Rebecca L. Gould

Background: Group mindfulness-based cognitive therapy (MBCT) is recommended for the treatment of subthreshold-to-mild depressive symptoms. Timely access to MBCT, however, is limited by accessibility issues. Self-help MBCT can overcome these issues, but is associated with poorer engagement. Incorporating virtual reality into self-help MBCT (VR-MBCT) may improve engagement, but relatively little is known about its feasibility and acceptability. Consequently, the aims of this study were to examine the acceptability, feasibility and preliminary signals of efficacy of VR-MBCT for reducing psychological distress in people with depression and/or anxiety symptoms. Methods: In two uncontrolled feasibility studies, participants aged ≥ 18 years with mild-to-moderately severe symptoms of depression and/or anxiety were recruited via self-referral. Participants received five VR-MBCT sessions (totalling approximately two hours in duration) each week for 8 weeks plus usual care. Co-primary outcomes were feasibility (recruitment, retention and data completion) and acceptability (course completion and satisfaction with VR-MBCT) in both studies. Secondary outcomes included measures of depression, anxiety, mental well-being and mindfulness, assessed at pre- and post-intervention. Results: In Study 1, 35 participants (100% of the target) were recruited, 22 participants (63%) were retained, 20–22 participants (57–63%) completed outcome measures at both timepoints, and 18 participants (51%) completed 4 weeks of VR-MBCT. In Study 2, 48 participants (96% of the target) were recruited, 26 participants (54%) were retained, 23–26 participants (48–54%) completed outcome measures at both timepoints, and 22 participants (46%) completed 4 weeks of VR-MBCT. Satisfaction with VR-MBCT was high in both studies. Data were suggestive of improvements in anxiety, depression, mental well-being and mindfulness from pre- to post-intervention in both studies. Rates of reliable improvement were 77–90% in Study 1 and 62–70% in Study 2. Conclusions: There was good evidence of the acceptability of VR-MBCT with respect to course satisfaction and feasibility in terms of recruitment. Although consistent with previous studies, findings suggested that further improvements could be made regarding retention/attrition, data completion and initial engagement. Preliminary signals of efficacy suggested that VR-MBCT may reduce psychological distress and improve mental wellbeing and mindfulness in people with depression and/or anxiety symptoms. However, results should be interpreted with caution due to study limitations.

Most people living with dementia are cared for at home by unpaid family carers who experience substantially higher rates of anxiety and depression compared to the general population: approximately ...

Background: HomeHealth is a home-based, voluntary sector service supporting older people with mild frailty to maintain independence through behaviour change. Support workers discuss the person’s priorities and enable setting/achieving goals around mobility, nutrition, socialising and/or psychological well-being. Aims: We tested clinical and cost-effectiveness of HomeHealth for maintaining independence in older people with mild frailty in a randomised controlled trial. Methods: Design: Single-blind, parallel randomised controlled trial open between 18 January 2021 and 4 July 2023, with mixed-methods process evaluation. Setting: Community-dwelling older people aged 65+ years with mild frailty from 27 general practices and community settings in London, Yorkshire and Hertfordshire. Randomisation: Participants were randomised 1 : 1 to receive HomeHealth or treatment as usual. Outcomes: Primary outcome was independence in activities of daily living (modified Barthel Index), analysed using linear mixed models. Secondary outcomes included frailty phenotype score, extended activities of daily living, well-being, psychological distress, loneliness, cognition, falls and mortality. Health economic outcomes included quality of life, capability and service use, including hospital admissions. Cost-effectiveness acceptability curves and cost-effectiveness planes were used to represent the probability of cost-effectiveness compared to treatment as usual. Process evaluation: We conducted semistructured interviews with participants receiving the intervention, HomeHealth workers and other stakeholders supporting service delivery. Interviews were thematically analysed. Fidelity of audio-recorded appointments was assessed by two independent raters. We evaluated potential mechanisms of impact using data from appointments attended, types of goals set and progress towards goals. Findings: We recruited 388 participants, mean age 81.4 years (standard deviation 6.5), 64% female and 94% White British/European. HomeHealth did not improve Barthel Index scores at 12 months (0.250, 95% confidence interval −0.932 to 1.432). At 6 months, we found small significant reductions in psychological distress (−1.237, 95% confidence interval −2.127 to −0.348), and frailty phenotype score (−0.252, 95% confidence interval −0.487 to −0.017). At 12 months, we found significant improvements in well-being (1.449, 95% confidence interval 0.124 to 2.775), reduced unplanned admissions (incidence rate ratio 0.65, 95% confidence interval 0.54 to 0.92) with lower associated costs (−£586/participant, 95% confidence interval −351 to −821). There were no differences in other outcomes. HomeHealth dominates treatment as usual with a negative point estimate for incremental costs (−796, 95% confidence interval −2016 to 424), positive point estimate for incremental quality-adjusted life-years (0.009, −0.021 to 0.039) and high probability of cost-effectiveness. Process evaluation: Sixty-four semistructured interviews were completed, including 49 participants and 15 HomeHealth workers/stakeholders. The service was acceptable and safe, with good fidelity of delivery. Participants made progress on personalised goals, most working on enhancing mobility. They found the service empowering, and received emotional/practical support. Engagement was more challenging when participants identified no need for change, had significant memory impairment or new/declining illness. Flexibility around varying symptoms and incorporating behaviour change into existing routines promoted engagement. Conclusion: HomeHealth did not improve independent functioning for older people with mild frailty. There were small significant improvements in frailty status, psychological distress and well-being and a 35% reduction in unplanned admissions, with high probability of cost-effectiveness. Limitations: We used a pragmatic design with intervention delivery in real-world settings during/after the COVID-19 pandemic, potentially with more variability in delivery. Our findings might not apply to other geographical settings/healthcare systems. Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR128334.

Managing multiple long-term conditions (MLTCs) is a growing priority for health and social care systems, as MLTCs often lead to frailty and reduced resilience to adverse health events. Behaviour change interventions for this population have shown limited effectiveness. We developed HomeHealth, a home-based behaviour change intervention for older adults with mild frailty and evaluated it in a randomised controlled trial in England. As part of the process evaluation, we conducted a qualitative sub-study to examine barriers and facilitators to engagement, approaches to goal setting, and strategies for tailoring future interventions. Forty-nine participants with MLTCs who received HomeHealth were interviewed, within 6-months of their final intervention session. Participants had an average age of 80.3 years, 65% female, 76% white British, and lived with an average of 5.1 health conditions (range 2–11). Data were thematically analysed. Three themes were developed: (1) prioritising symptoms over conditions; (2) coping with and adapting to symptoms; and (3) tailoring goal setting for MLTCs. Impacts were driven by cumulative symptom burden rather than diagnoses, with mobility-related impairment being the primary concern. Symptom-focused goal setting supported engagement, but symptom fluctuations hindered progress. Findings underscore the importance of person-centred approaches. Targeting goals around functional impairment and symptom management may improve engagement compared to condition-focused strategies. Supporting adaptive behaviours during symptom exacerbations and providing positive feedback on effort, rather than completion, could sustain motivation and promote long-term behaviour change.

1. Motor Neuron Disease (MND), also known by its most prevalent subtype, Amyotrophic Lateral Sclerosis (ALS), is an ultimately fatal progressive neurodegenerative disease causing a gradual series o...

Background: Generalised anxiety disorder (GAD) is the most common anxiety disorder in older people and is characterised by excessive anxiety and worry that is experienced as being difficult to control. Current recommended first-line treatments for GAD include pharmacotherapy and psychological therapy, but some people experience GAD that does not respond to these treatments. Such treatment-resistant GAD (TR-GAD) is associated with numerous negative outcomes in older people. However, evidence-based guidance on how to manage TR-GAD in older people is lacking. Previous research suggests that Acceptance and Commitment Therapy (ACT), tailored to the needs and preferences of older people with TR-GAD, may help reduce anxiety in this population. Aims: To determine the clinical and cost-effectiveness of tailored ACT plus usual care (UC) in comparison to UC alone for reducing anxiety in older people with TR-GAD. Methods: The CONTACT-GAD trial is an international, multi-centre, parallel, two-arm RCT with a 9-month internal pilot phase. 296 individuals aged ≥ 60 years with TR-GAD will be recruited from primary and secondary care services (and their equivalent in Australia) and via self-referral at approximately 11 UK sites and 4 Australian sites. TR-GAD will be defined as GAD that has failed to respond adequately to pharmacotherapy and/or psychotherapy, as described in step 3 of the UK's stepped care model for GAD (and its equivalent in Australia). Participants will be randomly allocated to receive up to 14 one-to-one sessions of ACT with a booster session at approximately 3-months post-intervention plus UC or UC alone by an online randomisation system. Participants will complete outcome measures at baseline and 6- and 12-months post-randomisation. The primary outcome will be anxiety at six months. Secondary outcomes will include quality of life, depression, psychological flexibility, resource use, health-related quality of life, capability, adverse events, satisfaction with therapy, personally meaningful behaviour change and engagement in activities. Outcome assessors will be blind to treatment allocation. Primary analyses will be by intention-to-treat, with data being analysed using multi-level modelling. Discussion: The CONTACT-GAD trial will provide much needed evidence on the management of TR-GAD in older people. Trial registration: ISRCTN Registry, https://www.isrctn.com/ISRCTN85462326 , registered 04/01/2023. Protocol version: 3.0 (09/05/2025).

Background: Mindfulness-based interventions (MBIs) have been shown to improve university students’ well-being. However, previous studies have not systematically explored factors that can facilitate or hinder engagement in MBIs among Saudi university students, nor how MBIs can be culturally adapted to meet their needs. Objective: This study aimed to (1) explore the perspectives of Saudi female university students about factors influencing engagement with MBIs, (2) explore the cultural appropriateness of MBIs, and (3) systematically identify recommendations for developing a culturally appropriate MBI. Methods: A qualitative research approach was used to collect data using semistructured individual interviews and focus groups. Two established frameworks for behavioral interventions were applied to guide the interview topics and data analysis. The COM-B (Capability, Opportunity, and Motivation Domains of Behavior Change) model was applied to identify potential enablers and barriers influencing students’ engagement with MBIs. The cultural adaptation framework by Bernal et al was used to explore the cultural appropriateness of MBIs. Subsequently, recommendations for developing MBIs, with a specific focus on an online version, were systematically formulated using the Theory and Techniques Tool. Data were analyzed using mixed inductive-deductive thematic analysis. Results: Fourteen Saudi female university students (mean age 24, SD 4.9 years) participated in semistructured interviews and focus groups. Numerous potential enablers and barriers to MBI engagement were identified. Factors that may influence engagement pertained to capability (variation in knowledge of mindfulness), opportunity (anticipated difficulty finding time), and motivation (variation in anticipated and experienced benefits of mindfulness). Participants also highlighted several considerations that may enhance the cultural relevance of MBIs, drawing on the cultural adaptation domains by Bernal et al. These included the importance of aligning MBIs with the local cultural context, incorporating metaphors and examples rooted in Saudi and Arab culture, and accommodating students’ preferences for the duration of MBIs. Key recommendations for developing culturally appropriate MBIs for Saudi university students included providing clear information to improve understanding of mindfulness, providing practical strategies and skills to overcome barriers such as time constraints, delivering MBIs in both Arabic and English, and ensuring that MBIs’ content aligns with local cultural values and contexts. Conclusions: Findings and recommendations aim to enhance the feasibility, acceptability, engagement, and effectiveness of MBIs among Saudi university students, particularly female students. However, whether they do in fact achieve these aims is unknown. Future research should endeavor to evaluate the effectiveness of proposed recommendations and explore the enablers and barriers to MBI engagement in a broader population of Saudi students.

Background: Motor neuron disease is a progressive, fatal neurodegenerative disease for which there is no cure. Formal psychological therapies are not routinely part of United Kingdom standard motor neuron disease care due to a lack of evidence-based guidance resulting from a paucity of clinical trials. We aimed to evaluate the clinical and cost-effectiveness of Acceptance and Commitment Therapy plus usual care compared to usual care alone for improving psychological health in people living with motor neuron disease. Methods: We conducted qualitative interviews with 15 people living with motor neuron disease, 10 caregivers and 12 healthcare professionals. Findings were used to develop an Acceptance and Commitment Therapy intervention specifically for people living with motor neuron disease. Next, we examined its acceptability and feasibility in an uncontrolled feasibility study with 29 people living with motor neuron disease. Findings from qualitative interviews with 14 people living with motor neuron disease and 11 therapists were used to revise the intervention. Finally, we conducted a multicentre, parallel, two-arm randomised controlled trial in 16 United Kingdom motor neuron disease care centres/clinics. Eligible participants were aged ≥ 18 years with motor neuron disease. Participants were randomly assigned (1 : 1) to receive up to eight sessions of Acceptance and Commitment Therapy plus usual care or usual care alone and followed up at 6 and 9 months post randomisation by blinded outcome assessors. The primary outcome was total score on the McGill Quality of Life Questionnaire-Revised at 6 months. Secondary outcomes included health status using the EuroQol-5 Dimensions, five-level version. Primary analyses were by intention to treat. Results: Acceptance and Commitment Therapy was acceptable to people living with motor neuron disease, and it was feasible to recruit participants, hence trial progression criteria were met. From September 2019 to August 2022, 191 participants were recruited: 97 were allocated to Acceptance and Commitment Therapy plus usual care and 94 to usual care alone. Mean age was 61.9 years (standard deviation 11.4), 58% were male and 95% were White/White British. Acceptance and Commitment Therapy plus usual care was superior to usual care alone on the McGill Quality of Life Questionnaire-Revised at 6 months [adjusted mean difference 0.66 (95% confidence interval 0.22 to 1.10); Cohen’s d = 0.46 (95% confidence interval 0.16 to 0.77); p = 0.003] and 9 months [adjusted mean difference 0.76 (95% confidence interval 0.30 to 1.22); Cohen’s d = 0.53 (95% confidence interval 0.21 to 0.85); p = 0.001]. Mean differences in total costs and quality-adjusted life-years at 9 months between Acceptance and Commitment Therapy plus usual care versus usual care alone were not statistically significant [costs: £1019 (95% confidence interval −£34 to £2074); quality-adjusted life-years: 0.019 (95% confidence interval −0.07 to 0.05)]. The incremental cost-effectiveness ratio was £88,507/quality-adjusted life-year: this decreased to £13,817/quality-adjusted life-year in those with medium disease-related deterioration in subgroup analyses. Conclusion: Acceptance and Commitment Therapy plus usual care is clinically effective at maintaining or improving psychological health, as measured by the McGill Quality of Life Questionnaire-Revised, in people living with motor neuron disease compared to usual care alone. It was not cost-effective overall when calculated using a standard health status measure (EuroQol-5 Dimensions, five-level version). However, it was cost-effective in a subgroup of people experiencing a medium rate of disease-related deterioration. Limitations: Participants from ethnic minorities were under-represented, despite recruiting from sites with diverse communities. Between-group differences in outcomes may have been partly attributable to expectancy or non-specific therapeutic effects due to the lack of an active control. Cost-effectiveness analyses may have been underpowered to detect significant between-group differences. Future work: Studies should examine the effectiveness of Acceptance and Commitment Therapy in diverse populations, compared to an active control, using a more appropriate measure to assess cost-effectiveness, and in those with different rates of disease-related deterioration. Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 16/81/01.