Feasibility randomized-controlled trial of online acceptance and commitment therapy for painful peripheral neuropathy in people living with HIV: The OPEN study.

BACKGROUND: Neuropathic pain negatively affects quality of life among people living with HIV (PLWH). This study examined the feasibility of conducting a full-scale randomized-controlled trial of online acceptance and commitment therapy ("ACT OPEN") for neuropathic pain in PLWH. METHODS: Using a parallel-groups design, thirty-eight participants were randomized to ACT OPEN or a waitlist control (2:1). Participants completed standard self-report outcome measures at baseline, and two- and five-months post-randomization. Participants were aware of their allocation, but assessment was blinded. RESULTS: Twenty-five participants were randomized to ACT OPEN and 13 to the control (of 133 referrals). ACT OPEN completion was 69% and two-month trial retention was 82%. Treatment credibility and satisfaction scores for ACT OPEN were comparable to scores reported in previous trials of cognitive-behavioural treatments for pain. Four adverse events were reported during the study, including one serious adverse event; all of these were unrelated to the research procedures. Small to moderate effects and 95% confidence intervals suggest that the true effect may favour ACT OPEN for improvements in pain intensity/interference and depression. CONCLUSIONS: A full-scale RCT of online ACT for pain management in PLWH may be feasible with refinements to trial design to facilitate recruitment. SIGNIFICANCE: Research on pain management in people living with HIV has primarily focused on pharmacological treatments with limited success. This is the first study to show the potential feasibility of a psychological treatment based on acceptance and commitment therapy delivered online and tailored for pain management in people with HIV ("ACT OPEN"). ACT OPEN may be a promising treatment in this population and further evaluation in a full-scale randomized-controlled trial appears warranted. TRIAL REGISTRATION: The trial was registered (clinicaltrials.gov; NCT03584412).

Acceptability of psychologically-based pain management and online delivery for people living with HIV and chronic neuropathic pain: a qualitative study.

OBJECTIVES: Chronic neuropathic pain is common in people living with HIV. Psychological treatments can improve quality of life for people with chronic pain in general, and online delivery can increase access to these treatments. However, the acceptability of psychological treatment and online delivery have not been investigated in-depth in people living with HIV and chronic neuropathic pain. Therefore, a qualitative study was undertaken to explore views about a psychological treatment for pain management in this population and to investigate the acceptability of online treatment delivery. METHODS: Qualitative interviews were conducted and analysed using inductive thematic analysis, adopting a critical realist perspective. Twenty-six people living with HIV and chronic neuropathic pain completed semi-structured interviews. Their views about a psychological treatment for pain management and online delivery were explored in-depth. RESULTS: Three themes and 12 subthemes were identified. Theme one represents a desire for a broader approach to pain management, including not wanting to take more pills and having multidimensional goals that were not just focussed on pain relief. Theme two includes barriers to online psychologically-based pain management, including concerns about using the Internet and confidentiality. Theme three describes treatment facilitators, including accessibility, therapist support, social connection, and experiencing success. CONCLUSIONS: A psychological treatment for chronic neuropathic pain management appears acceptable for people living with HIV. Therapist-supported online delivery of cognitive-behavioural pain management may be acceptable for people living with HIV given appropriate development of the treatment to address identified barriers to engagement. These data can inform developments to enhance engagement in online psychologically-informed pain management in people living with HIV and more broadly in remote delivery of psychological treatments.

The application of psychologically informed practice: observations of experienced physiotherapists working with people with chronic pain.

OBJECTIVES: Psychologically informed practice (PIP) is advocated for physiotherapists to help people with chronic pain. There is little research observing how PIP is delivered in clinical practice. This study describes behaviours and techniques used by experienced physiotherapists working with groups of people with chronic pain. SETTING AND PARTICIPANTS: Experienced physiotherapists (n=4) were observed working with groups of people with chronic pain in out-patient pain management, and physiotherapy departments, in a large UK city centre teaching hospital. DESIGN: We observed the clinical behaviours and interpersonal skills of experienced psychologically informed physiotherapists, enriched by their accounts of intentions. The physiotherapists were audio and video recorded delivering group movement sessions. Recordings were reviewed with the physiotherapists for elaboration of intentions, then thematically analysed for comparison with defined CBT competencies. RESULTS: Four themes representing physiotherapist intentions when working with people with chronic pain were identified; building a therapeutic alliance, reducing perceived threat, reconceptualising beliefs and somatic experience, and fostering self-efficacy. The physiotherapists also reflected on challenges including engaging patients in self-management, encouraging activity and reinforcing rather than correcting movement. Considerable overlap existed between the observed behaviours in this study and existing CBT competencies. CONCLUSIONS: This paper complements current recommendations for delivering psychologically informed physiotherapy by providing examples of these skills being used in clinical practice. Further research supporting the development of training for, and mentoring of, physiotherapists, to promote competence and confidence in delivering psychologically informed interventions is recommended.

A qualitative study of the experience and impact of neuropathic pain in people living with HIV.

Painful distal symmetrical polyneuropathy is common in HIV and is associated with reduced quality of life. Research has not explored the experience of neuropathic pain in people with HIV from a person-centred perspective. Therefore, a qualitative interview study was conducted to more deeply understand the experience and impact of neuropathic pain in this population. Semistructured interviews were conducted with 26 people with HIV and peripheral neuropathic pain symptoms. Interviews explored the impact of pain and participants' pain management strategies. Interviews were transcribed verbatim and analysed using thematic analysis. Four themes and 11 subthemes were identified. Theme 1 reflects the complex characterisation of neuropathic pain, including the perceived unusual nature of this pain and diagnostic uncertainty. Theme 2 centred on the interconnected impacts of pain on mood and functioning and includes how pain disrupts relationships and threatens social inclusion. Theme 3 reflects the struggle for pain relief, including participants' attempts to "exhaust all options" and limited success in finding lasting relief. The final theme describes how pain management is complicated by living with HIV; this theme includes the influence of HIV stigma on pain communication and pain as an unwanted reminder of HIV. These data support the relevance of investigating and targeting psychosocial factors to manage neuropathic pain in HIV.

Implementation of Patient-Reported Outcomes (PROMs) from specialist pain clinics in England and Wales: Experience from a nationwide study.

INTRODUCTION: Evaluating outcomes in routine clinical practice is a significant challenge for specialist pain clinics due to the complexity of interventions provided and the subjective nature of pain. This study reports findings from implementation of Patient Reported Outcomes (PROMs) in pain clinics in England and Wales between 2011 and 2013. METHODS: A paper-based questionnaire was administered at a first appointment in participating centres. This assessed quality of life, experience of health care and health care usage with postal follow-up at 6 and 12 months by the research team. Feasibility was assessed in terms of response rates, completion rates and outcomes. RESULTS: Ninety-one (56%) clinics participated, entering 9,588 patients (19% of those eligible). For responders, there was a 92% item completion rate. The dropout rate was high, 46% and 19% returned questions at 6 and 12 months, respectively. Quality of life at baseline was low, with a mean EQ5D-3L Time Trade Off value of 0.32. Amongst responders at 12 months, 92% continued to experience significant pain. For those with planned discharges 30% achieved the Minimal Important Change for quality of life. Nonetheless, 70% reported positive experiences of care. CONCLUSIONS: Patients attending UK pain clinics report an extraordinarily poor quality of life and difficulty with understanding their condition. Problems with PROMs implementation included initial recruitment, follow-up response rates, classification systems and benchmarking. Successful implementation should include use of electronic data capture, feedback and focus on gradual improvement. To achieve this would require extended periods of funding. SIGNIFICANCE: No nationwide evaluation of the effectiveness of specialist pain clinics had previously been attempted. Comparison of patient outcomes from services enables improvement. This work provides a platform to improve methods of routine PROMs capture in pain clinics, measure clinical effectiveness and identify areas for potential research.

Developing a core outcome domain set to assessing effectiveness of interdisciplinary multimodal pain therapy: the VAPAIN consensus statement on core outcome domains.

Interdisciplinary multimodal pain therapy (IMPT) is a biopsychosocial treatment approach for patients with chronic pain that comprises at least psychological and physiotherapeutic interventions. Core outcome sets (COSs) are currently developed in different medical fields to standardize and improve the selection of outcome domains, and measurement instruments in clinical trials, to make trial results meaningful, to pool trial results, and to allow indirect comparison between interventions. The objective of this study was to develop a COS of patient-relevant outcome domains for chronic pain in IMPT clinical trials. An international, multiprofessional panel (patient representatives [n = 5], physicians specialized in pain medicine [n = 5], physiotherapists [n = 5], clinical psychologists [n = 5], and methodological researchers [n = 5]) was recruited for a 3-stage consensus study, which consisted of a mixed-method approach comprising an exploratory systematic review, a preparing online survey to identify important outcome domains, a face-to-face consensus meeting to agree on COS domains, and a second online survey (Delphi) establishing agreement on definitions for the domains included. The panel agreed on the following 8 domains to be included into the COS for IMPT: pain intensity, pain frequency, physical activity, emotional wellbeing, satisfaction with social roles and activities, productivity (paid and unpaid, at home and at work, inclusive presentism and absenteeism), health-related quality of life, and patient's perception of treatment goal achievement. The complexity of chronic pain in a biopsychosocial context is reflected in the current recommendation and includes physical, mental, and social outcomes. In a subsequent step, measurement instruments will be identified via systematic reviews.

Reviewing outcomes of psychological interventions with torture survivors: Conceptual, methodological and ethical Issues.

BACKGROUND: Torture survivors face multiple problems, including psychological difficulties, whether they are refugees or remain in the country where they were tortured. Provision of rehabilitation varies not only with the needs of survivors and resources available, but also with service models, service provider preferences and the local and country context. Despite increasing efforts in research on effectiveness of psychological interventions with torture survivors, results are inconclusive. METHODS: We undertook a Cochrane systematic review of psychological, social and welfare provision, with meta-analysis to best estimate efficacy. The process raised conceptual, methodological and ethical issues of relevance to the wider field. FINDINGS: We searched very widely, but rejected hundreds of papers which recommended treatment without providing evidence. We found nine randomised controlled trials, from developed and under-resourced settings. All conceptualised survivors' problems in psychiatric terms, using outcomes of post-traumatic stress symptoms, distress, and quality of life, by self-report, with or without translation or unstandardised interpretation, and with little mention of cultural or language issues. None used social or welfare interventions. Four related studies used narrative exposure therapy (NET) in a brief form, and without ensuring a safe setting as recommended. Five used mixed methods, including exposure, cognitive behavioural therapy, and eye movement desensitisation. Combined, the studies showed no immediate improvement in PTSD, distress, or quality of life; at six months follow-up, a minority showed some improvement in PTSD and distress, although participants remained severely affected. CONCLUSIONS: While applauding researchers' commitment in running these trials, we raise ethical issues about exposure in particular, and about the effects of shortcomings in methodology, particularly around assessment using unfamiliar cultural frameworks and language, and the lack of concern about dropout which may indicate harm. The issues addressed aid interpretation of existing research, and guide clinical practice as well as future studies evaluating its effectiveness.