MEMPHIS: a smartphone app using psychological approaches for women with chronic pelvic pain presenting to gynaecology clinics: a randomised feasibility trial.

OBJECTIVES: To evaluate the feasibility of a randomised trial of a modified, pre-existing, mindfulness meditation smartphone app for women with chronic pelvic pain. DESIGN: Three arm randomised feasibility trial. SETTING: Women were recruited at two gynaecology clinics in the UK. Interventions were delivered via smartphone or computer at a location of participants choosing. PARTICIPANTS: Women were eligible for the study if they were over 18, had been experiencing organic or non-organic chronic pelvic pain for 6 months or more, and had access to a computer or smartphone. 90 women were randomised. INTERVENTIONS: Daily mindfulness meditation delivered by smartphone app, an active control app which delivered muscle relaxation techniques, and usual care without app. Interventions were delivered over 60 days. PRIMARY AND SECONDARY OUTCOME MEASURES: Outcomes included length of recruitment, follow-up rates, adherence to the app interventions, and clinical outcomes measured at baseline, two, three and 6 months. RESULTS: The target sample size was recruited in 145 days. Adherence to the app interventions was extremely low (mean app use 1.8 days mindfulness meditation group, 7.0 days active control). Fifty-seven (63%) women completed 6-month follow-up, and 75 (83%) women completed at least one postrandomisation follow-up. The 95% CIs for clinical outcomes were consistent with no benefit from the mindfulness meditation app; for example, mean differences in pain acceptance scores at 60 days (higher scores are better) were -2.3 (mindfulness meditation vs usual care, 95% CI: -6.6 to 2.0) and -4.0 (mindfulness meditation vs active control, 95% CI: -8.1 to 0.1). CONCLUSIONS: Despite high recruitment and adequate follow-up rates, demonstrating feasibility, the extremely low adherence suggests a definitive randomised trial of the mindfulness meditation app used in this study is not warranted. Future research should focus on improving patient engagement. TRIAL REGISTRATION NUMBERS: NCT02721108; ISRCTN10925965; Results.

mHealth: providing a mindfulness app for women with chronic pelvic pain in gynaecology outpatient clinics: qualitative data analysis of user experience and lessons learnt.

OBJECTIVES: To determine whether a pre-existing smartphone app to teach mindfulness meditation is acceptable to women with chronic pelvic pain (CPP) and can be integrated into clinical practice within the National Health Service (NHS) CPP pathways, and to inform the design of a potential randomised clinical trial. DESIGN: A prestudy patient and public involvement (PPI) group to collect feedback on the acceptability of the existing app and study design was followed by a three-arm randomised feasibility trial. In addition, we undertook interviews and focus groups with patients and staff to explore app usability and acceptability. We also obtained participant comments on the research process, such as acceptability of the study questionnaires. SETTING: Two gynaecology clinics within Barts Health NHS, London, UK. PARTICIPANTS: Patients with CPP lasting ≥6 months with access to smartphone or personal computer and understanding of basic English. INTERVENTION: The intervention was mindfulness meditation content plus additional pain module delivered by a smartphone app. Active controls received muscle relaxation content from the same app. Passive (waiting list) controls received usual care. MAIN OUTCOME MEASURES: Themes on user feedback, app usability and integration, and reasons for using/not using the app. RESULTS: The use of the app was low in both active groups. Patients in the prestudy PPI group, all volunteers, were enthusiastic about the app (convenience, content, portability, flexibility, ease of use). Women contributing to the interview or focus group data (n=14), from a 'real world' clinic (some not regular app users), were less positive, citing as barriers lack of opportunities/motivation to use the app and lack of familiarity and capabilities with technology. Staff (n=7) were concerned about the potential need for extra support for them and for the patients, and considered the app needed organisational backing and peer acceptance. CONCLUSION: The opinions of prestudy PPI volunteers meeting in their private time may not represent those of patients recruited at a routine clinic appointment. It may be more successful to codesign/codevelop an app with typical users than to adapt existing apps for use in real-world clinical populations. TRIAL REGISTRATION NUMBER: ISRCTN10925965.

Novel primary care treatment package for patients with medically unexplained symptoms: a cohort intervention study.

BACKGROUND: Existing care models for patients with persistent medically unexplained symptoms (MUS) do not adequately address the needs of these patients. New and innovative intervention strategies are necessary to achieve better health and corresponding economic outcomes. AIM: To explore the feasibility of implementing a pragmatic care package that provides primary care treatment for patients with persistent MUS and to evaluate recruitment, retention, and acceptability as well as the potential impact on clinical outcomes and service utilisation. DESIGN & SETTING: Prospective cohort intervention study involving a cluster of seven GP surgeries in Newham, East London, providing a 'One-Stop-Shop' primary care treatment service. METHOD: The care package included: identification, assessment, engagement, psychoeducation, and a choice of group interventions (mindfulness-based stress reduction [MBSR] and body-oriented psychological therapy [BOPT]). Baseline and follow-up data on somatic symptom levels (PHQ-15), health-related quality of life (SF-36, EQ-5D) and service utilisation was analysed. RESULTS: In total, 145 patients were referred and assessed for eligibility, and 93 were included in the study. Participants engaged well with different components of the care package and gained significant improvements in somatic symptom levels with corresponding increases of quality-of-life ratings and a reduction in healthcare utilisation (GP contacts and referrals to specialist services) as well as associated healthcare costs. CONCLUSION: The primary care treatment package can be successfully implemented in primary care at a relatively low cost and easily adopted into routine care. The body-oriented approach is well accepted by clinicians and patients. Controlled trials should be conducted to test the efficacy of the treatment package.

Effectiveness and cost-effectiveness of body psychotherapy in the treatment of negative symptoms of schizophrenia--a multi-centre randomised controlled trial.

BACKGROUND: Negative symptoms of schizophrenia are frequently associated with poor long term outcomes. Established interventions have little, if any, positive effects on negative symptoms. Arts Therapies such as Body Psychotherapy (BPT) have been suggested to reduce negative symptoms, but the existing evidence is limited. In a small exploratory trial a manualised form of group BPT led to significantly lower negative symptom levels both at the end of treatment and at 4 months follow-up as compared to supportive counseling. We designed a large multi-site trial to assess the effectiveness of a manualised BPT intervention in reducing negative symptoms, compared to an active control. METHODS/DESIGN: In a randomised controlled trial, 256 schizophrenic outpatients with negative symptoms will be randomly allocated either to BPT or Pilates groups. In both conditions, patients will be offered two 90 minutes sessions per week in groups of about 8 patients over a period of 10 weeks. Outcomes are assessed at the end of treatment and at six months follow-up. The primary outcome is severity of negative symptoms, as measured by the Positive and Negative Symptom Scale (PANSS), whilst a range of secondary outcome measures include general psychopathology, social contacts, and quality of life. We will also assess the cost-effectiveness of the intervention. DISCUSSION: The study aims to evaluate the effectiveness of a promising form of group therapy which may help alleviate negative symptoms that are associated with unfavourable long-term outcomes and have so far been difficult to treat. If the trial is successful, it will add a new and effective option in the treatment of negative symptoms. Group BPT is manualised, might be attractive to many patients because of its unusual approach, and could potentially be rolled out to services at relatively little additional cost. TRIAL REGISTRATION: Current Controlled Trials ISRCTN84216587.

Functional relaxation as complementary therapy in irritable bowel syndrome: a randomized, controlled clinical trial.

OBJECTIVES: Irritable bowel syndrome (IBS) is a frequently disabling and almost invariably distressing disease with a high overall prevalence. Numerous trials identified the importance of psychogenic and emotional etiological factors, and this is obvious in clinical practice. Although relaxation techniques are frequently recommended, there is still a lack of evidence for their efficacy in the management of IBS. This study therefore aims to determine the efficacy of functional relaxation (FR) in IBS. SUBJECTS: The subjects were 80 patients with IBS. INTERVENTIONS: Participants were randomly allocated either to FR or to enhanced medical care (EMC: treatment as usual plus two counseling interviews) as control intervention with 2 weekly sessions over the 5-week trial each. Thirty-nine (39) patients completed FR and 39 received EMC. OUTCOME MEASURES: An impairment-severity score (IS) was employed as the primary outcome parameter with assessment at baseline, after treatment, and again after 3-month follow-up. RESULTS: FR was significantly superior to EMC with a standardized effect size of 0.85. The achieved effects through FR remained stable in terms of psychic and bodily impairment after 3-month follow-up. CONCLUSIONS: The results of our trial suggest a positive effect of FR training on subjective functional impairment in the IS, if provided in addition to treatment as usual (TAU). There appears to be a clinically relevant long-term benefit of FR as a nonpharmacological and complementary therapy approach in IBS.