scholarly journals Understanding Implementation of a Digital Self-Monitoring Intervention for Relapse Prevention in Psychosis: Protocol for a Mixed Method Process Evaluation

10.2196/15634 ◽  
2019 ◽  
Vol 8 (12) ◽  
pp. e15634 ◽  
Author(s):  
Stephanie Allan ◽  
Hamish Mcleod ◽  
Simon Bradstreet ◽  
Sara Beedie ◽  
Bethany Moir ◽  
...  

Background Relapse is common in people who experience psychosis and is associated with many negative consequences, both societal and personal. People who relapse often exhibit changes (early warning signs [EWS]) in the period before relapse. Successful identification of EWS offers an opportunity for relapse prevention. However, several known barriers impede the use of EWS monitoring approaches. Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) is a complex digital intervention that uses a mobile app to enhance the detection and management of self-reported changes in well-being. This is currently being tested in a pilot cluster randomized controlled trial. As digital interventions have not been widely used in relapse prevention, little is known about their implementation. Process evaluation studies run in parallel to clinical trials can provide valuable data on intervention feasibility. Objective This study aims to transparently describe the protocol for the process evaluation element of the EMPOWER trial. We will focus on the development of a process evaluation framework sensitive to the worldview of service users, mental health staff, and carers; the aims of the process evaluation itself; the proposed studies to address these aims; and a plan for integration of results from separate process evaluation studies into one overall report. Methods The overall process evaluation will utilize mixed methods across 6 substudies. Among them, 4 will use qualitative methodologies, 1 will use a mixed methods approach, and 1 will use quantitative methodologies. Results The results of all studies will be triangulated into an overall analysis and interpretation of key implementation lessons. EMPOWER was funded in 2016, recruitment finished in January 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in December 2019. Conclusions The findings from this study will help identify implementation facilitators and barriers to EMPOWER. These insights will inform both upscaling decisions and optimization of a definitive trial. Trial Registration ISRCTN Registry ISRCTN99559262; http://www.isrctn.com/ISRCTN99559262 International Registered Report Identifier (IRRID) DERR1-10.2196/15634

2019 ◽  
Author(s):  
Stephanie Allan ◽  
Hamish Mcleod ◽  
Simon Bradstreet ◽  
Sara Beedie ◽  
Bethany Moir ◽  
...  

BACKGROUND Relapse is common in people who experience psychosis and is associated with many negative consequences, both societal and personal. People who relapse often exhibit changes (early warning signs [EWS]) in the period before relapse. Successful identification of EWS offers an opportunity for relapse prevention. However, several known barriers impede the use of EWS monitoring approaches. Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) is a complex digital intervention that uses a mobile app to enhance the detection and management of self-reported changes in well-being. This is currently being tested in a pilot cluster randomized controlled trial. As digital interventions have not been widely used in relapse prevention, little is known about their implementation. Process evaluation studies run in parallel to clinical trials can provide valuable data on intervention feasibility. OBJECTIVE This study aims to transparently describe the protocol for the process evaluation element of the EMPOWER trial. We will focus on the development of a process evaluation framework sensitive to the worldview of service users, mental health staff, and carers; the aims of the process evaluation itself; the proposed studies to address these aims; and a plan for integration of results from separate process evaluation studies into one overall report. METHODS The overall process evaluation will utilize mixed methods across 6 substudies. Among them, 4 will use qualitative methodologies, 1 will use a mixed methods approach, and 1 will use quantitative methodologies. RESULTS The results of all studies will be triangulated into an overall analysis and interpretation of key implementation lessons. EMPOWER was funded in 2016, recruitment finished in January 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in December 2019. CONCLUSIONS The findings from this study will help identify implementation facilitators and barriers to EMPOWER. These insights will inform both upscaling decisions and optimization of a definitive trial. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15634


2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Claire Carswell ◽  
Joanne Reid ◽  
Ian Walsh ◽  
William Johnston ◽  
Helen McAneney ◽  
...  

Abstract Background Haemodialysis can negatively impact quality of life and mental health. Arts-based interventions used successfully in other settings to improve health and well-being, could help address the impact of haemodialysis. This study aimed to evaluate the feasibility and acceptability of conducting a randomised controlled trial (RCT) of an arts-based intervention for patients receiving haemodialysis. Methods A parallel convergent mixed-methods design was used, including a pilot cluster RCT and qualitative process evaluation. Phase 1 evaluated recruitment and retention rates through a pilot cluster RCT at a single haemodialysis unit in Northern Ireland. Participants included patients who received haemodialysis for ESKD, were over the age of 18 and had the capacity to consent. These participants were randomised to the intervention or control group according to their haemodialysis shift. The intervention involved six one-hour, one-to-one facilitated arts sessions during haemodialysis. Phase 2 explored intervention and trial acceptability through a qualitative process evaluation using semi-structured interviews based on the RE-AIM framework. Participants included 13 patients who participated in phase 1 of the study, including 9 participants from the experimental group and four participants from the control group, and nine healthcare professionals who were present on the unit during implementation. Results Out of 122 outpatient haemodialysis patients, 94 were assessed as eligible for participation. Twenty-four participants were randomised, meaning 80% of the target sample size was recruited and the attrition rate at 3 months was 12.5% (n = 3). Participants viewed the arts as more accessible and enjoyable than anticipated following implementation. All participants who started the intervention (n = 11) completed the full six sessions. Qualitative benefits of the intervention suggest improvements in mental well-being. Patient choice and facilitation were important factors for successful implementation. Conclusion An arts-based intervention for patients receiving haemodialysis is acceptable for both patients and healthcare professionals, and a definitive trial is feasible. The intervention may help improve mental-wellbeing in patients receiving haemodialysis, but this requires further investigation in a definitive trial. Trial registration The trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496.


2020 ◽  
Author(s):  
Claire Carswell ◽  
Joanne Reid ◽  
Ian Walsh ◽  
William Johnston ◽  
Helen McAneney ◽  
...  

Abstract BackgroundHaemodialysis can negatively impact quality of life and mental health. Arts-based interventions used successfully in other settings to improve health and well-being, could help address the impact of haemodialysis. This study aimed to evaluate the feasibility and acceptability of conducting a randomised controlled trial (RCT) of an arts-based intervention for patients receiving haemodialysisMethodsA parallel convergent mixed-methods design was used, including a pilot cluster RCT and qualitative process evaluation. Phase 1 evaluated recruitment and retention rates through a pilot cluster RCT at a single haemodialysis unit in Northern Ireland. Participants included patients who received haemodialysis for ESKD, were over the age of 18 and had the capacity to consent. These participants were randomised to the intervention or control group according to their haemodialysis shift. The intervention involved six one-hour, one-to-one facilitated arts sessions during haemodialysis. Phase 2 explored intervention and trial acceptability through a qualitative process evaluation using semi-structured interviews based on the RE-AIM framework. Participants included 13 patients who participated in phase 1 of the study, including 9 participants from the experimental group and four participants from the control group, and nine healthcare professionals who were present on the unit during implementation. ResultsOut of 122 outpatient haemodialysis patients, 94 were assessed as eligible for participation. Twenty-four participants were randomised, meaning 80% of the target sample size was recruited and the attrition rate at 3 months was 12.5% (n=3). Participants viewed the arts as more accessible and enjoyable than anticipated following implementation. All participants who started the intervention (n=11) completed the full six sessions. Qualitative benefits of the intervention suggest improvements in mental well-being. Patient choice and facilitation were important factors for successful implementation. ConclusionAn arts-based intervention for patients receiving haemodialysis is acceptable for both patients and healthcare professionals, and a definitive trial is feasible. The intervention may help improve mental-wellbeing in patients receiving haemodialysis, but this requires further investigation in a definitive trial.Trial registrationThe trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496.


BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e045570
Author(s):  
Jenny Lloyd ◽  
Gretchen Bjornstad ◽  
Aleksandra Borek ◽  
Beth Cuffe-Fuller ◽  
Mary Fredlund ◽  
...  

ObjectivesParent carers of children with special educational needs or disability are at risk of poorer mental and physical health. In response to these needs, we codeveloped the ‘Healthy Parent Carers’ (HPC) programme. This study examined the views and experiences of participants in the HPC feasibility trial to inform programme refinement.Intervention, setting and participantsHPC is a peer-led group-based intervention (supported by online materials) for primary carers of disabled children, encouraging behaviours linked with health and well-being. It was delivered by two lead and six assistant peer facilitators in six community sites (one lead and one assistant per group) in South West England over six or 12 sessions. Control participants had online materials only. The trial involved 47 intervention and 45 control parent carers (97% female and 97% white) and eight facilitators (one male).DesignA preplanned mixed methods process evaluation using questionnaires and checklists (during and after the intervention), qualitative interviews with participants after intervention (n=18) and a focus group with facilitators after trial.ResultsHPC was highly acceptable to participants and facilitators and experiences were very positive. Participants reported that the programme increased awareness of what parent carers could and could not change and their self-efficacy to engage in health-promoting behaviours. The intended mechanisms of action (social identification and peer support) matched participants’ expectations and experiences. Control participants found the online-only programme flexible but isolating, as there were no opportunities to share ideas and problem solve with peers, the key function of the programme. Areas for improvement were identified for programme content, facilitator training and delivery.ConclusionHPC was acceptable, well received and offers considerable potential to improve the health of parent carers. Under the pandemic, the challenge going forward is how best to maintain reach and fidelity to function while delivering a more virtual programme.Trial registration numberISRCTN151144652.


2016 ◽  
Vol 33 (S1) ◽  
pp. S608-S608
Author(s):  
M. Riley ◽  
M. Lovell ◽  
N. Gire ◽  
S. Lane ◽  
P.J. Taylor ◽  
...  

IntroductionThe early intervention service (EIS) approach is based on therapeutic interactions, which promote service user recovery from first episode psychosis. Collaborative therapeutic work between the service user and case manager depends on good communication. This can be a challenge for people with psychosis as the process of thought can be disrupted or stimulus misinterpreted leading to communication errors.ObjectiveThe objective is to develop an interactive tool that can assist service user's communication of distress, whilst employing a psychoeducational approach to the use of an informal therapeutic measurement scale; subjective units of distress (SUDs) and early warning signs (EWS). The ApTiC mobile intervention will include ten numerically graded emoticons from low to extreme distress. Each emoticon is associated with specific individualised service user descriptors and linked to an individually agreed action plan and level of response to be offered by a staff member.AimThe aim of the present study will be to examine the feasibility and acceptability of the ApTic mobile intervention in preparation for a larger randomised controlled trial.MethodsPhase one: qualitative research to inform the development of the complimentary tool and mobile app (qualitative). Phase two: a 12-week rater-blinded randomized control trial of ApTiC compared to routine EIS case management (quantitative).ResultsThe qualitative data will be presented.ConclusionsIt is expected that once validated, the SUDs based ApTiC will enhance rapport and understanding thus improving the recovery approach to well-being and hopefully preventing relapse or the involvement of the crisis team or hospital admissions.Disclosure of interestThe authors have not supplied their declaration of competing interest.


2020 ◽  
Author(s):  
Claire Carswell ◽  
Joanne Reid ◽  
Ian Walsh ◽  
William Johnston ◽  
Helen McAneney ◽  
...  

Abstract BackgroundHaemodialysis can negatively impact quality of life and mental health. Arts-based interventions used successfully in other settings to improve health and well-being, could help address the impact of haemodialysis. This study aimed to evaluate the feasibility and acceptability of conducting a randomised controlled trial (RCT) of an arts-based intervention for patients receiving haemodialysisMethodsA parallel convergent mixed-methods design was used, including a pilot cluster RCT and qualitative process evaluation. Phase 1 evaluated recruitment and retention rates through a pilot cluster RCT at a single haemodialysis unit in Northern Ireland. Participants included patients who received haemodialysis for ESKD, were over the age of 18 and had the capacity to consent. These participants were randomised to the intervention or control group according to their haemodialysis shift. The intervention involved six one-hour, one-to-one facilitated arts sessions during haemodialysis. Phase 2 explored intervention and trial acceptability through a qualitative process evaluation using semi-structured interviews based on the RE-AIM framework. Participants included 13 patients who participated in phase 1 of the study, including 9 participants from the experimental group and four participants from the control group, and nine healthcare professionals who were present on the unit during implementation. Results:Out of 122 outpatient haemodialysis patients, 94 were assessed as eligible for participation. Twenty-four participants were randomised, meaning 80% of the target sample size was recruited and the attrition rate at 3 months was 12.5% (n=3). Participants viewed the arts as more accessible and enjoyable than anticipated following implementation. All participants who started the intervention (n=11) completed the full six sessions. Qualitative benefits of the intervention suggest improvements in mental well-being. Patient choice and facilitation were important factors for successful implementation. Conclusion:An arts-based intervention for patients receiving haemodialysis is acceptable for both patients and healthcare professionals, and a definitive trial is feasible. The intervention may help improve mental-wellbeing in patients receiving haemodialysis, but this requires further investigation in a definitive trial.Trial registrationThe trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496.


2018 ◽  
Author(s):  
Sepali Guruge ◽  
Souraya Sidani ◽  
Lu Wang ◽  
Bharati Sethi ◽  
Denise Spitzer ◽  
...  

BACKGROUND Older adults are the fastest growing age group worldwide and in Canada. Immigrants represent a significant proportion of older Canadians. Social isolation is common among older adults and has many negative consequences, including limited community and civic participation, increased income insecurity, and increased risk of elder abuse. Additional factors such as the social, cultural, and economic changes that accompany migration, language differences, racism, and ageism heighten older immigrants’ vulnerability to social isolation. OBJECTIVE This mixed-methods sequential (qualitative-quantitative) study seeks to clarify older immigrants’ social needs, networks, and support and how these shape their capacity, resilience, and independence in aging well in Ontario. METHODS Theoretically, our research is informed by an intersectionality perspective and an ecological model, allowing us to critically examine the complexity surrounding multiple dimensions of social identity (eg, gender and immigration) and how these interrelate at the micro (individual and family), meso (community), and macro (societal) levels in diverse geographical settings. Methodologically, the project is guided by a collaborative, community-based, mixed-methods approach to engaging a range of stakeholders in Toronto, Ottawa, Waterloo, and London in generating knowledge. The 4 settings were strategically chosen for their diversity in the level of urbanization, size of community, and the number of immigrants and immigrant-serving organizations. Interviews will be conducted in Arabic, Mandarin, and Spanish with older women, older men, family members, community leaders, and service providers. The study protocol has received ethics approval from the 4 participating universities. RESULTS Quantitative and qualitative data collection is ongoing. The project is funded by the Social Sciences and Humanities Council of Canada. CONCLUSIONS Comparative analyses of qualitative and quantitative data within and across sites will provide insights about common and unique factors that contribute to the well-being of older immigrants in different regions of Ontario. Given the comprehensive approach to incorporating local knowledge and expert contributions from multilevel stakeholders, the empirical and theoretical findings will be highly relevant to our community partners, help facilitate practice change, and improve the well-being of older men and women in immigrant communities. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12616


10.2196/31789 ◽  
2021 ◽  
Vol 10 (11) ◽  
pp. e31789
Author(s):  
Sabine Kaiser ◽  
Monica Martinussen ◽  
Frode Adolfsen ◽  
Kyrre Breivik ◽  
Henriette Kyrrestad

Background Adolescents exposed to negative online events are at high risk to develop mental health problems. Little is known about what is effective for treatment in this group. NettOpp is a new mobile app for adolescents who have been exposed to cyberbullying or negative online experiences in Norway. Objective The aim of this paper is to provide a description of the content of the intervention and about a randomized controlled trial that will be conducted to examine the effectiveness of NettOpp. This protocol is written in accordance with the Spirit 2013 Checklist. Methods An effectiveness study with a follow-up examination after 3 months will be conducted to evaluate the mobile app. Adolescents will be recruited through schools and will be randomly assigned to the intervention (NettOpp) group and a waiting-list control group. The adolescents (aged 11 to 16 years) will respond to self-report questionnaires on the internet. Primary outcomes will be changes in mental health assessed with the Strengths and Difficulties Questionnaire, the WHO-Five Well-being Index, and the Child and Adolescent Trauma Screen. Results Recruitment will start in January 2022. The results from this study will be available in 2023. Conclusions There are few published evaluation studies on app-based interventions. This project and its publications will contribute new knowledge to the field. Trial Registration ClinicalTrials.gov NCT04176666; https://clinicaltrials.gov/ct2/show/NCT04176666 International Registered Report Identifier (IRRID) PRR1-10.2196/31789


2020 ◽  
Author(s):  
Anna Serlachius ◽  
Kiralee Schache ◽  
Anna Boggiss ◽  
David Lim ◽  
Kate Wallace-Boyd ◽  
...  

BACKGROUND The COVID-19 pandemic is likely to increase anxiety and distress in young people worldwide. It is important to prioritize mental health during crisis events to mitigate the negative and often long-term effects of the crises on young people, families, and society. Mental health and well-being apps represent a scalable approach for improving psychological outcomes in young people and have potential to improve the equity of service access. OBJECTIVE The Whitu: 7 Ways in 7 Days well-being app was recently developed by our group to address the urgent need for innovative approaches to reach young New Zealanders who are struggling to cope with the COVID-19 pandemic. The aim of this study is twofold: to evaluate the acceptability of the prototype app and to examine the effectiveness of the refined app at improving mental and emotional well-being and reducing depression, anxiety, and stress in young people in New Zealand. METHODS A two-phase mixed methods study will be undertaken to achieve these aims. During the first phase, 20 young people aged 16-30 years (including those of Māori and Pacific ethnicity) will participate in a qualitative study to help refine the prototype app. During the second phase, 90 young people aged 16-30 years will participate in a randomized waitlist-controlled trial (RCT) to evaluate the efficacy of the refined Whitu app at 4 weeks and 3 months after baseline. Outcomes will be evaluated using validated web-based questionnaires at baseline, 4 weeks, and 3 months. RESULTS The study received ethics approval in May 2020, and recruitment for the focus groups commenced in June 2020. Recruitment for the RCT is expected to commence in October 2020. Participants for both study phases will be recruited via social media and web-based communities. Data collection for the RCT is expected to be completed by January 2021, and analyses are expected to be completed by March 2021. Linear mixed modelling will be used to determine between-group differences in psychological outcomes. CONCLUSIONS There is an urgent need to develop culturally appropriate, scalable mental health interventions to address the psychological consequences of the COVID-19 pandemic. In this study, we will develop and test an evidence-based well-being app that, if effective, can be made available to all young people in New Zealand and internationally. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ACTRN12620000516987); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379597. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/23716


2021 ◽  
Vol 22 (1_suppl) ◽  
pp. 70S-82S
Author(s):  
Theo Edmonds ◽  
Hannah Drake ◽  
Josh Miller ◽  
Nachand Trabue ◽  
Cameron Lister ◽  
...  

Objectives. To increase the scale and efficacy of health promotion practice, culturally responsive approaches to well-being are needed in both communication and practice innovation. This mixed-methods evaluation sought to identify specific mechanisms used in a promising practice model and offers a potential theoretical framework to support public health programs in integrating culture and social justice into communication and intervention programs. Study Design. Rooted at the intersection of ethnographic and phenomenological worldviews, this mixed-methods, retrospective process evaluation used publicly available empirical and experiential data centered on the arts, science, and social justice to identify critical mechanisms used and incorporate them into an emergent theoretical framework. Method. The retrospective process evaluation used an ethnography-informed approach combined with scientific literature reviews. To integrate adjacent ideas into the emergent theoretical framework, a phenomenologically informed theme development approach was used. Results. The evaluation resulted in a five-step framework, called MOTIF, with the potential to be utilized in diverse situational and geographic contexts. Data that surfaced from related literature reviews revealed adjacent mechanisms from positive psychology, critical consciousness theory, and innovation design that were incorporated into the emergent framework. Conclusion. MOTIF may offer a culturally responsive public health communication and innovation process capable of promoting health equity through the cultivation of relationships between artists, community participants, and public health agencies and researchers who collectively endeavor to craft innovative solutions for population health and well-being.


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