David Fowler

Background: Early Intervention in Psychosis services improves outcomes for young people with psychosis, but 25% disengage in the first 12 months with costs to their mental health. Objectives: To refine a toolkit and training and evaluate effectiveness, implementation, and cost-effectiveness of the Early Youth Engagement-2 intervention to reduce disengagement. Design: Cluster randomised controlled trial with economic and process evaluation. Randomisation: Randomisation at team level stratified by site. Masking: Research assistants, outcome assessors and statisticians were masked to treatment allocation for the primary disengagement and cost-effectiveness outcomes. Participants and teams administering the interventions were unmasked. Setting: Twenty Early Intervention in Psychosis teams in five sites across England. Participants: A total of 1027 young people (14–35 years) with first-episode psychosis (F20–29, 31; ICD-10); 20–282 Early Intervention in Psychosis staff. Intervention: Team-based motivational engagement (Early Youth Engagement-2) intervention, delivered by Early Intervention in Psychosis clinicians alongside standardised Early Intervention in Psychosis, supported by the implementation toolkit (training, website and booklet series). Comparison: Standardised Early Intervention in Psychosis, including National Institute for Health and Care Excellence guidelines approved interventions. Main outcome measures: Primary outcome – time to disengagement over 26 months (days from date of allocation to care co-ordinator to date of last contact following refusal to engage with service, or lack of response to contact for consecutive 3-month period). Secondary outcomes – mental health, recovery, quality of life, service use, at 6 and 12 months. Economic outcomes – National Health Service mental healthcare costs, wider societal care costs, clinical and social outcomes over 12 months; cost-effectiveness. Process evaluation outcomes – fidelity to the Early Youth Engagement-2 model, implementation process scores, therapeutic alliance, qualitative outcomes. Results: Disengagement was 16% across both arms. The multivariable Cox regression on 1005 participants estimated an adjusted hazard ratio for Early Youth Engagement-2 + standardised Early Intervention in Psychosis (n = 652) versus standardised Early Intervention in Psychosis service alone (n = 375) of 1.07 (95% confidence interval 0.76 to 1.49; p = 0.713). There were no observed differences between arms for any secondary outcomes. The health economic evaluation indicated lower mean mental healthcare costs of –£788 (95% CI –£3571 to £1994) and marginally improved mental health states for intervention participants. Early Youth Engagement-2 participants spent 30 more days per year in education and training (95% CI 1.52 to 53.68; probability positive outcome for the intervention: 99%), but these outcomes must be viewed very cautiously as only 22% of the sample provided data. The process evaluation revealed heterogeneous implementation fidelity and constant pressure to adapt to widespread disruption from COVID-19. There was no effect on therapeutic alliance: the most likely active change mechanism was through psychoeducation. Limitations: Lower than expected disengagement, high loss to follow-up and impact of COVID-19 on fidelity, implementation and outcomes. Conclusions: In the primary clinical effectiveness analysis, 95% confidence limits ruled out a reduction of more than 24% in the risk of disengagement with the Early Youth Engagement-2 intervention. In a cost-effectiveness analysis, estimates fell in the direction of dominance of the Early Youth Engagement-2 intervention (reduced costs, marginally better mental health states). Future work: Dissemination of the booklet and website resources and an adapted version of the model as stand-alone tools for use in good-practice routine Early Intervention in Psychosis care. Study registration: This study is registered as ISRCTN 51629746. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 16/31/87) and is published in full in Health and Social Care Delivery Research; Vol. 13, No. 33. See the NIHR Funding and Awards website for further award information.

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.

Aim: Psychosis spectrum disorders continue to rank highly among causes of disability. This has resulted in efforts to expand the range of treatment targets beyond symptom remission to include other recovery markers, including social and occupational function and quality of life. Although the efficacy of psychosocial interventions in early psychosis has been widely reported, the acceptability of these interventions is less well‐known. This study explores the participant perspective on a novel, psychosocial intervention combining cognitive remediation and social recovery therapy. Methods: We employed a qualitative research design, based on semi‐structured interviews and reflexive thematic analysis. Six participants with early psychosis were recruited from the intervention arm of a randomized pilot study, three women and three men, aged between 22 and 27 years. Results: Four themes were developed through the analytical process, namely, (1) a solid therapeutic foundation, (2) multi‐directional flow of knowledge, (3) a tailored toolset, and (4) an individual pathway to recovery. Participants also provided pragmatic feedback about how to improve the delivery of the therapy assessments and intervention. Both the themes and pragmatic feedback are described. Conclusions: People with early psychosis described the intervention as acceptable, engaging, helpful and person‐centred, suggesting its potential role in a multicomponent therapy model of early intervention in psychosis services. Participants in this study also highlight the importance of an individualized approach to therapy, the vital role of the therapeutic relationship and the ecological validity and value of adopting an assertive outreach delivery, providing therapy outside a conventional clinic setting.

Background: Marginalized groups are more likely to experience problems with technology-related access, motivation, and skills. This is known as the “digital divide.” Technology-related exclusion is a potential barrier to the equitable implementation of digital health. SlowMo therapy was developed with an inclusive, human-centered design to optimize accessibility and bridge the “digital divide.” SlowMo is an effective, blended digital psychological therapy for paranoia in psychosis. Objective: This study explores the “digital divide” and mobile app engagement in the SlowMo randomized controlled trial. Methods: Digital literacy was assessed at baseline, and a multidimensional assessment of engagement (ie, adherence [via system analytics and self-report] and self-reported user experience) was conducted at 12 weeks after therapy. Engagement was investigated in relation to demographics (ie, gender, age, ethnicity, and paranoia severity). Results: Digital literacy data demonstrated that technology use and confidence were lower in Black people and older people (n=168). The engagement findings indicated that 80.7% (96/119) of therapy completers met the a priori analytics adherence criteria. However, analytics adherence did not differ by demographics. High rates of user experience were reported overall (overall score: mean 75%, SD 17.1%; n=82). No differences in user experience were found for ethnicity, age, or paranoia severity, although self-reported app use, enjoyment, and usefulness were higher in women than in men. Conclusions: This study identified technology-related inequalities related to age and ethnicity, which did not influence engagement with SlowMo, suggesting that the therapy design bridged the “digital divide.” Intervention design may moderate the influence of individual differences on engagement. We recommend the adoption of inclusive, human-centered design to reduce the impact of the “digital divide” on therapy outcomes. Trial Registration: ISRCTN Registry ISRCTN32448671; https://www.isrctn.com/ISRCTN32448671

Objectives: Little is known about the factors that can maintain the distress related to voice‐hearing experiences in youth. Building upon understandings developed with adults, this study aimed to explore the associations between negative relating between hearer and voices, persecutory beliefs about voices and voice‐related distress in a clinical sample of adolescents. The study also aimed to investigate associations between relating to voices and wider patterns of social relating. Design: This was an observational, cross‐sectional, survey study. Methods: Thirty‐four young people (age 14–18 years) who were hearing voices completed measures about voices (characteristics, relating and beliefs) and relating to social others (negative relating styles, social connectedness and belongingness). Participants were patients of NHS mental health services. Bivariate correlations explored associations between relating to voices and distress, beliefs about voices and distress, and between relating to voices and social relating variables. Results: Perceiving the voices as dominant, intrusive, and persecutory and resisting them was significantly associated with distress. Adjusting for loudness and negative content rendered the association between persecutory beliefs and distress non‐significant. Fear of separation and of being alone in relation to social others was associated with distancing from voices. Being suspicious, uncommunicative and self‐reliant and/or being sadistic and intimidating towards social others was significantly associated with dependence towards the voices. Greater hearer‐to‐voice dependence was associated with lower perceived social belongingness and connectedness. Conclusions: Beliefs about voices being persecutory, dominant, intrusive and resisting voices seem to be significant contributors of distress in young people. In terms of proximity and power, relating to voices and social others appears to be contrasting.

Background: Young people with social disability and non-psychotic severe and complex mental health problems are an important group. Without intervention, their social problems can persist and have large economic and personal costs. Thus, more effective evidence-based interventions are needed. Social recovery therapy is an individual therapy incorporating cognitive–behavioural techniques to increase structured activity as guided by the participant’s goals.Objective: This trial aimed to test whether or not social recovery therapy provided as an adjunct to enhanced standard care over 9 months is superior to enhanced standard care alone. Enhanced standard care aimed to provide an optimal combination of existing evidence-based interventions.Design: A pragmatic, single-blind, superiority randomised controlled trial was conducted in three UK centres: Sussex, Manchester and East Anglia. Participants were aged 16–25 years with persistent social disability, defined as < 30 hours per week of structured activity with social impairment for at least 6 months. Additionally, participants had severe and complex mental health problems, defined as at-risk mental states for psychosis or non-psychotic severe and complex mental health problems indicated by a Global Assessment of Functioning score ≤ 50 persisting for ≥ 6 months. Two hundred and seventy participants were randomised 1 : 1 to either enhanced standard care plus social recovery therapy or enhanced standard care alone. The primary outcome was weekly hours spent in structured activity at 15 months post randomisation. Secondary outcomes included subthreshold psychotic, negative and mood symptoms. Outcomes were collected at 9 and 15 months post randomisation, with maintenance assessed at 24 months.Results: The addition of social recovery therapy did not significantly increase weekly hours in structured activity at 15 months (primary outcome treatment effect –4.44, 95% confidence interval –10.19 to 1.31). We found no evidence of significant differences between conditions in secondary outcomes at 15 months: Social Anxiety Interaction Scale treatment effect –0.45, 95% confidence interval –4.84 to 3.95; Beck Depression Inventory-II treatment effect –0.32, 95% confidence interval –4.06 to 3.42; Comprehensive Assessment of At-Risk Mental States symptom severity 0.29, 95% confidence interval –4.35 to 4.94; or distress treatment effect 4.09, 95% confidence interval –3.52 to 11.70. Greater Comprehensive Assessment of At-Risk Mental States for psychosis scores reflect greater symptom severity. We found no evidence of significant differences at 9 or 24 months. Social recovery therapy was not estimated to be cost-effective. The key limitation was that missingness of data was consistently greater in the enhanced standard care-alone arm (9% primary outcome and 15% secondary outcome missingness of data) than in the social recovery therapy plus enhanced standard care arm (4% primary outcome and 9% secondary outcome missingness of data) at 15 months.Conclusions: We found no evidence for the clinical superiority or cost-effectiveness of social recovery therapy as an adjunct to enhanced standard care. Both arms made large improvements in primary and secondary outcomes. Enhanced standard care included a comprehensive combination of evidence-based pharmacological, psychotherapeutic and psychosocial interventions. Some results favoured enhanced standard care but the majority were not statistically significant. Future work should identify factors associated with the optimal delivery of the combinations of interventions that underpin better outcomes in this often-neglected clinical group.Trial registration: Current Controlled Trials ISRCTN47998710.Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology AssessmentVol. 25, No. 70. See the NIHR Journals Library website for further project information.

Background: The SlowMo study demonstrated the effects of SlowMo, an eight‐session digitally supported reasoning intervention, on paranoia in a large‐scale randomized‐controlled trial with 362 participants with schizophrenia‐spectrum psychosis.Aim: The current evaluation aimed to investigate the impact of Patient and Public Involvement (PPI) in the SlowMo study.Method: PPI members were six women and three men from Sussex, Oxford and London with experience of using mental health services for psychosis. They received training and met at least 3‐monthly throughout the project. The impact of PPI was captured quantitatively and qualitatively through (i) a PPI log of recommendations and implementation; (ii) written subjective experiences of PPI members; (iii) meeting minutes; and (iv) outputs produced.Results: The PPI log revealed 107 recommendations arising from PPI meetings, of which 87 (81%) were implemented. Implementation was greater for recruitment‐, data collection‐ and organization‐related actions than for dissemination and emergent innovations. Qualitative feedback revealed impacts on study recruitment, data collection, PPI participants' confidence, knowledge, career aspirations and society more widely. Outputs produced included a film about psychosis that aired on BBC primetime television, novel webpages and journal articles. Barriers to PPI impact included geography, travel, funding, co‐ordination and well‐being.Discussion: A future challenge for PPI impact will be the extent to which peer innovation (innovative PPI‐led ideas) can be supported within research study delivery.Patient and Public Contribution: Planned Patient and Public Contribution in SlowMo comprised consultation and collaboration in (i) design, (ii) recruitment, (iii) qualitative interviews and analysis of service users' experiences of SlowMo therapy and (iv) dissemination.

Background: Reasoning may play a causal role in paranoid delusions in psychosis. SlowMo, a new digitally supported cognitive–behavioural therapy, targets reasoning to reduce paranoia. Objectives: To examine the effectiveness of SlowMo therapy in reducing paranoia and in improving reasoning, quality of life and well-being, and to examine its mechanisms of action, moderators of effects and acceptability. Design: A parallel-arm, assessor-blind, randomised controlled trial comparing SlowMo plus treatment as usual with treatment as usual alone. An online independent system randomised eligible participants (1 : 1) using randomly varying permuted blocks, stratified by site and paranoia severity. Setting: Community mental health services in three NHS mental health trusts in England, plus patient identification centres. Participants: A total of 362 participants with schizophrenia-spectrum psychosis. Eligibility criteria comprised distressing and persistent (≥ 3 months) paranoia. Interventions: Eight face-to-face SlowMo sessions over 12 weeks plus treatment as usual, or treatment as usual alone (control group). Main outcome measures: The primary outcome measure was paranoia measured by the Green Paranoid Thoughts Scale and its revised version, together with observer-rated measures of persecutory delusions (The Psychotic Symptom Rating Scales delusion scale and delusion items from the Scale for the Assessment of Positive Symptoms). The secondary outcome measures were reasoning (measures of belief flexibility, jumping to conclusions, and fast and slow thinking), well-being, quality of life, schemas, service use and worry. Results: A total of 362 participants were recruited between 1 May 2017 and 14 May 2019: 181 in the SlowMo intervention group and 181 in the treatment-as-usual (control) group. One control participant subsequently withdrew. In total, 325 (90%) participants provided primary Green Paranoid Thoughts Scale outcome data at 12 weeks (SlowMo, n = 162; treatment as usual, n = 163). A total of 145 (80%) participants in the SlowMo group completed all eight therapy sessions. SlowMo was superior to treatment as usual in reducing paranoia on all three measures used: Green Paranoid Thoughts Scale total at 12 weeks (Cohen’s d = 0.30, 95% confidence interval 0.09 to 0.51; p = 0.005) and 24 weeks (Cohen’s d = 0.20, 95% confidence interval –0.02 to 0.40; p = 0.063); Psychotic Symptom Rating Scales delusions at 12 weeks (Cohen’s d = 0.47, 95% confidence interval 0.17 to 0.78; p = 0.002) and 24 weeks (Cohen’s d = 0.50, 95% confidence interval 0.20 to 0.80; p = 0.001); and Scale for the Assessment of Positive Symptoms persecutory delusions at 12 weeks (Cohen’s d = 0.43, 95% confidence interval 0.03 to 0.84; p = 0.035) and 24 weeks (Cohen’s d = 0.54, 95% confidence interval 0.14 to 0.94; p = 0.009). Reasoning (belief flexibility, possibility of being mistaken and Fast and Slow Thinking Questionnaire measure) improved, but jumping to conclusions did not improve. Worry, quality of life, well-being and self-concept also improved, improving most strongly at 24 weeks. Baseline characteristics did not moderate treatment effects. Changes in belief flexibility and worry mediated changes in paranoia. Peer researcher-led qualitative interviews confirmed positive experiences of the therapy and technology. Nineteen participants in the SlowMo group and 21 participants in the treatment-as-usual group reported 54 adverse events (51 serious events, no deaths). Limitations: The trial included treatment as usual as the comparator and, thus, the trial design did not control for the effects of time with a therapist. Conclusions: To the best of our knowledge, this is the largest trial of a psychological therapy for paranoia in people with psychosis and the first trial using a brief targeted digitally supported therapy. High rates of therapy uptake demonstrated acceptability. It was effective for paranoia, comparable to longer therapy, and equally effective for people with different levels of negative symptoms and working memory. Mediators were improvements in belief flexibility and worry. Our results suggest that targeting reasoning helps paranoia. Future work: Further examination of SlowMo mechanisms of action and implementation. Trial registration: Current Controlled Trials ISRCTN32448671. Funding: This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and National Institute for Health Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 8, No. 11. See the NIHR Journals Library website for further project information.

BACKGROUND Marginalized groups are more likely to experience problems with technology-related access, motivation, and skills. This is known as the “digital divide.” Technology-related exclusion is a potential barrier to the equitable implementation of digital health. SlowMo therapy was developed with an inclusive, human-centered design to optimize accessibility and bridge the “digital divide.” SlowMo is an effective, blended digital psychological therapy for paranoia in psychosis. OBJECTIVE This study explores the “digital divide” and mobile app engagement in the SlowMo randomized controlled trial. METHODS Digital literacy was assessed at baseline, and a multidimensional assessment of engagement (ie, adherence [via system analytics and self-report] and self-reported user experience) was conducted at 12 weeks after therapy. Engagement was investigated in relation to demographics (ie, gender, age, ethnicity, and paranoia severity). RESULTS Digital literacy data demonstrated that technology use and confidence were lower in Black people and older people (n=168). The engagement findings indicated that 80.7% (96/119) of therapy completers met the a priori analytics adherence criteria. However, analytics adherence did not differ by demographics. High rates of user experience were reported overall (overall score: mean 75%, SD 17.1%; n=82). No differences in user experience were found for ethnicity, age, or paranoia severity, although self-reported app use, enjoyment, and usefulness were higher in women than in men. CONCLUSIONS This study identified technology-related inequalities related to age and ethnicity, which did not influence engagement with SlowMo, suggesting that the therapy design bridged the “digital divide.” Intervention design may moderate the influence of individual differences on engagement. We recommend the adoption of inclusive, human-centered design to reduce the impact of the “digital divide” on therapy outcomes. CLINICALTRIAL ISRCTN Registry ISRCTN32448671; https://www.isrctn.com/ISRCTN32448671