Smartphone-Enhanced Symptom Management In Psychosis: Open, Randomized Controlled Trial.

BACKGROUND: Improving recovery from acute symptoms and preventing relapse are two significant challenges in severe mental illness. We developed a personalized smartphone-based app to monitor symptoms in real time and validated its acceptance, reliability, and validity. OBJECTIVE: To assess (i) acceptability of continuous monitoring to SMI patients and health professionals over 3 months; (ii) impact of active self-monitoring on positive psychotic symptoms assessed at 6 and 12 weeks; and (iii) the feasibility of detecting early warning signs of relapse. METHODS: The active symptom monitoring smartphone app was built into an end-to-end system in two NHS Trusts to enable real-time symptom self-monitoring and detection by the clinical team of early signs of relapse in people with severe mental illness. We conducted an open randomized controlled trial of active symptom monitoring compared to usual management to assess: (i) acceptability and safety of continuous monitoring over 3 months; (ii) impact of active self-monitoring on positive psychotic symptoms assessed at 6 and 12 weeks; (iii) feasibility of detecting early warning signs of relapse communicated to the healthcare staff via an app streaming data to the electronic health record. Eligible participants with a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of schizophrenia and related disorders, and a history of relapse within the previous two years were enrolled from an early intervention team and a community mental health team. RESULTS: Of 181 eligible patients, 81 (45%) consented and were randomized to either active symptom monitoring or management as usual. At 12 weeks, 90% (33/36) of those in the active monitoring group continued to use the system and exhibited an adherence rate (defined as responding to >33% of alerts) of 84% (30/36}. Active symptom monitoring was associated with no difference on the empowerment scale in comparison to the usual management group at 12 weeks. The pre-planned intent-to-treat analysis of the primary outcome, a positive score on the Positive and Negative Syndrome Scale (PANSS) scale, showed a significant reduction in the active symptom monitoring group over 12 weeks in the early intervention center. Alerts for personalized early warning signs of relapse were built into the workflows of both NHS Trusts, and 100% of health professional staff used the system in a new digital workflow. Qualitative analyses supported the acceptability of the system to participants and staff. CONCLUSIONS: The active smartphone monitoring system is feasible and was accepted by users in a 3-month study of people with severe mental illness, with surprisingly high levels of adherence. App use was associated with psychotic symptom improvement in recent-onset participants, but not those with longstanding illness, supporting the notion of improved self-management. When built into clinical management workflows to enable personalized alerts of symptom deterioration, the app has demonstrated utility in promoting earlier intervention for relapse. TRIAL REGISTRATION: ISRCTN Registry ISRCTN88145142; http://www.isrctn.com/ISRCTN88145142.

Calibration and cross-validation of MCCB and CogState in schizophrenia.

RATIONALE: Cognitive impairment associated with schizophrenia is a key predictor of functional outcomes. The FDA-accepted MATRICS Consensus Cognitive Battery (MCCB) is held to be the gold standard measure but there are concerns about its ease of administration, reliance on language causing problems with translation and possible practice effects. The CogState Schizophrenia Battery (SB) is suggested as a non-language-based alternative but there is no substantial, independent comparison. OBJECTIVES: The objective of this study was to assess the reliability and validity of these two assessment batteries. METHODS: One hundred forty-three participants with DSM-IV schizophrenia and schizoaffective disorder were recruited into three similar studies. Each study administered MCCB and SB tests on consecutive days (baseline 1 and 2) and follow-up 3-4 weeks later. RESULTS: Batteries' test-retest reliability was similar: SB composites correlated r = 0.66-0.78 between baselines, MCCB domains r = 0.69-0.90. Baseline 2 and follow-up SB composites correlated r = 0.65-0.80 and MCCB domains r = 0.62-0.87. MCCB tasks' practice effects (Glass' ∆ = 0.02-0.46) exceeded SB's (Glass' ∆ = 0.02-0.34). While the batteries' total scores correlated strongly (r = 0.79-0.82), apparently equivalent cognitive domains on each battery (e.g. psychomotor-attention) correlated r = 0.22-0.60, indicating substantial differences between some supposed counterparts. CONCLUSIONS: Clinical trials using either battery would benefit from initial practice sessions to ameliorate practice effects but the SB may be more suitable to measure change in the absence of repeated baselines. The MCCB domains' better correlations with social skills performance suggest that it may have an advantage for measuring cognition in relation to functional outcome.

Mobile early detection and connected intervention to coproduce better care in severe mental illness.

Current approaches to the management of severe mental illness have four major limitations: 1) symptom reporting is intermittent and subject to problems with reliability; 2) service users report feelings of disengagement from their care planning; 3) late detection of symptoms delay interventions and increase the risk of relapse; and 4) care systems are held back by the costs of unscheduled hospital admissions that could have been avoided with earlier detection and intervention. The ClinTouch system was developed to close the loop between service users and health professionals. ClinTouch is an end-to-end secure platform, providing a validated mobile assessment technology, a web interface to view symptom data and a clinical algorithm to detect risk of relapse. ClinTouch integrates high-resolution, continuous longitudinal symptom data into mental health care services and presents it in a form that is easy to use for targeting care where it is needed. The architecture and methodology can be easily extended to other clinical domains, where the paradigm of targeted clinical interventions, triggered by the early detection of decline, can improve health outcomes.

Modafinil combined with cognitive training: pharmacological augmentation of cognitive training in schizophrenia.

Several efforts to develop pharmacological treatments with a beneficial effect on cognition in schizophrenia are underway, while cognitive remediation has shown modest effects on cognitive performance. Our goal was to test if pharmacological augmentation of cognitive training would result in enhancement of training-induced learning. We chose modafinil as the pharmacological augmenting agent, as it is known to have beneficial effects on learning and cognition. 49 participants with chronic schizophrenia were enroled in a double-blind, placebo-controlled study across two sites and were randomised to either modafinil (200mg/day) or placebo. All participants engaged in a cognitive training program for 10 consecutive weekdays. The primary outcome measure was the performance on the trained tasks and secondary outcome measures included MATRICS cognitive battery, proxy measures of everyday functioning and symptom measures. 84% of the participants completed all study visits. Both groups showed significant improvement in the performance of the trained tasks suggesting potential for further learning. Modafinil did not induce differential enhancement on the performance of the trained tasks or any differential enhancement of the neuropsychological and functional measures compared to placebo. Modafinil showed no significant effects on symptom severity. Our study demonstrated that combining pharmacological compounds with cognitive training is acceptable to patients and can be implemented in large double-blind randomised controlled trials. The lack of differential enhancement of training-induced learning raises questions, such as choice and optimal dose of drug, cognitive domains to be trained, type of cognitive training, intervention duration and chronicity of illness that require systematic investigation in future studies.

Poor savouring and low self-efficacy are predictors of anhedonia in patients with schizophrenia spectrum disorders.

Previous research suggests that negative schizotypes may be impaired in their ability to savour pleasant events (Applegate et al., 2009) and that schizophrenia patients believe that everyday tasks are excessively difficult to complete so that they attempt these tasks less frequently (MacCarthy et al., 1986; Bentall et al., 2010). It is possible that these beliefs and behaviours underpin negative symptoms such as anhedonia, avolition, apathy and associality. In the present study, 50 schizophrenia patients and 100 matched controls (half employed and half unemployed) completed self-report measures of self-efficacy and savouring. Patients reported savouring past, present and future events less than employed and unemployed groups, irrespective of mood state and I.Q. Patients also rated everyday tasks as more difficult to master. Inpatients compared to outpatients rated tasks more difficult but less important although they did not differ on the savouring measure. Abnormal judgements of difficulty and the reduced propensity to mentally rehearse past or future positive experiences to up-regulate mood could explain negative symptom patients' lack of engagement in everyday activities and eventual social withdrawal. These findings suggest the need to develop cognitive-behavioural savouring and self-efficacy interventions for patients experiencing the negative symptoms of schizophrenia.

Risk factors associated with repetition of self-harm in black and minority ethnic (BME) groups: a multi-centre cohort study.

BACKGROUND: Little information is available to inform clinical assessments on risk of self-harm repetition in ethnic minority groups. METHODS: In a prospective cohort study, using data collected from six hospitals in England for self-harm presentations occurring between 2000 and 2007, we investigated risk factors for repeat self-harm in South Asian and Black people in comparison to Whites. RESULTS: During the study period, 751 South Asian, 468 Black and 15,705 White people presented with self-harm in the study centres. Repeat self-harm occurred in 4379 individuals, which included 229 suicides (with eight of these fatalities being in the ethnic minority groups). The risk ratios for repetition in the South Asian and Black groups compared to the White group were 0.6, 95% CI 0.5-0.7 and 0.7, 95% CI 0.5-0.8, respectively. Risk factors for repetition were similar across all three groups, although excess risk versus Whites was seen in Black people presenting with mental health symptoms, and South Asian people reporting alcohol use and not having a partner. Additional modelling of repeat self-harm count data showed that alcohol misuse was especially strongly linked with multiple repetitions in both BME groups. LIMITATIONS: Ethnicity was not recorded in a third of cases which may introduce selection bias. Differences may exist due to cultural diversity within the broad ethnic groups. CONCLUSION: Known social and psychological features that infer risk were present in South Asian and Black people who repeated self-harm. Clinical assessment in these ethnic groups should ensure recognition and treatment of mental illness and alcohol misuse.