Telephone interventions, delivered by healthcare professionals, for educating and psychosocially supporting informal caregivers of adults with diagnosed illnesses

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To evaluate the effectiveness of telephone interventions, delivered by healthcare professionals, when compared to usual care or non-telephone-based support interventions for educating and psychosocially supporting informal carers of people with acute and chronic diagnosed illnesses, on these carers' quality of life, psychosocial and physical well-being. We aim, additionally, to evaluate the cost-effectiveness of telephone interventions

Varenicline for smoking cessation and reduction in people with severe mental illnesses : systematic review and meta-analysis

AIMS: To determine the effectiveness and safety of varenicline in treating tobacco dependence in patients with severe mental illness. DESIGN: A systematic review and meta-analysis of randomised controlled trials that compared varenicline with a placebo or an alternative intervention for smoking cessation or reduction. SETTING: Both in-patient and out-patient settings in any country. PARTICIPANTS: Adult patients aged 18 and over with any type of severe mental illness. The systematic review included eight studies comprising 398 participants. MEASURES: Primary outcome measures were (1) smoking cessation (2) smoking reduction measured by changes in the number of cigarettes smoked per day and (3) number of psychiatric adverse events, which were collected at the end of treatment. FINDINGS: The random-effect pooled estimates from the five studies that reported smoking related outcomes found that varenicline is statistically superior to placebo in smoking cessation (risk ratios 4.33; 95% CI: 1.96-9.56), and smoking reduction was higher in varenicline groups (mean reduced daily cigarettes was 6.39; 95% CI: 2.22-10.56). There is no significant difference regarding neuropsychiatric and other adverse events. CONCLUSIONS: Varenicline appears to be significantly more effective than placebo in assisting with smoking cessation and reduction in people with severe mental illness. There appears to be no clear evidence that varenicline was associated with an increased risk of neuropsychiatric or other adverse events compared with placebo. This article is protected by copyright. All rights reserved

Homeopathy for treatment of irritable bowel syndrome

BACKGROUND: Irritable bowel syndrome (IBS) is a common, chronic disorder that leads to decreased health-related quality of life and work productivity. A previous version of this review was not able to draw firm conclusions about the effectiveness of homeopathic treatment for IBS and recommended that further high quality RCTs were conducted to explore the clinical and cost effectiveness of homeopathic treatment for IBS. Two types of homeopathic treatment were evaluated in this systematic review: 1. Clinical homeopathy where a specific remedy is prescribed for a specific condition; 2. Individualised homeopathic treatment, where a homeopathic remedy based on a person's individual symptoms is prescribed after a detailed consultation. OBJECTIVES: To assess the effectiveness and safety of homeopathic treatment for IBS. SEARCH METHODS: For this update we searched MEDLINE, CENTRAL, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Allied and Complementary Medicine Database (AMED), the Cochrane IBD Group Specialised Register and trials registers from inception to 31 August 2018. SELECTION CRITERIA: Randomised controlled trials (RCTs), cohort and case-control studies that compared homeopathic treatment with placebo, other control treatments, or usual care, in adults with IBS were considered for inclusion. DATA COLLECTION AND ANALYSIS: Two authors independently assessed the risk of bias and extracted data. The primary outcome was global improvement in IBS as measured by an IBS symptom severity score. Secondary outcomes included quality of life, abdominal pain, stool frequency, stool consistency, and adverse events. The overall certainty of the evidence supporting the primary and secondary outcomes was assessed using the GRADE criteria. We used the Cochrane risk of bias tool to assess risk of bias. We calculated the mean difference (MD) and 95% confidence interval (CI) for continuous outcomes and the risk ratio (RR) and 95% CI for dichotomous outcomes. MAIN RESULTS: Four RCTs (307 participants) were included. Two studies compared clinical homeopathy (homeopathic remedy, asafoetida or asafoetida plus nux vomica) to placebo for IBS with constipation (IBS-C). One study compared individualised homeopathic treatment (consultation plus remedy) to usual care for the treatment of IBS in female patients. One study was a three armed RCT comparing individualised homeopathic treatment to supportive listening or usual care. The risk of bias in three studies (the two studies assessing clinical homeopathy and the study comparing individualised homeopathic treatment to usual care) was unclear on most criteria and high for selective reporting in one of the clinical homeopathy studies. The three armed study comparing individualised homeopathic treatment to usual care and supportive listening was at low risk of bias in four of the domains and high risk of bias in two (performance bias and detection bias).A meta-analysis of the studies assessing clinical homeopathy, (171 participants with IBS-C) was conducted. At short-term follow-up of two weeks, global improvement in symptoms was experienced by 73% (46/63) of asafoetida participants compared to 45% (30/66) of placebo participants (RR 1.61, 95% CI 1.18 to 2.18; 2 studies, very low certainty evidence). In the other clinical homeopathy study at two weeks, 68% (13/19) of those in the asafoetida plus nux vomica arm and 52% (12/23) of those in the placebo arm experienced a global improvement in symptoms (RR 1.31, 95% CI 0.80 to 2.15; very low certainty evidence). In the study comparing individualised homeopathic treatment to usual care (N = 20), the mean global improvement score (feeling unwell) at 12 weeks was 1.44 + 4.55 (n = 9) in the individualised homeopathic treatment arm compared to 1.41 + 1.97 (n=11) in the usual care arm (MD 0.03; 95% CI -3.16 to 3.22; very low certainty evidence).In the study comparing individualised homeopathic treatment to usual care, the mean IBS symptom severity score at 6 months was 210.44 + 112.4 (n = 16) in the individualised homeopathic treatment arm compared to 237.3 + 110.22 (n = 60) in the usual care arm (MD -26.86, 95% CI -88.59 to 34.87; low certainty evidence). The mean quality of life score (EQ-5D) at 6 months in homeopathy participants was 69.07 (SD 17.35) compared to 63.41 (SD 23.31) in usual care participants (MD 5.66, 95% CI -4.69 to 16.01; low certainty evidence).For In the study comparing individualised homeopathic treatment to supportive listening, the mean IBS symptom severity score at 6 months was 210.44 + 112.4 (n = 16) in the individualised homeopathic treatment arm compared to 262 + 120.72 (n = 18) in the supportive listening arm (MD -51.56, 95% CI -129.94 to 26.82; very low certainty evidence). The mean quality of life score at 6 months in homeopathy participants was 69.07 (SD 17.35) compared to 63.09 (SD 24.38) in supportive listening participants (MD 5.98, 95% CI -8.13 to 20.09; very low certainty evidence).None of the included studies reported on abdominal pain, stool frequency, stool consistency, or adverse events. AUTHORS' CONCLUSIONS: The results for the outcomes assessed in this review are uncertain. Thus no firm conclusions regarding the effectiveness and safety of homeopathy for the treatment of IBS can be drawn. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy for IBS compared to placebo or usual care

Telephone interventions, delivered by healthcare professionals, for providing education and psychosocial support for informal caregivers of adults with diagnosed illnesses

BACKGROUND: Maintaining care for ill persons in the community is heavily dependent on support from unpaid caregivers. Many caregivers, however, find themselves in a caring role for which they are ill prepared and may require professional support. The telephone is an easily accessible method of providing support irrespective of geographical location. OBJECTIVES: The objective of this review was to evaluate the effectiveness of telephone support interventions, delivered by healthcare professionals, when compared to usual care or non-telephone-based support interventions for providing education and psychosocial support for informal caregivers of people with acute and chronic diagnosed illnesses, and to evaluate the cost-effectiveness of telephone interventions in this population. SEARCH METHODS: We searched the following databases from inception to 16 November 2018: the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; Embase; PsycINFO; ProQuest Dissertations and Theses A&I; and CINAHL Complete. We also searched 11 caregiver-specific websites, three conference links, and two clinical trial registries. SELECTION CRITERIA: We included randomised controlled trials (RCTs) (including cluster-RCTs) and quasi-RCTs. We excluded cross-over trials because of the high risk of carry-over effects from one intervention to another. DATA COLLECTION AND ANALYSIS: Two authors independently screened citations against the review's inclusion criteria, extracted data, and assessed the included studies using the Cochrane 'Risk of bias' tool. The review's prespecified primary (quality of life and burden) and secondary outcomes (skill acquisition, psychological health, knowledge, health status and well-being, family functioning, satisfaction, and economic outcomes), where reported, were assessed at the end of intervention delivery and at short-term (≤ 3 months), medium-term (> 3 to ≤ 6 months) and longer-term time points (> 6 to 12 months) following the intervention. Where possible, meta-analyses were conducted, otherwise results were reported narratively. MAIN RESULTS: We included 21 randomised studies involving 1,690 caregivers; 19 studies compared telephone support interventions and usual care, of which 18 contributed data to the analyses. Two studies compared telephone and non-telephone professional support interventions. Caregiver ages ranged from 19 years to 87 years across studies. The majority of participants were female (> 70.53%), with two trials including females only. Most caregivers were family members, educated beyond secondary or high school level or had the equivalent in years of education. All caregivers were based in the community. Overall risk of bias was high for most studies.The results demonstrated that there is probably little or no difference between telephone support interventions and usual care for the primary outcome of quality of life at the end of intervention (SMD -0.02, 95% CI -0.24 to 0.19, 4 studies, 364 caregivers) (moderate-certainty evidence) or burden at the end of intervention (SMD -0.11, 95% CI -0.30 to 0.07, 9 studies, 788 caregivers) (low-certainty evidence). For one study where quality of life at the end of intervention was reported narratively, the findings indicated that a telephone support intervention may result in slightly higher quality of life, compared with usual care. Two further studies on caregiver burden were reported narratively; one reported that telephone support interventions may decrease burden, the other reported no change in the intervention group, compared with usual care.We are uncertain about the effects of telephone support interventions on caregiver depression at the end of intervention (SMD -0.37, 95% CI -0.70 to -0.05, 9 studies, 792 caregivers) due to very low-certainty evidence for this outcome. Depression was reported narratively for three studies. One reported that the intervention may reduce caregiver depression at the end of intervention, but this effect was not sustained at short-term follow-up. The other two studies reported there may be little or no difference between telephone support and usual care for depression at the end of intervention. Six studies measured satisfaction with the intervention but did not report comparative data. All six reported high satisfaction scores with the intervention. No adverse events, including suicide or suicide ideation, were measured or reported by any of the included studies.Our analysis indicated that caregiver anxiety may be slightly reduced (MD -6.0, 95% CI -11.68 to -0.32, 1 study, 61 caregivers) and preparedness to care slightly improved (SMD 0.37, 95% CI 0.09 to 0.64, 2 studies, 208 caregivers) at the end of intervention, following telephone-only support interventions compared to usual care. Findings indicated there may be little or no difference between telephone support interventions and usual care for all of the following outcomes at the end of intervention: problem-solving, social activity, caregiver competence, coping, stress, knowledge, physical health, self-efficacy, family functioning, and satisfaction with supports (practical or social). There may also be little or no effect of telephone support interventions for quality of life and burden at short-term follow-up or for burden and depression at medium-term follow-up.Litttle or no difference was found between groups for any of the reported outcomes in studies comparing telephone and non-telephone professional support interventions. We are uncertain as to the effects of telephone support interventions compared to non-telephone support interventions for caregiver burden and depression at the end of intervention. No study reported on quality of life or satisfaction with the intervention and no adverse events were reported or noted in the two studies reporting on this comparison. AUTHORS' CONCLUSIONS: Although our review indicated slight benefit may exist for telephone support interventions on some outcomes (e.g. anxiety and preparedness to care at the end of intervention), for most outcomes, including the primary outcomes, telephone-only interventions may have little or no effect on caregiver outcomes compared to usual care. The findings of the review were mainly based on studies with overall high risk of bias, and few participants. Further high-quality trials, with larger sample sizes are required

Assessment of Cytokines, microRNA and patient related outcome measures in Conversion Disorder/Functional Neurological Disorder (CD/FND) : the CANDO clinical feasibility study

Background: Conversion disorder/functional neurological disorder (CD/FND) occurs often in neurological settings and can lead to long-term distress, disability and demand on health care services. Systemic low-grade inflammation might play a role, however, the pathogenic mechanism is still unknown. Aim: 1) To explore the feasibility to establish and assess a cohort of CD/FND with motor symptoms, involving persons with lived experience (PPI). 2) To generate proof of concept regarding a possible role for cytokines, microRNA, cortisol levels and neurocognitive symptoms in patients with motor CD/FND. Method: Feasibility study. Results: The study showed active involvement of patients despite high clinical illness burden and disability, neurocognitive symptoms, childhood adverse experiences (ACE) and current life events. The study provided valuable knowledge regarding the feasibility of conducting a study in these patients that will inform future study phases. In the sample there were elevated levels of IL6, IL12, IL17A, IFNg, TNFa and VEGF-a, suggesting systemic low-grade inflammation. Also, microRNAs involved in inflammation and vascular inflammation were correlated with TNFa and VEGFa respectively, suggesting proof of concept for an epigenetic mechanism. Owing to the COVID-19 outbreak, the patient sample was limited to 15 patients. Conclusion: It is a novelty that this study is conducted in the clinical setting. This innovative, translational study explores stress-related SLI in CD/FND patients and the feasibility of a larger project aiming to develop new treatments for this vulnerable population. Given the positive findings, there is scope to conduct further research into the mechanism of disease in CD/FND

A randomised controlled trial of computerised cognitive behaviour therapy for the treatment of depression in primary care: the Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT) trial.

BACKGROUND: Computerised cognitive behaviour therapy (cCBT) has been developed as an efficient form of therapy delivery with the potential to enhance access to psychological care. Independent research is needed which examines both the clinical effectiveness and cost-effectiveness of cCBT over the short and longer term. OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of cCBT as an adjunct to usual general practitioner (GP) care against usual GP care alone, for a free-to-use cCBT program (MoodGYM; National Institute for Mental Health Research, Australian National University, Canberra, Australia) and a commercial pay-to-use cCBT program (Beating the Blues(®); Ultrasis, London, UK) for adults with depression, and to determine the acceptability of cCBT and the experiences of users. DESIGN: A pragmatic, multicentre, three-armed, parallel, randomised controlled trial (RCT) with concurrent economic and qualitative evaluations. Simple randomisation was used. Participants and researchers were not blind to treatment allocation. SETTING: Primary care in England. PARTICIPANTS: Adults with depression who scored ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9). INTERVENTIONS: Participants who were randomised to either of the two intervention groups received cCBT (Beating the Blues or MoodGYM) in addition to usual GP care. Participants who were randomised to the control group were offered usual GP care. MAIN OUTCOME MEASURES: The primary outcome was depression at 4 months (PHQ-9). Secondary outcomes were depression at 12 and 24 months; measures of mental health and health-related quality of life at 4, 12 and 24 months; treatment preference; and the acceptability of cCBT and experiences of users. RESULTS: Clinical effectiveness: 210 patients were randomised to Beating the Blues, 242 patients were randomised to MoodGYM and 239 patients were randomised to usual GP care (total 691). There was no difference in the primary outcome (depression measured at 4 months) either between Beating the Blues and usual GP care [odds ratio (OR) 1.19, 95% confidence interval (CI) 0.75 to 1.88] or between MoodGYM and usual GP care (OR 0.98, 95% CI 0.62 to 1.56). There was no overall difference across all time points for either intervention compared with usual GP care in a mixed model (Beating the Blues versus usual GP care, p = 0.96; and MoodGYM versus usual GP care, p = 0.11). However, a small but statistically significant difference between MoodGYM and usual GP care at 12 months was found (OR 0.56, 95% CI 0.34 to 0.93). Free-to-use cCBT (MoodGYM) was not inferior to pay-to-use cCBT (Beating the Blues) (OR 0.91, 90% CI 0.62 to 1.34; p = 0.69). There were no consistent benefits of either intervention when secondary outcomes were examined. There were no serious adverse events thought likely to be related to the trial intervention. Despite the provision of regular technical telephone support, there was low uptake of the cCBT programs. Cost-effectiveness: cost-effectiveness analyses suggest that neither Beating the Blues nor MoodGYM appeared cost-effective compared with usual GP care alone. Qualitative evaluation: participants were often demotivated to access the computer programs, by reason of depression. Some expressed the view that a greater level of therapeutic input would be needed to promote engagement. CONCLUSIONS: The benefits that have previously been observed in developer-led trials were not found in this large pragmatic RCT. The benefits of cCBT when added to routine primary care were minimal, and uptake of this mode of therapy was relatively low. There remains a clinical and economic need for effective low-intensity psychological treatments for depression with improved patient engagement. TRIAL REGISTRATION: This trial is registered as ISRCTN91947481. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme

Integrated therapist and online CBT for depression in primary care (INTERACT): study protocol for a multi-centre randomised controlled trial

BACKGROUND: Cognitive behavioural therapy (CBT) is an effective treatment for depression. Self-directed online CBT interventions have made CBT more accessible at a lower cost. However, adherence is often poor and, in the absence of therapist support, effects are modest and short-term. Delivering CBT online using instant messaging is clinically and cost-effective; however, most existing platforms are limited to instant messaging sessions, without the support of between-session "homework" activities. The INTERACT intervention integrates online CBT materials and 'high-intensity' therapist-led CBT, delivered remotely in real-time. The INTERACT trial will evaluate this novel integration in terms of clinical and cost-effectiveness, and acceptability to therapists and clients. METHODS: Pragmatic, two parallel-group multi-centre individually randomised controlled trial, with 434 patients recruited from primary care practices in Bristol, London and York. Participants with depression will be identified via General Practitioner record searches and direct referrals. INCLUSION CRITERIA: aged ≥ 18 years; score ≥ 14 on Beck Depression Inventory (BDI-II); meeting International Classification of Diseases (ICD-10) criteria for depression. EXCLUSION CRITERIA: alcohol or substance dependency in the past year; bipolar disorder; schizophrenia; psychosis; dementia; currently under psychiatric care for depression (including those referred but not yet seen); cannot complete questionnaires unaided or requires an interpreter; currently receiving CBT/other psychotherapy; received high-intensity CBT in the past four years; participating in another intervention trial; unwilling/unable to receive CBT via computer/laptop/smartphone. Eligible participants will be randomised to integrated CBT or usual care. Integrated CBT utilises the standard Beckian intervention for depression and comprises nine live therapist-led sessions, with (up to) a further three if clinically appropriate. The first session is 60-90 min via videocall, with subsequent 50-min sessions delivered online, using instant messaging. Participants allocated integrated CBT can access integrated online CBT resources (worksheets/information sheets/videos) within and between sessions. Outcome assessments at 3-, 6-, 9- and 12-month post-randomisation. The primary outcome is the Beck Depression Inventory (BDI-II) score at 6 months (as a continuous variable). A nested qualitative study and health economic evaluation will be conducted. DISCUSSION: If clinically and cost-effective, this model of integrated CBT could be introduced into existing psychological services, increasing access to, and equity of, CBT provision. TRIAL REGISTRATION: ISRCTN, ISRCTN13112900. Registered on 11/11/2020. Currently recruiting participants. Trial registration data are presented in Table 1