Research Into Digital Health Intervention for Mental Health: 25-Year Retrospective on the Ethical and Legal Challenges.

Digital mental health interventions are routinely integrated into mental health services internationally and can contribute to reducing the global mental health treatment gap identified by the World Health Organization. Research teams designing and delivering evaluations frequently invest substantial effort in deliberating on ethical and legal challenges around digital mental health interventions. In this article, we reflect on our own research experience with digital mental health intervention design and evaluation to identify 8 of the most critical challenges that we or others have faced, and that have ethical or legal consequences. These include: (1) harm caused by online recruitment work; (2) monitoring of intervention safety; (3) exclusion of specific demographic or clinical groups; (4) inadequate robustness of effectiveness and cost-effectiveness findings; (5) adequately conceptualizing and supporting engagement and adherence; (6) structural barriers to implementation; (7) data protection and intellectual property; and (8) regulatory ambiguity relating to digital mental health interventions that are medical devices. As we describe these challenges, we have highlighted serious consequences that can or have occurred, such as substantial delays to studies if regulations around Software as a Medical Device (SaMD) are not fully understood, or if regulations change substantially during the study lifecycle. Collectively, the challenges we have identified highlight a substantial body of required knowledge and expertise, either within the team or through access to external experts. Ensuring access to knowledge requires careful planning and adequate financial resources (for example, paying public contributors to engage in debate on critical ethical issues or paying for legal opinions on regulatory issues). Access to such resources can be planned for on a per-study basis and enabled through funding proposals. However, organizations regularly engaged in the development and evaluation of digital mental health interventions should consider creating or supporting structures such as advisory groups that can retain necessary competencies, such as in medical device regulation.

Healing Houses systematic review: design, sustainability, opportunities and barriers facing Soteria and peer respite development.

BACKGROUND: Soteria houses and peer respites, collectively called Healing Houses, are alternatives to psychiatric hospitalisation. AIMS: The aim of this research is to review Healing Houses in relation to design characteristics (architectural and service), sustainability and development opportunities and barriers. METHODS: This systematic review followed a PROSPERO protocol (CRD42022378089). Articles were identified from journal database searches, hand searching websites, Google Scholar searches, expert consultation and backwards and forward citation searches. RESULTS: Eight hundred and forty-nine documents were screened in three languages (English, German and Hebrew) and 45 documents were included from seven countries. The review highlights 11 architectural design characteristics (atmosphere, size, soft room, history, location, outdoor space, cleanliness, interior design, facilities, staff only areas and accessibility), six service design characteristics (guiding principles, living and working together, consensual treatment, staff, supporting personal meaning making and power), five opportunities (outcomes, human rights, economics, hospitalization and underserved) and four types of barriers (clinical, economic and regulatory, societal and ideological). The primary sustainability issue was long-term funding. CONCLUSION: Future research should focus on operationalizing a "home-like" atmosphere and the impact of design features such as green spaces on wellbeing of staff and service users. Future research could also produce design guidelines for Healing Houses.

Is personal recovery a transdiagnostic concept? Testing the fit of the CHIME framework using narrative experiences.

BACKGROUND: Personal recovery is operationalized in the CHIME framework (connectedness, hope, identity, meaning in life, and empowerment) of recovery processes. CHIME was initially developed through analysis of experiences of people mainly with psychosis, but it might also be valid for investigating recovery in mood-related, autism and other diagnoses. AIMS: To examine whether personal recovery is transdiagnostic by studying narrative experiences in several diagnostic groups. METHODS: Thirty recovery narratives, retrieved from "Psychiatry Story Bank" (PSB) in the Netherlands, were analyzed by three coders using CHIME as a deductive framework. New codes were assigned using an inductive approach and member checks were performed after consensus was reached. RESULTS: All five CHIME dimensions were richly reported in the narratives, independent of diagnosis. Seven new domains were identified, such as "acknowledgement by diagnosis" and "gaining self-insight". These new domains were evaluated to fit well as subdomains within the original CHIME framework. On average, 54.2% of all narrative content was classified as experienced difficulties. CONCLUSIONS: Recovery stories from different diagnostic perspectives fit well into the CHIME framework, implying that personal recovery is a transdiagnostic concept. Difficulties should not be ignored in the context of personal recovery based on its substantial presence in the recovery narratives.

Widening participation - recruitment methods in mental health randomised controlled trials: a qualitative study.

BACKGROUND: Barriers to mental health research participation are well documented including distrust of services and research; and stigma surrounding mental health. They can contribute to a lack of diversity amongst participants in mental health research, which threatens the generalisability of knowledge. Given the recent widespread use of the internet in medical research, this study aimed to explore the perspectives of key partners on the use of online (e.g. social media) and offline (e.g. in-person) recruitment as an approach to improving diversity in mental health randomised controlled trials (RCTs). METHODS: Face-to-face and online interviews/focus groups with researchers working in mental health and Patient and Public Involvement partners in the United Kingdom. Recordings were transcribed and analysed using a combination of inductive and deductive thematic analysis. RESULTS: Three focus groups and three interviews were conducted with a total N = 23 participants. Four overarching themes were identified: (1) recruitment reach; (2) Demographic factors that affect selection of recruitment method; (3) safety of technology, and; (4) practical challenges. Five main factors were identified that affect the choice of recruitment method: age, complexity of mental health problem and stigma, cultural and ethnicity differences and digital divide. The use of online methods was considered more accessible to people who may feel stigmatised by their mental health condition and with a benefit of reaching a wider population. However, a common view amongst participants was that online methods require closer data monitoring for quality of responders, are not fully secure and less trustworthy compared to offline methods that enable participants to build relationships with health providers. Funding, staff time and experience, organisational support, and technical issues such as spam or phishing emails were highlighted as practical challenges facing online recruitment. All participants agreed that using a hybrid approach tailored to the population under study is paramount. CONCLUSIONS: This study highlighted the importance of offering a flexible and multifaceted recruitment approach by integrating online with offline methods to support inclusivity and widening participation in mental health research. The findings will be used to develop considerations for researchers designing RCTs to improve recruitment in mental health research.

Differences Between Online Trial Participants Who Have Used Statutory Mental Health Services and Those Who Have Not: Analysis of Baseline Data From 2 Pragmatic Trials of a Digital Health Intervention.

BACKGROUND: Digital health interventions (DHIs) are an established element of mental health service provision internationally. Regulators have positioned the best practice standard of evidence as an interventional study with a comparator reflective of standard care, often operationalized as a pragmatic trial. DHIs can extend health provision to those not currently using mental health services. Hence, for external validity, trials might openly recruit a mixture of people who have used mental health services and people who have not. Prior research has demonstrated phenomenological differences in mental health experience between these groups. Some differences between service users and nonservice users might influence the change created by DHIs; hence, research should systematically examine these differences to inform intervention development and evaluation work. This paper analyzes baseline data collected in the NEON (Narrative Experiences Online; ie, for people with experience of psychosis) and NEON-O (NEON for other [eg, nonpsychosis] mental health problems) trials. These were pragmatic trials of a DHI that openly recruited people who had used specialist mental health services and those who had not. All participants were experiencing mental health distress. NEON Trial participants had experienced psychosis in the previous 5 years. OBJECTIVE: This study aims to identify differences in baseline sociodemographic and clinical characteristics associated with specialist mental health service use for NEON Trial and NEON-O Trial participants. METHODS: For both trials, hypothesis testing was used to compare baseline sociodemographic and clinical characteristics of participants in the intention-to-treat sample who had used specialist mental health services and those who had not. Bonferroni correction was applied to significance thresholds to account for multiple testing. RESULTS: Significant differences in characteristics were identified in both trials. Compared with nonservice users (124/739, 16.8%), NEON Trial specialist service users (609/739, 82.4%) were more likely to be female (P<.001), older (P<.001), and White British (P<.001), with lower quality of life (P<.001) and lower health status (P=.002). There were differences in geographical distribution (P<.001), employment (P<.001; more unemployment), current mental health problems (P<.001; more psychosis and personality disorders), and recovery status (P<.001; more recovered). Current service users were more likely to be experiencing psychosis than prior service users. Compared with nonservice users (399/1023, 39%), NEON-O Trial specialist service users (614/1023, 60.02%) had differences in employment (P<.001; more unemployment) and current mental health problems (P<.001; more personality disorders), with lower quality of life (P<.001), more distress (P<.001), less hope (P<.001), less empowerment (P<.001), less meaning in life (P<.001), and lower health status (P<.001). CONCLUSIONS: Mental health service use history was associated with numerous differences in baseline characteristics. Investigators should account for service use in work to develop and evaluate interventions for populations with mixed service use histories. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-020-04428-6.

Application and Extension of the Alcohol Recovery Narratives Conceptual Framework.

Recovery narratives are personal stories of health problems and recovery. A systematic review proposed a conceptual framework characterising alcohol misuse recovery narratives, consisting of eight principal dimensions, each with types and subtypes. The current study aims to apply and extend this preliminary conceptual framework. Semi-structured interviews were conducted to collect alcohol misuse recovery narratives from adult participants. A two-stage inductive and deductive thematic analysis approach was used to assess the relevance of the dimensions and types included in the preliminary conceptual framework and identify new components. The sample consisted of 11 participants from diverse socioeconomic backgrounds who had previously displayed varying degrees of alcohol misuse. All conceptual framework dimensions (genre, identity, recovery setting, drinking trajectories, drinking behaviours and traits, stages, spirituality and religion, and recovery experience) were present in the collected narratives. Three dimensions were extended by adding types and subtypes. Whilst the existing conceptual framework fitted the collected narratives, a new dimension describing the alcohol environment was required to fully characterise narratives. Types included in the alcohol environment dimension were policy and practice and social dynamics. The extended framework could guide the production of resources enabling clinicians to engage with narratives shared by their clients.

Remotely Delivered Interventions to Support Women With Symptoms of Anxiety in Pregnancy: Mixed Methods Systematic Review and Meta-analysis.

BACKGROUND: Symptoms of anxiety are common in pregnancy, with severe symptoms associated with negative outcomes for women and babies. Low-level psychological therapy is recommended for women with mild to moderate anxiety, with the aim of preventing an escalation of symptoms and providing coping strategies. Remotely delivered interventions have been suggested to improve access to treatment and support and provide a cost-effective, flexible, and timely solution. OBJECTIVE: This study identifies and evaluates remotely delivered, digital, or web-based interventions to support women with symptoms of anxiety during pregnancy. METHODS: This mixed methods systematic review followed a convergent segregated approach to synthesize qualitative and quantitative data. The ACM Digital Library, Allied and Complementary Medicine Database, Applied Social Sciences Index and Abstracts, Centre for Reviews and Dissemination database, the Cochrane Central Register of Controlled Trials, the Cochrane Library, CINAHL, Embase, Health Technology Assessment Library, IEEE Xplore, Joanna Briggs Institute, Maternity and Infant Care, MEDLINE, PsycINFO, and the Social Science Citation Index were searched in October 2020. Quantitative or qualitative primary research that included pregnant women and evaluated remotely delivered interventions reporting measures of anxiety, fear, stress, distress, women's views, and opinions were included. RESULTS: Overall, 3 qualitative studies and 14 quantitative studies were included. Populations included a general antenatal population and pregnant women having anxiety and depression, fear of childbirth, insomnia, and preterm labor. Interventions included cognitive behavioral therapy, problem solving, mindfulness, and educational designs. Most interventions were delivered via web-based platforms, and 62% (8/13) included direct contact from trained therapists or coaches. A meta-analysis of the quantitative data found internet-based cognitive behavioral therapy and facilitated interventions showed a beneficial effect in relation to the reduction of anxiety scores (standardized mean difference -0.49, 95% CI -0.75 to -0.22; standardized mean difference -0.48, 95% CI -0.75 to -0.22). Due to limitations in the amount of available data and study quality, the findings should be interpreted with caution. Synthesized findings found some evidence to suggest that interventions are more effective when women maintain regular participation which may be enhanced by providing regular contact with therapists or peer support, appropriate targeting of interventions involving components of relaxation and cognitive-based skills, and providing sufficient sessions to develop new skills without being too time consuming. CONCLUSIONS: There is limited evidence to suggest that women who are pregnant may benefit from remotely delivered interventions. Components of interventions that may improve the effectiveness and acceptability of remotely delivered interventions included providing web-based contact with a therapist, health care professional, or peer community. Women may be more motivated to complete interventions that are perceived as relevant or tailored to their needs. Remote interventions may also provide women with greater anonymity to help them feel more confident in disclosing their symptoms.

Review of Mobile Apps for Women With Anxiety in Pregnancy: Maternity Care Professionals' Guide to Locating and Assessing Anxiety Apps.

BACKGROUND: Mental health and pregnancy apps are widely available and have the potential to improve health outcomes and enhance women's experience of pregnancy. Women frequently access digital information throughout their pregnancy. However, health care providers and women have little information to guide them toward potentially helpful or effective apps. OBJECTIVE: This review aimed to evaluate a methodology for systematically searching and reviewing commercially available apps that support pregnant women with symptoms of anxiety in order to assist maternity care professionals in identifying resources that they could recommend for these women. METHODS: A stepwise systematic approach was used to identify, select, describe, and assess the most popular and highly user-rated apps available in the United Kingdom from January to March 2021. This included developing a script-based search strategy and search process, writing evaluation criteria, and conducting a narrative description and evaluation of the selected apps. RESULTS: Useful search terms were identified, which included nonclinical, aspirational, and problem-based phrases. There were 39 apps selected for inclusion in the review. No apps specifically targeted women with anxiety in pregnancy. Of the 39 apps included in the review, 33 (85%) focused solely on mind-body techniques to promote relaxation, stress reduction, and psychological well-being. Only 8 of the 39 (21%) apps included in the review reported that health care professionals had contributed to app development and only 1/39 (3%) provided empirical evidence on the effectiveness and acceptability of the app. The top 12/39 (31%) apps were evaluated by 2 independent reviewers using the developed criteria and scores. There was a small negative correlation between the reviewers' scores and app user rating scores, with higher user rating scores associated with lower reviewer scores. CONCLUSIONS: App developers, publishers, and maternity care professionals should seek advice from women with lived experience of anxiety symptoms in pregnancy to locate, promote, and optimize the visibility of apps for pregnant women. There is a lack of resources that provide coping strategies based on current evidence for the treatment of anxiety in pregnancy. Maternity care providers are limited in their ability to locate and recommend acceptable and trustworthy apps because of the lack of information on the evidence base, development, and testing of apps. Maternity care professionals and women need access to libraries of trusted apps that have been evaluated against relevant and established criteria.

'Maybe I Shouldn't Talk': The Role of Power in the Telling of Mental Health Recovery Stories.

Mental health 'recovery narratives' are increasingly used within teaching, learning and practice environments. The mainstreaming of their use has been critiqued by scholars and activists as a co-option of lived experience for organisational purposes. But how people report their experiences of telling their stories has not been investigated at scale. We present accounts from 71 people with lived experience of multiple inequalities of telling their stories in formal and informal settings. A reflexive thematic analysis was conducted within a critical constructivist approach. Our overarching finding was that questions of power were central to all accounts. Four themes were identified: (1) Challenging the status quo; (2) Risky consequences; (3) Producing 'acceptable' stories; (4) Untellable stories. We discuss how the concept of narrative power foregrounds inequalities in settings within which recovery stories are invited and co-constructed, and conclude that power imbalances complicate the seemingly benign act of telling stories of lived experience.

How do recorded mental health recovery narratives create connection and improve hopefulness?

BACKGROUND: Mental health recovery narratives are an active ingredient of recovery-oriented interventions such as peer support. Recovery narratives can create connection and hope, but there is limited evidence on the predictors of impact. AIMS: The aim of this study was to identify characteristics of the narrator, narrative content and participant which predict the short-term impact of recovery narratives on participants. METHOD: Independent studies were conducted in an experimental (n = 40) and a clinical setting (n = 13). In both studies, participants with mental health problems received recorded recovery narratives and rated impact on hopefulness and connection. Predictive characteristics were identified using multi-level modelling. RESULTS: The experimental study found that narratives portraying a narrator as living well with mental health problems that is intermediate between no and full recovery, generated higher self-rated levels of hopefulness. Participants from ethnic minority backgrounds had lower levels of connection with narrators compared to participants from a white background, potentially due to reduced visibility of a narrator's diversity characteristics. CONCLUSIONS: Narratives describing partial but not complete recovery and matching on ethnicity may lead to a higher impact. Having access to narratives portraying a range of narrator characteristics to maximise the possibility of a beneficial impact on connection and hopefulness.

Post-traumatic growth in psychosis: a systematic review and narrative synthesis.

BACKGROUND AND OBJECTIVE: People with psychosis report experiences of highly traumatic events. Positive change or post-traumatic growth (PTG) can occur as a result of traumatic experiences. Yet there is limited attention on PTG in psychosis, possibly due to the negative impact of psychotic symptoms on functioning and quality of life. The aim of this review was to identify significant correlates and mediators of PTG in psychosis, and to develop a conceptual framework synthesising facilitators of PTG in psychosis. METHOD: Ten electronic databases were searched in seven languages, and five journals and grey literature were searched in English. Quantitative studies were eligible if examining correlates, mediators, or the temporal relationship between PTG and one or more variables. Qualitative studies were eligible if describing PTG arising from experiences of psychosis. Findings from quantitative papers were grouped by analysis method, with significant correlates, mediators, and temporal relationships descriptively reported upon. Narrative synthesis was conducted on findings in qualitative papers. RESULTS: Thirty-seven papers were included. Significant correlates and mediators of PTG were identified. Mediators of PTG in psychosis included meaning in life, coping self-efficacy, core beliefs, and self-reported recovery. No studies describing the temporal relationship between PTG and psychosis were identified. The narrative synthesis identified seven facilitators of PTG in psychosis: Personal identity and strength, Receiving support, Opportunities and possibilities, Strategies for coping, Perspective shift, Emotional experience, and Relationships, giving the acronym PROSPER. CONCLUSIONS: Individuals with psychosis can be supported to grow from traumatic experiences. Clinicians can support PTG through the provision of trauma-informed care that supports positively valued identity changes. For researchers, the findings provide an evidence-based theoretical framework for conceptualising PTG, which can be validated through longitudinal cohort studies and underpin the development of new clinical interventions.

Not the story you want? Assessing the fit of a conceptual framework characterising mental health recovery narratives.

PURPOSE: Narratives of recovery have been central to the development of the recovery approach in mental health. However, there has been a lack of clarity around definitions. A recent conceptual framework characterised recovery narratives based on a systematic review and narrative synthesis of existing literature, but was based on a limited sample. The aims of this study were to assess the relevance of the framework to the narratives of more diverse populations, and to develop a refined typology intended to inform narrative-based research, practice and intervention development. METHOD: 77 narrative interviews were conducted with respondents from four under-researched mental health sub-populations across England. Deductive and inductive analysis was used to assess the relevance of the dimensions and types of the preliminary typology to the interview narratives. RESULTS: Five or more dimensions were identifiable within 97% of narratives. The preliminary typology was refined to include new definitions and types. The typology was found not to be relevant to two narratives, whose narrators expressed a preference for non-verbal communication. These are presented as case studies to define the limits of the typology. CONCLUSION: The refined typology, based on the largest study to date of recovery narratives, provides a defensible theoretical base for clinical and research use with a range of clinical populations. Implications for practice include ensuring a heterogeneous selection of narratives as resources to support recovery, and developing new approaches to supporting non-verbal narrative construction.

The mechanisms and processes of connection: developing a causal chain model capturing impacts of receiving recorded mental health recovery narratives.

BACKGROUND: Mental health recovery narratives are a core component of recovery-oriented interventions such as peer support and anti-stigma campaigns. A substantial number of recorded recovery narratives are now publicly available online in different modalities and in published books. Whilst the benefits of telling one's story have been investigated, much less is known about how recorded narratives of differing modalities impact on recipients. A previous qualitative study identified connection to the narrator and/or to events in the narrative to be a core mechanism of change. The factors that influence how individuals connect with a recorded narrative are unknown. The aim of the current study was to characterise the immediate effects of receiving recovery narratives presented in a range of modalities (text, video and audio), by establishing the mechanisms of connection and the processes by which connection leads to outcomes. METHOD: A study involving 40 mental health service users in England was conducted. Participants were presented with up to 10 randomly-selected recovery narratives and were interviewed on the immediate impact of each narrative. Thematic analysis was used to identify the mechanisms of connection and how connection leads to outcome. RESULTS: Receiving a recovery narrative led participants to reflect upon their own experiences or those of others, which then led to connection through three mechanisms: comparing oneself with the narrative and narrator; learning about other's experiences; and experiencing empathy. These mechanisms led to outcomes through three processes: the identification of change (through attending to narrative structure); the interpretation of change (through attending to narrative content); and the internalisation of interpretations. CONCLUSIONS: This is the first study to identify mechanisms and processes of connection with recorded recovery narratives. The empirically-based causal chain model developed in this study describes the immediate effects on recipients. This model can inform selection of narratives for use in interventions, and be used to support peer support workers in recounting their own recovery narratives in ways which are maximally beneficial to others.

Mental Health Recovery Narratives and Their Impact on Recipients: Systematic Review and Narrative Synthesis.

OBJECTIVE: Mental health recovery narratives are often shared in peer support work and antistigma campaigns. Internet technology provides access to an almost unlimited number of narratives, and yet little is known about how they affect recipients. The aim of this study was to develop a conceptual framework characterizing the impact of recovery narratives on recipients. METHOD: A systematic review of evidence about the impact of mental health recovery narratives was conducted. Searches used electronic databases (n = 9), reference tracking, hand-searching of selected journals (n = 2), grey literature searching, and expert consultation (n = 7). A conceptual framework was generated through a thematic analysis of included articles, augmented by consultation with a Lived Experience Advisory Panel. RESULTS: In total, 8137 articles were screened. Five articles were included. Forms of impact were connectedness, understanding of recovery, reduction in stigma, validation of personal experience, affective responses, and behavioural responses. Impact was moderated by characteristics of the recipient, context, and narrative. Increases in eating disorder behaviours were identified as a harmful response specific to recipients with eating disorders. CONCLUSIONS: Mental health recovery narratives can promote recovery. Recovery narratives might be useful for clients with limited access to peers and in online interventions targeted at reducing social isolation in rural or remote locations, but support is needed for the processing of the strong emotions that can arise. Caution is needed for use with specific clinical populations. Protocol registration: Prospero-CRD42018090923.

Characteristics of positive feedback provided by UK health service users: content analysis of examples from two databases.

BACKGROUND: Most feedback received by health services is positive. Our systematic scoping review mapped all available empirical evidence for how positive patient feedback creates healthcare change. Most included papers did not provide specific details on positive feedback characteristics. OBJECTIVES: Describe positive feedback characteristics by (1) developing heuristics for identifying positive feedback; (2) sharing annotated feedback examples; (3) describing their positive content. METHODS: 200 items were selected from two contrasting databases: (1) https://careopinion.org.uk/; (2) National Health Service (NHS) Friends and Family Test data collected by an NHS trust. Preliminary heuristics and positive feedback categories were developed from a small convenience sample, and iteratively refined. RESULTS: Categories were identified: positive-only; mixed; narrative; factual; grateful. We propose a typology describing tone (positive-only, mixed), form (factual, narrative) and intent (grateful). Separating positive and negative elements in mixed feedback was sometimes impossible due to ambiguity. Narrative feedback often described the cumulative impact of interactions with healthcare providers, healthcare professionals, influential individuals and community organisations. Grateful feedback was targeted at individual staff or entire units, but the target was sometimes ambiguous. CONCLUSION: People commissioning feedback collection systems should consider mechanisms to maximise utility by limiting ambiguity. Since being enabled to provide narrative feedback can allow contributors to make contextualised statements about what worked for them and why, then there may be trade-offs to negotiate between limiting ambiguity, and encouraging rich narratives. Groups tasked with using feedback should plan the human resources needed for careful inspection, and consider providing narrative analysis training.

Data Integrity Issues With Web-Based Studies: An Institutional Example of a Widespread Challenge.

This paper reports on the growing issues experienced when conducting web-based-based research. Nongenuine participants, repeat responders, and misrepresentation are common issues in health research posing significant challenges to data integrity. A summary of existing data on the topic and the different impacts on studies is presented. Seven case studies experienced by different teams within our institutions are then reported, primarily focused on mental health research. Finally, strategies to combat these challenges are presented, including protocol development, transparent recruitment practices, and continuous data monitoring. These strategies and challenges impact the entire research cycle and need to be considered prior to, during, and post data collection. With a lack of current clear guidelines on this topic, this report attempts to highlight considerations to be taken to minimize the impact of such challenges on researchers, studies, and wider research. Researchers conducting web-based research must put mitigating strategies in place, and reporting on mitigation efforts should be mandatory in grant applications and publications to uphold the credibility of web-based research.

Using online methods to recruit participants into mental health clinical trials: considerations and recommendations from the RE-MIND study.

BACKGROUND: Ensuring diversity in clinical trials can be a challenge, which may be exacerbated when recruiting vulnerable populations, such as participants with mental health illness. As recruitment continues to be the major cause of trial delays, researchers are turning to online recruitment strategies, e.g. social media, to reach a wider population and reduce recruitment time and costs. There is mixed evidence for the use of online recruitment strategies; therefore, the REcruitment in Mental health trials: broadening the 'net', opportunities for INclusivity through online methoDs (RE-MIND) study aimed to identify evidence and provide guidance for use of online strategies in recruitment to mental health trials, with a focus on whether online strategies can enhance inclusivity. This commentary, as part of the RE-MIND study, focusses on providing recommendations for recruitment strategy selection in future research with the aim to improve trial efficiency. A mixed-methods approach was employed involving three work packages: (I) an evidence review of a cohort of 97 recently published randomised controlled trials/feasibility or pilot studies in mental health to assess the impact of online versus offline recruitment; (II) a qualitative study investigating the experiences of n = 23 key stakeholders on use of an online recruitment approach in mental health clinical trials; (III) combining the results of WP1 and WP2 to produce recommendations on the use of an online recruitment strategy in mental health clinical trials. The findings from WP1 and 2 have been published elsewhere; this commentary represents the results of the third work package. CONCLUSION: For external validity, clinical trial participants should reflect the populations that will ultimately receive the interventions being tested, if proven effective. To guide researchers on their options for inclusive recruitment strategies, we have developed a list of considerations and practical recommendations on how to maximise the use of online recruitment methods.

The Implementation of Recommender Systems for Mental Health Recovery Narratives: Evaluation of Use and Performance.

BACKGROUND: Recommender systems help narrow down a large range of items to a smaller, personalized set. NarraGive is a first-in-field hybrid recommender system for mental health recovery narratives, recommending narratives based on their content and narrator characteristics (using content-based filtering) and on narratives beneficially impacting other similar users (using collaborative filtering). NarraGive is integrated into the Narrative Experiences Online (NEON) intervention, a web application providing access to the NEON Collection of recovery narratives. OBJECTIVE: This study aims to analyze the 3 recommender system algorithms used in NarraGive to inform future interventions using recommender systems for lived experience narratives. METHODS: Using a recently published framework for evaluating recommender systems to structure the analysis, we compared the content-based filtering algorithm and collaborative filtering algorithms by evaluating the accuracy (how close the predicted ratings are to the true ratings), precision (the proportion of the recommended narratives that are relevant), diversity (how diverse the recommended narratives are), coverage (the proportion of all available narratives that can be recommended), and unfairness (whether the algorithms produce less accurate predictions for disadvantaged participants) across gender and ethnicity. We used data from all participants in 2 parallel-group, waitlist control clinical trials of the NEON intervention (NEON trial: N=739; NEON for other [eg, nonpsychosis] mental health problems [NEON-O] trial: N=1023). Both trials included people with self-reported mental health problems who had and had not used statutory mental health services. In addition, NEON trial participants had experienced self-reported psychosis in the previous 5 years. Our evaluation used a database of Likert-scale narrative ratings provided by trial participants in response to validated narrative feedback questions. RESULTS: Participants from the NEON and NEON-O trials provided 2288 and 1896 narrative ratings, respectively. Each rated narrative had a median of 3 ratings and 2 ratings, respectively. For the NEON trial, the content-based filtering algorithm performed better for coverage; the collaborative filtering algorithms performed better for accuracy, diversity, and unfairness across both gender and ethnicity; and neither algorithm performed better for precision. For the NEON-O trial, the content-based filtering algorithm did not perform better on any metric; the collaborative filtering algorithms performed better on accuracy and unfairness across both gender and ethnicity; and neither algorithm performed better for precision, diversity, or coverage. CONCLUSIONS: Clinical population may be associated with recommender system performance. Recommender systems are susceptible to a wide range of undesirable biases. Approaches to mitigating these include providing enough initial data for the recommender system (to prevent overfitting), ensuring that items can be accessed outside the recommender system (to prevent a feedback loop between accessed items and recommended items), and encouraging participants to provide feedback on every narrative they interact with (to prevent participants from only providing feedback when they have strong opinions).

Perception and appropriation of a web-based recovery narratives intervention: qualitative interview study.

Introduction: Mental health recovery narratives are widely available to the public, and can benefit people affected by mental health problems. The NEON Intervention is a novel web-based digital health intervention providing access to the NEON Collection of recovery narratives. The NEON Intervention was found to be effective and cost-effective in the NEON-O Trial for people with nonpsychosis mental health problems (ISRCTN63197153), and has also been evaluated in the NEON Trial for people with psychosis experience (ISRCTN11152837). We aimed to document NEON Intervention experiences, through an integrated process evaluation. Methods: Analysis of interviews with a purposive sample of intervention arm participants who had completed trial participation. Results: We interviewed 34 NEON Trial and 20 NEON-O Trial participants (mean age 40.4 years). Some users accessed narratives through the NEON Intervention almost daily, whilst others used it infrequently or not at all. Motivations for trial participation included: exploring the NEON Intervention as an alternative or addition to existing mental health provision; searching for answers about mental health experiences; developing their practice as a mental health professional (for a subset who were mental health professionals); claiming payment vouchers. High users (10 + narrative accesses) described three forms of appropriation: distracting from difficult mental health experiences; providing an emotional boost; sustaining a sense of having a social support network. Most participants valued the scale of the NEON Collection (n = 659 narratives), but some found it overwhelming. Many felt they could describe the characteristics of a desired narrative that would benefit their mental health. Finding a narrative meeting their desires enhanced engagement, but not finding one reduced engagement. Narratives in the NEON Collection were perceived as authentic if they acknowledged the difficult reality of mental health experiences, appeared to describe real world experiences, and described mental health experiences similar to those of the participant. Discussion: We present recommendations for digital health interventions incorporating collections of digital narratives: (1) make the scale and diversity of the collection visible; (2) provide delivery mechanisms that afford appropriation; (3) enable contributors to produce authentic narratives; (4) enable learning by healthcare professionals; (5) consider use to address loneliness.

Effectiveness and cost-effectiveness of online recorded recovery narratives in improving quality of life for people with non-psychotic mental health problems: a pragmatic randomized controlled trial.

Narratives describing first-hand experiences of recovery from mental health problems are widely available. Emerging evidence suggests that engaging with mental health recovery narratives can benefit people experiencing mental health problems, but no randomized controlled trial has been conducted as yet. We developed the Narrative Experiences Online (NEON) Intervention, a web application providing self-guided and recommender systems access to a collection of recorded mental health recovery narratives (n=659). We investigated whether NEON Intervention access benefited adults experiencing non-psychotic mental health problems by conducting a pragmatic parallel-group randomized trial, with usual care as control condition. The primary endpoint was quality of life at week 52 assessed by the Manchester Short Assessment (MANSA). Secondary outcomes were psychological distress, hope, self-efficacy, and meaning in life at week 52. Between March 9, 2020 and March 26, 2021, we recruited 1,023 participants from across England (the target based on power analysis was 994), of whom 827 (80.8%) identified as White British, 811 (79.3%) were female, 586 (57.3%) were employed, and 272 (26.6%) were unemployed. Their mean age was 38.4±13.6 years. Mood and/or anxiety disorders (N=626, 61.2%) and stress-related disorders (N=152, 14.9%) were the most common mental health problems. At week 52, our intention-to-treat analysis found a significant baseline-adjusted difference of 0.13 (95% CI: 0.01-0.26, p=0.041) in the MANSA score between the intervention and control groups, corresponding to a mean change of 1.56 scale points per participant, which indicates that the intervention increased quality of life. We also detected a significant baseline-adjusted difference of 0.22 (95% CI: 0.05-0.40, p=0.014) between the groups in the score on the "presence of meaning" subscale of the Meaning in Life Questionnaire, corresponding to a mean change of 1.1 scale points per participant. We found an incremental gain of 0.0142 quality-adjusted life years (QALYs) (95% credible interval: 0.0059 to 0.0226) and a £178 incremental increase in cost (95% credible interval: -£154 to £455) per participant, generating an incremental cost-effectiveness ratio of £12,526 per QALY compared with usual care. This was lower than the £20,000 per QALY threshold used by the National Health Service in England, indicating that the intervention would be a cost-effective use of health service resources. In the subgroup analysis including participants who had used specialist mental health services at baseline, the intervention both reduced cost (-£98, 95% credible interval: -£606 to £309) and improved QALYs (0.0165, 95% credible interval: 0.0057 to 0.0273) per participant as compared to usual care. We conclude that the NEON Intervention is an effective and cost-effective new intervention for people experiencing non-psychotic mental health problems.