Distinguishing emotional distress from mental disorder: A qualitative exploration of the Four-Dimensional Symptom Questionnaire (4DSQ).

BACKGROUND: Primary care clinicians see people experiencing the full range of mental health problems. Determining when symptoms reflect disorder is complex. The Four-Dimensional Symptom Questionnaire (4DSQ) uniquely distinguishes general distress from depressive and anxiety disorders. It may support diagnostic conversations and targeting of treatment. AIM: We aimed to explore peoples' experiences of completing the 4DSQ and their perceptions of their resulting score profile across distress, depression, anxiety and physical symptoms. DESIGN AND SETTING: A qualitative study conducted in the UK with people recruited from primary care and community settings. METHOD: Participants completed the 4DSQ then took part in semi-structured telephone interviews. They were interviewed about their experience of completing the 4DSQ, their perceptions of their scores across four dimensions, and the perceived utility if used with a clinician. Interviews were transcribed verbatim and data were analysed thematically. RESULTS: Twenty-four interviews were conducted. Most participants found the 4DSQ easy to complete and reported that scores across the four dimensions aligned well with their symptom experience. Distinct scores for distress, depression and anxiety appeared to support improved self-understanding. Some valued the opportunity to discuss their scores and provide relevant context. Many felt the use of the 4DSQ with clinicians would be helpful and likely to support treatment decisions, although some were concerned about time-limited consultations. CONCLUSION: Distinguishing general distress from depressive and anxiety disorders aligned well with people's experience of symptoms. Use of the 4DSQ as part of mental health consultations may support targeting of treatment and personalisation of care.

Depression follow-up monitoring with the PHQ-9: open cluster-randomised controlled trial.

BACKGROUND: Outcome monitoring of depression is recommended but lacks evidence of patient benefit in primary care. AIM: To test monitoring depression using the PHQ-9 questionnaire with patient feedback. DESIGN AND SETTING: Open cluster-randomised controlled trial in 141 group practices. METHOD: Adults with new depressive episodes were recruited through records searches and opportunistically. EXCLUSION CRITERIA: dementia, psychosis, substance misuse, suicide risk. The PHQ-9 questionnaire was to be administered soon after diagnosis, and 10-35 days later. PRIMARY OUTCOME: Beck Depression Inventory (BDI-II) score at 12 weeks. SECONDARY OUTCOMES: BDI-II at 26 weeks; Work and Social Adjustment Scale and EuroQol EQ-5D-5L quality of life at 12 and 26 weeks; antidepressant treatment, mental health service use, adverse events, and Medical Informant Satisfaction Scale over 26 weeks. RESULTS: 302 intervention arm patients were recruited and 227 controls. At 12 weeks 252 (83.4%) and 195 (85.9%) were followed-up respectively. Only 41% of intervention arm patients had a GP follow-up PHQ-9 recorded. There was no significant difference in BDI-II score at 12 weeks (mean difference -0.46; 95% CI -2.16,1.26), adjusted for baseline depression, baseline anxiety, sociodemographic factors, and clustering by practice). EQ-5D-5L quality of life scores were higher in the intervention arm at 26 weeks (adjusted mean difference 0.053; 95% CI 0.093,0.013). A clinically significant difference in depression at 26 weeks could not be ruled out. No significant differences were found in social functioning, adverse events, or satisfaction. In a per-protocol analysis, antidepressant use and mental health contacts were significantly greater in intervention arm patients with a recorded follow-up PHQ-9. CONCLUSIONS: No evidence was found of improved depression outcome at 12 weeks from monitoring. The findings of possible benefits over 26 weeks warrant replication, investigating possible mechanisms, preferably with automated delivery of monitoring and more instructive feedback.

Experiences of using a supported digital intervention for cancer survivors in primary care: a qualitative process evaluation.

BACKGROUND: Increasing healthy behaviours (e.g. physical activity) can improve cancer survivors' quality of life. Renewed is a digital intervention developed to provide behaviour change advice with brief healthcare practitioner support. A three-arm randomised controlled trial (Renewed, Renewed with support or a control condition) suggested that prostate cancer survivors in the supported arm had slightly greater estimates of improvements in quality of life compared to other cancer survivors. This study explored participants' experiences using Renewed to understand how it might have worked and why it might have provided greater benefit for prostate cancer survivors and those in the supported arm. METHODS: Thirty-three semi-structured telephone interviews with cancer survivors' (breast, colorectal, prostate) from the Renewed trial explored their experiences of using Renewed and their perceptions of the intervention. Data were analysed using inductive thematic analysis. RESULTS: Some participants only used Renewed modestly but still made behaviour changes. Barriers to using Renewed included low perceived need, joining the study to advance scientific knowledge or 'to give back', or due to perceived availability of support in their existing social networks. Prostate cancer survivors reported less social support outside of Renewed compared to participants with other cancers. CONCLUSION: Renewed may support healthy behaviour changes among cancer survivors even with limited use. Interventions targetting individuals who lack social support may be beneficial. IMPLICATIONS FOR CANCER SURVIVORS: Cancer survivors' experiences may inform the development of digital interventions to better serve this population.

Determining the clinical and cost-effectiveness of nasal sprays and a physical activity and stress management intervention to reduce respiratory tract infections in primary care: A protocol for the 'Immune Defence' randomised controlled trial.

BACKGROUND: Most adults in the UK experience at least one viral respiratory tract infection (RTI) per year. Individuals with comorbidities and those with recurrent RTIs are at higher risk of infections. This can lead to more severe illness, worse quality of life and more days off work. There is promising evidence that using common nasal sprays or improving immune function through increasing physical activity and managing stress, may reduce the incidence and severity of RTIs. METHODS AND DESIGN: Immune Defence is an open, parallel group, randomised controlled trial. Up to 15000 adults from UK general practices, with a comorbidity or risk factor for infection and/or recurrent infections (3 or more infections per year) will be randomly allocated to i) a gel-based nasal spray designed to inhibit viral respiratory infections; ii) a saline nasal spray, iii) a digital intervention promoting physical activity and stress management, or iv) usual care with brief advice for managing infections, for 12 months. Participants will complete monthly questionnaires online. The primary outcome is the total number of days of illness due to RTIs over 6 months. Key secondary outcomes include: days with symptoms moderately bad or worse; days where work/normal activities were impaired; incidence of RTI; incidence of COVID-19; health service contacts; antibiotic usage; beliefs about antibiotics; intention to consult; number of days of illness in total due to respiratory tract infections over 12 months. Economic evaluation from an NHS perspective will compare the interventions, expressed as incremental cost effectiveness ratios. A nested mixed methods process evaluation will examine uptake and engagement with the interventions and trial procedures. TRIAL STATUS: Recruitment commenced in December 2020 and the last participant is expected to complete the trial in April 2024. DISCUSSION: Common nasal sprays and digital interventions to promote physical activity and stress management are low cost, accessible interventions applicable to primary care. If effective, they have the potential to reduce the individual and societal impact of RTIs. TRIAL REGISTRATION: Prospectively registered with ISRCTN registry (17936080) on 30/10/2020. SPONSOR: This RCT is sponsored by University of Southampton. The sponsors had no role in the study design, decision to publish, or preparation of the manuscript.

Psychology Meets Biology in COVID-19: What We Know and Why It Matters for Public Health.

Psychosocial factors are related to immune, viral, and vaccination outcomes. Yet, this knowledge has been poorly represented in public health initiatives during the COVID-19 pandemic. This review provides an overview of biopsychosocial links relevant to COVID-19 outcomes by describing seminal evidence about these associations known prepandemic as well as contemporary research conducted during the pandemic. This focuses on the negative impact of the pandemic on psychosocial health and how this in turn has likely consequences for critically relevant viral and vaccination outcomes. We end by looking forward, highlighting the potential of psychosocial interventions that could be leveraged to support all people in navigating a postpandemic world and how a biopsychosocial approach to health could be incorporated into public health responses to future pandemics.

How do people with MND and caregivers experience a digital mental health intervention? A qualitative study.

Objective: We urgently need to develop and evaluate more psychological interventions to support people with Motor Neurone Disease (MND) and caregivers. We used the person-based approach to develop a digital mental health intervention and conducted two studies to explore people's experiences of using it. Methods: In Study 1, we conducted think-aloud interviews with 9 people with MND and 8 caregivers, and used findings to refine the intervention. In Study 2, 18 people with MND and 9 caregivers used the intervention for 6 weeks after which in-depth interviews were conducted. Data from both studies were combined and analysed using thematic analysis. Results: We developed 3 main themes around intervention acceptability, engagement, and usefulness. Participants highlighted the importance of accessibility and realistic presentation of information and support. Tailoring and timing intervention use to suit own needs, preferences, and disease stage was also important. Participants used the strategies presented to develop a positive outlook and regain some control. They also faced some challenges using these strategies in the context of dealing with progressive loss. Conclusion: People with MND and caregivers can find digital mental health interventions useful. Intervention accessibility and flexibility are important for developing acceptable and engaging interventions for MND.

Experiences of psychological interventions in neurodegenerative diseases: a systematic review and thematic synthesis.

Background: Psychological interventions for managing emotional distress in neurodegenerative diseases are needed, but progressive worsening of symptoms and increasing disability might pose difficulties with engagement. We aimed to synthesise the experiences of engaging with and using psychological interventions in neurodegenerative diseases and identify relevant barriers and facilitators. Methods: Systematic searches were conducted in six electronic databases and results were screened. We included qualitative and mixed methods studies reporting patient or caregivers' views or experiences of psychological interventions. Qualitative data were extracted and thematically synthesised. Results: 34 papers were included, covering a range of diseases and interventions. Engagement was facilitated by flexible intervention formats and tailoring to the specific needs of people with neurodegenerative diseases. Interventions were sometimes inaccessible or burdensome because of physical and cognitive symptoms, and the time and effort required for the intervention. Participants' levels of acceptance and readiness often differed and influenced engagement with the intervention. Across different interventions, participants experienced wide-ranging benefits including changes in insight, perspective, self-efficacy, emotions and relationships. Conclusion: Although people with neurodegenerative diseases and caregivers experience benefits from psychological interventions, burden-reducing adaptations and sensitive tailoring to the specific disease context is required to improve acceptability and engagement.

A randomised controlled trial of a digital intervention (Renewed) to support symptom management, wellbeing and quality of life in cancer survivors.

BACKGROUND: Many cancer survivors following primary treatment have prolonged poor quality of life. AIM: To determine the effectiveness of a bespoke digital intervention to support cancer survivors. DESIGN: Pragmatic parallel open randomised trial. SETTING: UK general practices. METHODS: People having finished primary treatment (<= 10 years previously) for colo-rectal, breast or prostate cancers, with European-Organization-for-Research-and-Treatment-of-Cancer QLQ-C30 score <85, were randomised by online software to: 1)detailed 'generic' digital NHS support ('LiveWell';n=906), 2) a bespoke complex digital intervention ('Renewed';n=903) addressing symptom management, physical activity, diet, weight loss, distress, or 3) 'Renewed-with-support' (n=903): 'Renewed' with additional brief email and telephone support. RESULTS: Mixed linear regression provided estimates of the differences between each intervention group and generic advice: at 6 months (primary time point: n's respectively 806;749;705) all groups improved, with no significant between-group differences for EORTC QLQ-C30, but global health improved more in both intervention groups. By 12 months there were: small improvements in EORTC QLQ-C30 for Renewed-with-support (versus generic advice: 1.42, 95% CIs 0.33-2.51); both groups improved global health (12 months: renewed: 3.06, 1.39-4.74; renewed-with-support: 2.78, 1.08-4.48), dyspnoea, constipation, and enablement, and lower NHS costs (generic advice £265: in comparison respectively £141 (153-128) and £77 (90-65) lower); and for Renewed-with-support improvement in several other symptom subscales. No harms were identified. CONCLUSION: Cancer survivors quality of life improved with detailed generic online support. Robustly developed bespoke digital support provides limited additional short term benefit, but additional longer term improvement in global health enablement and symptom management, with substantially lower NHS costs.

Using nasal sprays to prevent respiratory tract infections: a qualitative study of online consumer reviews and primary care patient interviews.

OBJECTIVES: Nasal sprays could be a promising approach to preventing respiratory tract infections (RTIs). This study explored lay people's perceptions and experiences of using nasal sprays to prevent RTIs to identify barriers and facilitators to their adoption and continued use. DESIGN: Qualitative research. Study 1 thematically analysed online consumer reviews of an RTI prevention nasal spray. Study 2 interviewed patients about their reactions to and experiences of a digital intervention that promotes and supports nasal spray use for RTI prevention (reactively: at 'first signs' of infection and preventatively: following possible/probable exposure to infection). Interview transcripts were analysed using thematic analysis. SETTING: Primary care, UK. PARTICIPANTS: 407 online customer reviews. 13 purposively recruited primary care patients who had experienced recurrent infections and/or had risk factors for severe infections. RESULTS: Both studies identified various factors that might influence nasal spray use including: high motivation to avoid RTIs, particularly during the COVID-19 pandemic; fatalistic views about RTIs; beliefs about alternative prevention methods; the importance of personal recommendation; perceived complexity and familiarity of nasal sprays; personal experiences of spray success or failure; tolerable and off-putting side effects; concerns about medicines; and the nose as unpleasant and unhygienic. CONCLUSIONS: People who suffer disruptive, frequent or severe RTIs or who are vulnerable to RTIs are interested in using a nasal spray for prevention. They also have doubts and concerns and may encounter problems. Some of these may be reduced or eliminated by providing nasal spray users with information and advice that addresses these concerns or helps people overcome difficulties.

Implementing a Health Care Professional-Supported Digital Intervention for Survivors of Cancer in Primary Care: Qualitative Process Evaluation of the Renewed Intervention.

BACKGROUND: Primary care plays an important role in supporting survivors of cancer; however, support is limited because of practitioners' perceived lack of expertise and time. A digital intervention for survivors of cancer could provide an efficient way for primary care staff to support survivors of cancer without the need to accumulate expertise and skills to help patients make behavior changes; providing very brief support alongside this could maximize adherence to digital interventions. Renewed is a digital intervention that combines web-based behavior change advice with brief health care practitioner support from a nurse or health care assistant. Knowledge about the views and experiences of primary care staff providing support alongside a digital intervention for survivors of cancer is sparse, limiting the understanding of the acceptability and feasibility of this type of intervention. OBJECTIVE: This study aims to explore supporters' experiences of providing support to survivors of cancer using Renewed, understand potential barriers to and facilitators of the implementation of Renewed in practice, and investigate the strengths and weaknesses of the intervention from the perspective of health care professionals. METHODS: This was a qualitative process evaluation nested within a large trial evaluating Renewed. A total of 28 semistructured telephone interviews were conducted with nurses and health care assistants. Data were analyzed using inductive thematic analysis. RESULTS: Four themes were developed during the analysis, which reflected the factors that supporters identified as hindering or enabling them to provide support alongside Renewed Online: Renewed Online as an acceptable digital tool with some improvements, confidence in enacting the supporter role, practicalities of delivering support alongside a digital intervention, and managing a patient-led approach. The analysis suggests that supporters perceived that a digital intervention such as Renewed would be beneficial in supporting survivors of cancer in primary care and fit within current practices. However, barriers to providing support alongside the intervention were also identified, including concerns about how to facilitate rapport building and, in a minority, concerns about using a nondirective approach, in which most advice and support is provided through digital interventions, with brief additional support provided by primary care staff. CONCLUSIONS: These findings add to the literature on how best to provide support alongside digital interventions, suggesting that although most practitioners cope well with a nondirective approach, a minority requires more training to feel confident in implementing this. This study suggests that the barriers to providing formal support to survivors of cancer in primary care could be successfully overcome with an approach such as Renewed, where a digital intervention provides most of the support and expertise, and health care practitioners provide additional brief human support to maximize engagement. Strategies to maximize the chances of successful implementation for this type of intervention are also discussed.

Patient perceptions of vulnerability to recurrent respiratory tract infections and prevention strategies: a qualitative study.

OBJECTIVES: Respiratory tract infections (RTIs) are extremely common, usually self-limiting, but responsible for considerable work sickness absence, reduced quality of life, inappropriate antibiotic prescribing and healthcare costs. Patients who experience recurrent RTIs and those with certain comorbid conditions have higher personal impact and healthcare costs and may be more likely to suffer disease exacerbations, hospitalisation and death. We explored how these patients experience and perceive their RTIs to understand how best to engage them in prevention behaviours. DESIGN: A qualitative interview study. SETTING: Primary care, UK. METHODS: 23 participants who reported recurrent RTIs and/or had relevant comorbid health conditions were interviewed about their experiences of RTIs. Interviews took place as the COVID-19 pandemic began. Data were analysed using inductive thematic analysis. RESULTS: Three themes were developed: Understanding causes and vulnerability, Attempting to prevent RTIs, Uncertainty and ambivalence about prevention, along with an overarching theme; Changing experiences because of COVID-19. Participants' understandings of their susceptibility to RTIs were multifactorial and included both transmission via others and personal vulnerabilities. They engaged in various approaches to try to prevent infections or alter their progression yet perceived they had limited personal control. The COVID-19 pandemic had improved their understanding of transmission, heightened their concern and motivation to avoid RTIs and extended their repertoire of protective behaviours. CONCLUSIONS: Patients who experience frequent or severe RTIs are likely to welcome and benefit from advice and support regarding RTI prevention. To engage people effectively, those developing interventions or delivering health services must consider their beliefs and concerns about susceptibility and prevention.

Developing an internet-delivered intervention targeting residual cognitive symptoms after major depressive disorder: a person-based approach.

BACKGROUND: Cognitive difficulties are rarely addressed after the treatment of major depressive disorder (MDD). New scalable treatments are needed. To ensure relevance and engagement of novel interventions, there is a need to understand the perspectives of the users. AIM: Explore former depressed adults needs and perspectives during the planning and development of a novel internet-delivered intervention targeting residual cognitive symptoms after MDD. METHOD: The planning phase included exploratory qualitative interviews with former depressed adults (n = 16). In the development phase, a prototype including psychoeducation, attention training and compensatory strategies was tested in think-aloud interviews with former depressed adults (n = 7) and psychologists (n = 4). Data were analysed thematically. RESULTS: Analysis of exploratory interviews identified four themes. Experiences of residual cognitive symptoms consisted of two sub-themes (Everyday life is more demanding; Concerns about cognitive difficulties). Coping with residual cognitive symptoms had two sub-themes (Compensatory strategies; Acceptance). Needs from an intervention consisted of two-subthemes (Need for information; Therapist support). Barriers for engagement consisted of three sub-themes (Being overwhelmed; Not being motivated; Frequent registration). Analysis of think-aloud interviews was organized into three themes: Positive perceptions of content; Concerns regarding content; Perceptions of Layout, Visuals and Navigation. CONCLUSION: The intervention may address concerns and consequences of cognitive difficulties by including psychoeducation, compensatory strategies and elements to increase acceptance and motivation, provided in manageable proportions.

Findings from the development and implementation of a novel course consisting of both group and individual Alexander Technique lessons for low back pain.

OBJECTIVES: (1) To develop a mixed course of individual and group lessons in the Alexander Technique (AT) for low back pain, and (2) to explore its: (a) effectiveness and (b) acceptability to both participant AT teachers and patients. DESIGN: Single-centre study, mixed methods. SETTING: Members of the public in the Brighton area (community recruitment), and patients from six Hampshire General Practices (GP) (National Health Service (NHS) recruitment). PARTICIPANTS: People with chronic or recurrent low back pain; AT teachers. INTERVENTIONS: Iterative development and implementation of a 10-lesson (6 group, 4 individual) AT course. OUTCOME MEASURES: Perceptions from semistructured interviews analysed using inductive thematic analysis. Descriptive analysis of RMDQ (Roland-Morris Disability Questionnaire) over 12 weeks. RESULTS: Thirty-nine participants with low back pain were included and 32 AT teachers were interviewed, 7 of whom taught on the course. Some participants had reservations, preferring only individual lessons, but the majority found the sharing of experience and learning in groups helpful. There was also concern regarding group teaching among some AT teachers, but most also found it acceptable. By 12 weeks, RMDQ score among participants fell from 10.38 to 4.39, a change of -5.99. 29 of 39 (74%) participants had a clinically important reduction in RMDQ score of 2.5 or more. CONCLUSION: Some patients and practitioners had reservations about group AT lessons, but most found groups helpful. Further development is needed, but the course of individual and group lessons has the potential to cost-effectively deliver clinically important benefits to patients with back pain, who are known to improve little and slowly.

Emotional distress and well-being among people with motor neurone disease (MND) and their family caregivers: a qualitative interview study.

OBJECTIVE: We aimed to get an in-depth understanding of the emotions experienced by people with motor neurone disease (MND) and their caregivers, and to explore what impacts emotional distress and well-being. DESIGN: Qualitative study using semi-structured interviews with people with MND and caregivers. SETTING: Participants were recruited from across the UK and took part in interviews conducted either face to face, by telephone or email to accommodate for varying levels of disability. PARTICIPANTS: 25 people with MND and 10 caregivers took part. Participants were purposively sampled based on their MND diagnosis, symptoms and time since diagnosis. DATA ANALYSIS: Data were analysed using inductive reflexive thematic analysis. RESULTS: Eight broad themes were generated (20 subthemes). Participants described the emotional distress of losing physical function and having a threatened future because of poor prognosis. Keeping up with constant changes in symptoms and feeling unsupported by the healthcare system added to emotional distress. Finding hope and positivity, exerting some control, being kinder to oneself and experiencing support from others were helpful strategies for emotional well-being. CONCLUSION: The study provides a broad understanding of what impacts emotional distress and well-being and discusses implications for psychological interventions for people with MND and caregivers. Any communication and support provided for people with MND and their caregivers, needs to pay attention to concepts of hope, control and compassion.

A Digital Intervention for Primary Care Practitioners to Support Antidepressant Discontinuation (Advisor for Health Professionals): Development Study.

BACKGROUND: The number of people receiving antidepressants has increased in the past 3 decades, mainly because of people staying on them longer. However, in many cases long-term treatment is not evidence based and risks increasing side effects. Additionally, prompting general practitioners (GPs) to review medication does not improve the rate of appropriate discontinuation. Therefore, GPs and other health professionals may need help to support patients discontinuing antidepressants in primary care. OBJECTIVE: This study aims to develop a digital intervention to support practitioners in helping patients discontinue inappropriate long-term antidepressants (as part of a wider intervention package including a patient digital intervention and patient telephone support). METHODS: A prototype digital intervention called Advisor for Health Professionals (ADvisor HP) was planned and developed using theory, evidence, and a person-based approach. The following elements informed development: a literature review and qualitative synthesis, an in-depth qualitative study, the development of guiding principles for design elements, and theoretical behavioral analyses. The intervention was then optimized through think-aloud qualitative interviews with health professionals while they were using the prototype intervention. RESULTS: Think-aloud qualitative interviews with 19 health professionals suggested that the digital intervention contained useful information and was readily accessible to practitioners. The development work highlighted a need for further guidance on drug tapering schedules for practitioners and clarity about who is responsible for broaching the subject of discontinuation. Practitioners highlighted the need to have information in easily and quickly accessible formats because of time constraints in day-to-day practice. Some GPs felt that some information was already known to them but understood why this was included. Practitioners differed in their ideas about how they would use ADvisor HP in practice, with some preferring to read the resource in its entirety and others wanting to dip in and out as needed. Changes were made to the wording and structure of the intervention in response to the feedback provided. CONCLUSIONS: ADvisor HP is a digital intervention that has been developed using theory, evidence, and a person-based approach. The optimization work suggests that practitioners may find this tool to be useful in supporting the reduction of long-term antidepressant use. Further quantitative and qualitative evaluation through a randomized controlled trial is needed to examine the feasibility, effectiveness, and cost-effectiveness of the intervention.

Self-management for chronic widespread pain including fibromyalgia: A systematic review and meta-analysis.

BACKGROUND: Chronic widespread pain (CWP) including fibromyalgia has a prevalence of up to 15% and is associated with substantial morbidity. Supporting psychosocial and behavioural self-management is increasingly important for CWP, as pharmacological interventions show limited benefit. We systematically reviewed the effectiveness of interventions applying self-management principles for CWP including fibromyalgia. METHODS: MEDLINE, Embase, PsycINFO, The Cochrane Central Register of Controlled Trials and the WHO International Clinical Trials Registry were searched for studies reporting randomised controlled trials of interventions adhering to self-management principles for CWP including fibromyalgia. Primary outcomes included physical function and pain intensity. Where data were sufficient, meta-analysis was conducted using a random effects model. Studies were narratively reviewed where meta-analysis could not be conducted Evidence quality was rated using GRADE (Grading of Recommendations, Assessment, Development and Evaluations) (PROSPERO-CRD42018099212). RESULTS: Thirty-nine completed studies were included. Despite some variability in studies narratively reviewed, in studies meta-analysed self-management interventions improved physical function in the short-term, post-treatment to 3 months (SMD 0.42, 95% CI 0.20, 0.64) and long-term, post 6 months (SMD 0.36, 95% CI 0.20, 0.53), compared to no treatment/usual care controls. Studies reporting on pain narratively had greater variability, however, those studies meta-analysed showed self-management interventions reduced pain in the short-term (SMD -0.49, 95% CI -0.70, -0.27) and long-term (SMD -0.38, 95% CI -0.58, -0.19) compared to no treatment/usual care. There were few differences in physical function and pain when self-management interventions were compared to active interventions. The quality of the evidence was rated as low. CONCLUSION: Reviewed studies suggest self-management interventions can be effective in improving physical function and reducing pain in the short and long-term for CWP including fibromyalgia. However, the quality of evidence was low. Future research should address quality issues whilst making greater use of theory and patient involvement to understand reported variability.

Intervention Planning for the Tinnitus E-Programme 2.0, an Internet-Based Cognitive Behavioral Intervention for Tinnitus.

Purpose The purpose of this study is to comprehensively describe the intervention planning process for the Tinnitus E-Programme 2.0, an Internet-based cognitive behavioral intervention for tinnitus. Method Theory-, evidence-, and person-based approaches to intervention development were used. In Phase 1, quantitative systematic reviews were used to identify potentially effective intervention techniques and design features. Primary mixed-methods research involving adults with tinnitus explored the acceptability of the first version of the intervention. In Phase 2, person-based guiding principles highlighted key intervention design objectives and features to address needs of the intervention's target group (identified in Phase 1) to maximize its acceptability, feasibility of delivery, and effectiveness. Theory-based "behavioral analysis" and "logic modeling" comprehensively described intervention content and potential mechanisms of action. From this planning work, a prototype intervention was developed. Results The intervention design objectives outlined in the guiding principles were to (a) normalize tinnitus, (b) support users to maintain a regular relaxation practice, (c) minimize the worsening of users' tinnitus sensation, and (d) ensure the intervention is accessible to those with hearing loss. Behavioral analysis and logic modeling identified intervention processes (e.g., illness perceptions, beliefs about consequences, skills, goals) and purported mediators (acceptance of tinnitus, negative thinking, use of the cognitive skills tools for managing negative thoughts, and practicing regular relaxation) hypothesized to facilitate reductions in tinnitus symptom severity. Conclusions The guiding principles highlight key design objectives and features to consider when developing interventions for tinnitus. The logic model offers hypothesized mechanisms of action that can be tested in future process analyses.

Views and experiences of people with acne vulgaris and healthcare professionals about treatments: systematic review and thematic synthesis of qualitative research.

OBJECTIVES: The objective of this study was to systematically review and synthesise qualitative papers exploring views and experiences of acne and its treatments among people with acne, their carers and healthcare professionals (HCPs). DESIGN: Systematic review and synthesis of qualitative papers. METHODS: Papers were identified through Medline, EMBASE, PubMed, PsychINFO and CINAHL on 05 November 2019, forward and backward citation searching, Google Scholar and contacting authors. Inclusion criteria were studies reporting qualitative data and analysis, studies carried out among people with acne, their carers or HCPs and studies comprising different skin conditions, including acne. The title and abstracts of papers were independently screened by three researchers. Appraisal was carried out using the adapted Critical Appraisal Skills Programme tool. Thematic synthesis was used to synthesise findings. RESULTS: A total of 20 papers were included from six countries. Papers explored; experiences living with acne, psychosocial impact of acne, views on causation of acne, perceptions of acne treatments, ambivalence and ambiguity in young people's experience of acne and HCPs' attitudes towards acne management. Findings suggest that people often viewed acne as short-term and that this had implications for acne management, particularly long-term treatment adherence. People often felt that the substantial impact of acne was not recognised by others, or that their condition was 'trivialised' by HCPs. The sense of a lack of control over acne and control over treatment was linked to both psychological impact and treatment adherence. Concerns and uncertainty over acne treatments were influenced by variable advice and information from others. CONCLUSIONS: People need support with understanding the long-term management of acne, building control over acne and its treatments, acknowledging the impact and appropriate information to reduce the barriers to effective treatment use. PROSPERO REGISTRATION NUMBER: CRD42016050525.

Supporting Self-management Among Young People With Acne Vulgaris Through a Web-Based Behavioral Intervention: Development and Feasibility Randomized Controlled Trial.

BACKGROUND: Acne is a common skin condition that is most prevalent in young people. It can have a substantial impact on the quality of life, which can be minimized with the appropriate use of topical treatments. Nonadherence to topical treatments for acne is common and often leads to treatment failure. OBJECTIVE: The aim of this study is to develop a web-based behavioral intervention to support the self-management of acne and to assess the feasibility of recruitment, retention, and engagement of users with the intervention. METHODS: The intervention was developed iteratively using the LifeGuide software and following the person-based approach for intervention development. The target behavior was appropriate use of topical treatments. Barriers and facilitators identified from the qualitative research and evidence from the wider literature were used to identify techniques to improve and promote their use. Young people with acne aged 14-25 years who had received treatment for acne in the past 6 months were invited to participate through mail-out from primary care practices in the South of England in a parallel, unblinded randomized trial. Participants were automatically randomized using a computer-generated algorithm to usual care or to usual care plus access to the web-based intervention. Usage data was collected, and a series of questionnaires, including the primary outcome measure for skin-specific quality of life (Skindex-16), were collected at baseline and at the 4- and 6-week follow-ups. RESULTS: A total of 1193 participants were invited, and 53 young people with acne were randomized to usual care (27/53, 51%) or usual care plus intervention (26/53, 49%). The response rate for the primary outcome measure (Skindex-16) was 87% at 4 weeks, 6 weeks, and at both time points. The estimate of mean scores between groups (with 95% CI) using linear regression showed a trend in the direction of benefit for the web-based intervention group in the primary outcome measure (Skindex-16) and secondary measures (Patient Health Questionnaire-4 and the Problematic Experiences of Therapy Scale). Intervention usage data showed high uptake of the core module in the usual care plus web-based intervention group, with 88% (23/26) of participants completing the module. Uptake of the optional modules was low, with less than half visiting each (myth-busting quiz: 27%; living with spots or acne: 42%; oral antibiotics: 19%; what are spots or acne: 27%; other treatments: 27%; talking to your general practitioner: 12%). CONCLUSIONS: This study demonstrated the feasibility of delivering a trial of a web-based intervention to support self-management in young people with acne. Additional work is needed before a full definitive trial, including enhancing engagement with the intervention, recruitment, and follow-up rates. TRIAL REGISTRATION: ISRCTN 78626638; https://tinyurl.com/n4wackrw.

'That's just how I am': a qualitative interview study to identify factors influencing engagement with a digital intervention for tinnitus self-management.

OBJECTIVES: To explore users' reactions to and expectations of the Tinnitus E-Programme 2.0, a digital cognitive behavioural intervention for tinnitus, and to identify contextual factors and mechanisms of action that may influence user engagement with the intervention. DESIGN: Qualitative interview study. METHODS: Think-aloud and semi-structured interviews were carried out with 19 people with tinnitus. Interviews explored participants' views of the intervention's information and advice, its wider intervention goals (e.g. behaviour change, self-management), and factors that may strengthen or impede users' engagement. Data were analysed using inductive thematic analysis, and findings were used to develop a conceptual model of user engagement with the intervention. RESULTS: Generally, participants expressed positive views of the intervention, its intervention components, and its design features. Identified contextual factors included pre-existing attitudes, beliefs, skills, and knowledge (e.g. perceptions of tinnitus symptom severity, openness to tinnitus management, and psychological techniques); previous experience of tinnitus management; and characteristics of the condition (e.g. heterogeneous nature of tinnitus, stage in healthcare journey). These contextual factors were hypothesized to influence engagement through four mechanisms of action: motivation to change tinnitus-related attitudes and behaviour; perceived personal relevance of the intervention; expectations of benefit; and appeal of the intervention techniques. CONCLUSIONS: This study demonstrated the acceptability of the Tinnitus E-Programme 2.0 amongst its target group, while highlighting potential areas for improvement in future intervention modifications. Our findings identified contextual factors that others developing interventions for tinnitus or cognitive behavioural interventions may wish to consider.