scholarly journals Outcomes of an individual counselling programme in Grozny, Chechnya: a randomised controlled study

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e019794
Author(s):  
Annick Lenglet ◽  
Barbara Lopes-Cardozo ◽  
Leslie Shanks ◽  
Curtis Blanton ◽  
Concetta Feo ◽  
...  
Keyword(s):  
Mental Health ◽  
Short Form ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Study ◽  
Individual Counselling ◽  
Male Clients ◽  
And Gender ◽  
Randomised Controlled ◽  
The Impact

ObjectivesTo evaluate the effectiveness of individual counselling on functioning of clients participating in a mental health intervention in a humanitarian setting.DesignRandomised controlled trial.SettingMental health programme implemented by Médecins Sans Frontières in Grozny, Republic of Chechnya.Participants168 eligible clients were randomly assigned to the intervention and waitlisted (2 months) arms between November 2014 and February 2015.InterventionIndividual counselling sessions.Main outcome measuresChange in functioning was measured using the Short Form 6 (SF6) and gender-specific locally adapted Chechen functioning instruments in the intervention group at the end of counselling and the waitlisted group after their waitlisted period. Unadjusted differences in gain scores (DGSs) between intervention and waitlisted groups were calculated with effect size (Cohen’sd) for both tools. Linear regression compared the mean DGS in both groups.ResultsThe intervention group (n=78) improved compared with waitlisted controls (n=80) on the SF6 measures with moderate to large effect sizes: general health (DGS 12.14,d=0.52), body pain (DGS 10.26,d=0.35), social support (DGS 16.07,d=0.69) and emotional functioning (DGS 16.87,d=0.91). Similar improvement was seen using the Chechen functioning instrument score (female DGS −0.33,d=0.55; male DGS −0.40,d=0.99). Adjusted analysis showed significant improvement (p<0.05) in the intervention group for all SF6 measures and for the Chechen functioning instrument score in women but not men (p=0.07).ConclusionsIndividual counselling significantly improved participants’ ability to function in the intervention group compared with the waitlisted group. Further research is needed to determine whether similar positive results can be shown in other settings and further exploring the impact in male clients’ population.Trial registration numberNTR4689.

scholarly journals The side effects of service changes: exploring the longitudinal impact of participation in a randomised controlled trial (DOORWAYS) on staff perceptions of barriers to change

2019 ◽  
Author(s):  
Caroline Laker ◽  
Matteo Cella ◽  
Felicity Callard ◽  
Til Wykes
Keyword(s):  
Mental Health ◽  
Controlled Trial ◽  
Occupational Status ◽  
Intervention Group ◽  
Direct Care ◽  
Care Staff ◽  
Control Group ◽  
Staff Perceptions ◽  
Barriers To Change ◽  
Randomised Controlled

Abstract Background Staff and service users have expressed concerns that service improvements in U.K. mental health wards have been slow or transient. It is possible that certain changes are positive for some (e.g. service users), but negative for others (e.g. staff), which may affect implementation success. In this study, we explore whether a programme of change to improve the therapeutic milieu on mental health wards influenced staff perceptions of barriers to change, 12 months after implementation. Method A cluster randomised controlled trial called DOORWAYS was conducted on eight inner-city U.K. acute mental health wards. Randomisation was achieved using a list randomly generated by a computer. A psychologist trained ward staff (mainly nurses) to deliver evidence-based groups and supported their initial implementation. The impact of these changes was measured over 12 months (when 4 wards were randomised), according to nurses’ perceptions of barriers to change (VOCALISE), using unstructured multivariate linear regression models. This innovative analysis method allows maximum use of data in randomised controlled trials with reduced sample sizes due to substantial drop out rates. The contextual influences of occupational status (staff) and of workplace setting (ward) were also considered. Results Staff who participated in the intervention had significantly worse perceptions of barriers to change at follow up. The perceptions of staff in the control group did not change over time. In both groups (N=120), direct care staff had more negative perceptions of barriers to change, and perceptions varied according to ward. Across time, direct care staff in the intervention group became more negative than those in the control group. Conclusion Participation in this program of change, worsened staff perceptions of barriers to change. In addition, occupational status (being from the direct care group) had a negative effect on perceptions of barriers to change, an effect that continued across time and was worse in the intervention group. Those providing direct care should be offered extra support when changes are introduced and through the implementation process. More effort should be placed around reducing the perceived burden of innovation for staff in mental health wards.

scholarly journals The Effect of Physiotherapy Group Intervention in Reducing Pain Disorders and Mental Health Symptoms among Syrian Refugees: A Randomized Controlled Trial

2020 ◽  
Vol 17 (24) ◽  
pp. 9468
Author(s):  
Wegdan Hasha ◽  
Jannicke Igland ◽  
Lars T. Fadnes ◽  
Bernadette Kumar ◽  
Jasmin Haj-Younes ◽  
...  
Keyword(s):  
Mental Health ◽  
Chronic Pain ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
General Health Questionnaire ◽  
Intervention Group ◽  
Complex Interventions ◽  
Control Group ◽  
Syrian Refugees ◽  
The Impact

Chronic pain is common among refugees, and often related to mental health problems. Its management, however, is often challenging. A randomized waitlist-controlled trial was designed to study the effect of group physiotherapy activity and awareness intervention (PAAI) on reducing pain disorders, and secondarily improving mental health, among Syrian refugees. A total of 101 adult Syrian refugees suffering from chronic pain were randomized to either the intervention group or the control group, which thereafter also received PAAI after a waiting period. Pain intensity measured by the Brief Pain Inventory (BPI) was the primary outcome. Scores from the Impact of Events Scale-Revised (IES-R 22) and the General Health Questionnaire (GHQ-12) were secondary outcomes. Intention-to-treat analyses (ITT) showed no effect of the intervention on either pain levels (regression coefficient [B {95% CI} of 0.03 {−0.91, 0.96}], IESR scores [4.8 {−3.7, 13.4}] or GHQ-12 scores [−0.4 {−3.1, 2.3}]). Yet, participants highly appreciated the intervention. Despite the negative findings, our study contributes to the evidence base necessary to plan targeted and effective health care services for refugees suffering from chronic pain and highlights the challenge of evaluating complex interventions adapted to a specific group.

scholarly journals Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024589
Author(s):  
Wen Yao Mak ◽  
Loke Meng Ong ◽  
Bak Leong Goh ◽  
Sunita Bavanandan ◽  
Lily Mushahar ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Controlled Trial ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Open Label ◽  
Randomised Controlled ◽  
End Stage

IntroductionPeritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.Methods and analysisThe study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.Ethics and disseminationThe study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.Trial registration numberNCT03177031; Pre-results.

scholarly journals Decision aid on disclosure of mental health status to an employer: feasibility and outcomes of a randomised controlled trial

2013 ◽  
Vol 203 (5) ◽  
pp. 350-357 ◽  
Author(s):  
Claire Henderson ◽  
Elaine Brohan ◽  
Sarah Clement ◽  
Paul Williams ◽  
Francesca Lassman ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Decision Aid ◽  
Controlled Trial ◽  
Intervention Group ◽  
Decisional Conflict ◽  
Full Time ◽  
Randomised Controlled

BackgroundMany mental health service users delay or avoid disclosing their condition to employers because of experience, or anticipation, of discrimination. However, non-disclosure precludes the ability to request ‘reasonable adjustments’. There have been no intervention studies to support decisionmaking about disclosure to an employer.AimsTo determine whether the decision aid has an effect that is sustained beyond its immediate impact; to determine whether a large-scale trial is feasible; and to optimise the designs of a larger trial and of the decision aid.MethodIn this exploratory randomised controlled trial (RCT) in London, participants were randomly assigned to use of a decision aid plus usual care or usual care alone. Follow-up was at 3 months. Primary outcomes were: (a) stage of decision-making; (b) decisional conflict; and (c) employment-related outcomes (trial registration number: NCT01379014).ResultsWe recruited 80 participants and interventions were completed for 36 out of 40 in the intervention group; in total 71 participants were followed up. Intention-to-treat analysis showed that reduction in decisional conflict was significantly greater in the intervention group than among controls (mean improvement −22.7 (s.d. = 15.2) v. −11.2 (s.d. = 18.1), P = 0.005). More of the intervention group than controls were in full-time employment at follow-up (P = 0.03).ConclusionsThe observed reduction in decisional conflict regarding disclosure has a number of potential benefits which next need to be tested in a definitive trial.

scholarly journals Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  
Keyword(s):  
Primary Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Perceived Disability ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

scholarly journals Breast cancer application protocol: a randomised controlled trial to evaluate a self-management app for breast cancer survivors

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e034655
Author(s):  
Andy S K Cheng ◽  
Xiangyu Liu ◽  
Peter H F Ng ◽  
Cindy T T Kwok ◽  
Yingchun Zeng ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Breast Cancer Survivors ◽  
Controlled Trial ◽  
Intervention Group ◽  
Readiness For Change ◽  
Self Management ◽  
Controlled Study ◽  
Control Group ◽  
Problem Solving Skills ◽  
Randomised Controlled

IntroductionThe eHealth technologies that are being designed for chronic disease constitute a global trend towards health assessment and self-management. However, most of these approaches tend to focus on a single symptom or problem rather than on the multiple problems that are characteristic of many of these chronic illnesses. The aim of this study is to examine the effectiveness of and adherence to a self-management application (app) that identifies multiple problem areas related to surviving breast cancer as the targeted chronic illness.Methods and analysisThis is a randomised controlled study. Eligible participants will be allocated randomly into either an intervention group or a control group at a 1:1 ratio. The intervention group will be assigned to the self-management app (‘Be-with-You’), while the control group will use a general health app (‘Sham’ app). The primary outcomes will include the differences between the two groups in their health literacy, problem-solving skills and self-management skills. The secondary outcomes will include group differences in self-efficacy, readiness for change and health-related quality of life. All of these outcomes will be measured at baseline and at 4 weeks and 12 weeks after intervention. In addition, usability of these two mobile apps will be measured at 4 weeks and 12 weeks after intervention. The planned sample size is 476.Ethics and disseminationThe Human Subjects Ethics Sub-committee of The Hong Kong Polytechnic University approved the study (HSEARS20190922001, 24 September 2019). Dissemination of findings will occur at the local, national and international levels.Trial registration numberChiCTR1900026244.

scholarly journals The side effects of service changes: exploring the longitudinal impact of participation in a randomised controlled trial (DOORWAYS) on staff perceptions of barriers to change

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Caroline Laker ◽  
Matteo Cella ◽  
Deborah Agbediro ◽  
Felicity Callard ◽  
Til Wykes
Keyword(s):  
Mental Health ◽  
Controlled Trial ◽  
Occupational Status ◽  
Intervention Group ◽  
Direct Care ◽  
Care Staff ◽  
Control Group ◽  
Staff Perceptions ◽  
Barriers To Change ◽  
Randomised Controlled

Abstract Background Staff and service users have expressed concerns that service improvements in British mental health wards have been slow or transient. It is possible that certain changes are positive for some (e.g. service users), but negative for others (e.g. staff), which may affect implementation success. In this study, we explore whether a programme of change to improve the therapeutic milieu on mental health wards influenced staff perceptions of barriers to change, 12 months after implementation. Method A cluster randomised controlled trial called DOORWAYS was conducted on eight British, inner-city acute mental health wards. Randomisation was achieved using a list randomly generated by a computer. A psychologist trained ward staff (mainly nurses) to deliver evidence-based groups and supported their initial implementation. The impact of these changes was measured over 12 months (when 4 wards were randomised), according to nurses’ perceptions of barriers to change (VOCALISE), using unstructured multivariate linear regression models. This innovative analysis method allows maximum use of data in randomised controlled trials with reduced sample sizes due to substantial drop out rates. The contextual influences of occupational status (staff) and of workplace setting (ward) were also considered. Results Staff who participated in the intervention had significantly worse perceptions of barriers to change at follow up. The perceptions of staff in the control group did not change over time. In both groups (N = 120), direct care staff had more negative perceptions of barriers to change, and perceptions varied according to ward. Across time, direct care staff in the intervention group became more negative than those in the control group. Conclusion Participation in this program of change, worsened staff perceptions of barriers to change. In addition, occupational status (being from the direct care group) had a negative effect on perceptions of barriers to change, an effect that continued across time and was worse in the intervention group. Those providing direct care should be offered extra support when changes are introduced and through the implementation process. More effort should be placed around reducing the perceived burden of innovation for staff in mental health wards. Trial registration ISRCTN, ISRCTN 06545047. Registered 29/04/2010, https://www.isrctn.com/search?q=06545047

scholarly journals Feasibility and acceptability of suicide prevention therapy on acute psychiatric wards: randomised controlled trial

BJPsych Open ◽  
2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Gillian Haddock ◽  
Daniel Pratt ◽  
Patricia A. Gooding ◽  
Sarah Peters ◽  
Richard Emsley ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Suicide Prevention ◽  
Suicidal Behaviour ◽  
Controlled Trial ◽  
Prevention Therapy ◽  
Health And Social Care ◽  
Acute Psychiatric Wards ◽  
Randomised Controlled ◽  
The Impact

BackgroundSuicidal behaviour is common in acute psychiatric wards resulting in distress, and burden for patients, carers and society. Although psychological therapies for suicidal behaviour are effective in out-patient settings, there is little research on their effectiveness for in-patients who are suicidal.AimsOur primary objective was to determine whether cognitive–behavioural suicide prevention therapy (CBSP) was feasible and acceptable, compared with treatment as usual (TAU) for in-patients who are suicidal. Secondary aims were to assess the impact of CBSP on suicidal thinking, behaviours, functioning, quality of life, service use, cost-effectiveness and psychological factors associated with suicide.MethodA single-blind pilot randomised controlled trial comparing TAU to TAU plus CBSP in in-patients in acute psychiatric wards who are suicidal (the Inpatient Suicide Intervention and Therapy Evaluation (INSITE) trial, trial registration: ISRCTN17890126). The intervention consisted of TAU plus up to 20 CBSP sessions, over 6 months continuing in the community following discharge. Participants were assessed at baseline and at 6 weeks and 6 months post-baseline.ResultsA total of 51 individuals were randomised (27 to TAU, 24 to TAU plus CBSP) of whom 37 were followed up at 6 months (19 in TAU, 18 in TAU plus CBSP). Engagement, attendance, safety and user feedback indicated that the addition of CBSP to TAU for in-patients who are acutely suicidal was feasible and acceptable while on in-patient wards and following discharge. Economic analysis suggests the intervention could be cost-effective.DiscussionPsychological therapy can be delivered safely to patients who are suicidal although modifications are required for this setting. Findings indicate a larger, definitive trial should be conducted.Declaration of interestThe trial was hosted by Greater Manchester Mental health NHS Trust (formerly, Manchester Mental Health and Social Care NHS Trust). The authors are affiliated to the University of Manchester, Greater Manchester Mental Health Foundation Trust, Lancashire Care NHS Foundation trust and the Manchester Academic Health Sciences Centre. Y.A. is a trustee for a North-West England branch of the charity Mind.

scholarly journals Impacts of a Standing Desk Intervention within an English Primary School Classroom: A Pilot Controlled Trial

2020 ◽  
Vol 17 (19) ◽  
pp. 7048
Author(s):  
Aron P. Sherry ◽  
Natalie Pearson ◽  
Nicola D. Ridgers ◽  
William Johnson ◽  
Sally E. Barber ◽  
...  
Keyword(s):  
Mental Health ◽  
Primary School ◽  
Controlled Trial ◽  
School Setting ◽  
Intervention Group ◽  
Traditional Classroom ◽  
Control Group ◽  
Musculoskeletal Discomfort ◽  
Class Time ◽  
The Impact

Traditional classroom furniture dictates that children predominantly sit during class time. This study evaluated the impact of providing standing desks within a deprived UK primary school setting over 8 months using mixed-method approaches. All children within a Year 5 class (9–10-year-olds, n = 30) received an adjustable sit–stand desk, while another Year 5 class (n = 30) in a nearby school retained traditional furniture as a control classroom. At baseline, 4 months, and 8 months, activPAL monitors (PAL Technologies, Glasgow, UK) were worn for 7 days to provide time spent sitting and standing. Behavior-related mental health, musculoskeletal discomfort surveys, and a cognitive function test battery were also completed at all three timepoints. Intervention experiences from pupils and the teacher were captured using focus groups, interviews, and classroom observations. At both 4 months and 8 months, multi-level models revealed a reduction in class time sitting in the intervention group compared to the control group ((β (95%CI) 4 months −25.3% (−32.3, −18.4); 8 months −19.9% (−27.05, −12.9)). Qualitative data revealed challenges to teaching practicalities and a gradual decline in behavior-related mental health was observed (intervention vs. control: 4 months +5.31 (+2.55, +8.08); 8 months +7.92 (+5.18, +10.66)). Larger trials within similar high-priority settings are required to determine the feasibility and cost-effectiveness of providing standing desks to every child in the classroom.

scholarly journals The impact of an operation and management intervention on toilet usability in schools in the Philippines: a cluster randomised controlled trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Helen Buxton ◽  
Jed Dimaisip-Nabuab ◽  
Denise Duijster ◽  
Bella Monse ◽  
Habib Benzian ◽  
...  
Keyword(s):  
Teacher Satisfaction ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
The Philippines ◽  
School Level ◽  
Management Intervention ◽  
Sanitation And Hygiene ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Access to usable water, sanitation and hygiene provision in schools is included within indicators in the Sustainable Development Goals. Progress towards these indicators is dependent on developing an understanding of which intervention components are most effective to operate and maintain usable services. This study aimed to determine the impact of a school toilet operation and management intervention in the Philippines on toilet usability and student and teacher satisfaction, adjusted for clustering at school level. Methods In a non-blinded cluster randomised controlled trial, we compared improvements in usability and cleanliness of school toilets among those schools receiving a low-cost, replicable intervention. Toilet usability was measured based on Sustainable Development Goal indicators related to school sanitation defined by the UNICEF/WHO Joint Monitoring Programme for Water, Sanitation and Hygiene. Intervention schools received consumables, support kits, and structured tools designed to facilitate operation and maintenance of sanitation facilities. The primary outcome, toilet usability and cleanliness, was compared through a difference-in-difference analysis of toilet usability. Secondary outcomes of student and teacher satisfaction were measured through a survey at endline. All outcomes were adjusted for clustering at school level. Results 20 eligible schools in the Batangas region of the Philippines were randomly selected and allocated to either control or intervention group. We found that non-classroom toilets were 48% more likely to meet quality benchmarks in intervention schools, but this was not statistically significant. When including in-classroom toilets in the analysis, there were no significant differences in toilet usability - defined as accessible, functional, private and of high quality – between intervention and control schools. When stratified by toilet location, children in the intervention group clusters expressed a minor, but statistically significant increase in overall satisfaction with sanitation facilities (p = 0.035). Conclusion Water, sanitation and hygiene interventions in schools focusing on operation and maintenance showed potential to improve toilet usability, but universal achievement of SDG targets may require additional efforts addressing toilet infrastructure. Trial registration ClinicalTrials.gov NCT03204175, June 2017 prior to participant enrolment.

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