Using EMPOWER in daily life: a qualitative investigation of implementation experiences.

BACKGROUND: Digital self-management tools blended with clinical triage and peer support have the potential to improve access to early warning signs (EWS) based relapse prevention in schizophrenia care. However, the implementation of digital interventions in psychosis can be poor. Traditionally, research focused on understanding how people implement interventions has focused on the perspectives of mental health staff. Digital interventions are becoming more commonly used by patients within the context of daily life, which means there is a need to understand implementation from the perspectives of patients and carers. METHODS: Semi-structured one-on-one interviews with 16 patients who had access to the EMPOWER digital self-management intervention during their participation in a feasibility trial, six mental health staff members who supported the patients and were enrolled in the trial, and one carer participant. Interviews focused on understanding implementation, including barriers and facilitators. Data were coded using thematic analysis. RESULTS: The intervention was well implemented, and EMPOWER was typically perceived positively by patients, mental health staff and the carer we spoke to. However, some patients reported negative views and reported ideas for intervention improvement. Patients reported valuing that the app afforded them access to things like information or increased social contact from peer support workers that went above and beyond that offered in routine care. Patients seemed motivated to continue implementing EMPOWER in daily life when they perceived it was creating positive change to their wellbeing, but seemed less motivated if this did not occur. Mental health staff and carer views suggest they developed increased confidence patients could self-manage and valued using the fact that people they support were using the EMPOWER intervention to open up conversations about self-management and wellbeing. CONCLUSIONS: The findings from this study suggest peer worker supported digital self-management like EMPOWER has the potential to be implemented. Further evaluations of these interventions are warranted, and conducting qualitative research on the feasibility gives insight into implementation barriers and facilitators, improving the likelihood of interventions being usable. In particular, the views of patients who demonstrated low usage levels would be valuable.

Can acceptance and commitment therapy facilitate psychological adjustment after a severe traumatic brain injury? A pilot randomized controlled trial.

This study i⁠nvestigated if an Acceptance and Commitment Therapy (ACT) intervention (ACT-Adjust) can facilitate psychological adjustment and reduce psychological distress following severe traumatic brain injury (TBI). The study design comprised a single centre, two-armed, Phase II pilot randomized controlled trial. Nineteen individuals with severe TBI (PTA ≥7 days) who met a clinical threshold for psychological distress (Depression Anxiety Stress Scales-21; DASS > 9) were randomly allocated to either ACT-Adjust (n = 10) or an active control, Befriending Therapy (n = 9), in conjunction with a holistic rehabilitation programme. Primary (psychological flexibility, rehabilitation participation) and secondary (depression, anxiety & stress) outcomes were measured at three-time points (pre, post and follow up). Significant decreases were found for DASS-depression (group by time interaction, F 1,17 = 5.35, p = .03) and DASS-stress (group by time interaction, F 1,17 = 5.69, p = .03) in comparison to the Befriending group, but not for the primary outcome measures. The reduction in stress post-treatment was classed as clinically significant, however interaction differences for stress and depression were not maintained at one month follow up. Preliminary investigations indicate potential for ACT in decreasing psychological distress for individuals with a severe TBI with further sessions required to maintain treatment gains. The pilot results suggest further investigation is warranted in a larger scale clinical trial.

Developing a Hypothetical Implementation Framework of Expectations for Monitoring Early Signs of Psychosis Relapse Using a Mobile App: Qualitative Study.

BACKGROUND: Relapse is a common experience for people diagnosed with psychosis, which is associated with increased service costs and profound personal and familial distress. EMPOWER (Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery) is a peer worker-supported digital intervention that aims to enable service users to self-monitor their mental health with the aim of encouraging self-management and the shared use of personal data to promote relapse prevention. Digital interventions have not been widely used in relapse prevention and, therefore, little is currently known about their likely implementation-both within trials and beyond. OBJECTIVE: Seeking the perspectives of all relevant stakeholder groups is recommended in developing theories about implementation because this can reveal important group differences in understandings and assumptions about whether and for whom the intervention is expected to work. However, the majority of intervention implementation research has been retrospective. This study aimed to discover and theoretically frame implementation expectations in advance of testing and synthesize these data into a framework. METHODS: To develop a hypothetical implementation framework, 149 mental health professionals, carers, and people diagnosed with psychosis participated in 25 focus groups in both Australia and the United Kingdom. An interview schedule informed by the normalization process theory was used to explore stakeholders' expectations about the implementation of the EMPOWER intervention. Data were analyzed using thematic analysis and then theoretically framed using the Medical Research Council guidelines for understanding the implementation of complex interventions. RESULTS: All groups expected that EMPOWER could be successfully implemented if the intervention generated data that were meaningful to mental health staff, carers, and service users within their unique roles. However, there were key differences between staff, carers, and service users about what facilitators and barriers that stakeholders believe exist for intervention implementation in both the cluster randomized controlled trial stage and beyond. For example, service user expectations mostly clustered around subjective user experiences, whereas staff and carers spoke more about the impact upon staff interactions with service users. CONCLUSIONS: A hypothetical implementation framework synthesized from stakeholder implementation expectations provides an opportunity to compare actual implementation data gathered during an ongoing clinical trial, giving valuable insights into the accuracy of these stakeholders' previous expectations. This is among the first studies to assess and record implementation expectations for a newly developed digital intervention for psychosis in advance of testing in a clinical trial. TRIAL REGISTRATION: ISRCTN Registry ISRCTN99559262; http://www.isrctn.com/ISRCTN99559262.

A systematic review of recommended modifications of CBT for people with cognitive impairments following brain injury.

Due to diverse cognitive, emotional and interpersonal changes that can follow brain injury, psychological therapies often need to be adapted to suit the complex needs of this population. The aims of the study were to synthesise published recommendations for therapy modifications following brain injury from non-progressive traumatic, vascular, or metabolic causes and to determine how often such modifications have been applied to cognitive behavioural therapy (CBT) for post-injury emotional adjustment problems. A systematic review and narrative synthesis of therapy modifications recommended in review articles and reported in intervention studies was undertaken. Database and manual searches identified 688 unique papers of which eight review articles and 16 intervention studies met inclusion criteria. The review articles were thematically analysed and a checklist of commonly recommended modifications composed. The checklist items clustered under themes of: therapeutic education and formulation; attention; communication; memory; and executive functioning. When this checklist was applied to the intervention studies, memory aids and an emphasis on socialising patients to the CBT model were most frequently reported as adaptations. It was concluded that the inconsistent reporting of psychological therapy adaptations for people with brain injury is a barrier to developing effective and replicable therapies. We present a comprehensive account of potential modifications that should be used to guide future research and practice.

Brief compassion focused imagery for treatment of severe head injury.

OBJECTIVE: To determine whether participants with severe head injury (SHI) allocated to a brief compassion focused imagery (CFI) intervention show greater change in compassion than those exposed to relaxation imagery (RI). METHOD: Participants were exposed to a preparatory video to promote engagement and then randomly allocated to intervention. Pre- and post-preparatory measures were Motivation for Intervention and Fears of Compassion Scales, State-Trait Anxiety Inventory (STAI) and PANAS. Pre- and post-intervention self-report measures were the Empathy Quotient, Self-Compassion Scale, STAI and Relaxation Scale. Heart rate variability (HRV) was monitored throughout. RESULTS: Motivation for therapy increased after the preparatory video (z = 3.44, p = 0.001). Across the intervention, group differences were not found on self-report measures or HRV changes. When CFI and RI groups were pooled, improvement in relaxation (r = .41, p < 0.01) and state anxiety (r = .29, p < 0.05) were found across the intervention; these outcomes were not associated with changes in self-compassion or HRV. CONCLUSION: Brief CFI, a central aspect of compassion focused therapy, did not produce a reliable change in people with SHI. Enhanced motivation for psychological therapy after a brief preparatory video is relevant and underlines the need to understand mechanisms of action rather than the pursuing whole protocol approaches to therapy.

Using the primary process emotional-behavioural system to better meet patient needs in psychotherapy.

In order to increase therapeutic impact by enhancing awareness of clients' nonverbal communications, this article operationalizes the therapeutic alliance as a needs-satisfaction process. The client's competence as a needs seeker and the therapist assisting with the client's expression and satiation of basic social needs are proposed as being key mechanisms of change. Functional model of primary emotions derived from Panksepp's seven primary emotional systems (care seeking, caretaking, lust, fear and anxiety, anger, play, seeking, plus dominance and disgust) is integrated with Functional Analytic Psychotherapy's emphasis on in-session contingent natural reinforcement of clients' target behaviours. By identifying in-the-moment cues of underlying emotional-behavioural functions drawn from a categorization of clients' nonverbal communication can bridge the gap between client private events and therapist observables, in order to maximize therapist attunement and responsiveness to clients, and to increase the effectiveness of clinical interventions.

Cognitive and psychological flexibility after a traumatic brain injury and the implications for treatment in acceptance-based therapies: A conceptual review.

This paper provides a selective review of cognitive and psychological flexibility in the context of treatment for psychological distress after traumatic brain injury, with a focus on acceptance-based therapies. Cognitive flexibility is a component of executive function that is referred to mostly in the context of neuropsychological research and practice. Psychological flexibility, from a clinical psychology perspective, is linked to health and well-being and is an identified treatment outcome for therapies such as acceptance and commitment therapy (ACT). There are a number of overlaps between the constructs. They both manifest in the ability to change behaviour (either a thought or an action) in response to environmental change, with similarities in neural substrate and mental processes. Impairments in both show a strong association with psychopathology. People with a traumatic brain injury (TBI) often suffer impairments in their cognitive flexibility as a result of damage to areas controlling executive processes but have a positive response to therapies that promote psychological flexibility. Overall, psychological flexibility appears a more overarching construct and cognitive flexibility may be a subcomponent of it but not necessarily a pre-requisite. Further research into therapies which claim to improve psychological flexibility, such as ACT, needs to be undertaken in TBI populations in order to clarify its utility in this group.

Design and protocol for the Focusing on Clozapine Unresponsive Symptoms (FOCUS) trial: a randomised controlled trial.

BACKGROUND: For around a third of people with a diagnosis of schizophrenia, the condition proves to respond poorly to treatment with many typical and atypical antipsychotics. This is commonly referred to as treatment-resistant schizophrenia. Clozapine is the only antipsychotic with convincing efficacy for people whose symptoms are considered treatment-resistant to antipsychotic medication. However, 30-40 % of such conditions will have an insufficient response to the drug. Cognitive behavioural therapy has been shown to be an effective treatment for schizophrenia when delivered in combination with antipsychotic medication, with several meta-analyses showing robust support for this approach. However, the evidence for the effectiveness of cognitive behavioural therapy for people with a schizophrenia diagnosis whose symptoms are treatment-resistant to antipsychotic medication is limited. There is a clinical and economic need to evaluate treatments to improve outcomes for people with such conditions. METHODS/DESIGN: A parallel group, prospective randomised, open, blinded evaluation of outcomes design will be used to compare a standardised cognitive behavioural therapy intervention added to treatment as usual versus treatment as usual alone (the comparator group) for individuals with a diagnosis of schizophrenia for whom an adequate trial of clozapine has either not been possible due to tolerability problems or was not associated with a sufficient therapeutic response. The trial will be conducted across five sites in the United Kingdom. DISCUSSION: The recruitment target of 485 was achieved, with a final recruitment total of 487. This trial is the largest definitive, pragmatic clinical and cost-effectiveness trial of cognitive behavioural therapy for people with schizophrenia whose symptoms have failed to show an adequate response to clozapine treatment. Using a prognostic risk model, baseline information will be used to explore whether there are identifiable subgroups for which the treatment effect is greatest. TRIAL REGISTRATION: Current Controlled Trials ISRCTN99672552 . Registered 29(th) November 2012.

Metacognition in First Episode Psychosis: Item Level Analysis of Associations with Symptoms and Engagement.

Significant metacognitive impairments are observed in first episode psychosis (FEP) and chronic psychosis samples. There is evidence of associations between metacognition and presentation in FEP, but the relative contribution of metacognitive understanding of the self and the other is as yet unclear. The current study is a secondary analysis of date on metacognition, symptoms and engagement with treatment (help-seeking) in an FEP sample. In a cross-sectional cohort study, individuals in the first 12 months of treatment metacognition were assessed with the Metacognition Assessment Scale-Revised version (MAS-R). Psychotic symptomatology and help-seeking within treatment (clinician-rated service engagement) were also measured. An item level analysis of the MAS-R was conducted exploring associations between symptoms and cognitive, emotional, differentiation, integration and decentration aspects of metacognition. We report that associations between negative symptoms and deficits in the understanding of other's mental states extend across cognitive, emotional, integrative and decentration aspects of metacognition. We also report associations between negative symptoms and understanding one's own mind. We also note that cognitive and decentration aspects of metacognition were significantly associated with help-seeking once in treatment. Our findings suggest that an appreciation of metacognitive processes may inform treatment frameworks for FEP. Copyright © 2015 John Wiley & Sons, Ltd. KEY PRACTITIONER MESSAGES: Individual components of metacognition including the capacity to relate cognitive and emotional variables are important in first episode phychosis. Impaired metacognitive understanding of both one's own and others' mental states is associated with increased negative symptoms. Metacognitive variables may be important in understanding how different individuals seek help or engage with services after the initiation of treatment.

Fear of recurrence: results of a randomized trial of relapse detection in schizophrenia.

OBJECTIVE: We aimed to develop and establish the reliability and validity of a measure of Fear of Recurrence, measuring cognitive appraisals of relapse rather than standard early signs of relapse. We also aimed to establish the sensitivity and specificity to relapse. METHOD: Participants diagnosed with schizophrenia or a related disorder were randomized to one of two early signs monitoring conditions, using either the Early Signs Scale or the Fear of Recurrence Scale (FoRSe). Participants were followed up for 6-months or until relapse. RESULTS: A total of 169 participants were randomized to Standard (n = 86) or FoRSe (n = 83) monitoring. We found good evidence supporting reliability and validity of the FoRSe. In addition, a cut-off point of ≥ 5 was associated with an optimal sensitivity in both Standard (n = 26:79%, 95% CI = 62-89) and FoRSe (n = 18:72%, 95% CI = 52-86) monitoring. However, this degree of sensitivity was associated with a lower specificity in Standard (n = 30:35%, 96% CI = 23-50) and FoRSe (n = 25:46%, 95% CI = 32-60). Finally, Fear of Relapse was a significant predictor of time to relapse [Exp(ß) = 1.20, 95% CI = 1.01-1.42, p < .05]. CONCLUSION: The study provides evidence that Fear of Recurrence may be an important clinical construct linked to increased risk of relapse and poorer emotional recovery in people diagnosed with schizophrenia. PRACTITIONER POINTS: Monitoring Fear of Recurrence is as sensitive to relapse detection as monitoring early signs alone. Greater Fear of Relapse was associated with shorter duration to actual relapse. Fear of recurrence may be an important clinical feature linked to poorer emotional recovery and increased risk of relapse. Fear of Recurrence may be an important focus of psychological therapy to promote emotional recovery and prevention of relapse.

Anhedonia in prolonged schizophrenia spectrum patients with relatively lower vs. higher levels of depression disorders: associations with deficits in social cognition and metacognition.

This study has sought to explore whether there are at least two subtypes of anhedonia in schizophrenia: one closely linked with depression and another that occurs in the absence of depression which is related to a general paucity of internal experience. Participants were 163 adults with schizophrenia who completed assessments of depression, anhedonia, executive functioning, positive and negative symptoms, social cognition and metacognition. A cluster analysis based on participants' depression and anhedonia symptom scores produced three groups: High Depression/High Anhedonia (n=52), Low Depression/Low Anhedonia (n=52), and Low Depression/High Anhedonia (n=59). An ANCOVA and post hoc comparisons controlling for positive and negative symptoms found that the Low Depression/High Anhedonia group had poorer metacognition and social cognition than other groups. These findings point to the possibility of a subtype of anhedonia in schizophrenia, one occurring in the relative lesser levels of depression, and tied to deficits in the ability to think about oneself and others.

Metacognition, symptoms and premorbid functioning in a first episode psychosis sample.

Significant metacognitive impairments are observed in chronic psychosis samples but metacognition is less understood in first episode psychosis (FEP). The current study explored correlations between metacognition, symptoms and premorbid functioning in an FEP sample. In a cross-sectional cohort study, individuals in the first 12 months of treatment metacognition were assessed with the Metacognition Assessment Scale-Revised version (MAS-R). Psychotic symptomatology, premorbid adjustment, and clinician rated service engagement were also measured. Lower scores for metacognitive understanding of other's minds were significantly correlated with greater negative symptoms, poorer early adolescent social adjustment and poorer clinician rated help-seeking. Our findings suggest that FEP individuals with difficulties in understanding other's minds have more social deficits and may be less able to make effective use of treatment.

An examination of the potential benefits of expert guided physical activity for supporting recovery from extreme social withdrawal: Two case reports focused on the treatment of Hikikomori.

Extreme and long-term social withdrawal, first described in Japan as Hikikomori, has now become a globally recognized mental health problem. Intervention studies severely lag behind epidemiological and phenomenological research. We present two descriptive case reports of Japanese university students with Hikikomori who participated in an early phase test of a structured intervention involving physical activities that was developed and facilitated by clinicians and physical education specialists-Human Movement Consultation (HMC). The two recipients (19- and 29-years old at the start of treatment) completed approximately 40 consultation sessions delivered over 3 years consisting of a combination of outdoor workouts (i.e., walking, running, and cycling) and interpersonal sports (e.g., table tennis, badminton, and tennis). Changes in social withdrawal behavior were independently rated from clinical health records using a structured scale (the Glasgow Hikikomori Scale; GHS). Behavioral observations and scale data for both cases indicated improvements from pre-treatment levels of social withdrawal. At the end of the intervention, both had returned to normative levels of functioning. Case A returned to university and Case B secured a new job upon the completion of HMC. To help advance our understanding of treatment options, these case descriptions analyze potential change mechanisms in order to understand how HMC can support recovery from extreme social withdrawal. One key observation is that both outdoor workouts and interpersonal sports offer a non-threatening method of enabling Hikikomori to engage in interpersonal interactions. Such connections via structured activities may allow the reinstatement of social skills in a graded manner. In addition, an initial focus on physical experiences may help promote psychological and social connectedness without triggering the social fears and challenges that underlie the Hikikomori state. The findings from these two cases offer a framework to guide further research and the development of exercise-based interventions for this hidden and often neglected group.

Protocol for the development and validation of a patient reported measure (PRM) of treatment burden in stroke.

Background: Treatment burden is the workload of healthcare for people with long-term conditions and the impact on wellbeing. A validated measure of treatment burden after stroke is needed. We aim to adapt a patient-reported measure (PRM) of treatment burden in multimorbidity, PETS (Patient Experience with Treatment and Self-Management version 2.0), to create a stroke-specific measure, PETS-stroke. We aim to examine content validity, construct validity, reliability and feasibility in a stroke survivor population. Methods: 1) Adaptation of 60-item PETS to PETS-stroke using a taxonomy of treatment burden. 2) Content validity testing through cognitive interviews that will explore the importance, relevance and clarity of each item. 3) Evaluation of scale psychometric properties through analysis of data from stroke survivors recruited via postal survey (n=340). Factor structure will be tested with confirmatory factor analysis and Cronbach's alpha will be used to index internal consistency. Construct validity will be tested against: The Stroke Southampton Self-Management Questionnaire; The Satisfaction with Stroke Care Measure; and The Shortened Stroke Impact Scale. We will explore known-groups validity by exploring the association between treatment burden, socioeconomic deprivation and multimorbidity. Test-retest reliability will be examined via re-administration after 2 weeks. Acceptability and feasibility of use will be explored via missing data rates and telephone interviews with 30 participants. Conclusions: We aim to create a validated PRM of treatment burden after stroke. PETS-stroke is designed for use as an outcome measure in clinical trials of stroke treatments and complex interventions to ascertain if treatments are workable for patients in the context of their everyday lives.

The voice characterisation checklist: psychometric properties of a brief clinical assessment of voices as social agents.

Aim: There is growing interest in tailoring psychological interventions for distressing voices and a need for reliable tools to assess phenomenological features which might influence treatment response. This study examines the reliability and internal consistency of the Voice Characterisation Checklist (VoCC), a novel 10-item tool which assesses degree of voice characterisation, identified as relevant to a new wave of relational approaches. Methods: The sample comprised participants experiencing distressing voices, recruited at baseline on the AVATAR2 trial between January 2021 and July 2022 (n = 170). Inter-rater reliability (IRR) and internal consistency analyses (Cronbach's alpha) were conducted. Results: The majority of participants reported some degree of voice personification (94%) with high endorsement of voices as distinct auditory experiences (87%) with basic attributes of gender and age (82%). While most identified a voice intention (75%) and personality (76%), attribution of mental states (35%) to the voice ('What are they thinking?') and a known historical relationship (36%) were less common. The internal consistency of the VoCC was acceptable (10 items, α = 0.71). IRR analysis indicated acceptable to excellent reliability at the item-level for 9/10 items and moderate agreement between raters' global (binary) classification of more vs. less highly characterised voices, κ = 0.549 (95% CI, 0.240-0.859), p < 0.05. Conclusion: The VoCC is a reliable and internally consistent tool for assessing voice characterisation and will be used to test whether voice characterisation moderates treatment outcome to AVATAR therapy. There is potential wider utility within clinical trials of other relational therapies as well as routine clinical practice.

Investigating the relationship between negative symptoms and metacognitive functioning in psychosis: An individual participant data meta-analysis.

PURPOSE: Negative symptoms are a persistent, yet under-explored problem in psychosis. Disturbances in metacognition are a potential causal factor in negative symptom development and maintenance. This meta-analysis uses individual participant data (IPD) from existing research to assess the relationship between negative symptoms and metacognition treated as summed scores and domains. METHODS: Data sets containing individuals with negative symptoms and metacognition data, aged 16+ with psychosis, were identified according to pre-specific parameters. IPD integrity and completeness were checked and data were synthesized in two-stage meta-analyses of each negative symptoms cluster compared with metacognition in seemingly unrelated regression using restricted maximum likelihood estimation. Planned and exploratory sensitivity analyses were also conducted. RESULTS: Thirty-three eligible data sets were identified with 21 with sufficient similarity and availability to be included in meta-analyses, corresponding to 1301 participants. The strongest relationships observed were between summed scores of negative symptoms and metacognition. Metacognitive domains of self-reflectivity and understanding others' minds, and expressive negative symptoms emerged as significant in some meta-analyses. The uncertainty of several effect estimates increased significantly when controlling for covariates. CONCLUSIONS: This robust meta-analysis highlights the impact of using summed versus domain-specific scores of metacognition and negative symptoms, and relationships are not as clear-cut as once believed. Findings support arguments for further differentiation of negative symptom profiles and continued granular exploration of the relationship between metacognition and negative symptoms.

Investigating the relationship between specific negative symptoms and metacognitive functioning in psychosis: A systematic review.

BACKGROUND: Disrupted metacognition is implicated in development and maintenance of negative symptoms, but more fine-grained analyses would inform precise treatment targeting for individual negative symptoms. AIMS: This systematic review identifies and examines datasets that test whether specific metacognitive capacities distinctly influence negative symptoms. MATERIALS & METHODS: PsycINFO, EMBASE, Medline and Cochrane Library databases plus hand searching of relevant articles, journals and grey literature identified quantitative research investigating negative symptoms and metacognition in adults aged 16+ with psychosis. Authors of included articles were contacted to identify unique datasets and missing information. Data were extracted for a risk of bias assessment using the Quality in Prognostic Studies tool. RESULTS: 85 published reports met criteria and are estimated to reflect 32 distinct datasets and 1623 unique participants. The data indicated uncertainty about the relationship between summed scores of negative symptoms and domains of metacognition, with significant findings indicating correlation coefficients from 0.88 to -0.23. Only eight studies investigated the relationship between metacognition and individual negative symptoms, with mixed findings. Studies were mostly moderate-to-low risk of bias. DISCUSSION: The relationship between negative symptoms and metacognition is rarely the focus of studies reviewed here, and negative symptom scores are often summed. This approach may obscure relationships between metacognitive domains and individual negative symptoms which may be important for understanding how negative symptoms are developed and maintained. CONLCLUSION: Methodological challenges around overlapping participants, variation in aggregation of negative symptom items and types of analyses used, make a strong case for use of Individual Participant Data Meta-Analysis to further elucidate these relationships.

Acceptance and Commitment Therapy for people living with motor neuron disease: an uncontrolled feasibility study.

BACKGROUND: Motor neuron disease (MND) is a fatal, progressive neurodegenerative disease that causes progressive weakening and wasting of limb, bulbar, thoracic and abdominal muscles. Clear evidence-based guidance on how psychological distress should be managed in people living with MND (plwMND) is lacking. Acceptance and Commitment Therapy (ACT) is a form of psychological therapy that may be particularly suitable for this population. However, to the authors' knowledge, no study to date has evaluated ACT for plwMND. Consequently, the primary aim of this uncontrolled feasibility study was to examine the feasibility and acceptability of ACT for improving the psychological health of plwMND. METHODS: PlwMND aged ≥ 18 years were recruited from 10 UK MND Care Centres/Clinics. Participants received up to 8 one-to-one ACT sessions, developed specifically for plwMND, plus usual care. Co-primary feasibility and acceptability outcomes were uptake (≥ 80% of the target sample [N = 28] recruited) and initial engagement with the intervention (≥ 70% completing ≥ 2 sessions). Secondary outcomes included measures of quality of life, anxiety, depression, disease-related functioning, health status and psychological flexibility in plwMND and quality of life and burden in caregivers. Outcomes were assessed at baseline and 6 months. RESULTS: Both a priori indicators of success were met: 29 plwMND (104%) were recruited and 76% (22/29) attended ≥ 2 sessions. Attrition at 6-months was higher than anticipated (8/29, 28%), but only two dropouts were due to lack of acceptability of the intervention. Acceptability was further supported by good satisfaction with therapy and session attendance. Data were possibly suggestive of small improvements in anxiety and psychological quality of life from baseline to 6 months in plwMND, despite a small but expected deterioration in disease-related functioning and health status. CONCLUSIONS: There was good evidence of acceptability and feasibility. Limitations included the lack of a control group and small sample size, which complicate interpretation of findings. A fully powered RCT to evaluate the clinical and cost-effectiveness of ACT for plwMND is underway. TRIAL REGISTRATION: The study was pre-registered with the ISRCTN Registry (ISRCTN12655391).

Splitting Things Apart to Put Them Back Together Again: A Targeted Review and Analysis of Psychological Therapy RCTs Addressing Recovery From Negative Symptoms.

Negative symptoms have attracted growing attention as a psychological treatment target and the past 10 years has seen an expansion of mechanistic studies and clinical trials aimed at improving treatment options for this frequently neglected sub-group of people diagnosed with schizophrenia. The recent publication of several randomized controlled trials of psychological treatments that pre-specified negative symptoms as a primary outcome warrants a carefully targeted review and analysis, not least because these treatments have generally returned disappointing therapeutic benefits. This mini-review dissects these trials and offers an account of why we continue to have significant gaps in our understanding of how to support recovery in people troubled by persistent negative symptoms. Possible explanations for mixed trial results include a failure to separate the negative symptom phenotype into the clinically relevant sub-types that will respond to mechanistically targeted treatments. For example, the distinction between experiential and expressive deficits as separate components of the wider negative symptom construct points to potentially different treatment needs and techniques. The 10 negative symptom-focused RCTs chosen for analysis in this mini-review present over 16 different categories of treatment techniques spanning a range of cognitive, emotional, behavioral, interpersonal, and metacognitive domains of functioning. The argument is made that treatment development will advance more rapidly with the use of more precisely targeted psychological treatments that match interventions to a focused range of negative symptom maintenance processes.

Digital smartphone intervention to recognise and manage early warning signs in schizophrenia to prevent relapse: the EMPOWER feasibility cluster RCT.

BACKGROUND: Relapse is a major determinant of outcome for people with a diagnosis of schizophrenia. Early warning signs frequently precede relapse. A recent Cochrane Review found low-quality evidence to suggest a positive effect of early warning signs interventions on hospitalisation and relapse. OBJECTIVE: How feasible is a study to investigate the clinical effectiveness and cost-effectiveness of a digital intervention to recognise and promptly manage early warning signs of relapse in schizophrenia with the aim of preventing relapse? DESIGN: A multicentre, two-arm, parallel-group cluster randomised controlled trial involving eight community mental health services, with 12-month follow-up. SETTINGS: Glasgow, UK, and Melbourne, Australia. PARTICIPANTS: Service users were aged > 16 years and had a schizophrenia spectrum disorder with evidence of a relapse within the previous 2 years. Carers were eligible for inclusion if they were nominated by an eligible service user. INTERVENTIONS: The Early signs Monitoring to Prevent relapse in psychosis and prOmote Wellbeing, Engagement, and Recovery (EMPOWER) intervention was designed to enable participants to monitor changes in their well-being daily using a mobile phone, blended with peer support. Clinical triage of changes in well-being that were suggestive of early signs of relapse was enabled through an algorithm that triggered a check-in prompt that informed a relapse prevention pathway, if warranted. MAIN OUTCOME MEASURES: The main outcomes were feasibility of the trial and feasibility, acceptability and usability of the intervention, as well as safety and performance. Candidate co-primary outcomes were relapse and fear of relapse. RESULTS: We recruited 86 service users, of whom 73 were randomised (42 to EMPOWER and 31 to treatment as usual). Primary outcome data were collected for 84% of participants at 12 months. Feasibility data for people using the smartphone application (app) suggested that the app was easy to use and had a positive impact on motivations and intentions in relation to mental health. Actual app usage was high, with 91% of users who completed the baseline period meeting our a priori criterion of acceptable engagement (> 33%). The median time to discontinuation of > 33% app usage was 32 weeks (95% confidence interval 14 weeks to ∞). There were 8 out of 33 (24%) relapses in the EMPOWER arm and 13 out of 28 (46%) in the treatment-as-usual arm. Fewer participants in the EMPOWER arm had a relapse (relative risk 0.50, 95% confidence interval 0.26 to 0.98), and time to first relapse (hazard ratio 0.32, 95% confidence interval 0.14 to 0.74) was longer in the EMPOWER arm than in the treatment-as-usual group. At 12 months, EMPOWER participants were less fearful of having a relapse than those in the treatment-as-usual arm (mean difference -4.29, 95% confidence interval -7.29 to -1.28). EMPOWER was more costly and more effective, resulting in an incremental cost-effectiveness ratio of £3041. This incremental cost-effectiveness ratio would be considered cost-effective when using the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year gained. LIMITATIONS: This was a feasibility study and the outcomes detected cannot be taken as evidence of efficacy or effectiveness. CONCLUSIONS: A trial of digital technology to monitor early warning signs that blended with peer support and clinical triage to detect and prevent relapse is feasible. FUTURE WORK: A main trial with a sample size of 500 (assuming 90% power and 20% dropout) would detect a clinically meaningful reduction in relapse (relative risk 0.7) and improvement in other variables (effect sizes 0.3-0.4). TRIAL REGISTRATION: This trial is registered as ISRCTN99559262. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 27. See the NIHR Journals Library website for further project information. Funding in Australia was provided by the National Health and Medical Research Council (APP1095879).

WHAT WAS THE PROBLEM?: Relapse is a considerable problem for people with a diagnosis of schizophrenia. Relapse can be predicted by early warning signs that are unique to the person. They include withdrawal, fear and paranoia. WHAT WAS THE QUESTION?: Is it possible to investigate the effectiveness of an intervention to recognise and promptly manage early warning signs of relapse in schizophrenia with the aim of preventing relapse? WHAT DID WE DO?: We spoke with 88 mental health staff, 40 carers and 21 service users before we designed a system that used a mobile phone to help people monitor early warning signs. We included peer support to help people using the system reflect on their experiences. We hoped the overall system, called EMPOWER, would help people to be more in charge of their mental health. After consenting 86 people to the study, we were able to randomly assign 73 people either to use the EMPOWER system (42 people) or to receive their normal treatment alone (31 people). We used research measures over 1 year to help us better understand people's experiences. We also involved carers (for example family or friends) and mental health service providers in the research. WHAT DID WE FIND?: We found that it was possible to recruit people to the study and to gather research data. We also found that people used the EMPOWER system and found it acceptable. We found that those who used EMPOWER had a lower rate of relapse over 12 months than people who did not. They were also less likely to be fearful of relapse. We found that EMPOWER was likely to be cost-effective. WHAT DOES THIS MEAN?: This means that a study to investigate the effectiveness of a system to recognise and respond to early warning signs of relapse in schizophrenia is possible.