Previous research has shown that cognitive bias modification of interpretations (CBM-I) may be a promising intervention for anxiety in youth; however, results are mixed. Given the high comorbidity between anxiety and depression in youth, it is surprising that no child studies have targeted biases associated with both. This study aims to evaluate the effectiveness and acceptability of an online CBM-I intervention (Mindmaster) for children with symptom scores of anxiety or depression above a borderline or clinical threshold. The intervention has been codesigned with children, parents and mental health professionals to promote user engagement.
The study is a randomised controlled trial, with two parallel arms. Participants are 143 children aged 8–10 years with scores of anxiety and/or depressive symptoms above a borderline or clinical threshold. They will be allocated to either the intervention group or the waitlist control group. The intervention consists of 2 weeks of online CBM-I training, with four sessions (10–15 min) per week. Outcome assessments will be conducted at baseline, 4 weeks after baseline (post-training/post-waitlist) and 8 weeks after baseline (follow-up) for the intervention group only. The primary outcome is interpretation bias. Secondary outcomes are anxiety and depressive symptoms and life interference. Analyses will be conducted within an intention-to-treat framework using mixed models for repeated measures.
The study was approved by the University of New South Wales Human Research Ethics Committee (HC220758). Findings will be reported to (1) participating families; (2) presented at scientific conferences and (3) disseminated to peer-review publications. Data will be available from the corresponding author on request.
ACTRN12622001493730.
Glioblastoma (GBM) is the most common adult primary malignant brain tumour. The condition is incurable and, despite aggressive treatment at first presentation, almost all tumours recur after a median of 7 months. The aim of treatment at recurrence is to prolong survival and maintain health-related quality of life (HRQoL). Chemotherapy is typically employed for recurrent GBM, often using nitrosourea-based regimens. However, efficacy is limited, with reported median survivals between 5 and 9 months from recurrence. Although less commonly used in the UK, there is growing evidence that re-irradiation may produce survival outcomes at least similar to nitrosourea-based chemotherapy. However, there remains uncertainty as to the optimum approach and there is a paucity of available data, especially with regards to HRQoL. Brain Re-Irradiation Or Chemotherapy (BRIOChe) aims to assess re-irradiation, as an acceptable treatment option for recurrent IDH-wild-type GBM.
BRIOChe is a phase II, multi-centre, open-label, randomised trial in patients with recurrent GBM. The trial uses Sargent’s three-outcome design and will recruit approximately 55 participants from 10 to 15 UK radiotherapy sites, allocated (2:1) to receive re-irradiation (35 Gy in 10 daily fractions) or nitrosourea-based chemotherapy (up to six, 6-weekly cycles). The primary endpoint is overall survival rate for re-irradiation patients at 9 months. There will be no formal statistical comparison between treatment arms for the decision-making primary analysis. The chemotherapy arm will be used for calibration purposes, to collect concurrent data to aid interpretation of results. Secondary outcomes include HRQoL, dexamethasone requirement, anti-epileptic drug requirement, radiological response, treatment compliance, acute and late toxicities, progression-free survival.
BRIOChe obtained ethical approval from Office for Research Ethics Committees Northern Ireland (reference no. 20/NI/0070). Final trial results will be published in peer-reviewed journals and adhere to the ICMJE guidelines.
by Naureen Akber Ali Meghani, Joanne Hudson, Gareth Stratton, Jane Mullins
BackgroundThere are few studies that focus explicitly on the impact of the home environment on older adults’ sedentary behaviour (SB) and physical activity (PA) using the socio-ecological model (SEM). This study aims to investigate older adults’ PA and SB within the home environment integrating the SEM as a theoretical framework.
MethodsA qualitative exploratory research design was employed to conduct 33 in-depth interviews (IDIs) and five focus group (FGs; n = 16) with multi-diverse ethnic older adults (mean age 72±5 years). Using reflexive thematic analysis themes were generated from the data set and were interpreted using the SEM.
ResultsThe findings indicate that different levels of the SEM had an impact on older adults’ PA and SB. These include the 1) Individual level: Attitude, perception and motivation 2) Interpersonal level: Family and Friends: a motive to remain active 3) Organisational level: healthcare institutes, 4) Community level factors: Significance of social groups, 5) Physical Environment: Microenvironment and 6) Policy level factors (lockdown restrictions and healthcare system). This model can be utilised to foster activity within the home by focusing on the facilitators and barriers identified at each of these levels of influence.
ConclusionThe study findings suggest that modifying PA and SB in the home environment is complex and is influenced across different levels of the SEM. Therefore, a holistic approach is required that integrates these multiple influences. This understanding can inform the design of interventions that seek to optimize PA and minimize SB within the home environment.