The Sleep Or Mood Novel Adjunctive therapy (SOMNA) trial: a study protocol for a randomised controlled trial evaluating an internet-delivered cognitive behavioural therapy program for insomnia on outcomes of standard treatment for depression in men

BACKGROUND: Insomnia is a significant risk factor for depression onset, can result in more disabling depressive illness, and is a common residual symptom following treatment cessation that can increase the risk of relapse. Internet-based cognitive behavioural therapy for insomnia has demonstrated efficacy and acceptability to men who are less likely than women to seek help in standard care. We aim to evaluate whether internet delivered cognitive behavioural therapy for insomnia as an adjunct to a standard depression therapeutic plan can lead to improved mood outcomes.METHODS/DESIGN: Male participants aged 50 years or more, meeting Diagnostic and Statistical Manual of Mental Disorders criteria for current Major Depressive Episode and/or Dysthymia and self-reported insomnia symptoms, will be screened to participate in a single-centre double-blind randomised controlled trial with two parallel groups involving adjunctive internet-delivered cognitive behavioural therapy for insomnia and an internet-based control program. The trial will consist of a nine-week insomnia intervention period with a six-month follow-up period. During the insomnia intervention period participants will have their depression management coordinated by a psychiatrist using standard guideline-based depression treatments. The study will be conducted in urban New South Wales, Australia, where 80 participants from primary and secondary care and direct from the local community will be recruited. The primary outcome is change in the severity of depressive symptoms from baseline to week 12. DISCUSSION: This study will provide evidence on whether a widely accessible, evidence-based, internet-delivered cognitive behavioural therapy for insomnia intervention can lead to greater improvements than standard treatment for depression alone, in a group who traditionally do not readily access psychotherapy. The study is designed to establish effect size, feasibility and processes associated with implementing e-health solutions alongside standard clinical care, to warrant undertaking a larger more definitive clinical trial.Trial registration: Australian and New Zealand Clinical Trials Registry ACTRN12612000985886.The study is supported by beyondblue: the national depression and anxiety initiative National Priority Driven Research Program and funded through a donation from the Movember Foundation

Online, social media and mobile technologies for psychosis treatment: a systematic review on novel user-led interventions

Internet and mobile-based interventions provide a unique opportunity to deliver cost-effective, accessible, time-unlimited support to people with psychosis. The aims of this study were to systematically compile and analyze the evidence on the acceptability, feasibility, safety and benefits of online and mobile-based interventio is for psychosis. Methods: Systematic review of peer-reviewed studies examining the usability, acceptability, feasibility, safety or efficacy of user-led, Internet or mobile-based interventions, with at least 80% of participants diagnosed with schizophrenia-spectrum disorders. Results: Of 38 potentially relevant articles, 12 were eligible for inclusion. Interventions included web-based psycho-education; web-based psycho-education plus moderated forums for patients and supporters; integrated web-based therapy, social networking and peer and expert moderation; web-based CBT; personalized advice based on clinical monitoring; and text messaging interventions. Results showed that 74–86% of patients used the web-based interventions efficiently, 75–92% perceived them as positive and useful, and 70–86% completed or were engaged with the interventions over the follow-up. Preliminary evidence indicated that online and mobile-based interventions show promise in improving positive psychotic symptoms, hospital admissions, socialization, social connectedness, depression and medication adherence. Conclusions: Internet and mobile-based interventions for psychosis seem to be acceptable and feasible and have the potential to improve clinical and social outcomes. The heterogeneity, poor quality and early state of current research precludes any definite conclusions. Future research should investigate the efficacy of online and mobile interventions through controlled, well-powered studies, which investigate intervention and patient factors associated with take-up and intervention effects

A randomised feasibility study of serial magnetic resonance imaging to reduce treatment times in Charcot neuroarthropathy in people with diabetes (CADOM): A protocol

Background Charcot neuroarthropathy is a complication of peripheral neuropathy associated with diabetes which most frequently affects the lower limb. It can cause fractures and dislocations within the foot, which may progress to deformity and ulceration. Recommended treatment is immobilisation and offloading, with a below knee non-removable cast or boot. Duration of treatment varies from six months to more than one year. Small observational studies suggest that repeated assessment with Magnetic Resonance Imaging improves decision making about when to stop treatment, but this has not been tested in clinical trials. This study aims to explore the feasibility of using serial Magnetic Resonance Imaging without contrast in the monitoring of Charcot neuroarthropathy to reduce duration of immobilisation of the foot. A nested qualitative study aims to explore participants’ lived experience of Charcot neuroarthropathy and of taking part in the feasibility study. Methods We will undertake a two arm, open study, and randomise 60 people with a suspected or confirmed diagnosis of Charcot neuroarthropathy from five NHS, secondary care multidisciplinary Diabetic Foot Clinics across England. Participants will be randomised 1:1 to receive Magnetic Resonance Imaging at baseline and remission up to 12 months, with repeated foot temperature measurements and x-rays (standard care plus), or standard care plus with additional three-monthly Magnetic Resonance Imaging until remission up to 12 months (intervention). Time to confirmed remission of Charcot neuroarthropathy with off-loading treatment (days) and its variance will be used to inform sample size in a full-scale trial. We will look for opportunities to improve the protocols for monitoring techniques and the clinical, patient centred, and health economic measures used in a future study. For the nested qualitative study, we will invite a purposive sample of 10-14 people able to offer maximally varying experiences from the feasibility study to take part in semi-structured interviews to be analysed using thematic analysis. Discussion The study will inform the decision whether to proceed to a full-scale trial. It will also allow deeper understanding of the lived experience of Charcot neuroarthropathy, and factors that contribute to engagement in management and contribute to the development of more effective patient centred strategies. Trial registration ISRCTN, ISRCTN, 74101606. Registered on 6 November 2017, http://www.isrctn.com/ISRCTN74101606?q=CADom&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-searc

Utilizing Digital Health to Collect Electronic Patient-Reported Outcomes in Prostate Cancer: Single-Arm Pilot Trial

Background: Measuring patient-reported outcomes (PROs) requires an individual’s perspective on their symptoms, functional status, and quality of life. Digital health enables remote electronic PRO (ePRO) assessments as a clinical decision support tool to facilitate meaningful provider interactions and personalized treatment. Objective: This study explored the feasibility and acceptability of collecting ePROs using validated health-related quality of life (HRQoL) questionnaires for prostate cancer. Methods: Using Apple ResearchKit software, the Strength Through Insight app was created with content from validated HRQoL tools 26-item Expanded Prostate Cancer Index Composite (EPIC) or EPIC for Clinical Practice and 8-item Functional Assessment of Cancer Therapy Advanced Prostate Symptom Index. In a single-arm pilot study with patients receiving prostate cancer treatment at Thomas Jefferson University Hospital and affiliates, participants were recruited, and instructed to download Strength Through Insight and complete ePROs once a week over 12 weeks. A mixed methods approach, including qualitative pre- and poststudy interviews, was used to evaluate the feasibility and acceptability of Strength Through Insight for the collection and care management of cancer treatment. Results: Thirty patients consented to the study; 1 patient failed to complete any of the questionnaires and was left out of the analysis of the intervention. Moreover, 86% (25/29) reached satisfactory questionnaire completion (defined as completion of 60% of weekly questions over 12 weeks). The lower bound of the exact one-sided 95% CI was 71%, exceeding the 70% feasibility threshold. Most participants self-identified with having a high digital literacy level (defined as the ability to use, understand, evaluate, and analyze information from multiple formats from a variety of digital sources), and only a few participants identified with having a low digital literacy level (defined as only having the ability to gather information on the Web). Interviews were thematically analyzed to reveal the following: (1) value of emotional support and wellness in cancer treatment, (2) rise of social patient advocacy in online patient communities and networks, (3) patient concerns over privacy, and (4) desire for personalized engagement tools. Conclusions: Strength Through Insight was demonstrated as a feasible and acceptable method of data collection for ePROs. A high compliance rate confirmed the app as a reliable tool for patients with localized and advanced prostate cancer. Nearly all participants reported that using the smartphone app is easier than or equivalent to the traditional paper-and-pen approach, providing evidence of acceptability and support for the use of remote PRO monitoring. This study expands on current research involving the value of digital health, as a social and behavioral science, augmented with technology, can begin to contribute to population health management, as it shapes psychographic segmentation by demographic, socioeconomic, health condition, or behavioral factors to group patients by their distinct personalities and motivations, which influence their choices

Acceptability and proof of concept of internet-delivered treatment for depression, anxiety, and stress in university students: protocol for an open feasibility trial

BACKGROUND: In recent years, university counseling and mental health services have reported an increase in the number of clients seeking services and in yearly visits. This trend has been observed at many universities, indicating that behavioral and mental health issues pose significant problems for many college students. The aim of this study is to assess the acceptability and proof of concept of internet-delivered treatment for depression, anxiety, and stress for university students. METHODS/DESIGN: The study is an open feasibility trial of the SilverCloud programs for depression (Space from Depression), anxiety (Space from Anxiety), and stress (Space from Stress). All three are 8-module internet-delivered CBT (iCBT) intervention programs. Participants are assigned a supporter who provides weekly feedback on progress and exercises. Participants will complete the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), and stress subscale of the Depression, Anxiety, Stress Scale-21 (DASS-21) as the outcome measures for the depression, anxiety, and stress interventions, respectively. Other outcomes include measures of acceptability of, and satisfaction, with the intervention. Data will be collected at baseline, 8 weeks and 3-month follow-up. DISCUSSION: It is anticipated that the study will inform the researchers and service personnel of the programs' potential to reduce depression, anxiety, and stress in a student population as well as the protocols to be employed in a future trial. In addition, it will provide insight into students' engagement with the programs, their user experience, and their satisfaction with the online delivery format

A randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial

<b>Background</b><p></p> The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes.<p></p> <b>Methods</b><p></p> The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status).<p></p> <b>Discussion</b><p></p> Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of efficacy to inform the design of a future full-scale randomized controlled trial of the 'Living well with asthma' website

Adaptation and Feasibility Study of a Digital Health Program to Prevent Diabetes among Low-Income Patients: Results from a Partnership between a Digital Health Company and an Academic Research Team.

Background. The feasibility of digital health programs to prevent and manage diabetes in low-income patients has not been adequately explored. Methods. Researchers collaborated with a digital health company to adapt a diabetes prevention program for low-income prediabetes patients at a large safety net clinic. We conducted focus groups to assess patient perspectives, revised lessons for improved readability and cultural relevance to low-income and Hispanic patients, conducted a feasibility study of the adapted program in English and Spanish speaking cohorts, and implemented real-time adaptations to the program for commercial use and for a larger trial of in multiple safety net clinics. Results. The majority of focus group participants were receptive to the program. We modified the curriculum to a 5th-grade reading level and adapted content based on patient feedback. In the feasibility study, 54% of eligible contacted patients expressed interest in enrolling (n = 23). Although some participants' computer access and literacy made registration challenging, they were highly satisfied and engaged (80% logged in at least once/week). Conclusions. Underserved prediabetic patients displayed high engagement and satisfaction with a digital diabetes prevention program despite lower digital literacy skills. The collaboration between researchers and a digital health company enabled iterative improvements in technology implementation to address challenges in low-income populations

Reducing dementia risk by targeting modifiable risk factors in mid-life: study protocol for the Innovative midlife intervention for dementia deterrence (In-MINDD) randomised controlled feasibility trial

Background Dementia prevalence is increasing as populations live longer, with no cure and the costs of caring exceeding many other conditions. There is increasing evidence for modifiable risk factors which, if addressed in mid-life, can reduce the risk of developing dementia in later life. These include physical inactivity, low cognitive activity, mid-life obesity, high blood pressure, and high cholesterol. This study aims to assess the acceptability and feasibility and impact of giving those in mid-life, aged between 40 and 60 years, an individualised dementia risk modification score and profile and access to personalised on-line health information and goal setting in order to support the behaviour change required to reduce such dementia risk. A secondary aim is to understand participants’ and practitioners’ views of dementia prevention and explore the acceptability and integration of the Innovative Midlife Intervention for Dementia Deterrence (In-MINDD) intervention into daily life and routine practice. Methods/design In-MINDD is a multi-centre, primary care-based, single-blinded randomised controlled feasibility trial currently being conducted in four European countries (France, Ireland, the Netherlands and the UK). Participants are being recruited from participating general practices. Inclusion criteria will include age between 40 and 60 years; at least one modifiable risk factor for dementia risk (including diabetes, hypertension, obesity, renal dysfunction, current smoker, raised cholesterol, coronary heart disease, current or previous history of depression, self-reported sedentary lifestyle, and self-reported low cognitive activity) access to the Internet. Primary outcome measure will be a change in dementia risk modification score over the timescale of the trial (6 months). A qualitative process evaluation will interview a sample of participants and practitioners about their views on the acceptability and feasibility of the trial and the links between modifiable risk factors and dementia prevention. This work will be underpinned by Normalisation Process Theory. Discussion This study will explore the feasibility and acceptability of a risk profiler and on-line support environment to help individuals in mid-life assess their risk of developing dementia in later life and to take steps to alleviate that risk by tackling health-related behaviour change. Testing the intervention in a robust and theoretically informed manner will inform the development of a future, full-scale randomised controlled trial

Feasibility of a UK community-based, eTherapy mental health service in Greater Manchester: repeated-measures and between-groups study of ‘Living Life to the Full Interactive’, ‘Sleepio’ and ‘Breaking Free Online’ at ‘Self Help Services’

Objectives: There is increasing evidence to support the effectiveness of eTherapies for mental health, although limited data have been reported from community-based services. Therefore, this service evaluation reports on feasibility and outcomes from an eTherapy mental health service. Setting: ‘Self Help Services’, an Increasing Access to Psychological Therapies (IAPT) eTherapy service in Greater Manchester. Participants: 1068 service users referred to the service for secondary care for their mental health difficulties. Interventions: Participants were triaged into one of three eTherapy programmes: ‘Living Life to the Full Interactive’ for low mood, stress and anxiety; ‘Sleepio’ for insomnia; and ‘Breaking Free Online’ for substance misuse, depending on clinical need. Primary outcomes measures: Standardised psychometric assessments of depression, anxiety and social functioning, collected as part of the IAPT Minimum Data Set, were conducted at baseline and post-treatment. Results: Data indicated baseline differences, with the Breaking Free Online group having higher scores for depression and anxiety than the Living Life to the Full Interactive (depression CI 1.27 to 3.21, p<0.0001; anxiety CI 077 to 1.72, p<0.0001) and Sleepio (depression CI 1.19 to 4.52, p<0.0001; anxiety CI 2.16 to 5.23, p<0.0001) groups. Promising improvements in mental health scores were found within all three groups (all p<0.0001), as were significant reductions in numbers of service users reaching clinical threshold scores for mental health difficulties (p<0.0001). Number of days of engagement was not related to change from baseline for the Living Life to the Full or Sleepio programmes but was associated with degree of change for Breaking Free Online. Conclusion: Data presented provide evidence for feasibility of this eTherapy delivery model in supporting service users with a range of mental health difficulties and suggest that eTherapies may be a useful addition to treatment offering in community-based services