Early intervention in panic: pragmatic randomised controlled
                        trial

BackgroundMany people suffer from subthreshold and mild panic disorder and are at risk of developing more severe panic disorder.AimsThis study (trial registration: ISRCTN33407455) was conducted to evaluate the effectiveness of an early group intervention based on cognitive–behavioural principles to reduce panic disorder symptomatology.MethodParticipants with subthreshold or mild panic disorder were recruited from the general population and randomised to the intervention (n = 109) or a waiting-list control group (n = 108). The course was offered by 17 community mental health centres.ResultsIn the early intervention group, 43/109 (39%) participants presented with a clinically significant change on the Panic Disorder Severity Scale–Self Report (PDSS–SR) v. 17/108 (16%) in the control group (odds ratio (OR) for favourable treatment response 3.49, 95% CI 1.77–6.88, P = 0.001). The course also had a positive effect on DSM–IV panic disorder status (OR = 1.96, 95% CI=1.05–3.66, P = 0.037). The PDSS–SR symptom reduction was also substantial (between-group standardised mean difference of 0.68). The effects were maintained at 6-month follow-up.ConclusionsPeople presenting with subthreshold and mild panic disorder benefit from this brief intervention.

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Mindfulness-based programme for residents: study protocol of a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-035025 ◽

2020 ◽

Vol 10 (3) ◽

pp. e035025

Author(s):

Vanessa Marie-Jane Aeschbach ◽

Johannes Caspar Fendel ◽

Anja Simone Göritz ◽

Stefan Schmidt

Keyword(s):

Mental Distress ◽

Medical Center ◽

Controlled Trial ◽

Intervention Group ◽

Maintenance Phase ◽

Self Report ◽

Physiological Data ◽

Control Group ◽

Daily Routine ◽

Randomised Controlled

IntroductionResidency is a stressful phase associated with high prevalence of mental distress. Besides impaired personal health, mental distress in residents has an impact on the quality of patient care and produces economic costs. Therefore, there is demand for interventions that improve resident physicians’ mental health. The aim of the present study is to examine the effects of a mindfulness-based intervention that has been tailored to residents’ needs. Specifically, mindfulness has been supplemented by a focus on the concept of Muße.Methods and analysisThis study applies a randomised controlled multimethod design. Residents assigned to the intervention group will participate in an 8-week mindfulness course followed by a 4-month maintenance phase, whereas residents assigned to the control group will read text-based information about mindfulness on a weekly basis for the duration of 8 weeks. The intervention is focussed on a transfer of learnt techniques into the daily routine and is targeted to promote residents’ self-care as well as on building empathic relationships. Participants will be assessed before, directly after the intervention, after the maintenance phase as well as at follow-up 6 months after the intervention group completes the intervention. Assessments will consist of self-report measures, physiological data, qualitative interviews, third-party reports as well as implicit and projective measures and will focus on both psychopathology and salutogenesis. The primary outcome will be burnout. Data will be analysed using linear mixed modelling.Ethics and disseminationThe study was approved by the ethics committee of the Medical Center - University of Freiburg and is funded by the German Research Foundation as part of the interdisciplinary Collaborative Research Center ‘SFB Muße 1015’. The results of this study will be published in scientific journals and disseminated through the study’s website, and conferences.Trial registration numberDRKS00014015.

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Promoting the Community's Ability to Detect and Respond to Suicide Risk Through an Online Bystander Intervention Model-Informed Tool

Crisis ◽

10.1027/0227-5910/a000708 ◽

2020 ◽

pp. 1-7

Author(s):

Karien Hill ◽

Shawn Somerset ◽

Ralf Schwarzer ◽

Carina Chan

Keyword(s):

Suicide Prevention ◽

Suicide Risk ◽

Controlled Trial ◽

Intervention Group ◽

Bystander Intervention ◽

Self Report ◽

Innovative Technology ◽

Control Group ◽

Intervention Model ◽

Standard Material

Abstract. Background: The public health sector has advocated for more innovative, technology-based, suicide prevention education for the community, to improve their ability to detect and respond to suicide risk. Emerging evidence suggests addressing the bystander effect through the Bystander Intervention Model (BIM) in education material may have potential for suicide prevention. Aims: The current study aimed to assess whether BIM-informed tools can lead to improved readiness, confidence and intent in the community to detect and respond to suicide risk in others. Method: A sample of 281 adults recruited from the community participated in a randomized controlled trial comprising a factsheet designed according to the BIM (intervention group) and a standard factsheet about suicide and mental health (control group). Participants' self-reported detecting and responding to suicide risk readiness, confidence, and intent when presented with a suicidal peer was tested pre- and postintervention and compared across time and between groups. Results: The intervention group had significantly higher levels of detecting and responding to suicide risk readiness, confidence, and intent than the control group at postintervention (all p < .001) with moderate-to-large effect sizes. Limitations: The study was limited by a homogenous sample, too low numbers at follow-up to report, and self-report data only. Conclusion: This study demonstrates BIM-informed suicide prevention training may enhance the community's intervention readiness, confidence, and intent better than current standard material. Further testing in this area is recommended. While results were statistically significant, clinical significance requires further exploration.

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Can an online exercise prescription tool improve adherence to home exercise programmes in children with cerebral palsy and other neurodevelopmental disabilities? A randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-040108 ◽

2020 ◽

Vol 10 (12) ◽

pp. e040108

Author(s):

Rowan W Johnson ◽

Sian A Williams ◽

Daniel F Gucciardi ◽

Natasha Bear ◽

Noula Gibson

Keyword(s):

Exercise Prescription ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Programme ◽

Home Exercise ◽

Control Group ◽

Neurodevelopmental Disabilities ◽

Home Exercise Programme ◽

Exercise Programmes ◽

Randomised Controlled

ObjectiveDetermine the adherence to and effectiveness of an 8-week home exercise programme for children with disabilities delivered using Physitrack, an online exercise prescription tool, compared with traditional paper-based methods.DesignSingle-blinded, parallel-groups, randomised controlled trial (RCT).SettingIntervention took place in participants’ homes in Western Australia.ParticipantsChildren aged 6 to 17 years, with neurodevelopmental disabilities including cerebral palsy (CP), receiving community therapy services.InterventionAll participants completed an individualised home exercise programme, which was delivered to the intervention group using Physitrack and conventional paper-based methods for the control group.Primary outcome measuresAdherence to exercise programme, goal achievement and exercise performance.Secondary outcome measuresEnjoyment, confidence and usability of Physitrack.ResultsFifty-four participants with CP (n=37) or other neurodevelopmental disabilities (n=17) were recruited. Fifty-three were randomised after one early withdrawal. Forty-six completed the 8-week programme, with 24 in the intervention group and 22 in the control group. There was no difference between the two groups for percentage of exercises completed (intervention (n=22): 62.8% (SD 27.7), control (n=22): 55.8% (SD 19.4), between group mean difference −7.0% (95% CI: −21.6 to 7.5, p=0.34)). Both groups showed significant improvement in their self-rated performance of individualised goal activities, however there was no statistically significant difference between groups for goal achievement, quality of exercise performance, enjoyment, confidence or preferred method of delivery. There were no adverse events.ConclusionPhysitrack provides a therapist with a new means of providing an exercise programme with online tools such as exercise videos, but our preliminary findings indicate that it may be no better than a traditional paper-based method for improving exercise adherence or the other outcomes measured. Exercise programmes remain an intervention supported by evidence, but a larger RCT is required to fully evaluate online delivery methods.Trial registration detailsAustralian New Zealand Clinical Trials Registry; ACTRN12616000743460.

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A randomised feasibility trial of an employer-based intervention for enhancing successful return to work of cancer survivors (MiLES intervention)

BMC Public Health ◽

10.1186/s12889-021-11357-9 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

M. A. Greidanus ◽

A. E. de Rijk ◽

A. G. E. M. de Boer ◽

M. E. M. M. Bos ◽

P. W. Plaisier ◽

...

Keyword(s):

Return To Work ◽

Cancer Survivors ◽

Controlled Trial ◽

Intervention Group ◽

Work Outcomes ◽

Feasibility Trial ◽

Control Group ◽

Secondary Effect ◽

Quality Of Working Life ◽

Randomised Controlled

Abstract Background Employers express a need for support during sickness absence and return to work (RTW) of cancer survivors. Therefore, a web-based intervention (MiLES) targeted at employers with the objective of enhancing cancer survivors’ successful RTW has been developed. This study aimed to assess feasibility of a future definitive randomised controlled trial (RCT) on the effectiveness of the MiLES intervention. Also preliminary results on the effectiveness of the MiLES intervention were obtained. Methods A randomised feasibility trial of 6 months was undertaken with cancer survivors aged 18–63 years, diagnosed with cancer < 2 years earlier, currently in paid employment, and sick-listed < 1 year. Participants were randomised to an intervention group, with their employer receiving the MiLES intervention, or to a waiting-list control group (2:1). Feasibility of a future definitive RCT was determined on the basis of predefined criteria related to method and protocol-related uncertainties (e.g. reach, retention, appropriateness). The primary effect measure (i.e. successful RTW) and secondary effect measures (e.g. quality of working life) were assessed at baseline and 3 and 6 months thereafter. Results Thirty-five cancer survivors were included via medical specialists (4% of the initially invited group) and open invitations, and thereafter randomised to the intervention (n = 24) or control group (n = 11). Most participants were female (97%) with breast cancer (80%) and a permanent employment contract (94%). All predefined criteria for feasibility of a future definitive RCT were achieved, except that concerning the study’s reach (90 participants). After 6 months, 92% of the intervention group and 100% of the control group returned to work (RR: 0.92, 95% CI: 0.81–1.03); no difference were found with regard to secondary effect measures. Conclusions With the current design a future definitive RCT on the effectiveness of the MiLES intervention on successful RTW of cancer survivors is not feasible, since recruitment of survivors fell short of the predefined minimum for feasibility. There was selection bias towards survivors at low risk of adverse work outcomes, which reduced generalisability of the outcomes. An alternative study design is needed to study effectiveness of the MiLES intervention. Trial registration The study has been registered in the Dutch Trial Register (NL6758/NTR7627).

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Randomised controlled trial of a financial incentive for increasing the number of daily walking steps: study protocol

BMJ Open ◽

10.1136/bmjopen-2018-026086 ◽

2019 ◽

Vol 9 (6) ◽

pp. e026086

Author(s):

Yasutake Tomata ◽

Fumiya Tanji ◽

Dieta Nurrika ◽

Yingxu Liu ◽

Saho Abe ◽

...

Keyword(s):

Financial Incentives ◽

Primary Outcome ◽

Financial Incentive ◽

Controlled Trial ◽

Intervention Group ◽

Sample Size Calculation ◽

Community Dwelling ◽

Control Group ◽

Modifiable Factors ◽

Randomised Controlled

IntroductionPhysical activity is one of the major modifiable factors for promotion of public health. Although it has been reported that financial incentives would be effective for promoting health behaviours such as smoking cessation or attendance for cancer screening, few randomised controlled trials (RCTs) have examined the effect of financial incentives for increasing the number of daily steps among individuals in a community setting. The aim of this study is to investigate the effects of financial incentives for increasing the number of daily steps among community-dwelling adults in Japan.Methods and analysisThis study will be a two-arm, parallel-group RCT. We will recruit community-dwelling adults who are physically inactive in a suburban area (Nakayama) of Sendai city, Japan, using leaflets and posters. Participants that meet the inclusion criteria will be randomly allocated to an intervention group or a waitlist control group. The intervention group will be offered a financial incentive (a chance to get shopping points) if participants increase their daily steps from their baseline. The primary outcome will be the average increase in the number of daily steps (at 4–6 weeks and 7–9 weeks) relative to the average number of daily steps at the baseline (1–3 weeks). For the sample size calculation, we assumed that the difference of primary outcome would be 1302 steps.Ethics and disseminationThis study has been ethically approved by the research ethics committee of Tohoku University Graduate School of Medicine, Japan (No. 2018-1-171). The results will be submitted and published in a peer-reviewed scientific journal.Trial registration numberUMIN000033276; Pre-results.

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Effect of Engaging Trainees by Assessing Peer Performance: A Randomised Controlled Trial Using Simulated Patient Scenarios

BioMed Research International ◽

10.1155/2014/610591 ◽

2014 ◽

Vol 2014 ◽

pp. 1-7 ◽

Cited By ~ 5

Author(s):

Charlotte Loumann Krogh ◽

Charlotte Ringsted ◽

Charles B. Kromann ◽

Maria Birkvad Rasmussen ◽

Tobias Todsen ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Global Rating ◽

Training Performance ◽

Significant Difference ◽

Training Format ◽

Peer Performance ◽

And Performance ◽

Randomised Controlled

Introduction. The aim of this study was to explore the learning effect of engaging trainees by assessing peer performance during simulation-based training.Methods. Eighty-four final year medical students participated in the study. The intervention involved trainees assessing peer performance during training. Outcome measures were in-training performance and performance, both of which were measured two weeks after the course. Trainees’ performances were videotaped and assessed by two expert raters using a checklist that included a global rating. Trainees’ satisfaction with the training was also evaluated.Results. The intervention group obtained a significantly higher overall in-training performance score than the control group: mean checklist score 20.87 (SD 2.51) versus 19.14 (SD 2.65)P=0.003and mean global rating 3.25 SD (0.99) versus 2.95 (SD 1.09)P=0.014. Postcourse performance did not show any significant difference between the two groups. Trainees who assessed peer performance were more satisfied with the training than those who did not: mean 6.36 (SD 1.00) versus 5.74 (SD 1.33)P=0.025.Conclusion. Engaging trainees in the assessment of peer performance had an immediate effect on in-training performance, but not on the learning outcome measured two weeks later. Trainees had a positive attitude towards the training format.

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A Randomised Controlled Trial of Strategies to Prompt Attendance for a Pap Smear

Journal of Medical Screening ◽

10.1177/096914139500200408 ◽

1995 ◽

Vol 2 (4) ◽

pp. 211-218 ◽

Cited By ~ 23

Author(s):

Jenny Bowman ◽

Rob Sanson-Fisher ◽

Catherine Boyle ◽

Stephanie Pope ◽

Sally Redman

Keyword(s):

At Risk ◽

Randomised Controlled Trial ◽

Pap Smear ◽

Controlled Trial ◽

Self Report ◽

Health Clinic ◽

Control Group ◽

Screening Attendance ◽

Randomised Controlled

Objective – To assess the comparative efficacy, by randomised controlled trial, of three interventions designed to encourage “at risk” women to have a Pap smear: an educational pamphlet; letters inviting attendance at a women's health clinic; and letters from physicians. Methods – Subjects at risk for cervical cancer who had not been adequately screened were identified by a random community survey and randomly allocated to one of the intervention groups or a control group. Six months after intervention implementation, a follow up survey assessed subsequent screening attendance. Self report was validated by comparison with a national screening data base. Results – A significantly greater proportion of women (36.9%) within the group receiving a physician letter reported screening at follow up than in any other group (P =0.012). The variables most strongly predicting screening attendance were: age, perceived frequency of screening required, use of oral contraceptives, and allocation to receive the physician letter intervention. Conclusions – The relative efficacy of the GP letter in prompting screening attendance shows that this strategy is worthy of further investigation. There remains a need to examine the barriers to screening for older women, and to develop tailored strategies for this population.

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Hysteroscopic management of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial

QJM ◽

10.1093/qjmed/hcab115.005 ◽

2021 ◽

Vol 114 (Supplement_1) ◽

Author(s):

Hatem Hussein El-Gamal ◽

Walid El-Basuony Mohammad ◽

Ahmed Samir Mohamed Zeerban

Keyword(s):

Quality Of Life ◽

Caesarean Section ◽

Controlled Trial ◽

Intervention Group ◽

Expectant Management ◽

Control Group ◽

Randomised Controlled ◽

Caesarean Scar Defect ◽

Interventional Group

Abstract Background Long-term complaints after caesarean section, such as postmenstrual spotting, dysmenorrhea, dyspareunia, or chronic pelvic pain, are frequently described in relation to the presence of a niche. A post-caesarean niche is defined as an indentation in the myometrium at the site of the uterine scar. Two independent prospective cohort studies reported that the presence of a niche after caesarean section increases the risk of postmenstrual spotting for more than 2 days from 15 to 30%. Postmenstrual spotting may be caused by a mechanical outflow problem, with the retention of menstrual blood in a niche, or by the accumulation of blood because of impaired uterine contractions at the site of the niche. Additionally, newly formed fragile vessels in the niche may play a role in the formation of blood or fluid in the niche and uterine cavity. Objective The aim of this study was to compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. Methods This trial is a randomised controlled trial that provides evidence for the (cost) effectiveness of hysteroscopic resection of a niche versus expectant management in women with niche related postmenstrual spotting. It was carried out on 28 cases divided into two equal group. The study was conducted at Ain Shams University on the women reporting postmenstrual spotting after a caesarean section. The primary outcome was the number of days of postmenstrual spotting 6 months after randomization. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, quality of life, women’s satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, also at 6 months after randomization. Results The results of this study show a significant improvement in interventional group after 3 months more than the control group in bleeding micturition characteristics which includes total days of spotting, spotting end of menstruation, intermenstral spotting, discomfort from spotting, dysmenorrhea and daily pain during micturition, after 6 months the two group improved but the interventional group was significantly higher than control group. Regarding the radiological assessment it was found that there was a significant improvement in intervention group more than the control group after 3 months, also the control group improved after 6 months also, but the intervention groups was significantly higher than the control group. The quality of life show a significant increasing in intervention group more than the control group after 3 months of intervention, at the end of follow up the intervention group was significantly higher in quality of life more than the control group. Conclusion A hysteroscopic niche resection reduces postmenstrual spotting, and the discomfort from spotting, compared with expectant management after 3 months of follow-up in women with a niche with a residual myometrium of at least 3 mm.

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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

10.21203/rs.2.12594/v1 ◽

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.

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Guided Internet-delivered cognitive behavioural treatment for insomnia: a randomized trial

Psychological Medicine ◽

10.1017/s0033291713002249 ◽

2013 ◽

Vol 44 (7) ◽

pp. 1521-1532 ◽

Cited By ~ 54

Author(s):

A. van Straten ◽

J. Emmelkamp ◽

J. de Wit ◽

J. Lancee ◽

G. Andersson ◽

...

Keyword(s):

Controlled Trial ◽

Sleep Onset ◽

Intervention Group ◽

Sleep Diary ◽

The Internet ◽

Control Group ◽

Sleep Onset Latency ◽

Cognitive Behavioural ◽

Co Morbidity ◽

Significant Difference

BackgroundInsomnia is a prevalent problem with a high burden of disease (e.g. reduced quality of life, reduced work capacity) and a high co-morbidity with other mental and somatic disorders. Cognitive behavioural therapy (CBT) is effective in the treatment of insomnia but is seldom offered. CBT delivered through the Internet might be a more accessible alternative. In this study we examined the effectiveness of a guided Internet-delivered CBT for adults with insomnia using a randomized controlled trial (RCT).MethodA total of 118 patients, recruited from the general population, were randomized to the 6-week guided Internet intervention (n = 59) or to a wait-list control group (n = 59). Patients filled out an online questionnaire and a 7-day sleep diary before (T0) and after (T1) the 6-week period. The intervention group received a follow-up questionnaire 3 months after baseline (T2).ResultsAlmost three-quarters (72.9%) of the patients completed the whole intervention. Intention-to-treat (ITT) analysis showed that the treatment had statistically significant medium to large effects (p < 0.05; Cohen's d between 0.40 and 1.06), and resulted more often in clinically relevant changes, on all sleep and secondary outcomes with the exception of sleep onset latency (SOL) and number of awakenings (NA). There was a non-significant difference in the reduction in sleep medication between the intervention (a decrease of 6.8%) and control (an increase of 1.8%) groups (p = 0.20). Data on longer-term effects were inconclusive.ConclusionsThis study adds to the growing body of literature that indicates that guided CBT for insomnia can be delivered through the Internet. Patients accept the format and their sleep improves.

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