Effects of SlowMo, a blended digital therapy targeting reasoning, on paranoia among people with psychosis: a randomized clinical trial

Importance Persistent paranoia is common among patients with psychosis. Cognitive-behavioral therapy for psychosis can be effective. However, challenges in engagement and effectiveness remain. Objective To investigate the effects on paranoia and mechanisms of action of SlowMo, a digitally supported reasoning intervention, plus usual care compared with usual care only. Design, Setting, and Participants This parallel-arm, assessor-blinded, randomized clinical trial recruited participants at UK community health services from May 1, 2017, to May 14, 2019. Eligible participants consisted of a referral sample with schizophrenia-spectrum psychosis and distressing, persistent (≥3 months) paranoia. Interventions Individuals were randomized 1:1 to SlowMo, consisting of 8 digitally supported face-to-face sessions and a mobile app, plus usual care (n = 181) and usual care only (n = 181). Main Outcomes and Measures The primary outcome was paranoia, measured by the Green et al Paranoid Thoughts Scale (GPTS) total score at 24 weeks. Secondary outcomes included GPTS total score at 12 weeks and GPTS Part A (reference) and Part B (persecutory) scores, the Psychotic Symptom Rating Scales (PSYRATS Delusion subscale), reasoning (belief flexibility, possibility of being mistaken [Maudsley Assessment of Delusions, rated 0%-100%]), and jumping to conclusions (Beads Task). Results A total of 361 participants were included in intention-to-treat analysis, of whom 252 (69.8%) were male and 249 (69.0%) were White; the mean (SD) age was 42.6 (11.6) years. At 24 weeks, 332 participants (92.0%) provided primary outcome data. Of 181 participants in the SlowMo group, 145 (80.1%) completed therapy. SlowMo plus usual care was not associated with greater reductions than usual care in GPTS total score at 24 weeks (Cohen d, 0.20; 95% CI, −0.02 to 0.40; P = .06). There were significant effects on secondary paranoia outcomes at 12 weeks, including GPTS total score (Cohen d, 0.30; 95% CI, 0.09-0.51; P = .005), Part A score (Cohen d, 0.22; 95% CI, 0.06-0.39; P = .009), and Part B score (Cohen d, 0.32; 95% CI, 0.08-0.56; P = .009), and at 24 weeks, including Part B score (Cohen d, 0.25; 95% CI, 0.01-0.49; P = .04) but not Part A score (Cohen d, 0.12; 95% CI, −0.05 to 0.28; P = .18). Improvements were observed in an observer-rated measure of persecutory delusions (PSYRATS delusion) at 12 weeks (Cohen d, 0.47; 95% CI, 0.17-0.78; P = .002) and 24 weeks (Cohen d, 0.50; 95% CI, 0.20-0.80; P = .001) and belief flexibility at 12 weeks (Cohen d, 0.29; 95% CI, 0.09-0.49; P = .004) and 24 weeks (Cohen d, 0.28; 95% CI, 0.08-0.49; P = .005). There were no significant effects on jumping to conclusions. Improved belief flexibility and worry mediated paranoia change (range mediated, 36%-56%). Conclusions and Relevance SlowMo did not demonstrate significant improvements in the primary measure of paranoia at 24 weeks; however, a beneficial effect of SlowMo on paranoia was indicated by the results on the primary measure at an earlier point and on observer-rated paranoia and self-reported persecution at 12 and 24 weeks. Further work to optimize SlowMo’s effects is warranted

The impact of patient and public involvement in the SlowMo study: reflections on peer innovation

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

SlowMo, a digital therapy targeting reasoning in paranoia, versus treatment as usual in the treatment of people who fear harm from others: study protocol for a randomised controlled trial

Background: Paranoia is one of the most common symptoms of schizophrenia-spectrum disorders, and is associated with significant distress and disruption to the person’s life. Developing more effective and accessible psychological interventions for paranoia is a clinical priority. Our research team has approached this challenge in two main ways: firstly, by adopting an interventionist causal approach to increase effectiveness and secondly, by incorporating user-centred inclusive design methods to enhance accessibility and usability. Our resultant new digital intervention, SlowMo, intensively targets a reasoning style associated with paranoia, fast thinking, characterised by jumping to conclusions and belief inflexibility. It consists of an easy-to-use, enjoyable and memorable digital interface. An interactive web-based app facilitates delivery of face-to-face meetings which is then synchronised with an innovative mobile app for use in daily life. Methods/Design: We aim to test the clinical efficacy of SlowMo over 24 weeks to determine the mechanisms through which it reduces paranoia, and to identify participant characteristics that moderate its effectiveness. In a parallel-group randomised controlled trial, with 1:1 allocation, 360 participants with distressing persecutory beliefs will be independently randomised to receive either the SlowMo intervention added to treatment as usual (TAU) or TAU, using randomly varying permuted blocks, stratified by paranoia severity and site. Research workers will be blind to therapy allocation. The primary outcome is paranoia severity over 24 weeks; our hypothesised mechanism of change is reasoning; moderators include negative symptoms and working memory; and secondary outcomes include wellbeing, quality of life, and service use. The accessibility, usability and acceptability of the digital platform will be assessed. Discussion: SlowMo has been developed as the first blended digital therapy to target fears of harm from others through an inclusive design approach. In addition to testing its efficacy, this trial will add to our understanding of psychological mechanisms in paranoia. The study will examine the usability and adherence of a novel digital therapy, including an app for self-management, in a large sample of people affected by severe mental health difficulties

Broadening the concept of trauma : An exploration of Stockholm syndrome as a trauma response to childhood sexual abuse, and the adaptation of trauma-based skills in therapy

EThOS - Electronic Theses Online ServiceGBUnited Kingdo

SlowMo therapy, a new digital blended therapy for fear of harm from others: An account of therapy personalisation within a targeted intervention

OBJECTIVES: SlowMo therapy is a pioneering blended digital therapy for paranoia, augmenting face‐to‐face therapy with an interactive ‘webapp’ and a mobile app. A recent large‐scale trial demonstrated small–moderate effects on paranoia alongside improvements in self‐esteem, worry, well‐being and quality of life. This paper provides a comprehensive account of therapy personalisation within this targeted approach. DESIGN: Case examples illustrate therapy delivery and descriptive data are presented on personalised thought content. METHOD: Thought content was extracted from the webapp (n = 140 participants) and coded using newly devised categories: Worries: (1) Persecutory, (2) Negative social evaluation, (3) Negative self‐concept, (4) Loss/life stresses, (5) Sensory‐perceptual experiences and (6) Health anxieties. Safer thoughts: (1) Safer alternative (specific alternatives to worries), (2) Second‐wave (generalised) coping, (3) Positive self‐concept, (4) Positive activities and (5) Third‐wave (mindfulness‐based) coping. Data on therapy fidelity are also presented. RESULTS: Worries: ‘Persecutory’ (92.9% of people) and ‘Negative social evaluation’ (74.3%) were most common. ‘General worries/ life stresses’ (31.4%) and ‘Negative self‐concept’ (22.1%) were present in a significant minority; ‘Health anxieties’ (10%) and ‘Sensory‐perceptual’ (10%) were less common. Safer thoughts: ‘Second‐wave (general) coping’ (85%), ‘Safer alternatives’ (76.4%), ‘Positive self‐concept’ (65.7%) and ‘Positive activities’ (64.3%) were common with ‘Third‐wave’ (mindfulness) coping observed for 30%. Fidelity: Only three therapy withdrawals were therapy related. Session adherence was excellent (mean = 15.2/16; SD = 0.9). Behavioural work was conducted with 71% of people (119/168). CONCLUSION: SlowMo therapy delivers a targeted yet personalised approach. Potential mechanisms of action extend beyond reasoning. Implications for cognitive models of paranoia and causal interventionist approaches are discussed

The service user experience of SlowMo therapy:A co-produced thematic analysis of service users' subjective experience

Objectives SlowMo is the first blended digital therapy for paranoia, showing significant small-moderate reductions in paranoia in a recent large-scale randomized controlled trial (RCT). This study explored the subjective service-user experience of the SlowMo therapy content and design; the experience of the blended therapy approach, including the triangle of the therapeutic alliance; and the experience of the digital aspects of the intervention. Design Qualitative co-produced sub-study of an RCT. Methods Participants were 22 adult service users with schizophrenia-spectrum psychosis and persistent distressing paranoia, who completed at least one SlowMo therapy session and a 24-week follow-up, at one of 3 sites in Oxford, London, and Sussex, UK. They were interviewed by peer researchers, using a topic guide co-produced by the Patient and Public Involvement (PPI) team. The transcribed data were analysed thematically. Multiple coding and triangulation, and lay peer researcher validation were used to reach a consensus on the final theme structure. Results Six core themes were identified: (i) starting the SlowMo journey; (ii) the central role of the supportive therapist; (iii) slowing things down; (iv) value and learning from social connections; (v) approaches and challenges of technology; and (vi) improvements in paranoia and well-being. Conclusions For these service users, slowing down for a moment was helpful, and integrated into thinking over time. Learning from social connections reflected reduced isolation, and enhanced learning through videos, vignettes, and peers. The central role of the supportive therapist and the triangle of alliance between service user, therapist, and digital platform were effective in promoting positive therapeutic outcomes

Additional file 1: of SlowMo, a digital therapy targeting reasoning in paranoia, versus treatment as usual in the treatment of people who fear harm from others: study protocol for a randomised controlled trial

SPIRIT 2013 Checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 122 kb