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Exposure and response prevention (ERP) is the gold standard in the treatment of the obsessive-compulsive disorder (OCD). It can be delivered effectively using an individual or group therapy format. Nonetheless, a sizeable proportion of people diagnosed with OCD do not experience OCD symptom remission following ERP. Research suggests that participant engagement with ERP tasks predicts therapy outcomes but there is little consistent evidence across studies on what predicts engagement. A recent meta-analysis of participant engagement in cognitive-behavioral therapy for OCD found that group ERP had a comparatively lower dropout rate than individual ERP. Little is known about participant perceptions of ERP to guide an understanding of how the group therapy format may affect participant engagement. This study conducted a qualitative exploration of what helps or hinders participants' engagement in group ERP. It involved thematic analysis of semi-structured interview data collected at a 6-month follow-up from 15 adults with OCD who took part in group ERP. The study identified five main themes that captured participants' perceived facilitators and barriers to engagement in therapy: 'Group processes', 'Understanding how to overcome OCD', 'Personal relevance', 'Personal circumstances', and 'Attitudes towards ERP', which captured dynamically inter-related barriers and facilitators at the level of the client, therapist, therapy and social environment. Each theme and associated sub-themes are discussed in turn, followed by a consideration of the study's limitations and implications.

ImportanceDepression is prevalent. Treatment guidelines recommend practitioner-supported cognitive behavioral therapy self-help (CBT-SH) for mild to moderate depression in adults; however, dropout rates are high. Alternative approaches are required.ObjectiveTo determine if practitioner-supported mindfulness-based cognitive therapy self-help (MBCT-SH) is superior to practitioner-supported CBT-SH at reducing depressive symptom severity at 16 weeks postrandomization among patients with mild to moderate depression and secondarily to examine if practitioner-supported MBCT-SH is cost-effective compared with practitioner-supported CBT-SH.Design, Setting, and ParticipantsThis was an assessor- and participant-blinded superiority randomized clinical trial with 1:1 automated online allocation stratified by center and depression severity comparing practitioner-supported MBCT-SH with practitioner-supported CBT-SH for adults experiencing mild to moderate depression. Recruitment took place between November 24, 2017, and January 31, 2020. The study took place in 10 publicly funded psychological therapy services in England (Improving Access to Psychological Therapies [IAPT]). A total of 600 clients attending IAPT services were assessed for eligibility, and 410 were enrolled. Participants met diagnostic criteria for mild to moderate depression. Data were analyzed from January to October 2021.InterventionsParticipants received a copy of either an MBCT-SH or CBT-SH workbook and were offered 6 support sessions with a trained practitioner.Main Outcomes and MeasuresThe preregistered primary outcome was Patient Health Questionnaire (PHQ-9) score at 16 weeks postrandomization. The primary analysis was intention-to-treat with treatment arms masked.ResultsOf 410 randomized participants, 255 (62.2%) were female, and the median (IQR) age was 32 (25-45) years. At 16 weeks postrandomization, practitioner-supported MBCT-SH (n = 204; mean [SD] PHQ-9 score, 7.2 [4.8]) led to significantly greater reductions in depression symptom severity compared with practitioner-supported CBT-SH (n = 206; mean [SD] PHQ-9 score, 8.6 [5.5]), with a between-group difference of −1.5 PHQ-9 points (95% CI, −2.6 to −0.4; P = .009; d = −0.36). The probability of MBCT-SH being cost-effective compared with CBT-SH exceeded 95%. However, although between-group effects on secondary outcomes were in the hypothesized direction, they were mostly nonsignificant. Three serious adverse events were reported, all deemed not study related.Conclusions and RelevanceIn this randomized clinical trial, practitioner-supported MBCT-SH was superior to standard recommended treatment (ie, practitioner-supported CBT-SH) for mild to moderate depression in terms of both clinical effectiveness and cost-effectiveness. Findings suggest that MBCT-SH for mild to moderate depression should be routinely offered to adults in primary care services.Trial Registrationisrctn.org Identifier: ISRCTN13495752

Background Depression has serious personal, family and economic consequences. It is estimated that it will cost £12.15 billion to the economy each year in England by 2026. Improving access to psychological therapies (IAPT) is the National Health Service talking therapies service in England for adults experiencing anxiety or depression. Over 1 million people are referred to IAPT every year, over half experiencing depression. Where symptoms of depression are mild to moderate, people are typically offered cognitive behavioural therapy (CBT) self-help (CBT-SH) supported by a psychological well-being practitioner. The problem is that over half of people who complete treatment for depression in IAPT remain depressed despite receiving National Institute of Health and Care Excellent recommended treatment. Furthermore, less than half of IAPT service users complete treatment. This study seeks to investigate the effectiveness of an alternative to CBT-SH. Mindfulness-based cognitive therapy (MBCT) differs from CBT in focus, approach and practice, and may be more effective with a higher number of treatment completions. Methods/design This is a definitive randomised controlled trial comparing supported MBCT self-help (MBCT-SH) with CBT-SH for adults experiencing mild to moderate depression being treated in IAPT services. We will recruit 410 participants experiencing mild to moderate depression from IAPT services and randomise these to receive either an MBCT-based self-help workbook or a CBT-based self-help workbook. Participants will be asked to complete their workbook within 16 weeks, with six support sessions with a psychological well-being practitioner. The primary outcome is depression symptom severity on treatment completion. Secondary outcomes are treatment completion rates and measures of generalized anxiety, well-being, functioning and mindfulness. An exploratory non-inferiority analysis will be conducted in the event the primary hypothesis is not supported. A semi-structured interview with participants will guide understanding of change processes. Discussion If the findings from this randomised controlled trial demonstrate that MBCT-SH is more effective than CBT-SH for adults experiencing depression, this will provide evidence for policy makers and lead to changes to clinical practice in IAPT services, leading to greater choice of self-help treatment options and better outcomes for service users. If the exploratory non-inferiority analysis is conducted and this indicates non-inferiority of MBCT-SH in comparison to CBT-SH this will also be of interest to policy makers when seeking to increase service user choice of self-help treatment options for depression. Trial registration Current Controlled Trial registration number: ISRCTN 13495752. Registered on 31 August 2017 (www.isrctn.com/ISRCTN13495752).

BACKGROUND There is no non-invasive objective assessment tool to measure keloid scar characteristics over time. This study aimed to ascertain the ability of the Antera 3D® camera to detect differences in keloid features pre- and post-steroid injection. In order to identify whether those variation could be considered as treatment response predicting factors. METHODS Enrolled patients received three intra-lesional steroid injections at four-weekly intervals. Images were taken with the Antera 3D camera 12 and 24 weeks after treatment. Keloids' colour, volume, and area as well as haemoglobin and melanin average levels and variation have been analysed pre- and post-steroid injection. t Tests and relative risk have been used to analyse the significance and association strength of our finding. RESULTS Forty patients have been enrolled in the study. Significant changes as been recorded in keloids' volume and colour after steroid injection (P

Aim: Assessing pain perception through self-reports may not be possible in some patients, for example, sedated. Our group considered if facial electromyography (fEMG) could provide a useful alternative, by testing on healthy participants subjected to experimental pain. Materials & methods: Activity of four facial muscles was recorded using fEMG alongside self-reported pain scores and physiological parameters. Results: The pain stimulus elicited significant activity on all facial muscles of interest as well as increases in heart rate. Activity from two of the facial muscles correlated significantly against pain intensity. Conclusion: Pain perception can be assessed through fEMG on healthy participants. We believe that this model would be valuable to clinicians that need to diagnose pain perception in circumstances where verbal reporting is not possible.

Background: It is recommended that people living with type 2 diabetes (PLwD) increase their levels of physical activity to help manage their condition. Previous studies have reported on strong family ties in South Asian culture. However, understanding of family involvement in relation to diabetes is South Asian culture is limited. Objective: To explore the influence of family roles within South Asian culture on physical activity by PLwD. Methods: 30 PLwD (13 men; aged 30-70 years), 17 family members of PLwD (4 men; 22-61 years) and nine doctors were recruited in metropolitan Lahore, Pakistan who mostly used state health services for relatively disadvantaged populations. Interviews were analyzed using thematic analysis. Results: Three themes were identified: (1) Going for a walk as (the only) convenient physical activity; (2) The role of family members in influencing physical activity; (3) Cultural acceptance of walking as physical activity. Across all themes gender and age create flexibilities or constraints for the choices of physical activity, available to PLwD. Intersections of gender, age and in addition family roles appear to create most flexibility for younger men, e.g., going for a run instead of just walking, and the constraints for a younger woman who may need to find another woman so as to not walk on her own. For an older woman these constraints are less severe, as it is acceptable to her, her family and the wider culture to be seen walking on her own. Conclusion: These complex pattern of flexibilities and constraints for urban dwellers who would not be able to afford or be permitted to use a fee charging sports facilities are not recognised by PROMPT, a recently published diabetes guideline for Pakistan. The findings suggest an urgent need to develop guidance which recognise familial expectations and propose lifestyle adjustments, acceptable to urban dwellers in a country like Pakistan. Disclosure O. Tariq: None. C. Rosten: None. J.W. Huber: None.

This is not a research paper but a personal and collective reflection of patient and public involvement (PPI) for the LIGHTMind 2 randomized control trial (www. isrctn. com/ISRCTN13495752). This trial compares two guided self-help psychological interventions for depression, and is delivered in the UK NHS Improving Access to Psychological Therapy services. The paper is the result of my reviewing our PPI 18 months into the trial. The PPI includes myself as a research team member and co-applicant, with lived experience of depression, mindfulness and cognitive behaviour therapy. There is a Lived Experience Advisory Panel of six people with lived experience of depression or mindfulness, who advise the researchers. Two people with lived experience of mental health difficulties and knowledge of PPI attend the Trial Steering Committee. This paper includes comments from some of the other people with lived experience and from researchers involved in the trial, included as co-authors. I offer the Johari window (Luft, 1970) and the 4Pi National Involvement Standards (NSUN, 2018) as a way of positioning the value of PPI. Developing relationships within PPI is identified as a way of moderating the fear that some people experience as they work with researchers. I describe the importance of principles that incorporate explicit statements about the value of PPI.

Currently, clinicians observe pain-related behaviors and use patient self-report measures in order to determine pain severity. This paper reviews the evidence when facial expression is used as a measure of pain. We review the literature reporting the relevance of facial expression as a diagnostic measure, which facial movements are indicative of pain, and whether such movements can be reliably used to measure pain. We conclude that although the technology for objective pain measurement is not yet ready for use in clinical settings, the potential benefits to patients in improved pain management, combined with the advances being made in sensor technology and artificial intelligence, provide opportunities for research and innovation.

Only about half of people with obsessive compulsive disorder (OCD) show clinically significant improvement following the recommended therapy, exposure and response prevention (ERP), partly due to poor therapy acceptability. A mindfulness-based approach to ERP (MB-ERP) has the potential to improve acceptability and outcomes.This was an internal pilot randomised controlled trial (RCT) of group MB-ERP compared to group ERP. 37 participants meeting DSM-IV OCD criteria were randomly allocated to MB-ERP or ERP.Both groups improved in OCD symptom severity. However, MB-ERP did not lead to clinically important improvements in OCD symptom severity at post-intervention compared to ERP - the minimum clinically important difference was not contained in the 95% confidence intervals. There were negligible between-group differences in engagement and MB-ERP did not appear to have broader benefits compared to ERP on depression, wellbeing or OCD-related beliefs. Conversely, MB-ERP led to medium/medium-large improvements in mindfulness compared to ERP.MB-ERP is unlikely to lead to clinically meaningful improvements in OCD symptom severity compared to ERP alone. We underline the importance of adhering to treatment guidelines recommending ERP for OCD. Insufficient attention may have been given to mindfulness practice/discussion in MB-ERP and further research is recommended to explore this possibility.

Objectives: Adapting health technology assessment (HTA) reports for different contexts could reduce the need for multiple reports on the same health technology with resultant saving of time and resources. This article describes an instrument, the adaptation toolkit, which has been developed to aid in the process of adaptation of HTA reports.Methods: The toolkit was developed by a partnership of HTA agencies and networks from across Europe. The role of the toolkit is to guide the user through the process of selecting possible relevant material from these report(s), assessing the relevance, reliability, and transferability of the material, and adapting it for the desired context.Results: The adaptation toolkit has been developed, it comprises a collection of resources that help the user assess whether data and information in existing HTA reports should and could be adapted for their own setting. The toolkit contains two sections: a preliminary speedy sifting section and the main toolkit. The main toolkit includes five domains: (i) technology use and development, (ii) safety, (iii) effectiveness (including efficacy), (iv) economic evaluation, and (v) organizational aspects. Legal, ethical, and social aspects are beyond the scope of the toolkit. The toolkit is designed for the adaptation of evidence synthesis rather than primary research.Conclusions: The completed current version of the toolkit contains checklists and resources to aid in the adaptation of HTA reports. This collection of resources is available for use by all HTA agencies and can be accessed at: http://www.eunethta.net/upload/WP5/EUnetHTA_HTA_Adaptation_Toolkit_October08.pdf..

Background Obsessive Compulsive Disorder (OCD) is a distressing and debilitating condition affecting 1-2% of the population. Exposure and response prevention (ERP) is a behaviour therapy for OCD with the strongest evidence for effectiveness of any psychological therapy for the condition. Even so, only about half of people offered ERP show recovery after the therapy. An important reason for ERP failure is that about 25% of people drop out early, and even for those who continue with the therapy, many do not regularly engage in ERP tasks, an essential element of ERP. A mindfulness-based approach has the potential to reduce drop-out from ERP and to improve ERP task engagement with an emphasis on accepting difficult thoughts, feelings and bodily sessions and on becoming more aware of urges, rather than automatically acting on them. Methods/Design This is a pilot randomised controlled trial of mindfulness-based ERP (MB-ERP) with the aim of establishing parameters for a definitive trial. Forty participants diagnosed with OCD will be allocated at random to a 10-session ERP group or to a 10-session MB-ERP group. Primary outcomes are OCD symptom severity and therapy engagement. Secondary outcomes are depressive symptom severity, wellbeing and obsessive-compulsive beliefs. A semi-structured interview with participants will guide understanding of change processes. Discussion Findings from this pilot study will inform future research in this area, and if effect sizes on primary outcomes are in favour of MB-ERP in comparison to ERP, funding for a definitive trial will be sought. Trial registration Current Controlled Trials registration number ISRCTN52684820. Registered on 30 January 2014.

Background: The way people use health technology assessment (HTA) terms varies considerably across Europe. Such variation can lead to misunderstandings when reading HTA reports from different contexts. This work is one of the outputs of the EUnetHTA Project and was undertaken between 2006 and 2008.Objectives: The aim of this study was to develop a glossary of HTA adaptation terms to help reduce the misunderstandings of terms used in HTA reports from contexts other than the reader's own.Methods: Several HTA glossaries were examined to identify ways in which an additional glossary could offer readers something new and to identify adaptation terms for inclusion. Twenty-eight European HTA organizations provided terms for the glossary and drafted descriptions and examples of how each specific term was used in their particular setting. The organizations then commented on the descriptions provided by the other groups and worked together to draft a single description for certain terms.Results: A glossary of HTA adaptation terms was developed. It provides a comprehensive range of descriptions, examples, and comments for forty-two potentially confusing HTA terms related to adaptation.Conclusions: This glossary will be a valuable resource for European HTA agencies when reading HTA reports produced in different contexts and for adapting HTA reports produced in other countries. The glossary will help improve understanding and help facilitate the adaptation process.

Objectives: Europe has many health technology assessment (HTA) agencies, each producing their own HTA reports. Adapting HTA reports for different contexts could reduce the need for multiple reports on the same health technology with resultant saving of time and resources. This study aims to examine and understand the process of adaptation, and to develop a toolkit that would help the adaptation of reports produced by other countries.Methods: The methods used were a review of the literature; a survey of twenty-nine European HTA organizations, two rounds of a Delphi survey, a face-to-face meeting of twenty-one European network for Health Technology Assessment (EUnetHTA) representatives, iterative rounds of review, and two rounds of quality assurance testing (termed applicability testing).Results: Descriptions of previous examples of adaptation in the literature are sparse. Most respondents had previous experience in adapting reports, and all believed that adaptation was useful, and there was the ability to benefit from the use of a toolkit to aid in the process. EUnetHTA Partners developed and tested an adaptation toolkit. The toolkit is composed of a series of checklists and resources that identify or clarify the relevance, reliability, and transferability of data and information from existing reports.Conclusions: Consensus of opinion from twenty-nine European organizations/networks has indicated that the adaptation of HTA reports would be desirable and beneficial. A toolkit was developed to help with the adaptation of HTA reports produced in other settings. This collection of resources is available for use by all HTA agencies and can be accessed at: http://www.eunethta.net/upload/WP5/EUnetHTA_HTA_Adaptation_Toolkit_October08.pdf.

Objectives To develop a health technology assessment (HTA) adaptation toolkit and glossary of adaptation terms for use by HTA agencies within EU member states to support them in adapting HTA reports written for other contexts. Methods The toolkit and glossary were developed by a partnership of 28 HTA agencies and networks across Europe (EUnetHTA work package 5), led by the UK National Coordinating Centre for Health Technology Assessment (NCCHTA). Methods employed for the two resources were literature searching, a survey of adaptation experience, two rounds of a Delphi survey, meetings of the partnership and drawing on the expertise and experience of the partnership, two rounds of review, and two rounds of quality assurance testing. All partners were requested to provide input into each stage of development. Results The resulting toolkit is a collection of resources, in the form of checklists of questions on relevance, reliability and transferability of data and information, and links to useful websites, that help the user assess whether data and information in existing HTA reports can be adapted for a different setting. The toolkit is designed for the adaptation of evidence synthesis rather than primary research. The accompanying glossary provides descriptions of meanings for HTA adaptation terms from HTA agencies across Europe. It seeks to highlight differences in the use and understanding of each word by HTA agencies. The toolkit and glossary are available for use by all HTA agencies and can be accessed via www.eunethta.net/. Conclusions These resources have been developed to help HTA agencies make better use of HTA reports produced elsewhere. They can be used by policy-makers and clinicians to aid in understanding HTA reports written for other contexts. The main implication of this work is that there is the potential for the adaptation of HTA reports and, if utilised, this should release resources to enable the development of further HTA reports. Recommendations for the further development of the toolkit include the potential to develop an interactive web-based version and to extend the toolkit to facilitate the adaptation of HTA reports on diagnostic testing and screening.