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Background: Increasing interest has centered on the psychotherapeutic working alliance as a means of understanding clinical change in digital mental health interventions in recent years. However, little is understood about how and to what extent a digital mental health program can have an impact on the working alliance and clinical outcomes in a blended (therapist plus digital program) cognitive behavioral therapy (bCBT) intervention for depression. Objective: This study aimed to test the difference in working alliance scores between bCBT and treatment as usual (TAU), examine the association between working alliance and depression severity scores in both arms, and test for an interaction between system usability and working alliance with regard to the association between working alliance and depression scores in bCBT at 3 -month assessments. Methods: We conducted a secondary data analysis of the E -COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment versus Treatment -as -usual) trial, which compared bCBT with TAU across 9 European countries. Data were collected in primary care and specialized services between April 2015 and December 2017. Eligible participants aged 18 years or older and diagnosed with major depressive disorder were randomized to either bCBT (n=476) or TAU (n=467). bCBT consisted of 6-20 sessions of bCBT (involving face-to-face sessions with a therapist and an internet-based program). TAU consisted of usual care for depression. The main outcomes were scores of the working alliance (Working Alliance Inventory -Short Revised-Client [WAI-SR-C]) and depressive symptoms (Patient Health Questionnaire -9 [PHQ-9]) at 3 months after randomization. Other variables included system usability scores (System Usability Scale -Client [SUS -C]) at 3 months and baseline demographic information. Data from baseline and 3 -month assessments were analyzed using linear regression models that adjusted for a set of baseline variables. Result

BackgroundAlthough major depressive disorder (MDD) is characterized by a pervasive negative mood, research indicates that the mood of depressed patients is rarely entirely stagnant. It is often dynamic, distinguished by highs and lows, and it is highly responsive to external and internal regulatory processes. Mood dynamics can be defined as a combination of mood variability (the magnitude of the mood changes) and emotional inertia (the speed of mood shifts). The purpose of this study is to explore various distinctive profiles in real-time monitored mood dynamics among MDD patients in routine mental healthcare. MethodsEcological momentary assessment (EMA) data were collected as part of the cross-European E-COMPARED trial, in which approximately half of the patients were randomly assigned to receive the blended Cognitive Behavioral Therapy (bCBT). In this study a subsample of the bCBT group was included (n = 287). As part of bCBT, patients were prompted to rate their current mood (on a 1-10 scale) using a smartphone-based EMA application. During the first week of treatment, the patients were prompted to rate their mood on three separate occasions during the day. Latent profile analyses were subsequently applied to identify distinct profiles based on average mood, mood variability, and emotional inertia across the monitoring period. ResultsOverall, four profiles were identified, which we labeled as: (1) "very negative and least variable mood" (n = 14) (2) "negative and moderate variable mood" (n = 204), (3) "positive and moderate variable mood" (n = 41), and (4) "negative and highest variable mood" (n = 28). The degree of emotional inertia was virtually identical across the profiles. ConclusionsThe real-time monitoring conducted in the present study provides some preliminary indications of different patterns of both average mood and mood variability among MDD patients in treatment in mental health settings. Such varying patterns were not found for emotional inertia., Funding Agencies|European CommissionEuropean CommissionEuropean Commission Joint Research Centre [603098-2]

Background: Internet- and mobile-based mental health interventions have the potential to narrow the treatment gap in ethnic groups. Little evidence exists on the cultural adaptation of such interventions. Cultural adaptation of evidence-based interventions distinguishes between surface and deep structure adaptation. Surface refers to matching materials (e.g., illustrations, language) or methods of treatment delivery to the target population, whereas deep structure adaptation considers cultural concepts of distress (CCD). So far, CCD have only been considered to a limited extent in cultural adaptation of psychological interventions, and there is a lack of well documented adaptation procedures. Aims: With a cross-disciplinary and mixed-method approach, following a new conceptual framework for cultural adaptation of scalable psychological interventions, this study aimed to develop both surface and deep structure adaptations of an internet- and mobile-based intervention called Hap-pas-Hapi for the treatment of psychological distress among Albanian migrants in Switzerland and Germany. Methods: A qualitative ethnopsychological study was conducted to examine the target group's CCD. Focus group discussions, an online survey, and individual key informant interviews were utilised to evaluate the original intervention, adaptation drafts and the final adapted intervention. A reporting system was developed to support the decision-making process and to report all adaptations in a transparent and replicable way. Results: The ongoing involvement of target population key informants provided valuable feedback for the development of a more person-centred intervention, which might enhance treatment acceptance, motivation and adherence. Discussion: This study provides empirical and theory-based considerations and suggestions for future implementation that may foster acceptability and effectiveness of culturally adapted evidence-based interventions.

Objective Although available evidence is modest, exercise could be beneficial in reducing behavioural and psychological symptoms of dementia. We aim to evaluate the cost-effectiveness of a dyadic exercise regimen for individuals with dementia and their main carer as therapy for behavioural and psychological symptoms of dementia. Methods Cost-effectiveness analysis within a two-arm, pragmatic, randomised, controlled, single-blind, parallel-group trial of a dyadic exercise regimen (individually tailored, for 20–30?min at least five times per week). The study randomised 131 community-dwelling individuals with dementia and clinically significant behavioural and psychological symptoms with a carer willing and able to participate in the exercise regimen; 52 dyads provided sufficient cost data for analyses. Results Mean intervention cost was £284 per dyad. For the subsample of 52 dyads, the intervention group had significantly higher mean cost from a societal perspective (mean difference £2728.60, p?=?0.05), but costs were not significantly different from a health and social care perspective. The exercise intervention was more cost-effective than treatment as usual from both societal and health and social care perspectives for the measure of behavioural and psychological symptoms (Neuropsychiatric Inventory). It does not appear cost-effective in terms of cost per quality-adjusted life year gain. Conclusions The exercise intervention has the potential to be seen as cost-effective when considering behavioural and psychological symptoms but did not appear cost-effective when considering quality-adjusted life year gains.

Objective The objective of this study is to evaluate the effectiveness of a simple dyadic (person with dementia and their main carer) exercise regimen as a therapy for the behavioural and psychological symptoms of dementia. Method A two arm, pragmatic, randomised, controlled, single-blind, parallel-group trial of a dyadic exercise regimen (individually tailored walking regimen designed to become progressively intensive and last between 20–30?min, at least five times per week).Community-dwelling individuals with ICD-10 confirmed dementia with the following: clinically significant behavioural and psychological symptoms, a carer willing and able to co-participate in the exercise regimen, and no physical conditions or symptoms that would preclude exercise participation were invited by mental health or primary care services into the study. Results One hundred and thirty-one dyads were recruited to this study. There was no significant difference in Behavioural and Psychological Symptoms as measured by the Neuropsychiatric Inventory at week 12 between the group receiving the dyadic exercise regimen and those that did not (adjusted difference in means (intervention minus control)?=??1.53, p?=?0.6, 95% CI [?7.37, 4.32]). There was a significant between-group difference in caregiver's burden as measured by the Zarit Caregiver Burden Inventory at week 12 (OR?=?0.18, p?=?0.01, CI [0.05, 0.69]) favouring the exercise group. Conclusions This study found that regular simple exercise does not appear to improve the behavioural and psychological symptoms of dementia, but did seem to attenuate caregiver burden. Further study to improve exercise uptake are needed.

The objective of the EVIDEM-EXERCISE study was to evaluatethe effectiveness of an exercise regime as a therapy for the behaviouraland psychological symptoms of dementia (BPSD). A pragmatic, ran-domized, controlled, single-blind, parallel-group trial of a dyadic exer-cise regime (tailored walking) for community-dwelling individuals withBPSD and their carers was undertaken. The primary outcome wasBehavioural and Psychological Symptoms as measured by the Neuro-Psychiatric Inventory at week 12. Results show no significant differ-ence of NPI score at week 12 between the group receiving the dyadicexercise regime and those that did not. Secondary outcome measure ofcaregiver’s burden was significantly improved; caregiver burden dou-bled by week 12 for the control group participants, but decreased forthose receiving the exercise intervention. In conclusion, this study foundthat regular simple exercise does not improve BPSD but did seem toattenuate changes of caregiver burden.

Background: Behavioral and psychological symptoms of dementia (BPSD) are common and are core symptoms of the condition. They cause considerable distress to the person with dementia and their carers and predict early institutionalization and death. Historically, these symptoms have been managed with anxiolytic and antipsychotic medication. Although potentially effective, such medication has been used too widely and is associated with serious adverse side-effects and increased mortality. Consequently, there is a need to evaluate non-pharmacological therapies for behavioral and psychological symptoms in this population. One such therapy is physical activity, which has widespread health benefits. The aim of this review is to summarize the current findings of the efficacy of physical activity on BPSD.

‘Evidenced based interventions in dementia’ (EVIDEM: www.EVIDEM.org.uk) is a 5-year research & development programme aiming to explore, evaluate and improve the quality of community based dementia care (Iliffe et al., 2008). The EVIDEM programme, like most clinical trials, relies on clinicians to recruit participants. Key NHS Stakeholders support was strong for EVIDEM and so we anticipated straightforward recruitment. However, this has not been the case; from a population exceeding 2000 people with dementia, one EVIDEM trial (EVIDEM-E: http://www.evidem.org.uk/projects/evidem-e.htm) recruited 6 participants over 6 months through clinical teams, despite minimal exclusion criteria. Our enquiries suggested that this was due to clinicians not distributing invitations, rather than a lack of interest from people with dementia and their carers. With recruitment alarmingly low and struggling to understand the incongruity between verbal support and limited promotion of the study, we invited team managers, nurses, occupational therapists, physiotherapists and psychologists to a facilitated roundtable discussion on their perceptions of research, impediments to their role as recruiters and ways to enhance recruitment.

Background Almost all of the 820,000 people in the UK with dementia will experience Behavioural and Psychological Symptoms of Dementia (BPSD). However, research has traditionally focused on treating cognitive symptoms, thus neglecting core clinical symptoms that often have a more profound impact on living with dementia. Recent evidence (Kales et al, 2007; Ballard et al, 2009) indicates that the popular approach to managing BPSD - prescription of anti-psychotic medication - can increase mortality and the risk of stroke in people with dementia as well as impair quality of life and accelerate cognitive decline. Consequently, there is a need to evaluate the impact that non-pharmacological interventions have on BPSD; we believe physical exercise is a particularly promising approach. Methods/Design We will carry out a pragmatic, randomised, single-blind controlled trial to evaluate the effectiveness of exercise (planned walking) on the behavioural and psychological symptoms of individuals with dementia. We aim to recruit 146 people with dementia and their carers to be randomized into two groups; one will be trained in a structured, tailored walking programme, while the other will continue with treatment as usual. The primary outcome (BPSD) will be assessed with the Neuropsychiatric Inventory (NPI) along with relevant secondary outcomes at baseline, 6 and 12 weeks. Discussion Designing this study has been challenging both ethically and methodologically. In particular to design an intervention that is simple, measurable, safe, non-invasive and enjoyable has been testing and has required a lot of thought. Throughout the design, we have attempted to balance methodological rigour with study feasibility. We will discuss the challenges that were faced and overcome in this paper.