Excellent hepatitis C virus cure rates despite increasing complexity of people who use drugs: Integrated-Test-stage Treat study final outcomes.

Achieving hepatitic C virus (HCV) elimination requires linking people who use drugs (PWUD) into care. We report final direct-acting antivirals (DAAs)-based outcomes from the Integrated-Test-stage -Treat (ITTREAT) study. Project ITTREAT (2013-2021), based at an addiction centre, was a 'one-stop' service with innovative linkage to care strategies. Primary outcome was sustained virological response (SVR12) (intention to treat ITT) including whether individuals were recruited in first (period 1) versus last four (period 2 included the COVID-19 pandemic) years of the study. Number recruited were n = 765, mean age 40.9 ± 10.1 years, 78% males, history of current/past injecting drug use (IDU) and alcohol use being 77% and 90%, respectively. Prevalence of a positive HCV PCR was 84% with 19% having cirrhosis. Comparing those recruited in period 2 versus period 1, there was increasing prevalence of IDU, 90% versus 72% (p < .001); homelessness, 67% versus 50% (p < .001); psychiatric diagnosis, 84% versus 50% (p < .001); overdose history 71% versus 31% (p < .001), receiving opioid agonist treatment (OAT) 75% versus 52% (p < .001) and comorbidity 44% versus 25% (p < .001). Of those treated with DAAs (n = 272), ITT SVR rates were 86% (95% CI: 81%-90%), being similar in period 2 versus period 1. Predictors of non-SVR were receiving OAT (OR 0.33, 95% CI: 0.12-0.87, p = .025) and ≥80% adherence (OR 0.01, 95% CI: 0.003-0.041, p < .001). Reinfection rates period 2 versus period 1 (per 100 person-years) were 1.84 versus 1.70, respectively. In the treated cohort, mortality was 15%, being mostly drug-related. Despite increasing complexity of PWUD, high SVR12 rates are achievable with use of OAT and good adherence.

Relating Therapy for Distressing Voices in the Context of Anorexia Nervosa: A Case Series.

ABSTRACT: Voice hearing experiences are commonly reported by patients with anorexia nervosa (AN) and are associated with negative outcomes. The "eating disorder voice" (EDV) can be understood within relational frameworks. Relating therapy (RT) has offered encouraging outcomes when targeted at voice hearing experiences transdiagnostically but has not been evaluated in the context of AN. This study aimed to offer a preliminary and mixed methods exploration of RT for the EDV. RT was delivered to three participants with a diagnosis of AN who were distressed by an EDV. Weight, negative impact of voices, and eating disorder cognitions were assessed at baseline, posttherapy and at brief follow-up. Participant experiences were explored through exit interviews. Therapy was completed by all participants. Weight gain was reported by two participants and maintained at brief follow-up. Positive changes were not reported on other measures. Qualitative data were suggestive of positive experiences that facilitated assertive responding.

A co-produced service evaluation of ethnic minority community service user experiences of a specialist mental health service during the COVID-19 pandemic.

BACKGROUND: For ethnic minority communities in the UK, the COVID-19 pandemic amplified existing health inequalities and created other consequential disadvantages like increased vulnerability to COVID-19, higher rates of hospital admissions, increased mortality and poorer mental health outcomes. While longer-term impacts of COVID-19 are considered, it is crucial for NHS mental health services to understand the specific barriers and needs of ethnic minority communities to provide consistent and equitable access to mental health services. These aspects were the focus of a service evaluation of a Sussex-wide mental health service conducted in co-production with experts-by-experience, public members, health professionals and researchers from ethnic minority communities. METHODS: Co-designed creative workshops (n = 13) and semi-structured qualitative interviews (n = 13) were used to explore experiences of accessing specialist mental health services during the COVID-19 pandemic. Participants were: Sussex Partnership NHS Foundation Trust (SPFT) service users recruited between October 2021 and January 2022; aged 16+; from ethnic minority community backgrounds. Data was analysed using Thematic Analysis. RESULTS: The analysis yielded five overarching themes contextualising service users' experiences: (1) limited awareness of SPFT mental health services; (2) effects of COVID-19 in gaining access to SPFT; (3) SPFT reaching out to ethnic minorities; (4) being supported, 4a) hiding my mental health status from friends and families, 4b) lack of ethnic diversity in services, and 4c) better provision of information and support services, (5) relationship between childhood experiences and current mental health. These findings led to seven key recommendations for future service developments within SPFT. CONCLUSIONS: Although this evaluation was set in the context of COVID-19, findings have highlighted specific mental health service needs for ethnic minorities that are applicable beyond the confines of the pandemic. Many benefited from online sessions seen as more inclusive. Mental health advocates, outreach and joint working with communities could help further reduce stigmatising attitudes and improve engagement with mental health services. Improved service awareness of the impact of childhood or historical traumas experienced by ethnic minority communities on current mental health, the role of cultural awareness training and availability of culturally adapted therapies is also needed. Many service improvement recommendations provided could impact all service users.

Voice Hearing in Borderline Personality Disorder Across Perceptual, Subjective, and Neural Dimensions.

BACKGROUND: Auditory verbal hallucinations (AVH) commonly occur in the context of borderline personality disorder (BPD) yet remain poorly understood. AVH are often perceived by patients with BPD as originating from inside the head and hence viewed clinically as "pseudohallucinations," but they nevertheless have a detrimental impact on well-being. METHODS: The current study characterized perceptual, subjective, and neural expressions of AVH by using an auditory detection task, experience sampling and questionnaires, and functional neuroimaging, respectively. RESULTS: Perceptually, reported AVH correlated with a bias for reporting the presence of a voice in white noise. Subjectively, questionnaire measures indicated that AVH were significantly distressing and persecutory. In addition, AVH intensity, but not perceived origin (i.e., inside vs outside the head), was associated with greater concurrent anxiety. Neurally, fMRI of BPD participants demonstrated that, relative to imagining or listening to voices, periods of reported AVH induced greater blood oxygenation level-dependent activity in anterior cingulate and bilateral temporal cortices (regional substrates for language processing). AVH symptom severity was associated with weaker functional connectivity between anterior cingulate and bilateral insular cortices. CONCLUSION: In summary, our results indicate that AVH in participants with BPD are (1) underpinned by aberrant perceptual-cognitive mechanisms for signal detection, (2) experienced subjectively as persecutory and distressing, and (3) associated with distinct patterns of neural activity that inform proximal mechanistic understanding. Our findings are like analogous observations in patients with schizophrenia and validate the clinical significance of the AVH experience in BPD, often dismissed as "pseudohallucinations." These highlight a need to reconsider this experience as a treatment priority.

Brief coping strategy enhancement for the treatment of distressing voices in the context of borderline personality disorder: A comparison with outcomes in the context of psychosis.

BACKGROUND: Voice hearing in the context of Borderline Personality Disorder (BPD) has traditionally been regarded as transient and an experience that lacks legitimacy. Consequently, there are no evidence-based treatments for the voices reported by BPD patients. Contrary to the traditional view, there is a growing literature suggesting that voice hearing in the context of BPD can be an enduring and distressing experience which shares similarities with voice hearing in the context of psychosis. Given these similarities, the aim of this study was to explore whether brief Coping Strategy Enhancement developed in the context of psychosis can be used to treat distressing voice hearing in the context of BPD. METHOD: This was a service evaluation carried out in a specialist NHS service delivering psychological therapies for distressing voices. Patients with either a BPD (n = 46) or a psychosis diagnosis (n = 125) received four sessions of Coping Strategy Enhancement (CSE). The primary outcome was voice-related distress. The pre-post outcomes for BPD patients were explored and compared with those achieved by the psychosis patients. RESULTS: Both the BPD and psychosis groups experienced a significant reduction in voice-related distress after CSE compared with baseline. The interaction between diagnosis group and time was small and statistically non-significant. CONCLUSION: These findings suggest a brief CSE intervention developed in the context of psychosis can be an effective starting point in the treatment of distressing voice hearing in the context of BPD. Such interventions have the potential to be integrated into broader BPD treatment programmes for those who hear voices.

A cross-sectional study of auditory verbal hallucinations experienced by people with a diagnosis of borderline personality disorder.

BACKGROUND: The presence of auditory verbal hallucinations (AVHs) does not currently feature in the main diagnostic criteria for borderline personality disorder (BPD). However, there is accumulating evidence that a high proportion of BPD patients report longstanding and frequent AVHs which constitute a significant risk factor for suicide plans and attempts, and hospitalization. AIM: This study addressed questions about the validity and phenomenology of AVHs in the context of BPD. The longer-term aim is to facilitate the development and translation of treatment approaches to address the unmet need of this population. METHOD: This was a cross-sectional study, combining phenomenological and psychological assessments administered in person and online. We explored the experiences of 48 patients with a diagnosis of BPD who were hearing AVHs. RESULTS: Participants gave 'consistent' reports on the measure of AVH phenomenology, suggesting that these experiences were legitimate. Similar to AVHs in a psychosis context, AVHs were experienced as distressing and appraised as persecutory. AVHs were found to be weakly associated with BPD symptoms. AVHs were also rated highly as a treatment priority by the majority of participants. CONCLUSION: The findings suggest that AVH is a legitimate and distressing symptom of BPD and a treatment priority for some patients. The relative independence of AVHs from other BPD symptoms and emotional states suggests that psychological treatment may need to be targeted specifically at the symptom of AVHs. This treatment could be adapted from cognitive behaviour therapy, the psychological intervention that is recommended for the treatment of AVHs in the context of psychosis.

A service evaluation of a group mindfulness-based intervention for distressing voices: how do findings from a randomized controlled trial compare with routine clinical practice?

BACKGROUND: Person-based cognitive therapy (PBCT) was developed as a treatment for psychosis. The effectiveness of group PBCT was examined in the Mindfulness for Voices (M4V) randomized controlled trial and generated promising results. Group PBCT was implemented as a trans-diagnostic treatment for distressing voices within the Sussex Voices Clinic (SVC), a specialist secondary care mental health service. AIM: To conduct a service evaluation of engagement, outcomes and cost of group PBCT within SVC, and to compare engagement and outcomes from routine practice with the M4V trial. Secondary aims were to explore predictors of levels of engagement and change in group PBCT. METHOD: Service level data from 95 SVC patients were evaluated. Descriptive statistics, hypothesis tests and linear regression models were used. The primary clinical outcome was voice-related distress. Engagement levels and pre-post effect sizes were estimated; associated predictors were explored. RESULTS: Fifty-nine per cent of patients completed group PBCT within SVC, compared with 72% within M4V. Completers within SVC had lower baseline depression scores compared with non-completers. There were significant improvements in voice-related distress (Cohen's d = -0.47; p = 0.001), subjective recovery (Cohen's d = 0.35; p = 0.001) and depression (Cohen's d = -0.20; p = 0.044); these outcomes were comparable to M4V. Higher baseline subjective recovery and lower depression both predicted improvement in voice-related distress. Therapy within SVC cost an average of £214 per patient. CONCLUSION: PBCT groups can be delivered trans-diagnostically in routine clinical practice. Engagement was lower when compared with an RCT, but outcomes were comparable. The low level of resources involved suggests that group PBCT can offer value for money.

ITTREAT (Integrated Community Test - Stage - TREAT) Hepatitis C service for people who use drugs: Real-world outcomes.

BACKGROUND/AIMS: Direct-acting antivirals (DAAs) provide an unprecedented opportunity for a "find-and-treat strategy." We aimed to report real-world clinical, patient reported and health economic outcomes of community-based hepatitis C virus (HCV) screening/treatment in people who use drugs (PWUDs). METHODS: Project ITTREAT (2013-2021), established at a drug and alcohol treatment centre, offered a comprehensive service. Generic (SF-12v2 and EQ-5D-5L) and liver-specific (SFLDQoL) health-related quality of life (HRQoL) were assessed before and after HCV treatment. Costs/case detected and cured were calculated. Primary outcome measure was sustained virological response (SVR) (intention to treat). RESULTS: Till March 2018, 573 individuals recruited, 462 (81%) males, mean age 40.5 ± 10.0 years. Of the 125 treated, 115 (92%) had past/current history of injecting drug use, 88 (70%) were receiving opioid agonist treatment and 50 (40%) were homeless. Twenty-six per cent received interferon-based and 74% DAA-only regimens. SVR (ITT) was 87% (90% with DAAs). Service uptake/HCV treatment completion rates were >95%, HCV reinfection being 2.63/100 person years (95% CI 0.67-10.33). HRQoL improved significantly at end of treatment (EOT) in those with SVR: SFLDQoL (symptoms, memory, distress, loneliness, hopelessness, sleep and stigma) (P

Differences in Achilles tendon stiffness in people with gout: a pilot study.

BACKGROUND: Gout has been associated with weaker foot/leg muscles and altered gait patterns. There is also evidence of on-going foot pain and an increased risk of tendinopathy, with the Achilles and patella tendons most frequently affected in gout. Additionally, the inflammation associated with gout may change tissue elasticity. Ultrasound imaging utilising shear wave elastography (SWE) offers a non-invasive method of quantifying changes in tendon stiffness. SWE findings have not previously been reported in individuals with gout. We sought to determine differences in Achilles tendon stiffness in people with gout compared to controls (non-gout). METHODS: A cross sectional study comparing 24 people with gout and 26 age/sex-matched controls. Clinical and demographic data were collated, and US imaging used to determine tendon thickness, presence of gouty tophi and/or aggregates and levels of angiogenesis. Ten shear wave elastography (SWE) measures were taken along the centre of a longitudinal section of the mid-portion of each Achilles tendon. Prior to data collection, intra-observer error was good (>0.69). Data were summarised using descriptive statistics and a repeated measures ANCOVA was used to compare SWE measures between the two groups for the left and right foot separately after accounting for Body Mass Index (BMI). RESULTS: A small proportion of those with gout presented with intra-tendon aggregates and/or intra-tendon tophi in one or both tendons. There was no statistically significant difference in tendon thickness between groups. Neo-vascularity was present in a third of gout participants. SWE findings demonstrated significantly reduced tendon stiffness in those with gout compared to controls: right Achilles mdiff =1.04 m/s (95% CI (0.38 to 1.7) p = 0.003 and left Achilles mdiff = 0.7 m/s (95% CI 0.09 to 1.32) p = 0.025. No relationship between the presence of tophi and SWE values were detected. CONCLUSION: Subjects with chronic gout show significantly reduced Achilles tendon stiffness compared to non-gout controls. From a clinical standpoint, our findings were similar to SWE measurements in subjects with Achilles tendinopathy and who did not have gout.

Evaluating the "C" and "B" in brief cognitive behaviour therapy for distressing voices in routine clinical practice in an uncontrolled study.

Brief and single-symptom forms of cognitive behaviour therapy (CBT) for distressing voices may increase access to evidence-based psychological therapy and transcend diagnostic barriers. The current study evaluated the "C" and "B" in CBT for distressing voices in a transdiagnostic voices clinic. The B module (component of therapy) sought to enhance coping with voices, and the C module evaluated the accuracy of negative beliefs about the self and voices. The aims of the study were to investigate (a) whether modules B and/or C led to significant and clinically meaningful improvements on the primary outcome of voice-related distress, and (b) if changes in beliefs about self and voices (proposed change mechanisms) underpinned changes in voice distress across module C. Each module consisted of four sessions, individually tailored yet manualized, and designed with ease of staff training and delivery in mind. Assessment measures were administered at baseline (T1), post-module B (T2), and post-module C (T3). The results (N = 62) showed statistically significant medium-sized pre- and post-effects for voice-related distress from T1 to T2 and from T2 to T3, with large effects from T1 to T3. Just over half of the clients reported clinically meaningful improvements from T1 to T3. Neither beliefs about self nor voices were found to mediate improvements in voice distress during module C. The findings from this study suggest that both the B and C in CBT for voices can contribute to positive outcomes within routine clinical practice.

Brief Coping Strategy Enhancement for Distressing Voices: an Evaluation in Routine Clinical Practice.

BACKGROUND: Hearing voices can be a common and distressing experience. Psychological treatment in the form of cognitive behavioural therapy for psychosis (CBTp) is effective, but is rarely available to patients. The barriers to increasing access include a lack of time for clinicians to deliver therapy. Emerging evidence suggests that CBTp delivered in brief forms can be effective and offer one solution to increasing access. AIMS: We adapted an existing form of CBTp, coping strategy enhancement (CSE), to focus specifically on distressing voices in a brief format. This intervention was evaluated within an uncontrolled study conducted in routine clinical practice. METHOD: This was a service evaluation comparing pre-post outcomes in patients who had completed CSE over four sessions within a specialist out-patient service within NHS Mental Health Services. The primary outcome was the distress scale of the Psychotic Symptoms Rating Scale - Auditory Hallucinations (PSYRATS-AH). RESULTS: Data were available from 101 patients who had completed therapy. A reduction approaching clinical importance was found on the PSYRATS distress scale post-therapy when compared with the baseline. CONCLUSIONS: The findings from this study suggest that CSE, as a focused and brief form of CBTp, can be effective in the treatment of distressing voices within routine clinical practice. Within the context of the limitations of this study, brief CSE may best be viewed as the beginning of a therapeutic conversation and a low-intensity intervention in a stepped approach to the treatment of distressing voices.

Brief coping strategy enhancement for distressing voices: Predictors of engagement and outcome in routine clinical practice.

Cognitive behaviour therapy is recommended internationally as a treatment for psychosis (targeting symptoms such as auditory hallucinations, or "voices"). Yet mental health services are commonly unable to offer such resource-intensive psychological interventions. Brief, symptom-specific and less resource-intensive therapies are being developed as one initiative to increase access. However, as access increases, so might the risk of offering therapy to clients who are not optimally disposed to engage with and benefit from therapy. Thus, it is important to identify who is most/least likely to engage with and benefit from therapy, and when. In the current study, 225 clients were assessed for suitability for a brief, 4-session, manualized, cognitive behaviour therapy-based intervention for voices (named coping strategy enhancement therapy) and 144 commenced therapy, at a transdiagnostic voices clinic based in Sussex, UK. This article reports on the value of depression, anxiety, stress, insight into the origin of voices, length of voice hearing, and demographics in the prediction of engagement and outcomes. The study found that higher levels of baseline depression, anxiety, and stress were significantly associated with poorer outcomes, especially if clients also had high levels of voice-related distress. The engagement analyses showed that levels of voice-related distress at baseline predicted dropout. These findings highlight the importance of assessing negative affect and voice-related distress prior to commencing therapy for distressing voices, to help determine if the client is suitable or ready for brief-coping strategy enhancement.

HIV serostatus knowledge and serostatus disclosure with the most recent anal intercourse partner in a European MSM sample recruited in 13 cities: results from the Sialon-II study.

BACKGROUND: Knowledge of HIV status can be important in reducing the risk of HIV exposure. In a European sample of men-who-have-sex-with-men (MSM), we aimed to identify factors associated with HIV serostatus disclosure to the most recent anal intercourse (AI) partner. We also aimed to describe the impact of HIV serostatus disclosure on HIV exposure risks. METHODS: During 2013 and 2014, 4901 participants were recruited for the bio-behavioural Sialon-II study in 13 European cities. Behavioural data were collected with a self-administered paper questionnaire. Biological specimens were tested for HIV antibodies. Factors associated with HIV serostatus disclosure with the most recent AI partner were examined using bivariate and multilevel multivariate logistic regression analysis. We also describe the role of serostatus disclosure for HIV exposure of the most recent AI partner. RESULTS: Thirty-five percent (n = 1450) of the study participants reported mutual serostatus disclosure with their most recent AI partner or disclosed having HIV to their partner. Most of these disclosures occurred between steady partners (74%, n = 1077). In addition to the type of partner and HIV diagnosis status, other factors positively associated with HIV serostatus disclosure in the multilevel multivariate logistic regression model were recent testing, no condom use, and outness regarding sexual orientation. Disclosure rates were lowest in three south-eastern European cities. Following condom use (51%, n = 2099), HIV serostatus disclosure (20%, n = 807) was the second most common prevention approach with the most recent AI partner, usually resulting in serosorting. A potential HIV exposure risk for the partner was reported by 26% (111/432) of HIV antibody positive study participants. In 18% (20/111) of exposure episodes, an incorrect HIV serostatus was unknowingly communicated. Partner exposures were equally distributed between steady and non-steady partners. CONCLUSIONS: The probability of HIV exposure through condomless AI is substantially lower after serostatus disclosure compared to non-disclosure. Incorrect knowledge of one's HIV status contributes to a large proportion of HIV exposures amongst European MSM. Maintaining or improving condom use for anal intercourse with non-steady partners, frequent testing to update HIV serostatus awareness, and increased serostatus disclosure particularly between steady partners are confirmed as key aspects for reducing HIV exposures amongst European MSM.

Multi-modal hallucinations across diagnoses: What relationships do they have with voice-related distress?

BACKGROUND: Research into hallucinatory experiences has focused primarily upon hallucinations within the auditory modality, to the relative neglect of other modalities. Furthermore, the exploration of auditory hallucinations (or 'voices') has focused primarily upon the experiences of people with a diagnosis of psychosis. The presence of multi-modal hallucinations may have implications across diagnoses for levels of distress, formulation and the targeting of psychological interventions. METHODS: This study presents a cross-sectional analysis of observational data from the PREFER survey (N = 335). Linear regression was used to explore the relationships between voice-related distress and the presence, number, type and timing of multi-modal hallucinations. RESULTS: Simple relationships were not found between distress and the presence of hallucinations in visual, tactile, olfactory or gustatory modalities, or in the number of modalities experienced. When considering the degree to which another modality hallucination was experienced simultaneously with voices, there was some evidence that the degree of co-occurrence with visual hallucinations was predictive of distress. CONCLUSIONS: The co-occurrence of voices with visual hallucinations may be associated with relatively greater distress, but not consistently, and the association between multimodal hallucinations and clinical impact appear complex and potentially variable from individual to individual. Further study of associated variables such as perceived voice power may further illuminate these relationships.

A thematic analysis of barriers and facilitators to participant engagement in group exposure and response prevention therapy for obsessive-compulsive disorder.

Exposure and response prevention (ERP) is the gold standard in the treatment of the obsessive-compulsive disorder (OCD). It can be delivered effectively using an individual or group therapy format. Nonetheless, a sizeable proportion of people diagnosed with OCD do not experience OCD symptom remission following ERP. Research suggests that participant engagement with ERP tasks predicts therapy outcomes but there is little consistent evidence across studies on what predicts engagement. A recent meta-analysis of participant engagement in cognitive-behavioral therapy for OCD found that group ERP had a comparatively lower dropout rate than individual ERP. Little is known about participant perceptions of ERP to guide an understanding of how the group therapy format may affect participant engagement. This study conducted a qualitative exploration of what helps or hinders participants' engagement in group ERP. It involved thematic analysis of semi-structured interview data collected at a 6-month follow-up from 15 adults with OCD who took part in group ERP. The study identified five main themes that captured participants' perceived facilitators and barriers to engagement in therapy: 'Group processes', 'Understanding how to overcome OCD', 'Personal relevance', 'Personal circumstances', and 'Attitudes towards ERP', which captured dynamically inter-related barriers and facilitators at the level of the client, therapist, therapy and social environment. Each theme and associated sub-themes are discussed in turn, followed by a consideration of the study's limitations and implications.

Cardiac interoception in patients accessing secondary mental health services: A transdiagnostic study.

BACKGROUND: Abnormalities in the regulation of physiological arousal and interoceptive processing are implicated in the expression and maintenance of specific psychiatric conditions and symptoms. We undertook a cross-sectional characterisation of patients accessing secondary mental health services, recording measures relating to cardiac physiology and interoception, to understand how physiological state and interoceptive ability relate transdiagnostically to affective symptoms. METHODS: Participants were patients (n = 258) and a non-clinical comparison group (n = 67). Clinical diagnoses spanned affective disorders, complex personality presentations and psychoses. We first tested for differences between patient and non-clinical participants in terms of cardiac physiology and interoceptive ability, considering interoceptive tasks and a self-report measure. We then tested for correlations between cardiac and interoceptive measures and affective symptoms. Lastly, we explored group differences across recorded clinical diagnoses. RESULTS: Patients exhibited lower performance accuracy and confidence in heartbeat discrimination and lower heartbeat tracking confidence relative to comparisons. In patients, greater anxiety and depression predicted greater self-reported interoceptive sensibility and a greater mismatch between performance accuracy and sensibility. This effect was not observed in comparison participants. Significant differences between patient groups were observed for heart rate variability (HRV) although post hoc differences were not significant after correction for multiple comparisons. Finally, accuracy in heartbeat tracking was significantly lower in schizophrenia compared to other diagnostic groups. CONCLUSIONS: The multilevel characterisation presented here identified certain physiological and interoceptive differences associated with psychiatric symptoms and diagnoses. The clinical stratification and therapeutic targeting of interoceptive mechanisms is therefore of potential value in treating certain psychiatric conditions.

OUTdoor Swimming as a nature-based Intervention for DEpression (OUTSIDE): study protocol for a feasibility randomised control trial comparing an outdoor swimming intervention to usual care for adults experiencing mild to moderate symptoms of depression.

BACKGROUND: Depression is common and the prevalence increasing worldwide; at least 1 in 10 people will experience depression in their lifetime. It is associated with economic costs at the individual, healthcare and societal level. Recommended treatments include medication and psychological therapies. However, given the long waiting times, and sometimes poor concordance and engagement with these treatments, a greater range of approaches are needed. Evidence for the potential of outdoor swimming as an intervention to support recovery from depression is emerging, but randomised controlled trials (RCTs) evaluating clinical and cost-effectiveness are lacking. This study seeks to investigate the feasibility of conducting a definitive superiority RCT, comparing an 8-session outdoor swimming course offered in addition to usual care compared to usual care only, in adults who are experiencing mild to moderate symptoms of depression. Feasibility questions will examine recruitment and retention rates, acceptability of randomisation and measures, and identify the primary outcome measure that will inform the sample size calculation for a definitive full-scale RCT. This study will also explore potential facilitators and barriers of participation through evaluation questionnaires, focus-group discussions and interviews. METHODS/DESIGN: To address these aims and objectives, a feasibility superiority RCT with 1:1 allocation will be undertaken. We will recruit 88 participants with mild to moderate symptoms of depression through social prescribing organisations and social media in three sites in England. Participants will be randomised to either (1) intervention (8-session outdoor swimming course) plus usual care or (2) usual care only. Both groups will be followed up for a further 8 weeks. DISCUSSION: If findings from this feasibility RCT are favourable, a fully powered RCT will be conducted to investigate the clinical- and cost-effectiveness of the intervention. Findings from the definitive trial will provide evidence about outdoor swimming for depression for policymakers and has the potential to lead to greater choice of interventions for adults experiencing symptoms of depression. TRIAL REGISTRATION: Current controlled trial registration number is ISRCTN 90851983 registered on 19 May 2022.

Trialling an optimised social groups intervention in services to enhance social connectedness and mental health in vulnerable young people (TOGETHER): Study protocol for a feasibility randomised controlled trial.

BACKGROUND: Calls have been made to rethink the mental health support currently available for young people. This study aims to help re-focus and reduce the inaccessibility of mental health services by offering an adapted version of a theoretically-driven, evidence-based, guided psychosocial intervention known as 'Groups 4 Health' (G4H). To date, the G4H intervention has mainly been trialled in Australia, with promising positive effects on social connection, mental health and well-being. The present study examines the feasibility of running a randomised controlled trial when delivering the G4H intervention for young people in the UK. METHODS: The TOGETHER study is a feasibility randomised controlled trial of an adapted version of the G4H intervention. Participants are aged 16-25, currently experiencing mental health difficulties and recruited from mental health services. The target sample size is 30, with 15 in each trial arm. Participants are randomly allocated to either G4H plus treatment as usual, or treatment as usual alone. The primary outcomes of interest are the feasibility of recruitment, randomisation, data collection and retention to the study at 10 and 14 week follow up, as well as the acceptability, and accessibility of the study protocol and G4H intervention. DISCUSSION: The results of this study will indicate if further optimisation is required to improve the feasibility, acceptability and accessibility of the intervention and study protocol procedures as perceived by end users and practitioners. This offers a significant opportunity to support the local and national demand for accessible, innovative, and effective psychosocial youth mental health support. TRIAL REGISTRATION: ISRCTN registry (ISRCTN12505807). Registration date: 11/04/2022.

Increasing access to CBT for psychosis patients: study protocol for a randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE3).

BACKGROUND: The National Institute for Health and Care Excellence (NICE) recommends that cognitive behaviour therapy (CBT) is offered to all patients with a psychosis diagnosis. However, only a minority of psychosis patients in England and Wales are offered CBT. This is attributable, in part, to the resource-intensive nature of CBT. One response to this problem has been the development of CBT in brief formats that are targeted at a single symptom and are deliverable by briefly trained therapists. We have developed Guided self-help CBT (the GiVE intervention) as a brief form of CBT for distressing voices and reported evidence for the feasibility of a randomised controlled trial (RCT) when the intervention was delivered by briefly trained therapists (assistant psychologists). This study will investigate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists following a brief training. METHODS: This study is a pragmatic, two-arm, parallel group, superiority RCT comparing the GiVE intervention (delivered by assistant psychologists) and treatment as usual to treatment as usual alone, recruiting across three sites, using 1:1 allocation and blind post-treatment and follow-up assessments. A nested qualitative study will develop a model for implementation. DISCUSSION: If the GiVE intervention is found to be effective when delivered by assistant psychologists, this intervention could significantly contribute to increasing access to evidence-based psychological interventions for psychosis patients. Furthermore, implementation across secondary care services within the UK's National Health Service may pave the way for other symptom-specific and less resource-intensive CBT-informed interventions for psychosis patients to be developed and evaluated. TRIAL REGISTRATION: Current Controlled Trials ISRCTN registration number: 12748453. Registered on 28 September 2022.

Clinical Effectiveness and Cost-Effectiveness of Supported Mindfulness-Based Cognitive Therapy Self-help Compared With Supported Cognitive Behavioral Therapy Self-help for Adults Experiencing Depression: The Low-Intensity Guided Help Through Mindfulness (LIGHTMind) Randomized Clinical Trial.

Importance: Depression is prevalent. Treatment guidelines recommend practitioner-supported cognitive behavioral therapy self-help (CBT-SH) for mild to moderate depression in adults; however, dropout rates are high. Alternative approaches are required. Objective: To determine if practitioner-supported mindfulness-based cognitive therapy self-help (MBCT-SH) is superior to practitioner-supported CBT-SH at reducing depressive symptom severity at 16 weeks postrandomization among patients with mild to moderate depression and secondarily to examine if practitioner-supported MBCT-SH is cost-effective compared with practitioner-supported CBT-SH. Design, Setting, and Participants: This was an assessor- and participant-blinded superiority randomized clinical trial with 1:1 automated online allocation stratified by center and depression severity comparing practitioner-supported MBCT-SH with practitioner-supported CBT-SH for adults experiencing mild to moderate depression. Recruitment took place between November 24, 2017, and January 31, 2020. The study took place in 10 publicly funded psychological therapy services in England (Improving Access to Psychological Therapies [IAPT]). A total of 600 clients attending IAPT services were assessed for eligibility, and 410 were enrolled. Participants met diagnostic criteria for mild to moderate depression. Data were analyzed from January to October 2021. Interventions: Participants received a copy of either an MBCT-SH or CBT-SH workbook and were offered 6 support sessions with a trained practitioner. Main Outcomes and Measures: The preregistered primary outcome was Patient Health Questionnaire (PHQ-9) score at 16 weeks postrandomization. The primary analysis was intention-to-treat with treatment arms masked. Results: Of 410 randomized participants, 255 (62.2%) were female, and the median (IQR) age was 32 (25-45) years. At 16 weeks postrandomization, practitioner-supported MBCT-SH (n = 204; mean [SD] PHQ-9 score, 7.2 [4.8]) led to significantly greater reductions in depression symptom severity compared with practitioner-supported CBT-SH (n = 206; mean [SD] PHQ-9 score, 8.6 [5.5]), with a between-group difference of -1.5 PHQ-9 points (95% CI, -2.6 to -0.4; P = .009; d = -0.36). The probability of MBCT-SH being cost-effective compared with CBT-SH exceeded 95%. However, although between-group effects on secondary outcomes were in the hypothesized direction, they were mostly nonsignificant. Three serious adverse events were reported, all deemed not study related. Conclusions and Relevance: In this randomized clinical trial, practitioner-supported MBCT-SH was superior to standard recommended treatment (ie, practitioner-supported CBT-SH) for mild to moderate depression in terms of both clinical effectiveness and cost-effectiveness. Findings suggest that MBCT-SH for mild to moderate depression should be routinely offered to adults in primary care services. Trial Registration: isrctn.org Identifier: ISRCTN13495752.