Smartphone App Using Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS): Protocol for a Randomized Feasibility Trial.

BACKGROUND: Female chronic pelvic pain (CPP) is defined as intermittent or constant pelvic or lower abdominal pain occurring in a woman for at least 6 months. Up to a quarter of women are estimated to be affected by CPP worldwide and it is responsible for one fifth of specialist gynecological referrals in the United Kingdom. Psychological interventions are commonly utilized. As waiting times and funding capacity impede access to face-to-face consultations, supported self-management (SSM) has emerged as a viable alternative. Mindfulness meditation is a potentially valuable SSM tool, and in the era of mobile technology, this can be delivered to the individual user via a smartphone app. OBJECTIVE: To assess the feasibility of conducting a trial of a mindfulness meditation intervention delivered by a mobile phone app for patients with CPP. The main feasibility objectives were to assess patient recruitment and app adherence, to obtain information to be used in the sample size estimate of a future trial, and to receive feedback on usability of the app. METHODS: Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS) is a three-arm feasibility trial, that took place in two hospitals in the United Kingdom. Eligible participants were randomized in a 1:1:1 ratio to one of three treatment arms: (1) the intervention arm, consisting of a guided, spoken mindfulness meditation app; (2) an active control arm, consisting of a progressive muscle relaxation app; and (3) usual care (no app). Participants were followed-up for 6 months. Key feasibility outcomes included the time taken to recruit all patients for the study, adherence, and estimates to be used in the sample size calculation for a subsequent full-scale trial. Upon completion of the feasibility trial we will conduct focus groups to explore app usability and reasons for noncompliance. RESULTS: Recruitment for MEMPHIS took place between May 2016 and September 2016. The study was closed March 2017 and the report was submitted to the NIHR on October 26, 2017. CONCLUSIONS: This feasibility trial will inform the design of a large multicentered trial to assess the clinical effectiveness of mindfulness meditation delivered via a smartphone app for the treatment of CPP. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02721108; https://clinicaltrials.gov/ct2/show/NCT02721108 (Archived by WebCite at http://www.webcitation.org/6wLMAkuaU); BioMed Central: ISRCTN10925965; https://www.isrctn.com/ISRCTN10925965 (Archived by WebCite at http://www.webcitation.org/6wLMVLuys).

Novel Three-Day, Community-Based, Nonpharmacological Group Intervention for Chronic Musculoskeletal Pain (COPERS): A Randomised Clinical Trial.

BACKGROUND: Chronic musculoskeletal pain is the leading cause of disability worldwide. The effectiveness of pharmacological treatments for chronic pain is often limited, and there is growing concern about the adverse effects of these treatments, including opioid dependence. Nonpharmacological approaches to chronic pain may be an attractive alternative or adjunctive treatment. We describe the effectiveness of a novel, theoretically based group pain management support intervention for chronic musculoskeletal pain. METHODS AND FINDINGS: We conducted a multi-centre, pragmatic, randomised, controlled effectiveness and cost-effectiveness (cost-utility) trial across 27 general practices and community musculoskeletal services in the UK. We recruited 703 adults with musculoskeletal pain of at least 3 mo duration between August 1, 2011, and July 31, 2012, and randomised participants 1.33:1 to intervention (403) or control (300). Intervention participants were offered a participative group intervention (COPERS) delivered over three alternate days with a follow-up session at 2 wk. The intervention introduced cognitive behavioural approaches and was designed to promote self-efficacy to manage chronic pain. Controls received usual care and a relaxation CD. The primary outcome was pain-related disability at 12 mo (Chronic Pain Grade [CPG] disability subscale); secondary outcomes included the CPG disability subscale at 6 mo and the following measured at 6 and 12 mo: anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), pain acceptance (Chronic Pain Acceptance Questionnaire), social integration (Health Education Impact Questionnaire social integration and support subscale), pain-related self-efficacy (Pain Self-Efficacy Questionnaire), pain intensity (CPG pain intensity subscale), the census global health question (2011 census for England and Wales), health utility (EQ-5D-3L), and health care resource use. Analyses followed the intention-to-treat principle, accounted for clustering by course in the intervention arm, and used multiple imputation for missing or incomplete primary outcome data. The mean age of participants was 59.9 y, with 81% white, 67% female, 23% employed, 85% with pain for at least 3 y, and 23% on strong opioids. Symptoms of depression and anxiety were common (baseline mean HADS scores 7.4 [standard deviation 4.1] and 9.2 [4.6], respectively). Overall, 282 (70%) intervention participants met the predefined intervention adherence criterion. Primary outcome data were obtained from 88% of participants. There was no significant difference between groups in pain-related disability at 6 or 12 mo (12 mo: difference -1.0, intervention versus control, 95% CI -4.9 to 3.0), pain intensity, or the census global health question. Anxiety, depression, pain-related self-efficacy, pain acceptance, and social integration were better in the intervention group at 6 mo; at 12 mo, these differences remained statistically significant only for depression (-0.7, 95% CI -1.2 to -0.2) and social integration (0.8, 95% CI 0.4 to 1.2). Intervention participants received more analgesics than the controls across the 12 mo. The total cost of the course per person was £145 (US$214). The cost-utility analysis showed there to be a small benefit in terms of quality-adjusted life years (QALYs) (0.0325, 95% CI -0.0074 to 0.0724), and on the cost side the intervention was a little more expensive than usual care (i.e., £188 [US$277], 95% CI -£125 [-US$184] to £501 [US$738]), resulting in an incremental cost-effectiveness ratio of £5,786 (US$8,521) per QALY. Limitations include the fact that the intervention was relatively brief and did not include any physical activity components. CONCLUSIONS: While the COPERS intervention was brief, safe, and inexpensive, with a low attrition rate, it was not effective for reducing pain-related disability over 12 mo (primary outcome). For secondary outcomes, we found sustained benefits on depression and social integration at 6 and 12 mo, but there was no effect on anxiety, pain-related self-efficacy, pain acceptance, pain intensity, or the census global health question at 12 mo. There was some evidence that the intervention may be cost-effective based on a modest difference in QALYs between groups. TRIAL REGISTRATION: ISRCTN Registry 24426731.

Does therapeutic writing help people with long-term conditions? Systematic review, realist synthesis and economic considerations.

BACKGROUND: Writing therapy to improve physical or mental health can take many forms. The most researched model of therapeutic writing (TW) is unfacilitated, individual expressive writing (written emotional disclosure). Facilitated writing activities are less widely researched. DATA SOURCES: Databases, including MEDLINE, EMBASE, PsycINFO, Linguistics and Language Behaviour Abstracts, Allied and Complementary Medicine Database and Cumulative Index to Nursing and Allied Health Literature, were searched from inception to March 2013 (updated January 2015). REVIEW METHODS: Four TW practitioners provided expert advice. Study procedures were conducted by one reviewer and checked by a second. Randomised controlled trials (RCTs) and non-randomised comparative studies were included. Quality was appraised using the Cochrane risk-of-bias tool. Unfacilitated and facilitated TW studies were analysed separately under International Classification of Diseases, Tenth Revision chapter headings. Meta-analyses were performed where possible using RevMan version 5.2.6 (RevMan 2012, The Cochrane Collaboration, The Nordic Cochrane Centre, Copenhagen, Denmark). Costs were estimated from a UK NHS perspective and three cost-consequence case studies were prepared. Realist synthesis followed Realist and Meta-narrative Evidence Synthesis: Evolving Standards guidelines. OBJECTIVES: To review the clinical effectiveness and cost-effectiveness of TW for people with long-term conditions (LTCs) compared with no writing, or other controls, reporting any relevant clinical outcomes. To conduct a realist synthesis to understand how TW might work, and for whom. RESULTS: From 14,658 unique citations, 284 full-text papers were reviewed and 64 studies (59 RCTs) were included in the final effectiveness reviews. Five studies examined facilitated TW; these were extremely heterogeneous with unclear or high risk of bias but suggested that facilitated TW interventions may be beneficial in individual LTCs. Unfacilitated expressive writing was examined in 59 studies of variable or unreported quality. Overall, there was very little or no evidence of any benefit reported in the following conditions (number of studies): human immunodeficiency virus (six); breast cancer (eight); gynaecological and genitourinary cancers (five); mental health (five); asthma (four); psoriasis (three); and chronic pain (four). In inflammatory arthropathies (six) there was a reduction in disease severity [n = 191, standardised mean difference (SMD) -0.61, 95% confidence interval (CI) -0.96 to -0.26] in the short term on meta-analysis of four studies. For all other LTCs there were either no data, or sparse data with no or inconsistent, evidence of benefit. Meta-analyses conducted across all of the LTCs provided no evidence that unfacilitated emotional writing had any effect on depression at short- (n = 1563, SMD -0.06, 95% CI -0.29 to 0.17, substantial heterogeneity) or long-term (n = 778, SMD -0.04 95% CI -0.18 to 0.10, little heterogeneity) follow-up, or on anxiety, physiological or biomarker-based outcomes. One study reported costs, no studies reported cost-effectiveness and 12 studies reported resource use; and meta-analysis suggested reduced medication use but no impact on health centre visits. Estimated costs of intervention were low, but there was insufficient evidence to judge cost-effectiveness. Realist synthesis findings suggested that facilitated TW is a complex intervention and group interaction contributes to the perception of benefit. It was unclear from the available data who might benefit most from facilitated TW. LIMITATION: Difficulties with developing realist synthesis programme theory meant that mechanisms operating during TW remain obscure. CONCLUSIONS: Overall, there is little evidence to support the therapeutic effectiveness or cost-effectiveness of unfacilitated expressive writing interventions in people with LTCs. Further research focused on facilitated TW in people with LTCs could be informative. STUDY REGISTRATION: This study is registered as PROSPERO CRD42012003343. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Exercise for depression in elderly residents of care homes: a cluster-randomised controlled trial.

BACKGROUND: Depression is common and is associated with poor outcomes among elderly care-home residents. Exercise is a promising low-risk intervention for depression in this population. We tested the hypothesis that a moderate intensity exercise programme would reduce the burden of depressive symptoms in residents of care homes. METHODS: We did a cluster-randomised controlled trial in care homes in two regions in England; northeast London, and Coventry and Warwickshire. Residents aged 65 years or older were eligible for inclusion. A statistician independent of the study randomised each home (1 to 1·5 ratio, stratified by location, minimised by type of home provider [local authority, voluntary, private and care home, private and nursing home] and size of home [<32 or ≥32 residents]) into intervention and control groups. The intervention package included depression awareness training for care-home staff, 45 min physiotherapist-led group exercise sessions for residents (delivered twice weekly), and a whole home component designed to encourage more physical activity in daily life. The control consisted of only the depression awareness training. Researchers collecting follow-up data from individual participants and the participants themselves were inevitably aware of home randomisation because of the physiotherapists' activities within the home. A researcher masked to study allocation coded NHS routine data. The primary outcome was number of depressive symptoms on the geriatric depression scale-15 (GDS-15). Follow-up was for 12 months. This trial is registered with ISRCTN Register, number ISRCTN43769277. FINDINGS: Care homes were randomised between Dec 15, 2008, and April 9, 2010. At randomisation, 891 individuals in 78 care homes (35 intervention, 43 control) had provided baseline data. We delivered 3191 group exercise sessions attended on average by five study participants and five non-study residents. Of residents with a GDS-15 score, 374 of 765 (49%) were depressed at baseline; 484 of 765 (63%) provided 12 month follow-up scores. Overall the GDS-15 score was 0·13 (95% CI -0·33 to 0·60) points higher (worse) at 12 months for the intervention group compared with the control group. Among residents depressed at baseline, GDS-15 score was 0·22 (95% CI -0·52 to 0·95) points higher at 6 months in the intervention group than in the control group. In an end of study cross-sectional analysis, including 132 additional residents joining after randomisation, the odds of being depressed were 0·76 (95% CI 0·53 to 1·09) for the intervention group compared with the control group. INTERPRETATION: This moderately intense exercise programme did not reduce depressive symptoms in residents of care homes. In this frail population, alternative strategies to manage psychological symptoms are required. FUNDING: National Institute for Health Research Health Technology Assessment.

Clinical service organisation for heart failure.

BACKGROUND: Chronic heart failure (CHF) is a serious, common condition associated with frequent hospitalisation. Several different disease management interventions (clinical service organisation interventions) for patients with CHF have been proposed. OBJECTIVES: To update the previously published review which assessed the effectiveness of disease management interventions for patients with CHF. SEARCH METHODS: A number of databases were searched for the updated review: CENTRAL, (the Cochrane Central Register of Controlled Trials) and DARE, on The Cochrane Library, ( Issue 1 2009); MEDLINE (1950-January 2009); EMBASE (1980-January 2009); CINAHL (1982-January 2009); AMED (1985-January 2009). For the original review (but not the update) we had also searched: Science Citation Index Expanded (1981-2001); SIGLE (1980-2003); National Research Register (2003) and NHS Economic Evaluations Database (2001). We also searched reference lists of included studies for both the original and updated reviews. SELECTION CRITERIA: Randomised controlled trials (RCTs) with at least six months follow up, comparing disease management interventions specifically directed at patients with CHF to usual care. DATA COLLECTION AND ANALYSIS: At least two reviewers independently extracted data and assessed study quality. Study authors were contacted for further information where necessary. Data were analysed and presented as odds ratios (OR) with 95% confidence intervals (CI). MAIN RESULTS: Twenty five trials (5,942 people) were included. Interventions were classified by: (1) case management interventions (intense monitoring of patients following discharge often involving telephone follow up and home visits); (2) clinic interventions (follow up in a CHF clinic) and (3) multidisciplinary interventions (holistic approach bridging the gap between hospital admission and discharge home delivered by a team). The components, intensity and duration of the interventions varied, as did the 'usual care' comparator provided in different trials.Case management interventions were associated with reduction in all cause mortality at 12 months follow up, OR 0.66 (95% CI 0.47 to 0.91, but not at six months. No reductions were seen for deaths from CHF or cardiovascular causes. However, case management type interventions reduced CHF related readmissions at six month (OR 0.64, 95% CI 0.46 to 0.88, P = 0.007) and 12 month follow up (OR 0.47, 95% CI 0.30 to 0.76). Impact of these interventions on all cause hospital admissions was not apparent at six months but was at 12 months (OR 0.75, 95% CI 0.57 to 0.99, I(2) = 58%).   CHF clinic interventions (for six and 12 month follow up) revealed non-significant reductions in all cause mortality, CHF related admissions and all cause readmissions. Mortality was not reduced in the two studies that looked at multidisciplinary interventions. However, both all cause and CHF related readmissions were reduced (OR 0.46, 95% CI 0.46-0.69, and 0.45, 95% CI 0.28-0.72, respectively).  AUTHORS' CONCLUSIONS: Amongst CHF patients who have previously been admitted to hospital for this condition there is now good evidence that case management type interventions led by a heart failure specialist nurse reduces CHF related readmissions after 12 months follow up, all cause readmissions and all cause mortality.  It is not possible to say what the optimal components of these case management type interventions are, however telephone follow up by the nurse specialist was a common component.Multidisciplinary interventions may be effective in reducing both CHF and all cause readmissions. There is currently limited evidence to support interventions whose major component is follow up in a CHF clinic.

Effective delivery styles and content for self-management interventions for chronic musculoskeletal pain: a systematic literature review.

OBJECTIVES: The objective of the study was to report the evidence for effectiveness of different self-management course characteristics and components for chronic musculoskeletal pain. METHODS: We searched 9 relevant electronic databases for randomized, controlled trials (RCTs). Two reviewers selected studies against inclusion criteria and assessed their quality. We classified RCTs according to type of course delivery (group, individual, mixed or remote), tutor (healthcare professional, lay or mixed), setting (medical, community or occupational), duration (more or less than 8 weeks), and the number and type of components (psychological, lifestyle, pain education, mind body therapies, and physical activity). We extracted data on pain intensity, physical function, self-efficacy, global health, and depression and compared these outcomes for self-management and usual care or waiting list control. We used random effects standardized mean difference meta-analysis. We looked for patterns of clinically important and statistically significant beneficial effects for courses with different delivery characteristics and the presence or absence of components across outcomes over 3 follow-up intervals. RESULTS: We included 46 RCTs (N=8539). Group-delivered courses that had healthcare professional input showed more beneficial effects. Longer courses did not necessarily give better outcomes. There was mixed evidence of effectiveness for components of courses, but data for courses with a psychological component showed slightly more consistent beneficial effects over each follow-up period. DISCUSSION: Serious consideration should be given to the development of short (<8 weeks) group and healthcare professional-delivered interventions but more research is required to establish the most effective and cost-effective course components.