RESUMEN
BACKGROUND: Intrusive mental imagery is associated with anxiety and mood instability within bipolar disorder and therefore represents a novel treatment target. Imagery Based Emotion Regulation (IBER) is a brief structured psychological intervention developed to enable people to use the skills required to regulate the emotional impact of these images. METHODS: Participants aged 18 and over with a diagnosis of bipolar disorder and at least a mild level of anxiety were randomly assigned (1:1) to receive IBER plus treatment as usual (IBER + TAU) or treatment as usual alone (TAU). IBER was delivered in up to 12 sessions overs 16 weeks. Clinical and health economic data were collected at baseline, end of treatment and 16-weeks follow-up. Objectives were to inform the recruitment process, timeline and sample size estimate for a definitive trial and to refine trial procedures. We also explored the impact on participant outcomes of anxiety, depression, mania, and mood stability at 16-weeks and 32-weeks follow-up. RESULTS: Fifty-seven (28: IBER + TAU, 27: TAU) participants from two sites were randomised, with 50 being recruited within the first 12 months. Forty-seven (82%) participants provided outcome data at 16 and 32-weeks follow-up. Thirty-five participants engaged in daily mood monitoring at the 32-week follow-up stage. Retention in IBER treatment was high with 27 (96%) attending ≥ 7 sessions. No study participants experienced a serious adverse event. DISCUSSION: The feasibility criteria of recruitment, outcome completion, and intervention retention were broadly achieved, indicating that imagery-focused interventions for bipolar disorder are worthy of further investigation.
RESUMEN
BACKGROUND: Down syndrome is the most common cause of learning disability, affecting approximately 1 in every 700 babies. Children with Down syndrome have particular difficulties with speech and language. This makes it challenging for them to participate fully in life, access healthcare services and educational opportunities. Improving the language skills of young children with Down syndrome is vital for their future social and emotional well-being and behaviour, and consequently contribution to society. As Down syndrome is detected before or at birth, we can provide support from early on. There are currently no standard interventions for improving the language skills of children with Down syndrome under the age of 36 months. Evidence suggests that early parent-based interventions may be effective in improving language outcomes. In partnership with parents and speech and language therapists, we have co-developed an intervention focusing on early social communication skills and our preliminary work shows that it can lead to better language in children with Down syndrome. Our aim is to carry out a feasibility study which will inform a future pilot/full trial to test whether the intervention is effective in improving language skills before children with Down syndrome start school. METHODS: This is a two-arm feasibility randomised controlled trial (RCT), with 1:1 randomisation stratified by trial site comparing the intervention (plus standard NHS speech and language therapy) with no intervention (standard NHS speech and language therapy only). We aim to recruit between 25 and 30 children with Down syndrome aged between 11 and 36 months. Sites are defined by the geographical boundaries of three National Health Service (NHS) Trusts. Recruitment is from NHS Speech and Language Therapist caseloads within the 3 Trusts, and self-referral. In the intervention arm, parents/guardians will receive brief training on the parent-based intervention and a manual to follow with their child for 10 weeks. The children's language and early communication skills and family health outcomes will be assessed by a blinded assessor at baseline, post-intervention and 6 month follow-up. Questionnaire and semi-structured interviews will explore the acceptability of the intervention to parents and SLTs. DISCUSSION: The feasibility study's outcomes will determine whether it would be viable to progress to a full-trial and whether adjustments need to made to the procedures, data collection methods, intervention delivery and the intensity of support needed. We want to assess whether our early intervention can be delivered and rolled out through NHS Speech and Language Therapy (SLT) Services. We anticipate that NHS SLT Services will need to make ongoing changes due to the COVID-19 pandemic, so it is likely that we will need to make adjustments for the definitive trial. We will also calculate descriptive statistics of the language outcome measure which we will use for any future sample size calculation. TRIAL REGISTRATION: ISRCTN13902755. Registered on 25 August 2020. http://www.isrctn.com/ISRCTN13902755.
RESUMEN
BACKGROUND: Anxiety is highly prevalent in people diagnosed with bipolar disorder (BD), and can persist between acute episodes of mania and depression. Recent studies indicate that people with BD are prone to experiencing frequent, intrusive and emotional mental images which further fuel their levels of anxiety and mood instability. These intrusive emotional mental images represent a specific target for treatment for this disorder with the potential to reduce anxiety and improve mood stability. A new brief structured psychological intervention for BD called Imagery Based Emotion Regulation (IBER) has been developed, which translates experimental work in the area of imagery and emotion into a skills training programme to improve the regulation of intrusive and distressing emotional mental images in BD. A feasibility trial is required in order to assess whether a full randomised controlled trial is indicated in order to evaluate this approach. METHODS: The design is a two-arm feasibility randomised controlled trial (RCT), with 1:1 randomisation stratified by trial site and minimised on medication status and anxiety severity. Participants are 60 individuals diagnosed with bipolar disorder and experiencing at least a mild level of anxiety. Sites are defined by the geographical boundaries of two National Health Service (NHS) Trusts, with recruitment from NHS teams, GP surgeries and self-referral. The intervention is up to 12 sessions of Imagery Based Emotion Regulation within 16 weeks. The comparator is NHS standard care. The primary aim is to assess the feasibility of conducting a powered multi-site RCT to evaluate effectiveness. Measures of anxiety, depression, mania, mood stability and health care use will be conducted at baseline, end of treatment and at 16-week follow-up. DISCUSSION: This is the first feasibility trial of an imagery-based intervention for the treatment of anxiety in bipolar disorder. If the trial proves feasible, a large multi-site trial will be required. TRIAL REGISTRATION: ISRCTN16321795. Registered on October 16, 2018. 10.1186/ISRCTN16321795.
RESUMEN
BACKGROUND: There are marked disparities between pre-school children in key skills affecting school readiness, disparities that commonly persist and influence children's later academic achievements, employment, and adjustment. Much of this disparity is linked to socio-economic disadvantage and its impact on the home learning environment. Children's Centres are an ideal context in which to implement and evaluate programmes to address this problem. They principally serve the 30% worst areas on the Indices of Deprivation Affecting Children, providing for families from the antenatal period up to age 5 years, aiming to promote parenting skills and provide care for children. METHODS: We are conducting a randomised controlled trial, based in Children Centres, to evaluate a parenting intervention for caregivers of children between 28 and 45 months of age. The intervention provides training to parents in dialogic book-sharing. The training is run by a facilitator who sees parents in small groups, on a weekly basis over 7 weeks. The study is a cluster randomised controlled trial. Twelve of the Children's Centres in the town of Reading in the UK have been randomly assigned to an index or control condition. The primary outcome is child cognition (language, attention, and executive function); and secondary outcomes are child social development, behaviour problems, and emotion regulation, parenting during book-sharing and problem solving and parental child behaviour management strategies. Data are collected at baseline, post-intervention and 4-6 months post-intervention. DISCUSSION: The Impact of Early-years Provision in Children's Centres trial (EPICC) aims to evaluate the impact of an early parenting intervention on several key risk factors for compromised child development, including aspects of parenting and child cognition, social development, behaviour problems and emotion regulation. The study is being carried out in Children's Centres, which largely serve the most disadvantaged families in the UK. Since the intervention is brief and, with modest levels of training, readily deliverable within Children's Centres and similar early childcare provision centres, demonstration that it is of benefit to child cognition, socio-emotional development and behaviour would be important. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN28513611 . Registered on 28 March 2017. This is version 1 of the protocol for the EPICC trial.
