Background Healthcare workers (HCWs) have faced considerable pressures during the COVID-19 pandemic. For some, this has resulted in mental health distress and disorder. Although interventions have sought to support HCWs, few have been evaluated. Aims We aimed to determine the effectiveness of the ‘Foundations’ application (app) on general (non-psychotic) psychiatric morbidity. Method We conducted a multicentre randomised controlled trial of HCWs at 16 NHS trusts (trial registration number: EudraCT: 2021-001279-18). Participants were randomly assigned to the app or wait-list control group. Measures were assessed at baseline, after 4 and 8 weeks. The primary outcome was general psychiatric morbidity (using the General Health Questionnaire). Secondary outcomes included: well-being; presenteeism; anxiety; depression and insomnia. The primary analysis used mixed-effects multivariable regression, presented as adjusted mean differences (aMD). Results Between 22 March and 3 June 2021, 1002 participants were randomised (500:502), and 894 (89.2%) followed-up. The sample was predominately women (754/894, 84.3%), with a mean age of 44⋅3 years (interquartile range (IQR) 34–53). Participants randomised to the app had a reduction in psychiatric morbidity symptoms (aMD = −1.39, 95% CI −2.05 to −0.74), improvement in well-being (aMD = 0⋅54, 95% CI 0⋅20 to 0⋅89) and reduction in insomnia (adjusted odds ratio (aOR) = 0⋅36, 95% CI 0⋅21 to 0⋅60). No other significant findings were found, or adverse events reported. Conclusions The app had an effect in reducing psychiatric morbidity symptoms in a sample of HCWs. Given it is scalable with no adverse effects, the app may be used as part of an organisation's tiered staff support package. Further evidence is needed on long-term effectiveness and cost-effectiveness.

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Background and Hypothesis Cognitive remediation (CR) benefits cognition and functioning in psychosis but we do not know the optimal level of therapist contact, so we evaluated the potential benefits of different CR modes. Study Design A multi-arm, multi-center, single-blinded, adaptive trial of therapist-supported CR. Participants from 11 NHS early intervention psychosis services were independently randomized to Independent, Group, One-to-One, or Treatment-as-usual (TAU). The primary outcome was functional recovery (Goal Attainment Scale [GAS]) at 15-weeks post randomization. Independent and TAU arms were closed after an interim analysis, and three informative contrasts tested (Group vs One-to-One, Independent vs TAU, Group + One-to-One vs TAU). Health economic analyses considered the cost per Quality Adjusted Life Year (QALY). All analyses used intention-to-treat principles. Study Results We analyzed 377 participants (65 Independent, 134 Group, 112 One-to-One, 66 TAU). GAS did not differ for Group vs One-to-One: Cohen’s d: 0.07, −0.25 to 0.40 95% CI, P = .655; Independent vs TAU: Cohen’s d: 0.07, −0.41 to 0.55 95% CI, P = .777. GAS and the cognitive score improved for Group + One-to-One vs TAU favoring CR (GAS: Cohen’s d: 0.57, 0.19–0.96 95% CI, P = .003; Cognitive score: Cohens d: 0.28, 0.07–0.48 95% CI, P = .008). The QALY costs were £4306 for Group vs TAU and £3170 for One-to-One vs TAU. Adverse events did not differ between treatment methods and no serious adverse events were related to treatment. Conclusions Both active therapist methods provided cost-effective treatment benefiting functional recovery in early psychosis and should be adopted within services. Some individuals benefited more than others so needs further investigation. Trial registration ISRCTN14678860 https://doi.org/10.1186/ISRCTN14678860  Now closed.

Objectives: To understand patient and therapist experiences of time-intensive and weekly exposure-based therapy for anxiety disorders delivered during pregnancy.Design: A qualitative study using semi-structured interviews with patients and therapists who had taken part in a feasibility trial of predominantly online time-intensive versus weekly CBT in pregnancy. Setting UK therapists and patients in a primary care setting Participants In-depth interviews were conducted with 45 women who had participated in the trial and 6 therapists who had delivered the treatments. Analysis: Data were analysed using reflexive thematic analysis. Results: Five themes were developed from the data that showed convergence from therapist and patient perspectives. These were: ‘Acquiring tools to navigate the perinatal period’; ‘Motivated yet constrained by pregnancy’; ‘Having the confidence to face fears and tolerate uncertainty’; ‘Momentum with the need for flexibility’; ‘Being isolated from the face-to-face world’.Conclusions: Exposure therapy is acceptable and helpful in pregnancy and can lead to lasting gains. Exposure is a key element of treatment and needs to be confidently conducted by therapists with perinatal knowledge and expertise. Treatments need to consider the unfolding context of pregnancy. The momentum of intensive therapy can lead to rapid improvements, but can be demanding for both patients and therapists, especially fitting round other commitments. Online treatments can work well and are a good fit for perinatal women, but this needs to be balanced with the need for connection, suggesting a hybrid model of delivery is the ideal.

BackgroundExposure-based cognitive-behaviour therapies (CBT) are effective but their acceptability in pregnancy is untested, despite affecting 15% of women. Time-intensive delivery of CBT (INT-CBT) may accelerate treatment response. AimsTo test the acceptability and feasibility of a trial of INT-CBT for antenatal anxiety disordersMethodThis multi-centre parallel-group trial recruited pregnant women with anxiety disorders from maternity and mental health settings and randomised (1:1) to INT-CBT or standard weekly CBT (WCBT). Participants received 12 hours of individual therapy using remote delivery (95%). Outcomes were assessed: at baseline; during treatment at week 2 and 6, and at 1 month and 3 months postpartum (by blinded assessors), alongside a qualitative interview. Pre-specified primary feasibility outcomes were evaluated and adjusted mean difference estimated for the proposed study primary outcome.ResultsAll feasibility outcomes were met. Of 135 screened, 59 women were recruited and randomised into the trial (29 INT-CBT :30 WCBT). 93% completed treatment and 81% provided data at 3m postpartum. No adverse effects were attributable to treatment. Women randomised to INT-CBT showed a reduction in anxiety (GAD-7) after two weeks of treatment (aMD=-4.17, 95%CI -6.03 to -2.31). There were differences in late pregnancy aMD=-1.72 (95%CI -3.99, 0.56), 1-month postpartum aMD=-2.13 (95%CI -5.14, 0.89), 3-month postpartum aMD=-0.11 (95%CI -3.23, 3.00). Women described the momentum of INT-CBT as helpful to drive change.ConclusionsExposure-based therapies are acceptable to pregnant women. INT-CBT may reduce anxiety quickly and should be tested in a confirmatory trial examining longer term outcomes.