent to which interventions that improve sleep also improve mental health. METHOD AND ANALYSIS: Randomised controlled trials (RCTs) describing the effects of interventions designed to improve sleep on mental health will be identified via a systematic search of four bibliographic databases (in addition to a search for unpublished literature). Hedges' g and associated 95% CIs will be computed from means and SDs where possible. Following this, meta-analysis will be used to synthesise the effect sizes from the primary studies and investigate the impact of variables that could potentially moderate the effects. The Jadad scale for reporting RCTs will be used to assess study quality and publication bias will be assessed via visual inspection of a funnel plot and Egger's test alongside Orwin's fail-safe n. Finally, mediation analysis will be used to investigate the extent to which changes in outcomes relating to mental health can be attributed to changes in sleep quality. ETHICS AND DISSEMINATION: This study requires no ethical approval. The findings will be submitted for publication in a peer-reviewed journal and promoted to relevant stakeholders. PROSPERO REGISTRATION NUMBER: CRD42017055450.

A structural equation model of the relationship between insomnia, negative affect, and paranoid thinking.

BACKGROUND: A growing body of evidence points to relationships between insomnia, negative affect, and paranoid thinking. However, studies are needed to examine (i) whether negative affect mediates the relation between insomnia and paranoid thinking, (ii) whether different types of insomnia exert different effects on paranoia, and (iii) to compare the impact of objective and self-reported sleeping difficulties. METHOD: Structural equation modelling was therefore used to test competing models of the relationships between self-reported insomnia, negative affect, and paranoia. n = 348 participants completed measures of insomnia, negative affect and paranoia. A subset of these participants (n = 91) went on to monitor their sleep objectively (using a portable sleep monitor made by Zeo) for seven consecutive nights. Associations between objectively recorded sleep, negative affect, and paranoia were explored using linear regression. RESULTS: The findings supported a fully mediated model where self-reported delayed sleep onset, but not self-reported problems with sleep maintenance or objective measures of sleep, was directly associated with negative affect that, in turn, was associated with paranoia. There was no evidence of a direct association between delayed sleep onset or sleep maintenance problems and paranoia. CONCLUSIONS: Taken together, the findings point to an association between perceived (but not objective) difficulties initially falling asleep (but not maintaining sleep) and paranoid thinking; a relationship that is fully mediated by negative affect. Future research should seek to disentangle the causal relationships between sleep, negative affect, and paranoia (e.g., by examining the effect of an intervention using prospective designs that incorporate experience sampling). Indeed, interventions might profitably target (i) perceived sleep quality, (ii) sleep onset, and / or (iii) emotion regulation as a route to reducing negative affect and, thus, paranoid thinking.

The prevalence of QT prolongation in a population of patients with substance use disorders.

INTRODUCTION AND AIMS: Drug induced QT prolongation occurs in patients with substance use disorders from prescription medications that prolong the QT, such as methadone. Knowing the prevalence of QT prolongation in this population is important for prescribers. This study aimed to investigate the prevalence of QT prolongation in patients with current substance use disorders. DESIGN AND METHODS: We undertook a retrospective review of electrocardiograms (ECG) from patients with substance use disorders from an urban general hospital with a large drug and alcohol service and toxicology unit. ECGs were taken from patients seen by the alcohol and drug unit over three years. The QT interval was measured manually on each ECG and defined as abnormal if above the line on the QT nomogram. The QT was also heart rate corrected using Fridericia's formula (QTcF) to investigate associated factors. RESULTS: Nine of 446 (2.0%; 95% confidence interval 1.0-3.9%) patients had an ECG with a prolonged QT interval. Three were prescribed methadone for opiate dependence (80, 90 and 125 mg daily), one also with hypokalemia; one prescribed escitalopram with hypokalaemia/hypomagnesaemia; three more with hypokalaemia alone. Only two patients had a prolonged QT with no identifiable cause. There was no association between QTcF and sex (P = 0.34), but there was a statistically significant association with age (Pearson R = 0.19, 95% confidence interval 0.10-0.28, P < 0.0001). DISCUSSION AND CONCLUSIONS: QT prolongation is rare in patients with substance use disorders and is most likely similar to the general population once cases related to methadone use and electrolyte abnormalities are excluded. [Scott AJ, Dunlop AJ, Brown A, Craig S. The prevalence of QT prolongation in a population of patients with substance use disorders. Drug Alcohol Rev 2017;36:239-244].

Self-help interventions for psychosis: a meta-analysis.

Self-help has been shown to be an effective intervention for a wide range of mental health problems. However, there is less evidence on the efficacy of self-help for psychosis and, to date, there has been no systematic review. A search of bibliographic databases identified 24 relevant studies with a total sample size of N=1816. Ten studies adopted a repeated measures design and 14 an independent group design (including RCTs and quasi-experimental studies). Self-help interventions had, on average, a small-to-medium-sized effect on overall symptoms (d+=0.33, 95% CI: 0.17 to 0.48). Sub-analyses revealed that self-help interventions had a small-to-medium-sized effect on positive symptoms (d+=0.42, 95% CI: 0.13 to 0.72), a small-to-medium-sized effect on negative symptoms (d+=0.37, 95% CI: 0.07 to 0.66), and a small-sized effect on outcomes associated with the symptoms of psychosis such as quality of life (d+=0.13, 95% CI: 0.02 to 0.24). Moderation analysis identified a number of factors that influenced treatment effects including the complexity of the intervention and amount of contact time. Self-help interventions for psychosis have a lot of potential and recommendations for further research are discussed.