RSS 1.0Depression
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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.
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Connectivity-guided intermittent theta burst versus repetitive transcranial magnetic stimulation for treatment-resistant depression: A randomized controlled trialDisruption in reciprocal connectivity between the right anterior insula and the left dorsolateral prefrontal cortex is associated with depression and may be a target for neuromodulation. In a five-center, parallel, double-blind, randomized controlled trial we personalized resting-state functional magnetic resonance imaging neuronavigated connectivity-guided intermittent theta burst stimulation (cgiTBS) at a site based on effective connectivity from the right anterior insula to the left dorsolateral prefrontal cortex. We tested its efficacy in reducing the primary outcome depression symptoms measured by the GRID Hamilton Depression Rating Scale 17-item over 8, 16 and 26 weeks, compared with structural magnetic resonance imaging (MRI) neuronavigated repetitive transcranial magnetic stimulation (rTMS) delivered at the standard stimulation site (F3) in patients with 'treatment-resistant depression'. Participants were randomly assigned to 20 sessions over 4-6 weeks of either cgiTBS (n = 128) or rTMS (n = 127) with resting-state functional MRI at baseline and 16 weeks. Persistent decreases in depressive symptoms were seen over 26 weeks, with no differences between arms on the primary outcome GRID Hamilton Depression Rating Scale 17-item score (intention-to-treat adjusted mean, -0.31, 95% confidence interval (CI) -1.87, 1.24, P = 0.689). Two serious adverse events were possibly related to TMS (mania and psychosis). MRI-neuronavigated cgiTBS and rTMS were equally effective in patients with treatment-resistant depression over 26 weeks (trial registration no. ISRCTN19674644).
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Specialist treatment for persistent depression in secondary care: Sustained effects from a multicentre UK study at 24 and 36 monthsBACKGROUND: Despite the known health costs of persistent depression, there is no established service framework for the treatment of this disorder and a lack of long-term outcome data to inform commissioning. To address this gap, we report the long-term clinical effectiveness of a randomised controlled trial (RCT) testing a specialist, collaborative model of care for people with persistent moderate to severe unipolar depression. METHODS: A multicentre, pragmatic, single-blind, parallel-group randomised controlled trial comparing outcomes from a Specialist Depression Service (SDS) offering collaborative treatment with cognitive behavioural therapy (CBT) and pharmacotherapy for 12 months with treatment as usual (TAU) for persistent, moderate-severe depression in UK secondary care. Participants were initially assessed at baseline, 3, 6, 9, 12, and 18 months, with primary endpoints (17-item Hamilton Depression Rating Scale [HDRS17], and a Global Assessment of Functioning [GAF]) reported elsewhere (Morriss et al., 2016). Additional long-term, post-treatment, follow-up was made at 24 and 36 months with outcomes presented here. CLINICALTRIALS: gov (NCT01047124) and ISRCTN registration (ISRCTN 10963342). RESULTS: At 24 months there remained a statistically significant between-group difference in HDRS(17)-2.69 (-5.14, -0.23) and a non-significant improvement in GAF 2.85 (-1.23, 6.94), both favouring the SDS. Simple statistics are presented at 36 months, due to attrition, showing higher continued response and remission vs TAU across all measures. LIMITATIONS: Potential bias through loss to follow-up, particularly beyond 24 months. CONCLUSIONS: Compared with standard secondary care, SDS management of persistent moderate-severe depression, produced long-term clinical benefits, sustained following treatment completion, suggesting a model for future specialist care.
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To have and to hold: An exploratory qualitative study exploring why research participants with treatment-resistant depression undergoing transcranial magnetic stimulation treatment requested copies of their research brain MRI scansPURPOSE: There has been little research providing an in-depth exploration of the reasons behind research participants, particularly in mental health settings, requesting copies of their research data, such as magnetic resonance imaging (MRI) scans. BRIGhTMIND is a large double blind randomised controlled trial using functional and structural magnetic resonance imaging to create personalised targets for transcranial magnetic stimulation delivery, and a number of trial participants requested copies of these scans. METHODS: Seven participants involved in the BRIGhTMIND trial completed semi-structured interviews exploring their reasons behind their request for copies of their MRI scans. The qualitative data was co-analysed between researchers and patient and public involvement and engagement representatives using inductive thematic analysis. RESULTS: The interviews produced consistent themes concerning curiosity to visualise their MRI scans, and the hope that their participation would result in a better understanding of the nature and future treatment of depression. Concerns around the rights to access their own personal health data emerged as a clear theme as did their own ability to interpret any radiological information. DISCUSSION: This study provides insight into the reasons why research participants with depression would like to retain copies of their MRI scans and the perceived role that such techniques may have for improving research and neuromodulation treatments in depression. Such first-hand experiential accounts emphasises the importance of listening to participants perspectives and lived experience, in order to improve research and health outcomes. Future research could aim to provide greater verbal and written information for participants, including details about the accessibility to their MRI scans, the difference between research and clinical MRI scans, and educational materials to help with the interpretation of MRI images.
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Clinical effectiveness of active Alpha-Stim AID versus sham Alpha-Stim AID in major depression in primary care in England (Alpha-Stim-D): a multicentre, parallel group, double-blind, randomised controlled trialBackground Randomised sham-controlled trials of cranial electrostimulation with the Alpha-Stim Anxiety Insomnia and Depression (AID) device have reported improved anxiety and depression symptoms; however, no adequately powered sham-controlled trials in major depression are available. We investigated whether active Alpha-Stim AID is superior to sham Alpha-Stim AID in terms of clinical effectiveness for depression symptoms in major depression. Methods The Alpha-Stim-D trial was a multicentre, parallel group, double-blind, randomised controlled trial, recruiting participants from 25 primary care centres in two regions in England, UK. Eligible participants were aged 16 years or older with a current diagnosis of primary major depression, a score of 10–19 on the nine-item Patient Health Questionnaire, and had been offered or prescribed and reported taking antidepressant medication for at least 6 weeks in the previous 3 months. Main exclusion criteria were contraindications to Alpha-Stim AID device use, having persistent suicidal ideation or self-harm, neurological conditions, a substance use disorder or dependence, an eating disorder, bipolar disorder, or non-affective psychosis, or receiving psychological treatment in the past 3 months. Eligible participants were randomly assigned (1:1, minimised by region, anxiety disorder, and antidepressant use) to 1 h daily use of active (100 μA) or sham Alpha-Stim AID treatment for 8 weeks. Randomisation was via an independent web-based system, with participants, outcome assessors, and data analyst masked to treatment assignment. The primary outcome was change from baseline in score on the 17-item Hamilton Depression Rating Scale (HDRS-17, GRID version) at 16 weeks after randomisation, with participants analysed by intention to treat (ITT; all randomly assigned participants). Safety was assessed in all randomly assigned participants. The trial is registered with the ISRCTN registry (ISRCTN11853110); status completed. Findings Between Sept 8, 2020, and Jan 14, 2022, 236 eligible participants were randomly assigned to active or sham Alpha-Stim AID (n=118 each). 156 (66%) participants were women, 77 (33%) were men, and three (1%) self-reported as other gender; 200 (85%) were White British or Irish; and the mean age was 38·0 years (SD 15·3; range 16–83). 102 (86%) participants in the active Alpha-Stim AID group and 98 (83%) in the sham group were followed up 16 weeks after randomisation. In the ITT population, mean change in GRID-HDRS-17 at 16 weeks was –5·9 (95% CI –7·1 to –4·8) in the active Alpha-Stim AID group and –6·5 (–7·7 to –5·4) in the sham group (mean change difference –0·6 [95% CI –1·0 to 2·2], p=0·46). Among the 236 participants, 17 adverse events were reported in 17 (7%) participants (nine [8%] participants in the active Alpha-Stim AID group; and eight [7%] participants in the sham group). One serious adverse event of suicidal ideation leading to hospitalisation was reported in the sham group, which was judged to be unrelated to the device. Interpretation Active Alpha-Stim AID was safe and acceptable, but no more clinically effective than sham Alpha-Stim AID in major depression. Funding
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Factors influencing COVID-19 health protective behaviours in Zambian university students with symptoms of low moodBACKGROUND: Health protective behaviours are crucial in the prevention of the spread of COVID-19, particularly in university students who typically live and study in large groups. Depression and anxiety are common in students and can impact young people's motivations to follow health advice. The study aims to assess the relationship between mental health and COVID-19 health-protective behaviours in Zambian university students with symptoms of low mood. METHODS: The study was a cross-sectional, online survey of Zambian university students. Participants were also invited to take part in a semi-structured interview to explore views about COVID-19 vaccination. Invitation emails were sent explaining the study aims and directed students who self-identified as having low mood in the past two weeks to an online survey. Measures included COVID-19 preventive behaviours, COVID-19-related self-efficacy, and Hospital and Anxiety Depression scale. RESULTS: A total of 620 students (n=308 female, n=306 male) participated in the study, with a mean participant age of 22.47±3.29 years (range 18-51). Students reported a mean protective behaviour score of 74.09/105 and 74% scored above the threshold for possible anxiety disorder. Three-way ANOVA showed lower COVID-19 protective behaviours in students with possible anxiety disorder (p=.024) and those with low self-efficacy (p<0.001). Only 168 (27%) said they would accept vaccination against COVID-19, with male students being twice as likely to be willing to accept COVID-19 vaccination (p<0.001). Of 50 students interviewed. 30 (60%) expressed fears about the vaccination and 16 (32%) were concerned about a lack of information. Only 8 (16%) participants expressed doubts about effectiveness. CONCLUSION: Students who self-identify as having symptoms of depression have high levels of anxiety. The results suggest that interventions to reduce anxiety and promote self-efficacy might enhance students' COVID-19 protective behaviours. Qualitative data provided insight into the high rates of vaccine hesitancy in this population.
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Psychological risk factors for depression in the UK general population: derailment, self-criticism and self-reassuranceABSTRACTUK depression prevalence is increasing. In this study we appraised the relationships between psychological factors of derailment, self-criticism, self-reassurance and depression, to identify individual differences within the UK general population indicating those at higher risk. Participants completed self-report measures regarding these constructs. Relationships were assessed using correlation and path analyses. Derailment and self-criticism predicted depression positively, whereas self-reassurance predicted depression negatively. Self-criticism mediated derailment?s relation to depression. Self-reassurance moderated derailment?s relation to depression, with low self-reassurance indicating greater depression, though self-reassurance was not found to moderate the effect of derailment-associated self-criticism on depression. In depression treatment therefore derailment should be considered as a target factor to be reduced, since derailment indicates a risk of depression for individuals with high self-criticism or low self-reassurance. .
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Making remote measurement technology work in multiple sclerosis, epilepsy and depression: survey of healthcare professionalsBACKGROUND: Epilepsy, multiple sclerosis (MS) and depression are long term, central nervous system disorders which have a significant impact on everyday life. Evaluating symptoms of these conditions is problematic and typically involves repeated visits to a clinic. Remote measurement technology (RMT), consisting of smartphone apps and wearables, may offer a way to improve upon existing methods of managing these conditions. The present study aimed to establish the practical requirements that would enable clinical integration of data from patients' RMT, according to healthcare professionals. METHODS: This paper reports findings from an online survey of 1006 healthcare professionals currently working in the care of people with epilepsy, MS or depression. The survey included questions on types of data considered useful, how often data should be collected, the value of RMT data, preferred methods of accessing the data, benefits and challenges to RMT implementation, impact of RMT data on clinical practice, and requirement for technical support. The survey was presented on the JISC online surveys platform. RESULTS: Among this sample of 1006 healthcare professionals, respondents were positive about the benefits of RMT, with 73.2% indicating their service would be likely or highly likely to benefit from the implementation of RMT in patient care plans. The data from patients' RMT devices should be made available to all nursing and medical team members and could be reviewed between consultations where flagged by the system. However, results suggest it is also likely that RMT data would be reviewed in preparation for and during a consultation with a patient. Time to review information is likely to be one of the greatest barriers to successful implementation of RMT in clinical practice. CONCLUSIONS: While further work would be required to quantify the benefits of RMT in clinical practice, the findings from this survey suggest that a wide array of clinical team members treating epilepsy, MS and depression would find benefit from RMT data in the care of their patients. Findings presented could inform the implementation of RMT and other digital interventions in the clinical management of a range of neurological and mental health conditions.
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Sleep deprivation as a treatment for major depressive episodes: A systematic review and meta-analysisSummary Sleep deprivation, alone or in combination with pharmacological treatment and as part of a chronotherapy package, is of potential use for people with major depressive episodes, however the evidence base is still conflicting. The aim of this systematic review and meta-analysis is to assess the clinical effects of sleep deprivation in comparison to any other intervention for the acute and long-term treatment of mood disorders. We searched electronic databases and trial registries (last update: 16th October 2021) for published and unpublished randomised controlled trials recruiting participants with a major depressive episode in unipolar or bipolar affective disorder. The clinical outcomes of interest were the reduction in depressive symptoms at different timepoints and the number of participants experiencing at least one side effect. Overall, 29 trials (1246 participants) were included. We did not find any difference in change in symptoms or all-cause discontinuation between interventions including SD compared to a control of the same intervention except without SD. In the included studies there were no available data for adverse events. Using the most methodologically rigorous approach, we did not find evidence that the addition of sleep deprivation to treatment packages leads to enhanced depressive outcomes.
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STAndardised DIagnostic Assessment for children and young people with emotional difficulties (STADIA): protocol for a multicentre randomised controlled trialIntroduction Emotional disorders (such as anxiety and depression) are associated with considerable distress and impairment in day-to-day function for affected children and young people and for their families. Effective evidence-based interventions are available but require appropriate identification of difficulties to enable timely access to services. Standardised diagnostic assessment (SDA) tools may aid in the detection of emotional disorders, but there is limited evidence on the utility of SDA tools in routine care and equipoise among professionals about their clinical value.Methods and analysis A multicentre, two-arm, parallel group randomised controlled trial, with embedded qualitative and health economic components. Participants will be randomised in a 1:1 ratio to either the Development and Well-Being Assessment SDA tool as an adjunct to usual clinical care, or usual care only. A total of 1210 participants (children and young people referred to outpatient, specialist Child and Adolescent Mental Health Services with emotional difficulties and their parent/carers) will be recruited from at least 6 sites in England. The primary outcome is a clinician-made diagnosis about the presence of an emotional disorder within 12 months of randomisation. Secondary outcomes include referral acceptance, diagnosis and treatment of emotional disorders, symptoms of emotional difficulties and comorbid disorders and associated functional impairment.Ethics and dissemination The study received favourable opinion from the South Birmingham Research Ethics Committee (Ref. 19/WM/0133). Results of this trial will be reported to the funder and published in full in the Health Technology Assessment (HTA) Journal series and also submitted for publication in a peer reviewed journal.Trial registration number ISRCTN15748675; Pre-results.
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Resting-state functional connectivity correlates of anxiety co-morbidity in major depressive disorderMajor depressive disorder (MDD) is frequently co-morbid with anxiety disorders. The co-morbid state has poorer functional outcomes and greater resistance to first line treatments, highlighting the need for novel treatment targets. This systematic review examined differences in resting-state brain connectivity associated with anxiety comorbidity in young- and middle-aged adults with MDD, with the aim of identifying novel targets for neuromodulation treatments, as these treatments are thought to work partly by altering dysfunctional connectivity pathways. Twenty-one studies met inclusion criteria, including a total of 1292 people with MDD. Only two studies included people with MDD and formally diagnosed co-morbid anxiety disorders; the remainder included people with MDD with dimensional anxiety measurement. The quality of most studies was judged as fair. Results were heterogeneous, partly due to a focus on a small set of connectivity relationships within individual studies. There was evidence for dysconnectivity between the amygdala and other brain networks in co-morbid anxiety, and an indication that abnormalities of default mode network connectivity may play an underappreciated role in this condition.
