The Feasibility and Acceptability of Remote Videoconference Use of the Brief Developmental Assessment Tool for Young Children with Congenital Heart Disease.

Background: Young children with congenital heart disease (CHD) are at heightened risk of developmental delay. The outbreak of COVID-19 and the ensuing lockdowns presented an opportunity to test the feasibility of using a short neurodevelopmental assessment tool-the Brief Developmental Assessment (BDA)-remotely via new technologies. Methods: We tested the feasibility and acceptability of remote testing of the tool's 6 domains of development with 30 children younger than 5 years with CHD and 10 healthy controls. Results: Despite some technical issues, parents largely responded positively to the use of the remote assessment as opposed to traditional face-to-face appointments, citing the beneficial saving of time, money, and childcare. Conclusions: The acceptability of the remote use of the BDA for the developmental screening of children with CHD will allow for the possibility of increased screening for more children and earlier identification of developmental problems, both during and after COVID-19 restrictions.

Postoperative morbidities with infant cardiac surgery and toddlers' neurodevelopment.

OBJECTIVE: To evaluate the relationship between morbidities after infant cardiac surgery and neurodevelopment and behaviour at age 2-3 years. DESIGN/SETTING: A prospective cohort follow-up study, in four paediatric cardiac centres. We excluded children with known syndromes. Home-based neurodevelopmental assessments using the Bayley Scales of Infant and Toddler Development 3rd Edition (Bayley-III) were undertaken in 81 children and secondary outcome measures of development and behaviour were completed by parents. A further 41 families completed the secondary outcome measures remotely. RESULTS: Children were grouped as multiple morbidities/extracorporeal life support (ECLS) (n=19), single morbidities (n=36) and no morbidities (n=59). Group comparisons found that children with multiple morbidities/ECLS, compared with no morbidities, had: (a) lower adjusted mean scores for core Bayley-III composites (none reached the level of statistical significance), with mean differences of cognitive -6.1 (95% CI -12.4 to 0.1) p=0.06, language -9.1 (95% CI -18.6 to 0.3) p=0.06 and motor -4.4 (95% CI -12.0 to 3.1) p=25; (b) greater adjusted odds of at least one low or borderline Bayley-III composite result 4.0 (95% CI 1.0 to 16.0) (p=0.05); (c) greater adjusted risk of an abnormal Ages and Stages Questionnaire (ASQ) result 5.3 (95% CI 1.3 to 21.1) (p=0.03) and a borderline ASQ result 4.9 (95% CI 1.0 to 25.0) (p=0.05); and no difference in the risk of an abnormal Strengths and Difficulties Questionnaire result 1.7 (95% CI 0.3 to 10.4) p=0.58. These outcomes were not statistically different between the single morbidity and no morbidity groups. CONCLUSIONS: Children who experience multiple morbidities/ECLS after infant heart surgery are at a greater risk of neurodevelopmental difficulties than their peers who had no complications and should be prioritised for neurodevelopmental follow-up.

Cognitive-behavioural therapy compared with standardised medical care for adults with dissociative non-epileptic seizures: the CODES RCT.

BACKGROUND: Dissociative (non-epileptic) seizures are potentially treatable by psychotherapeutic interventions; however, the evidence for this is limited. OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of dissociative seizure-specific cognitive-behavioural therapy for adults with dissociative seizures. DESIGN: This was a pragmatic, multicentre, parallel-arm, mixed-methods randomised controlled trial. SETTING: This took place in 27 UK-based neurology/epilepsy services, 17 liaison psychiatry/neuropsychiatry services and 18 cognitive-behavioural therapy services. PARTICIPANTS: Adults with dissociative seizures in the previous 8 weeks and no epileptic seizures in the previous year and meeting other eligibility criteria were recruited to a screening phase from neurology/epilepsy services between October 2014 and February 2017. After psychiatric assessment around 3 months later, eligible and interested participants were randomised between January 2015 and May 2017. INTERVENTIONS: Standardised medical care consisted of input from neurologists and psychiatrists who were given guidance regarding diagnosis delivery and management; they provided patients with information booklets. The intervention consisted of 12 dissociative seizure-specific cognitive-behavioural therapy 1-hour sessions (plus one booster session) that were delivered by trained therapists, in addition to standardised medical care. MAIN OUTCOME MEASURES: The primary outcome was monthly seizure frequency at 12 months post randomisation. The secondary outcomes were aspects of seizure occurrence, quality of life, mood, anxiety, distress, symptoms, psychosocial functioning, clinical global change, satisfaction with treatment, quality-adjusted life-years, costs and cost-effectiveness. RESULTS: In total, 698 patients were screened and 368 were randomised (standardised medical care alone, n = 182; and cognitive-behavioural therapy plus standardised medical care, n = 186). Primary outcome data were obtained for 85% of participants. An intention-to-treat analysis with multivariate imputation by chained equations revealed no significant between-group difference in dissociative seizure frequency at 12 months [standardised medical care: median of seven dissociative seizures (interquartile range 1-35 dissociative seizures); cognitive-behavioural therapy and standardised medical care: median of four dissociative seizures (interquartile range 0-20 dissociative seizures); incidence rate ratio 0.78, 95% confidence interval 0.56 to 1.09; p = 0.144]. Of the 16 secondary outcomes analysed, nine were significantly better in the arm receiving cognitive-behavioural therapy at a p-value < 0.05, including the following at a p-value ≤ 0.001: the longest dissociative seizure-free period in months 7-12 inclusive post randomisation (incidence rate ratio 1.64, 95% confidence interval 1.22 to 2.20; p = 0.001); better psychosocial functioning (Work and Social Adjustment Scale, standardised treatment effect -0.39, 95% confidence interval -0.61 to -0.18; p < 0.001); greater self-rated and clinician-rated clinical improvement (self-rated: standardised treatment effect 0.39, 95% confidence interval 0.16 to 0.62; p = 0.001; clinician rated: standardised treatment effect 0.37, 95% confidence interval 0.17 to 0.57; p < 0.001); and satisfaction with treatment (standardised treatment effect 0.50, 95% confidence interval 0.27 to 0.73; p < 0.001). Rates of adverse events were similar across arms. Cognitive-behavioural therapy plus standardised medical care produced 0.0152 more quality-adjusted life-years (95% confidence interval -0.0106 to 0.0392 quality-adjusted life-years) than standardised medical care alone. The incremental cost-effectiveness ratio (cost per quality-adjusted life-year) for cognitive-behavioural therapy plus standardised medical care versus standardised medical care alone based on the EuroQol-5 Dimensions, five-level version, and imputed data was £120,658. In sensitivity analyses, incremental cost-effectiveness ratios ranged between £85,724 and £206,067. Qualitative and quantitative process evaluations highlighted useful study components, the importance of clinical experience in treating patients with dissociative seizures and potential benefits of our multidisciplinary care pathway. LIMITATIONS: Unlike outcome assessors, participants and clinicians were not blinded to the interventions. CONCLUSIONS: There was no significant additional benefit of dissociative seizure-specific cognitive-behavioural therapy in reducing dissociative seizure frequency, and cost-effectiveness over standardised medical care was low. However, this large, adequately powered, multicentre randomised controlled trial highlights benefits of adjunctive dissociative seizure-specific cognitive-behavioural therapy for several clinical outcomes, with no evidence of greater harm from dissociative seizure-specific cognitive-behavioural therapy. FUTURE WORK: Examination of moderators and mediators of outcome. TRIAL REGISTRATION: Current Controlled Trials ISRCTN05681227 and ClinicalTrials.gov NCT02325544. 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. 43. See the NIHR Journals Library website for further project information.

Dissociative seizures resemble epileptic seizures or faints, but can be distinguished from them by trained doctors. Dissociation is the medical word for a 'trance-like' or 'switching off' state. People with dissociative seizures commonly have other psychological or physical problems. Quality of life may be low. The condition accounts for about one in every six patients seen in hospitals because of seizures. We wanted to find out if people with dissociative seizures receiving standardised treatment would also benefit from a talking therapy, called cognitive­behavioural therapy, made specific to this disorder. We did a randomised controlled trial to find out if people with dissociative seizures given standardised treatment and cognitive­behavioural therapy (talking therapy) would do better than those given standardised treatment alone. Standardised treatment of dissociative seizures began with careful diagnosis from a neurologist and then further assessment and treatment from a psychiatrist. In total, 368 people with dissociative seizures participated, with half receiving standardised treatment alone and half having talking therapy plus standardised treatment. We measured seizures and psychological and physical health in both trial groups. We also investigated whether or not cognitive­behavioural therapy was good value for money. After 12 months, patients in both trial groups seemed to have fewer monthly seizures, but there was no advantage in the talking therapy group. Patients in the talking therapy group had more consecutive days without seizures, reporting less impact from them in everyday situations. Patients in the talking therapy group, and their doctors, considered improvements to be better, and patients in this group reported greater satisfaction with treatment. However, the talking therapy was expensive and not as cost-effective as hoped. Interviews with patients and study clinicians showed that they valued aspects of both treatments and of the care provided by the multidisciplinary teams. Overall, cognitive­behavioural therapy designed for dissociative seizures plus standardised treatment was not better at reducing the total numbers of seizures reported, but did produce several positive benefits for participants compared with standardised treatment alone.

The experience of trial participation, treatment approaches and perceptions of change among participants with dissociative seizures within the CODES randomized controlled trial: A qualitative study.

BACKGROUND: Nested within a large, multicenter randomized controlled trial (RCT) for people with dissociative seizures (DS), the study used purposive sampling to explore participants' experience of participating in an RCT, their experience of DS-specific cognitive behavioral therapy (CBT) and another component of the RCT, Standardized Medical Care (SMC) and their perceptions of and reflections on seizure management and change. METHODS: A qualitative study using semistructured interviews was conducted with 30 participants in an RCT (the COgnitive behavioral therapy vs standardized medical care for adults with Dissociative non-Epileptic Seizures (CODES) Trial) investigating the effectiveness of two treatments for DS. Key themes and subthemes were identified using thematic framework analysis (TFA). RESULTS: Analysis yielded three overarching themes: taking part in a treatment trial - "the only thing out there", the experience of treatment techniques that were perceived to help with seizure management, and reflections on an "unpredictable recovery". CONCLUSIONS: People with DS are amenable to participating in a psychotherapy RCT and described a largely positive experience. They also described the applicability of aspects of DS-specific CBT and SMC in the management of their DS, received within the confines of the CODES trial. Factors that appeared to account for the variability in response to treatment delivery included individual preferences for the nature of sessions, the nature of therapeutic relationships, readiness to discuss trauma, other aspects of emotional avoidance, and whether therapy provided something new.

Parenting and mother-infant interactions in the context of maternal postpartum obsessive-compulsive disorder: Effects of obsessional symptoms and mood.

BACKGROUND: Maternal mental illness is associated with negative effects on the infant and child. Increased attention has been paid to the effects of specific perinatal disorders on parenting and interactions as an important mechanism of influence. OCD can be a debilitating disorder for the sufferer and those around them. Although OCD is a common perinatal illness, no previous studies have characterized parenting and mother infant interactions in detail for mothers with OCD. METHODS: 37 mothers with postpartum OCD and a 6 month old infant were compared with 37 community control dyads on a variety of measures of psychological distress and parenting. Observed mother-infant interactions were assessed independently. RESULTS: Obsessions and compulsions were reported in both groups, although they did not cause interference in the control group. Mothers with OCD were troubled by their symptoms for a mean of 9.6 hours/day. Mothers with OCD were less confident, reported more marital distress and less social support than healthy peers and were less likely to be breastfeeding. Infant temperament ratings did not differ. Mothers with OCD were rated as less sensitive in interactions than the comparison group, partly attributable to levels of concurrent depression. CONCLUSIONS: Maternal postpartum OCD is a disorder that can affect experiences of parenting and mother-infant interactions although this may not be driven by OCD symptoms. Longitudinal studies are required to assess the trajectory and impact of maternal difficulties as the infant develops.

Relationship between self-discrepancy and worries about penis size in men with body dysmorphic disorder.

We explored self-discrepancy in men with body dysmorphic disorder (BDD) concerned about penis size, men without BDD but anxious about penis size, and controls. Men with BDD (n=26) were compared to those with small penis anxiety (SPA; n=31) and controls (n=33), objectively (by measuring) and investigating self-discrepancy: actual size, ideal size, and size they felt they should be according to self and other. Most men under-estimated their penis size, with the BDD group showing the greatest discrepancy between perceived and ideal size. The SPA group showed a larger discrepancy than controls. This was replicated for the perceptions of others, suggesting the BDD group internalised the belief that they should have a larger penis size. There was a significant correlation between symptoms of BDD and this discrepancy. This self-actual and self-ideal/self-should discrepancy and the role of comparing could be targeted in therapy.

Sexual Functioning and Behavior of Men with Body Dysmorphic Disorder Concerning Penis Size Compared with Men Anxious about Penis Size and with Controls: A Cohort Study.

INTRODUCTION: Little is known about the sexual functioning and behavior of men anxious about the size of their penis and the means that they might use to try to alter the size of their penis. AIM: To compare sexual functioning and behavior in men with body dysmorphic disorder (BDD) concerning penis size and in men with small penis anxiety (SPA without BDD) and in a control group of men who do not have any concerns. METHODS: An opportunistic sample of 90 men from the community were recruited and divided into three groups: BDD (n = 26); SPA (n = 31) and controls (n = 33). MAIN OUTCOME MEASURES: The Index of Erectile Function (IEF), sexual identity and history; and interventions to alter the size of their penis. RESULTS: Men with BDD compared with controls had reduced erectile dysfunction, orgasmic function, intercourse satisfaction and overall satisfaction on the IEF. Men with SPA compared with controls had reduced intercourse satisfaction. There were no differences in sexual desire, the frequency of intercourse or masturbation across any of the three groups. Men with BDD and SPA were more likely than the controls to attempt to alter the shape or size of their penis (for example jelqing, vacuum pumps or stretching devices) with poor reported success. CONCLUSION: Men with BDD are more likely to have erectile dysfunction and less satisfaction with intercourse than controls but maintain their libido. Further research is required to develop and evaluate a psychological intervention for such men with adequate outcome measures.

Penile Dysmorphic Disorder: Development of a Screening Scale.

Penile dysmorphic disorder (PDD) is shorthand for men diagnosed with body dysmorphic disorder, in whom the size or shape of the penis is their main, if not their exclusive, preoccupation causing significant shame or handicap. There are no specific measures for identifying men with PDD compared to men who are anxious about the size of their penis but do not have PDD. Such a measure might be helpful for treatment planning, reducing unrealistic expectations, and measuring outcome after any psychological or physical intervention. Our aim was, therefore, to validate a specific measure, termed the Cosmetic Procedure Screening Scale for PDD (COPS-P). Eighty-one male participants were divided into three groups: a PDD group (n = 21), a small penis anxiety group (n = 37), and a control group (n = 23). All participants completed the COPS-P as well as standardized measures of depression, anxiety, social phobia, body image, quality of life, and erectile function. Penis size was also measured. The final COPS-P was based on nine items. The scale had good internal reliability and significant convergent validity with measures of related constructs. It discriminated between the PDD group, the small penis anxiety group, and the control group. This is the first study to develop a scale able to discriminate between those with PDD and men anxious about their size who did not have PDD. Clinicians and researchers may use the scale as part of an assessment for men presenting with anxiety about penis size and as an audit or outcome measure after any intervention for this population.

Phenomenology of men with body dysmorphic disorder concerning penis size compared to men anxious about their penis size and to men without concerns: a cohort study.

Men with body dysmorphic disorder (BDD) may be preoccupied with the size or shape of the penis, which may be causing significant shame or impairment. Little is known about the characteristics and phenomenology of such men and whether they can be differentiated from men with small penis anxiety (SPA) (who do not have BDD), and men with no penile concerns. Twenty-six men with BDD, 31 men with SPA, and 33 men without penile concerns were compared on psychopathology, experiences of recurrent imagery, avoidance and safety-seeking behaviours. Men with BDD had significantly higher scores than both the SPA group and no penile concern group for measures of imagery, avoidance, safety seeking and general psychopathology. The groups differed on the phenomenology of BDD specific to penile size preoccupation clearly from the worries of SPA, which in turn were different to those of the men without concerns. The common avoidance and safety seeking behaviours were identified in such men that may be used clinically.

Beliefs about penis size: validation of a scale for men ashamed about their penis size.

INTRODUCTION: No measures are available for understanding beliefs in men who experience shame about the perceived size of their penis. Such a measure might be helpful for treatment planning, and measuring outcome after any psychological or physical intervention. AIM: Our aim was to validate a newly developed measure called the Beliefs about Penis Size Scale (BAPS). METHOD: One hundred seventy-three male participants completed a new questionnaire consisting of 18 items to be validated and developed into the BAPS, as well as various other standardized measures. A urologist also measured actual penis size. MAIN OUTCOME MEASURES: The BAPS was validated against six psychosexual self-report questionnaires as well as penile size measurements. RESULTS: Exploratory factor analysis reduced the number of items in the BAPS from 18 to 10, which was best explained by one factor. The 10-item BAPS had good internal consistency and correlated significantly with measures of depression, anxiety, body image quality of life, social anxiety, erectile function, overall satisfaction, and the importance attached to penis size. The BAPS was not found to correlate with actual penis size. It was able to discriminate between those who had concerns or were dissatisfied about their penis size and those who were not. CONCLUSIONS: This is the first study to develop a scale for measurement of beliefs about penis size. It may be used as part of an assessment for men who experience shame about the perceived size of their penis and as an outcome measure after treatment. The BAPS measures various manifestations of masculinity and shame about their perceived penis size including internal self-evaluative beliefs; negative evaluation by others; anticipated consequences of a perceived small penis, and extreme self-consciousness.