RSS 1.0Depression
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Are patients aged 18-25 reviewed after one week of starting a selective serotonin reuptake inhibitor in a primary care setting?Aims: The National Institute for Health and Care Excellence (NICE) recommends that individuals aged 18-25 or those at increased risk of suicide should be reviewed within one week of initiating or increasing a selective serotonin reuptake inhibitor (SSRI) dose. This study aimed to assess compliance with these guidelines in primary care, identify barriers to timely reviews, and evaluate changes following a previous audit. Method(s): A retrospective review was conducted using SystmOne to identify patients aged 18-25 who started an SSRI between 1 December 2023 and 15 July 2024 in a Nottingham GP surgery. Data collected included the time from SSRI initiation to a booked and completed review, as well as instances of non-attendance (DNA). Findings were compared with a prior audit (1 August-24 November 2023) to assess improvements and ongoing challenges. Following the first audit cycle, results were shared and discussed within the practice, prompting greater awareness from all members of the multidisciplinary team (MDT) upon current guidance and performance. Result(s): In the initial audit, none of the 21 eligible patients had a review booked within one week, with an average booking time of 20 days and 30 days to an actual review. In the re-audit, 36 eligible patients were identified, with a slight improvement in booking time (19 days) and review completion (23 days). Three patients (8.3%) had a review scheduled within the recommended one-week timeframe. The main barrier remained appointment availability, with a shortage of GP slots limiting one-week follow-ups. High DNA rates persisted, with 14 patients missing their reviews in the re-audit. No standardised approach to DNAs was implemented, with some patients receiving multiple recall attempts and medication re-issues, while others had no further action documented. Conclusion(s): Over this one-year period, noticeable improvements were observed in both booked and actual SSRI review times. However, most patients still did not receive a timely review. Limited appointment availability and inconsistent follow-up for DNAs remained significant challenges. Expanding the role of other healthcare professionals, such as pharmacists, to conduct initial medication reviews could improve guideline compliance and reduce GP workload. Establishing a standardised protocol for DNAs, ensuring a set emergency medication supply and a timely follow-up, is essential to improving patient safety and treatment outcomes.
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Temporal dynamics in the association between depression and dementia : an umbrella review and meta-analysisBACKGROUND: Identifying modifiable risk factors is crucial for dementia prevention, a global health concern. Depression is considered a risk factor for dementia, but the temporal dynamics across the life course remain inconclusive. Therefore, we aimed to systematically assess the relationship between the timing of depression assessment and risk of all-cause late-life dementia. METHODS: We conducted an umbrella review and meta-analysis to assess incident dementia in individuals with non-current history of depression. PubMed and Ovid Embase, MEDLINE, and PsycInfo were searched from inception up to February 17, 2025. Systematic reviews with meta-analyses investigating the association between depression and incident late-life dementia were included. From eligible reviews, we also extracted data from studies reporting dementia risk as hazard ratios (HRs), analysing the timing of depression measurement using random-effects models for meta-analysis. This study is registered with PROSPERO, CRD42021249706. FINDINGS: Of the 7763 records identified, nine reviews were eligible for inclusion of the umbrella review. One review was judged to be of moderate quality, while the others were either low (n = 3) or critically low (n = 5). For our meta-analyses, 18 studies reporting depression onset in later life (n = 901,762 participants, n = 7595 incident dementia cases) and seven studies on depression assessed during midlife (n ≥ 2,501,269 participants, n ≥ 276,929 incident dementia cases) were included. All studies in the meta-analyses were deemed to be of good quality, with no strong evidence of publication bias. Pooled HRs indicated depression present in late-life (HR 1.95, 95% CI: 1.68-2.26; I (2) = 77.5%) and midlife (HR 1.56, 95% CI: 1.12-2.18; I (2) = 97.5%) significantly increased risk of all-cause dementia. INTERPRETATION: The findings suggest that depression across the life course may increase dementia risk; however, substantial heterogeneity and review quality should be considered when interpreting the strength of this evidence. A life course approach to the treatment and prevention of depression may help reduce the burden of dementia, but this will require scaling up access to effective mental health care for vulnerable populations. Further research is needed to clarify if the stronger late-life association reflects depression as an immediate risk factor or an early manifestation of neurodegenerative processes. FUNDING: National Institute for Health and Care Research, UK Research and Innovation, and Saudi Arabian Cultural Mission.
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Precision computerised cognitive behavioural therapy (cCBT) intervention for adolescents with depression (SPARX-UK) : protocol for the process evaluation of a pilot randomised controlled feasibility trialINTRODUCTION: While digital technologies can increase the availability and access to evidence-based interventions, little is known about how users engage with them and the mechanisms associated with effective outcomes. Process evaluations are an important component in understanding the aforementioned factors. The 'SPARX-UK' study is a randomised controlled pilot and feasibility trial evaluating personalised human-supported (from an 'eCoach') vs a self-directed computerised cognitive behavioural therapy intervention (cCBT), called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), aimed at adolescents with mild to moderate depression. We are comparing supported vs self-directed delivery of SPARX to establish which format should be used in a proposed definitive trial of SPARX. The control is a waitlist group. We will conduct a process evaluation alongside the trial to determine how the intervention is implemented and provide context for interpreting the feasibility trial outcomes. We will also look at the acceptability of SPARX and how users engage with the intervention. This protocol paper describes the rationale, aims and methodology of the SPARX-UK trial process evaluation. METHODS AND ANALYSIS: The process evaluation will use a mixed-methods design following the UK Medical Research Council's 2015 guidelines, comprising quantitative and qualitative data collection. This will include analysing data usage of participants in the intervention arms; purposively sampled, semi-structured interviews of adolescents, parents/guardians, eCoaches and clinicians/practitioners from the SPARX-UK trial; and analysis of qualitative comments from a survey from those who dropped out early from the trial. Quantitative data will be analysed descriptively. We will use thematic analysis in a framework approach to analyse qualitative data. Quantitative and qualitative data will be mixed and integrated to provide an understanding of how the intervention was implemented and how adolescents interacted with the intervention. This process evaluation will explore the experiences of adolescent participants, parents/guardians, eCoaches and clinicians/practitioners in relation to a complex digital intervention. ETHICS: Ethical approval was granted by the National Health Service (NHS) Health Research Authority South West - Cornwall & Plymouth Research Ethics Committee (Ethics Ref: 22/SW/0149). DISSEMINATION: Contextualising how the intervention was implemented, and the variations in uptake and engagement, will help us to understand the trial findings in greater depth. The findings from this process evaluation will also inform the decision about whether and how to proceed with a full randomised controlled trial, as well as the development of more effective interventions which can be personalised more precisely via varying levels of human support. We plan to publish the findings of the process evaluation and the wider project in peer-reviewed journals, as well as disseminate via academic conferences. TRIAL REGISTRATION NUMBER: ISRCTN: ISRCTN15124804. Registered on 16 January 2023, https://www.isrctn.com/ISRCTN15124804.
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Effects of social support interventions on depressive symptoms and quality of life among older adults : a systematic review and meta-analysisBACKGROUND: Interventions that include participation in social or group connections as measures to prevent or reduce depression have received little attention. This systematic review and meta-analysis aimed to determine the effects of social support interventions on depressive symptoms and Quality of life (QoL) among older adults. METHODS: A detailed search of six databases comprising Medline, CINAHL, PubMed, Cochrane Library, African Journals Online and Web of Science Core Collections was conducted until January 2025. A review protocol was developed and registered with the PROSPERO database (ID-CRD42021283342). A meta-analysis was used to synthesize the findings of the included studies based on subgroups of social support interventions. Of the 1524 articles found from the six databases, only 16 randomised controlled trials (14 parallel and 2 cluster) were eligible for inclusion. CONCLUSION: Social support interventions included emotional support, social engagement, instrumental, instrumental and appraisal, and social engagement and appraisal support. Meta-analysis findings indicated that social support interventions had non-significant effects on depression and QoL among older adults. Social support interventions have the potential to reduce depressive symptoms and improve QoL. However, current evidence is insufficient to determine the impact of social support interventions on depression and QoL in older adults.
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Cognitive impairment, depressive symptoms, and demographic characteristics of care home residents living with dementia in six countriesOBJECTIVES: As the prevalence of dementia and depression continues to increase globally, understanding the interplay between these conditions becomes important for effective diagnosis, treatment, and tailoring of interventions. We investigate the relationship between depressive symptoms and cognitive impairment and the potential role of sociodemographic characteristics, among care home residents in Australia, Germany, the Netherlands, Norway, Türkiye, and the United Kingdom. METHOD: The study used baseline data from an international cluster-randomised controlled trial comprising 1021 residents with dementia and depressive symptoms in 86 care home units. The relationship between cognitive impairment and depressive symptoms was investigated using linear mixed effects models, with country, age, sex, marital status, and education level as possible predictors. RESULTS: Higher severity of cognitive impairment was related to more severe depressive symptoms in all countries. The association was especially strong in Türkiye. Marital status was a significant predictor for depressive symptoms and education level predicted cognitive ability. CONCLUSION: Findings confirm that lower cognitive ability is associated with more depressive symptoms across different contexts in a large international sample. As thresholds to long-term care are likely to be set even higher in the future, interventions to alleviate depressive symptoms among older adults with dementia become even more important.
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Barriers and facilitators for implementing music interventions in care homes for people with dementia and depression : process evaluation results of the multinational cluster-randomized MIDDEL TrialA process evaluation was embedded in the multinational Music Interventions for Dementia and Depression in ELderly care (MIDDEL) trial to better understand barriers and facilitators for implementing music-based interventions (MBIs). Stakeholders from 66 care home units across 5 countries completed a survey at baseline (n = 229) and after a six-month intervention period (n = 101), comparing expectations and experiences between countries, intervention groups, and stakeholders. MBIs were evaluated and found to be relevant and feasible. Barriers include a lack of support, turnover among employees, and a lack of motivation. Facilitators include individual stakeholders who proactively facilitate and stimulate implementation, as well as the presence of stable, well-functioning teams, clear communication, and adhering to project plans. Fewer barriers than expected related to care staff workload and the time needed for implementing new MBIs in care homes. MBIs can be beneficial for people with dementia, yet implementation in care homes can be challenging due to contextual factors. Involving stakeholders in key positions is essential: care home managers are pivotal for policy-making and the sustainable adoption of MBIs, whereas the commitment and the involvement of care staff are needed for day-to-day implementation. Insight into these barriers to and facilitators of implementation can contribute to the interpretation of trial results.
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Pramipexole augmentation for the acute phase of treatment-resistant, unipolar depression : a placebo-controlled, double-blind, randomised trial in the UKBackgroundAbout 30% of patients with depression treated with antidepressant medication do not respond sufficiently to the first agents used. Pramipexole might usefully augment antidepressant medication in such cases of treatment-resistant depression, but data on its effects and tolerability are scarce. We aimed to assess the efficacy and tolerability of pramipexole augmentation of ongoing antidepressant treatment, over 48 weeks, in patients with treatment-resistant depression.
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Facilitators and barriers to participation of patients with treatment resistant depression in a randomised controlled trial of two forms of personalised magnetic resonance imaging targeted transcranial magnetic stimulation (the BRIGhTMIND trial)BACKGROUND: Magnetic resonance imaging (MRI) can personalise the site of transcranial magnetic stimulation (TMS) delivered as a course of 20 sessions for treatment-resistant depression (TRD). Facilitators and barriers to a randomised controlled trial (RCT) of MRI personalised TMS is understudied. AIM: Qualitative analysis to explore facilitators and barriers behind RCT participants' experience of personalised MRI-targeted TMS in people with TRD. METHODS: Nineteen participants from the BRIGhTMIND RCT of two forms of MRI personalised TMS, completed semi-structured interviews exploring the reasons behind the uptake and experience of TMS. The sample included fifteen participants who completed the treatment course and four who declined to proceed before randomisation. Interviews were analysed using thematic analysis, co-produced between researchers and patients and public involvement contributors. RESULTS: Facilitators were "hope" regarding the treatment itself, the influence of research staff, interest in a new treatment, and altruism. Barriers were concerns about their ability to commit to the trial and the nature of the TMS itself. Throughout the themes, clinicians and researchers made a difference by explaining and setting realistic expectations of the treatment and building rapport through daily patient contact. CONCLUSION: The study highlights the importance of understanding patients' concepts and experiences of TMS. The provision of optimal information to patients twinned with offering TMS outside office hours and the most efficacious, acceptable regimes of TMS delivery may maximise participation (Trial registration number ISRCTN19674644, registered on 01/10/2018). TRIAL REGISTRATION: Trial registration: ISRCTN19674644|| http://www.isrctn.org/ ) registered on 01/10/2018. Trial Identifying numbers: CPMS 39297, IRAS 245025.
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A qualitative exploration into the experience of mindfulness in moderate-severe persistent depressionDepression is a common and growing mental health problem, with around 5% of the world's population experiencing an episode of depression during their lifetime. Relapse rates are high, with around half experiencing more than one depressive episode and a further 10-20% experiencing a chronic and persistent depression. Mindfulness has been incorporated into treatments for depression and several studies have explored the impact of mindfulness training on depressive symptomatology and recurrence. However, to date no studies have looked at the changing relationship between mindfulness and depression in those naïve to mindfulness training. 20 participants with moderate-to-severe persistent depression were interviewed to explore their experience of mindfulness in the context of low mood. Thematic analysis captured six themes highlighting changes in mindfulness relating to the onset of depression. Themes included: behavioural withdrawal; perceptual detachment from one's experience; intentional reduction in awareness; increased self-criticism; mind racing; impaired cognitive performance. Thematic analysis suggested that mindfulness reduces in the context of moderate-to-severe persistent depression. This appears to occur indirectly as the consequence of depression-related processes, e.g., rumination and experiential avoidance, but also arises as a deliberately instigated self-protective strategy. However, findings seemed to indicate that reduced mindfulness maintains and intensifies depressive experience. Despite growing evidence of the value of mindfulness approaches for those with more chronic and severe depression, study findings suggest that introducing mindfulness to this population may be particularly challenging due to the intensity of symptomatology potentially obstructing access to a mindful perspective. Findings bear important implications for the treatment of depression and can inform future intervention development and delivery.
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A group psychological intervention for postnatal depression in British mothers of South Asian origin - the ROSHNI-2 RCTBACKGROUND: Postnatal depression is more common in British South Asian women than white women in the United Kingdom. Despite empirical evidence suggesting the effectiveness of cognitive-behavioural therapy as a first line of treatment, little evidence is available regarding its applicability to different minority ethnic groups. OBJECTIVES: Determining the clinical and cost-effectiveness of a culturally adapted group psychological intervention (Positive Health Programme) in primary care for British South Asian women with postnatal depression compared with treatment as usual. SETTING: General practices and children's centres in the North West, East Midlands, Yorkshire, Glasgow and London. PARTICIPANTS: British South Asian women meeting the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) depression criteria, aged 16 years or above, with infants up to 12 months. DESIGN: A multicentre randomised controlled trial with an internal pilot and partially nested design to compare treatment as usual plus the Positive Health Programme with treatment as usual in British South Asian women with postnatal depression, with a qualitative study to examine the acceptability and feasibility of the intervention. INTERVENTION: The Positive Health Programme, a culturally adapted group intervention based on the principles of cognitive-behavioural therapy delivered by facilitators over 12 sessions. OUTCOMES MEASURES: The primary outcome was recovery from depression (Hamilton Depression Rating Scale ≤ 7) at end of intervention (approximately 4-6 months). Analysis of the primary outcome and the long-term follow-up (at 12 months) used a logistic random-effects model to estimate the odds ratio of caseness between treatments, adjusting for centre, severity of depression and education at baseline. Cost data were collected using an Economic Patient Questionnaire. RESULTS: Seven hundred and thirty-two participants across four study centres were randomised by the Manchester Clinical Trials Unit. At 4 months, almost half of patients in the treatment (Positive Health Programme) group were recovered (138 or 49%), whereas 105 (37%) were recovered in the control (treatment as usual) group. By 12 months, the control (treatment as usual) and treatment (Positive Health Programme) group had over 50% recovery at 140 (54%) and 141 (54%), respectively. For the primary outcome, recovery from postnatal depression at end of intervention, we found a significant effect such that the odds of achieving recovery in the treatment group were almost twice as high compared to the treatment as usual group (odds ratio 1.97, 95% confidence interval 1.26 to 3.10). Between the two groups, there was no significant difference in the odds of recovery at 12 months (odds ratio 1.02, 95% confidence interval 0.62 to 1.66), highlighting a need for more intensive therapies and/or longer-term care plans for this group of patients. QUALITATIVE RESULTS: The intervention was considered feasible and acceptable from the perspectives of Positive Health Programme participants, facilitators, and general practitioners. The findings suggest improved emotional and social support and an enhanced sense of well-being. ECONOMIC EVALUATION: Positive Health Programme implementation was estimated to cost an average of £408 per participant. The intention-to-treat analysis shows that the Positive Health Programme intervention costs £22,198 per quality-adjusted life-year gain. Positive Health Programme was cost-effective on average but with a substantial uncertainty: the probability that Positive Health Programme was cost-effective was 44% (65%) at the willingness to pay £20,000 (£30,000) per quality-adjusted life-year. The Positive Health Programme was highly cost-effective for those who attended 5-8 sessions, costing £9040 per quality-adjusted life-year. LIMITATIONS: The study sample limits generalisability with other ethnic minority groups, and the cost-effectiveness analysis did not explore recall bias. CONCLUSIONS: The results of this study provide robust evidence that the culturally adapted psychological intervention for postnatal depression in South Asian women is effective at the primary end point and acceptable to women. FUTURE WORK: Further development of the Positive Health Programme intervention and evaluation, with longer-term outcome follow-ups and exploration of cost-effectiveness of remote delivery of the Positive Health Programme. STUDY REGISTRATION: Current Controlled Trials ISRCTN10697380. FUNDING: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/68/08) and is published in full in Health Technology Assessment; Vol. 29, No. 6. See the NIHR Funding and Awards website for further award information.
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Cost-effectiveness of a group psychological intervention for postnatal depression in British south Asian women : an economic evaluation from the ROSHNI-2 trialBACKGROUND: Minority ethnic groups often face ethnocultural barriers in accessing mental health treatments. The ROSHNI-2 trial compared culturally adapted cognitive behavioural therapy (Positive Health Programme [PHP]) with treatment as usual for postnatal depression in British south Asian women. We aimed to assess the cost-effectiveness of the PHP intervention. METHODS: The ROSHNI-2 trial was a multicentre, two-arm, assessor-blinded, randomised controlled trial; we conducted an economic evaluation over a 12-month period to assess the cost-effectiveness of PHP plus treatment as usual versus treatment as usual alone from the perspective of the English National Health Service and personal social services. In the trial, British south Asian women aged 16 years or older with a child aged up to 12 months, and meeting DSM-5 criteria for depression, were recruited from northwest England, Yorkshire, the East Midlands, and London. The PHP intervention involved 12 group sessions delivered by two trained bilingual facilitators, held once per week for 2 months and once per fortnight thereafter, each lasting 60-90 min. Questionnaires on depression symptoms, quality of life, and resource use were completed at baseline, 4 months (end of intervention), and 12 months after random assignment. Quality-adjusted life-years (QALYs) were used for the cost-utility analysis, and recovery from depression at 4 months (the primary clinical outcome), assessed using the Hamilton Rating Scale for Depression, informed the cost-effectiveness analysis. After the onset of the COVID-19 pandemic, the intervention was adapted for online delivery for the remaining participants. A stratified analysis compared the cost-effectiveness of online versus in-person delivery. The trial involved researchers with lived experience, and all methods, including health economic measures, were developed in consultation with service users, community members, and faith leaders. This is a preplanned analysis of the ROSHNI-2 trial, registered with ISRCTN (ISRCTN10697380). FINDINGS: From Feb 8, 2017, to March 29, 2020, 732 eligible women were enrolled: 368 participants were randomly assigned to the PHP arm and 364 to the treatment as usual arm. The base-case intention-to-treat analysis showed that PHP significantly increased costs (£712, 95% CI 311 to 1113) and QALYs (0·036, 95% CI 0·006 to 0·067), with an incremental cost-effectiveness ratio of £19 601 (7622 to 83 772). Based on the UK National Institute for Health and Care Excellence (NICE) maximum willingness-to-pay threshold of £30 000 per QALY, the likelihood of PHP being cost-effective was 77% from a health and social care perspective. Cost per remission from depression at the 4-month follow-up was £5509 (2916 to 17 860). In a stratified analysis of 34 participants attending online sessions during the pandemic, incremental QALY effects were 0·125 (0·048 to 0·203), resulting in costs of £202 (-3906 to 10 918) per additional QALY gained. INTERPRETATION: The average cost of PHP for postpartum women was below the lower end of the NICE threshold of £20 000-30 000 per QALY, excluding benefits to the child or potential gains such as reduced lost productivity from early remission. PHP, a culturally adapted group cognitive behavioural therapy-based intervention, might be a cost-effective intervention for postnatal depression in British south Asian women. Online PHP delivery showed promising clinical and cost-effective results for this group but requires a large-scale study. FUNDING: UK National Institute for Health and Care Research.
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Real world effectiveness of rTMS in depression and anxietyAims. Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation recommended by NICE for treatment of depression with minimal side-effects and a high patient acceptability. Our aim was to assess the effectiveness of rTMS in real world clinical service in alleviating symptoms of depression and anxiety. Methods. All patients receiving rTMS in our Centre for Neuromodulation Services (CNS) received 5 daily treatment sessions a week for a period of 5 weeks (25 sessions in total). All patients routinely completed PHQ-9, BDI-II and GAD-7 measures before and after the course of treatment. The scores on these measures were retrospectively analysed using paired-Sample t-test. Results. All 15 patients completed the PHQ-9 and GAD-7 scales while 10 patients completed BDI-II. Eleven patients (73%) had improved PHQ-9 scores post-treatment with average improvement of 5.5 points which was statistically significant [pairedsample t-test: t(14) = 3.019, p = 0.009]. Nine patients (90%) had improved BDI-II scores post-treatment with average reduction of 36% from baseline which was statistically significant [t (9) = 3.681, p = 0.005]. Eleven patients (73%) had improved GAD-7 scores post-treatment, with average reduction of 4 points. This reduction was also statistically significant [t(14) = 3.038, p = 0.009]. Improvement in all measures was also of a level that would be considered clinically significant for these measures. All patients tolerated the treatment well with no patients dropping out due to side effects. Conclusion. With the limitation of relatively small sample size, our initial analysis indicates that rTMS treatment offered in real world clinical service is effective in treating symptoms of depression. Although our protocol was not intended to treat anxiety, our patients had remarkable improvement in anxiety symptoms as well.
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Impact of rTMS treatment on utilisation of mental health servicesAims. Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation recommended by NICE for treatment of depression. Our aim was to study the impact of real world rTMS treatment on service utilisation. Methods. Data was collected for all patients who received rTMS treatment at the Centre for Neuromodulation Services (CNS) and followed up for 6 months. Sociodemographic data was collected for all patients. To understand service utilisation, data was collected to record involvement of mental health services including Community Mental Health Team, inpatient admission, Crisis and Home Treatment, Psychiatry Liaison and Talking Therapies. Results. Fifteen patients completed treatment in the year 2023 since inception of the service. All patients received 25 daily treatment sessions over a period of 5 weeks. 67% of the patients were female (N = 10). 93% of the patients were White-British (N = 14) with one patient with British-Indian ethnicity. The mean age of patients was 50.8 years. One-third of the patients were involved with more than two services within the Trust in the 6 months before referral for rTMS. Historically, most patients were involved with Talking Therapies (N = 13; 86%), Crisis and Liaison Teams (N = 10; 67%) and inpatient services (N = 9; 60%). Two (13%) patients were not on any medications at the time of starting treatment. In the 6 months after completion of treatment, only 3 (20%) patients were involved with more than one service while 3 (20%) patients were discharged from services. Conclusion. The referral pattern along with involvement of services revealed that complex patients requiring multiple services were referred for TMS treatment. The drop in number of services involved post completion of treatment suggests that TMS was effective in reducing service utilisation. The study sample was limited to a small group and the same would have to be repeated with a larger sample.
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Efficacy of a culturally adapted, cognitive behavioural therapy-based intervention for postnatal depression in British south Asian women (ROSHNI-2): A multicentre, randomised controlled trialBACKGROUND: Postnatal depression necessitates timely and effective interventions to mitigate adverse maternal and child outcomes in the short term and over the life course. British south Asian women with depression are often underserved and undertreated due to stigma, language barriers, and cultural barriers. This trial aimed to test the clinical efficacy of a culturally adapted, group cognitive behavioural therapy (CBT)-based intervention, the Positive Health Programme (PHP), delivered by non-specialist health workers for postnatal depression in British south Asian women. METHODS: This study was a randomised controlled trial, with culturally adapted recruitment and an internal pilot, comparing the PHP (intervention group) with treatment as usual (control group) in British south Asian women with postnatal depression. The study was conducted at five centres across the UK. Participants were aged 16 years or older, met the DSM-5 criteria for depression, and had infants aged 0-12 months. Randomisation (1:1) was stratified by centre, with a block size of 18, and was done through an independent remote telephone service. The PHP was delivered over 12 group sessions in 4 months. The primary outcome was recovery from depression (defined as a Hamilton Depression Rating Scale [HDRS] score ≤7) at 4 months after randomisation, and an assessment was also done at 12 months. Analysis was on an intention-to-treat basis including only participants with non-missing outcome data; we used a random-effects logistic regression model including fixed covariates for study site, baseline depression severity (HDRS score), parity, and years in education and a random coefficient for therapy group. This trial is registered with the ISRCTN (ISRCTN10697380). FINDINGS: Of the 9136 individuals approached for recruitment between Feb 8, 2017, and March 29, 2020, 4296 women were eligible for and consented to screening, among whom 732 screened positive and were randomly allocated: 368 (50%) to the PHP group and 364 (50%) to the control group. Participants were mostly of Pakistani (397 [55%] of 719 with available data), Indian (176 [24%]), or Bangladeshi ethnicity (127 [18%]), with an overall mean age of 31·4 years (SD 5·2), with their youngest infants having a mean age of 23·6 weeks (14·2). At 4 months from randomisation, the proportion of participants who showed recovery from depression on the HDRS was significantly higher in the PHP group (138 [49%] of 281) than in the control group (105 [37%] of 281; adjusted odds ratio 1·97 [95% CI 1·26-3·10]). At the 12-month follow-up, this difference was no longer significant (1·02 [95% CI 0·62-1·66]). INTERPRETATION: In British south Asian women with postnatal depression, a culturally adapted group CBT-based intervention could aid in quicker recovery from depression compared with treatment as usual. Further research is needed to identify how to sustain the treatment effect and establish strategies for scale-up. FUNDING: UK National Institute for Health and Care Research.
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Acceptability, tolerability and safety of the BRIGhTMIND trial: Connectivity-guided intermittent theta-burst stimulation versus F3- repetitive transcranial magnetic stimulation for treatment-resistant depressionBACKGROUND: The BRIGhTMIND study was a double-blind RCT comparing repetitive transcranial magnetic stimulation at a standard simulation site (the "F3" location given by the International 10-20 system, F3-rTMS) versus connectivity-guided intermittent theta burst stimulation (cgiTBS) for treatment-resistant depression. This present study reports the acceptability, safety, and tolerability of F3-rTMS versus cgiTBS. METHODS: The present study used quantitative and qualitative methods. Two hundred fifty-four participants were included in the quantitative BRIGhTMIND acceptability and safety analysis (n = 126 F3-rTMS, n = 128 cgiTBS). Qualitative analysis included interviews for 15 participants (n = 7 F3-rTMS, n = 8 cgiTBS) and 582 written comments made by any participant randomised to the BRIGhTMIND trial regarding their experience of TMS and the study. Statistical analyses were used to explore differences between F3-rTMS and cgiTBS, as well as associations between acceptability, impression of change and safety. Qualitative data was analysed using an inductive thematic framework approach. OUTCOMES: Acceptability, TMS benefits/negative effects and impression of improvement ratings did not differ across the two treatment protocols, with ratings maintained long-term (71.4 % rated TMS acceptable, 48.8 % indicated benefits of TMS outweighed negative effects and 52.2 % feeling somewhat or much better at 26 week follow-up n = 203). Impression of improvement was positively associated with acceptability and TMS benefits. Qualitative themes included participants' TMS experience, TMS response variability, and lay theories of effectiveness. Safety profiles were comparable between F3-rTMS and cgiTBS, with 74.5 % of participants (n = 190/254) experiencing at least one adverse event possibly, probably, or definitely related to TMS. The majority of adverse events were transient and mild, with a sizeable number requiring simple treatments or small adjustments to TMS intensity and coil positioning. The F3-rTMS group had a significantly greater proportion of participants that required small adjustments to TMS to tolerate treatment compared to the cgiTBS group. Serious adverse events were rare, with one serious event in each treatment arm possibly related to TMS (F3-rTMS- psychotic episode, cgiTBS-manic episode). CONCLUSION: F3-rTMS and cgiTBS are comparably safe, tolerable and highly acceptable interventions for treatment-resistant depression. BRIGhTMIND systematically collected data from a large sample, providing evidence to meet the information needs of patients, clinicians and policy makers.
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Magnetic resonance imaging connectivity features associated with response to transcranial magnetic stimulation in major depressive disorderTranscranial magnetic stimulation (TMS) is an FDA-approved neuromodulation treatment for major depressive disorder (MDD), thought to work by altering dysfunctional brain connectivity pathways, or by indirectly modulating the activity of subcortical brain regions. Clinical response to TMS remains highly variable, highlighting the need for baseline predictors of response and for understanding brain changes associated with response. This systematic review examined brain connectivity features, and changes in connectivity features, associated with clinical improvement following TMS in MDD. Forty-one studies met inclusion criteria, including 1097 people with MDD. Most studies delivered one of two types of TMS to left dorsolateral prefrontal cortex and measured connectivity using resting-state functional MRI. The subgenual anterior cingulate cortex was the most well-studied brain region, particularly its connectivity with the TMS target or with the "executive control network" of brain regions. There was marked heterogeneity in findings. There is a need for greater understanding of how cortical TMS modulates connectivity with, and the activity of, subcortical regions, and how these effects change within and across treatment sessions.
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Editorial: Prolonged grief disorder: Vulnerability and resilienceNo abstract available
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Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: A pilot and feasibility randomised controlled trial protocol for SPARX-UKBACKGROUND: A serious game called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), originally developed in New Zealand and incorporating cognitive behavioural therapy (CBT) principles, has been shown to help reduce symptoms of depression and anxiety in adolescents with mild to moderate depression in studies undertaken in Australasia. However, SPARX has never been trialled in the United Kingdom (UK), and there have been issues relating to low engagement when it has been used in a real-world context. AIMS: To conduct the first pilot and feasibility randomised controlled trial (RCT) in England to explore the use of SPARX in different settings. The trial will explore whether SPARX supported by an e-coach (assistant psychologists) improves adherence and engagement compared with self-directed (i.e. self-help) use. The trial results will be used to inform the optimal mode of delivery (SPARX supported vs. SPARX self-directed), to calculate an appropriate sample size for a full RCT, and to decide which setting is most suitable. METHODS: Following consultation with young people to ensure study suitability/appropriateness, a total of 120 adolescents (11-19 years) will be recruited for this three-arm study. Adolescents recruited for the study across England will be randomised to receive either SPARX with human support (from an e-coach), self-directed SPARX, or a waitlist control group. Assessments will be conducted online at baseline, week 4, and 8-10-week post-randomisation. The assessments will include measures which capture demographic, depression (Patient Health Questionnaire modified for adolescents [PHQ-A]) and anxiety (Revised Child Anxiety and Depression Scale [RCADS]) symptomatology, and health-related quality-of-life data (EQ-5D-Y and proxy version). Analyses will be primarily descriptive. Qualitative interviews will be undertaken with a proportion of the participants and clinical staff as part of a process evaluation, and the qualitative data gathered will be thematically analysed. Finally, feasibility data will be collected on recruitment details, overall study uptake and engagement with SPARX, participant retention, and youth-reported acceptability of the intervention. DISCUSSION: The findings will inform the design of a future definitive RCT of SPARX in the UK. If the subsequent definitive RCT demonstrates that SPARX is effective, then an online serious game utilising CBT principles ultimately has the potential to improve the provision of care within the UK's health services if delivered en masse. TRIAL REGISTRATION: ISRCTN: ISRCTN15124804. Registered on 16 January 2023, https://www.isrctn.com/ISRCTN15124804 .
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O024/ #106 Developing an augmentation approach for ITBS in Major Depressive Disorder Using Synchronised TacsTranscranial magnetic stimulation (TMS) is approved for treating major-depressive-disorder (MDD), a condition that affects 1 in 7 people during their lifetime. An increasingly popular protocol, due to short session time, is intermittent theta burst stimulation (iTBS), in which TMS pulse triplets repeat at 5Hz (a “theta” frequency). Response to TMS, including iTBS, is highly variable. We are examining a relatively inexpensive, easy-to-implement, approach to make iTBS act faster, for more people, by modifying “brain state” at the time of stimulation.
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Engagement With a remote symptom-tracking platform among participants with major depressive disorder: Randomized controlled trialBACKGROUND: Multiparametric remote measurement technologies (RMTs), which comprise smartphones and wearable devices, have the potential to revolutionize understanding of the etiology and trajectory of major depressive disorder (MDD). Engagement with RMTs in MDD research is of the utmost importance for the validity of predictive analytical methods and long-term use and can be conceptualized as both objective engagement (data availability) and subjective engagement (system usability and experiential factors). Positioning the design of user interfaces within the theoretical framework of the Behavior Change Wheel can help maximize effectiveness. In-app components containing information from credible sources, visual feedback, and access to support provide an opportunity to promote engagement with RMTs while minimizing team resources. Randomized controlled trials are the gold standard in quantifying the effects of in-app components on engagement with RMTs in patients with MDD. OBJECTIVE: This study aims to evaluate whether a multiparametric RMT system with theoretically informed notifications, visual progress tracking, and access to research team contact details could promote engagement with remote symptom tracking over and above the system as usual. We hypothesized that participants using the adapted app (intervention group) would have higher engagement in symptom monitoring, as measured by objective and subjective engagement. METHODS: A 2-arm, parallel-group randomized controlled trial (participant-blinded) with 1:1 randomization was conducted with 100 participants with MDD over 12 weeks. Participants in both arms used the RADAR-base system, comprising a smartphone app for weekly symptom assessments and a wearable Fitbit device for continuous passive tracking. Participants in the intervention arm (n=50, 50%) also had access to additional in-app components. The primary outcome was objective engagement, measured as the percentage of weekly questionnaires completed during follow-up. The secondary outcomes measured subjective engagement (system engagement, system usability, and emotional self-awareness). RESULTS: The levels of completion of the Patient Health Questionnaire-8 (PHQ-8) were similar between the control (67/97, 69%) and intervention (66/97, 68%) arms (P value for the difference between the arms=.83, 95% CI -9.32 to 11.65). The intervention group participants reported slightly higher user engagement (1.93, 95% CI -1.91 to 5.78), emotional self-awareness (1.13, 95% CI -2.93 to 5.19), and system usability (2.29, 95% CI -5.93 to 10.52) scores than the control group participants at follow-up; however, all CIs were wide and included 0. Process evaluation suggested that participants saw the in-app components as helpful in increasing task completion. CONCLUSIONS: The adapted system did not increase objective or subjective engagement in remote symptom tracking in our research cohort. This study provides an important foundation for understanding engagement with RMTs for research and the methodologies by which this work can be replicated in both community and clinical settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT04972474; https://clinicaltrials.gov/ct2/show/NCT04972474. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/32653.
