Protocol for a randomised controlled feasibility study of psychologically informed vestibular rehabilitation for people with persistent dizziness: INVEST trial

Abstract Background Dizziness is a common complaint that often persists and leads to disability and distress. Several cognitive and behavioural responses may contribute to the neurobiological adaptations that maintain persistent vestibular symptoms. This paper will present the protocol of a two-arm parallel group feasibility randomised controlled trial designed to determine whether a fully powered efficacy trial is achievable by examining the feasibility of recruitment, acceptability and potential benefits of an integrated cognitive behavioural therapy and vestibular rehabilitation (CBT-VR) treatment for people with persistent dizziness. Methods Forty adult patients will be recruited from a tertiary vestibular clinic with persistent movement–triggered dizziness for 3 months or longer who have moderate–high levels of dizziness handicap. Participants will be 1:1 randomised, using a minimisation procedure, to six sessions of either CBT-VR (intervention arm) or VR only (control arm). Measures will be collected at baseline and 4 months post randomisation. The primary feasibility outcomes include descriptive data on numbers meeting eligibility criteria, rates of recruitment, numbers retained post randomisation, treatment adherence and an acceptability questionnaire. Treatment effects on self-report outcomes will be estimated to determine that 95% confidence intervals for the effects are consistent with anticipated effects and minimum clinically important differences, and to provide information needed for the power calculation of an efficacy trial. A nested qualitative study will be conducted post-intervention (intervention group only) to explore the acceptability of the intervention and identify any areas in need of improvement. Discussion If a trial of CBT-VR is feasible, acceptability data will be used to enhance the intervention if needed and refine the multicentre RCT protocol. Future studies will need to consider the training required for other physiotherapists to deliver the intervention. Trial registration ClinicalTrials.gov, ISRCTN 10420559

Download Full-text

Protocol for a Randomised Controlled Feasibility Study of Psychologically Informed Vestibular Rehabilitation for People With Persistent Dizziness (INVEST Trial)

10.21203/rs.3.rs-120482/v1 ◽

2020 ◽

Author(s):

David Rhys Herdman ◽

Sam Norton ◽

Marousa Pavlou ◽

Louisa Murdin ◽

Rona Moss-Morris

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Vestibular Rehabilitation ◽

Self Report ◽

Power Calculation ◽

Efficacy Trial ◽

Post Intervention ◽

Eligibility Criteria ◽

Randomised Controlled ◽

Post Randomisation

Abstract Background: Dizziness is a common complaint that often persists and leads to disability and distress. Several cognitive and behavioural responses may contribute to the neurobiological adaptations that maintain persistent vestibular symptoms. This paper will present the protocol of a two-arm parallel group feasibility randomised controlled trial designed to determine whether a fully powered efficacy trial is achievable by examining the feasibility of recruitment, acceptability and potential benefits of an integrated cognitive behavioural therapy and vestibular rehabilitation (CBT-VR) treatment for people with persistent dizziness. Methods: Forty adult patients will be recruited from a tertiary vestibular clinic with persistent movement triggered dizziness for three months or longer who have moderate-high levels of dizziness handicap. Participants will be 1:1 randomised, using a minimisation procedure, to six sessions (12-14 weeks’) of either CBT-VR (intervention arm) or VR only (control arm). Measures will be collected at baseline and 4 months post randomisation. The primary feasibility outcomes include descriptive data on numbers meeting eligibility criteria, rates of recruitment, numbers retained post randomisation, treatment adherence and an acceptability questionnaire. Treatment effects on self-report outcomes will be estimated to determine that 95% confidence intervals for the effects are consistent with anticipated effects and minimum clinically important differences, and to provide information needed for the power calculation of an efficacy trial. A nested qualitative study will be conducted post-intervention (intervention group only) to explore the acceptability of the intervention and identify any areas in need of improvement. Discussion: If a trial of CBT-VR is feasible, acceptability data will be used to enhance the intervention if needed and refine the multicentre RCT protocol. Future studies will need to consider the training required for other physiotherapists to deliver the intervention.Trial registration: ISRCTN 10420559

Download Full-text

Early intervention in panic: pragmatic randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.109.072504 ◽

2010 ◽

Vol 196 (4) ◽

pp. 326-331 ◽

Cited By ~ 24

Author(s):

Peter Meulenbeek ◽

Godelief Willemse ◽

Filip Smit ◽

Anton van Balkom ◽

Philip Spinhoven ◽

...

Keyword(s):

Early Intervention ◽

Panic Disorder ◽

Group Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Self Report ◽

Control Group ◽

Cognitive Behavioural ◽

Clinically Significant ◽

Randomised Controlled

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.

Download Full-text

The efficacy of a resilience-enhancement program for mothers in Japan based on emotion regulation: study protocol for a randomized controlled trial

BMC Psychology ◽

10.1186/s40359-019-0344-6 ◽

2019 ◽

Vol 7 (1) ◽

Cited By ~ 1

Author(s):

Hiromi Tobe ◽

Mariko Sakka ◽

Kiyoko Kamibeppu

Keyword(s):

Emotion Regulation ◽

Child Maltreatment ◽

Parental Stress ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Self Report ◽

Baseline Survey ◽

Control Group ◽

Post Intervention

Abstract Background The demands of daily life often cause mothers high levels of distress and other negative emotions. Anger, including harsh verbal discipline, has been linked to child maltreatment, with long-term adverse effects on a child’s well-being. It is critically important to teach mothers stress management and emotion regulation in addition to parenting skills, but this is yet to be conducted in a formalized manner. Strengthening the multiple protective factors that constitute resilience helps reduce distress. The aim of this study is to evaluate the efficacy of a resilience-enhancement program for mothers. Methods We designed a two-arm, parallel, randomized trial with an active control. Mothers and their partners with children between three and six years old will be recruited. Following an online baseline survey, 140 mothers will be randomly allocated to either an intervention or control group. Self-report assessment will be conducted online post-intervention and at a two-month follow-up. The control group will participate in a serious of group discussions. The intervention group will participate in four bi-weekly 120-min sessions of a Cognitive Behavior Therapy-based program designed to enhance resilience, focusing on emotion regulation through cognitive reappraisal. Participants will be encouraged to apply and share the skills they acquire with their partner and children at home. Partners will also be assessed to explore their indirect influence from the mothers. Intention-to-treat analysis will be conducted and the two groups will be compared, applying covariate analysis. The primary outcome of the intervention is improved resilience. Secondary outcomes include improved anger control, self-esteem, cognition of children’s misbehavior, and reduced parental stress. Discussion To the best of our knowledge, this study will evaluate the first resilience-enhancement program focused on emotion regulation for mothers in Japan. It will contribute to the existing body of knowledge on building emotional resilience. If the program is found to be effective, it will provide an alternative means to enhance mothers’ resilience against stress and improve their ability to regulate emotion. In so doing, it will offer a way to prevent child maltreatment and protect the mental health of children and families. Trial registration UMIN000027232, May 3, 2017.

Download Full-text

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.

Download Full-text

Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

BMC Public Health ◽

10.1186/s12889-020-09878-w ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Lucie Waedel ◽

Anne Daubmann ◽

Antonia Zapf ◽

Olaf Reis

Keyword(s):

Substance Use ◽

Randomised Controlled Trial ◽

Intellectual Disabilities ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Post Intervention ◽

Randomised Controlled

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

Download Full-text

Efficacy of intergrating vestibular rehabilitation and cognitive behaviour therapy in persons with persistent dizziness in primary care- a study protocol for a randomised controlled trial

Trials ◽

10.1186/s13063-019-3660-5 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Lene Kristiansen ◽

L. H. Magnussen ◽

K. T. Wilhelmsen ◽

S. Mæland ◽

S. H. G. Nordahl ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Cognitive Behaviour Therapy ◽

Controlled Trial ◽

Intervention Group ◽

Vestibular Rehabilitation ◽

Integrated Treatment ◽

Gait Velocity ◽

Behaviour Therapy ◽

Cognitive Behaviour ◽

Randomised Controlled

Abstract Background Dizziness is a common complaint, and the symptom often persists, together with additional complaints. A treatment combining Vestibular Rehabilitation (VR) and Cognitive Behaviour Therapy (CBT) is suggested. However, further research is necessary to evaluate the efficacy of such an intervention. The objective of this paper is to present the design of a randomised controlled trial aiming at evaluating the efficacy of an integrated treatment of VR and CBT on dizziness, physical function, psychological complaints and quality of life in persons with persistent dizziness. Methods/design The randomised controlled trial is an assessor-blinded, block-randomised, parallel-group design, with a 6- and 12-month follow-up. The study includes 125 participants from Bergen (Norway) and surrounding areas. Included participants present with persistent dizziness lasting for at least 3 months, triggered or exacerbated by movement. All participants receive a one-session treatment (Brief Intervention Vestibular Rehabilitation; BI-VR) with VR before being randomised into a control group or an intervention group. The intervention group will further be offered an eight-session treatment integrating VR and CBT. The primary outcomes in the study are the Dizziness Handicap Inventory and preferred gait velocity. Discussion Previous studies combining these treatments have been of varying methodological quality, with small samples, and long-term effects have not been maintained. In addition, only the CBT has been administered in supervised sessions, with VR offered as home exercises. The current study focusses on the integrated treatment, a sufficiently powered sample size, and a standardised treatment programme evaluated by validated outcomes using a standardised assessment protocol. Trial registration www.clinicaltrials.gov, ID: NCT02655575. Registered on 14 January 2016.

Download Full-text

Effects of the Conceptual Model of Health Literacy as a Risk: A Randomised Controlled Trial in a Clinical Dental Context

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph15081630 ◽

2018 ◽

Vol 15 (8) ◽

pp. 1630 ◽

Cited By ~ 4

Author(s):

Linda Stein ◽

Maud Bergdahl ◽

Kjell Sverre Pettersen ◽

Jan Bergdahl

Keyword(s):

Health Literacy ◽

Conceptual Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

Convenience Sample ◽

Communication Techniques ◽

The Mean ◽

Randomised Controlled

Numerous conceptual models of health literacy have been proposed in the literature, but very few have been empirically validated in clinical contexts. The aim of this study was to test the effects of the conceptual model of health literacy as a risk in a clinical dental context. A convenience sample of 133 Norwegian-speaking adults was recruited. Participants were randomly allocated to an intervention group (n = 64, 54% women, mean age = 50 years) and a control group (n = 69, 49% women, mean age = 46 years). Clinical measurements were conducted pre-intervention and six months post-intervention. In the intervention group, communication regarding patients’ oral health was tailored to their health literacy levels using recommended communication techniques, whereas the control group received brief information not tailored to health literacy levels. The ANCOVA showed significant between-group effects, finding reduced post-intervention mean gingival (p < 0.000) and mean plaque (p < 0.000) indices in the intervention group when controlling for baseline index scores. The adjusted Cohen’s d indicated large effect sizes between the intervention group and the control group for both the mean gingival index (−0.98) and the mean plaque index (−1.33). In conclusion, the conceptual model of health literacy as a risk had a large effect on important clinical outcomes, such as gingival status and oral hygiene. The model may be regarded as a suitable supplement to patient education in populations.

Download Full-text

Efficacy of integrating vestibular rehabilitation and cognitive behaviour therapy in persons with long-term dizziness in primary care– a study protocol for a randomised controlled trial

10.21203/rs.2.10300/v2 ◽

2019 ◽

Author(s):

Lene Kristiansen ◽

Liv Heide Magnussen ◽

Kjersti Thulin Wilhelmsen ◽

Silje Mæland ◽

Stein-Helge Glad Nordahl ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Cognitive Behaviour Therapy ◽

Controlled Trial ◽

Intervention Group ◽

Vestibular Rehabilitation ◽

Integrated Treatment ◽

Gait Velocity ◽

Behaviour Therapy ◽

Cognitive Behaviour ◽

Randomised Controlled

Abstract Background: Dizziness is a common complaint, and the symptom often persists, together with additional complaints. A treatment combining of Vestibular Rehabilitation (VR) and Cognitive Behaviour Therapy (CBT) is suggested. However, further research is necessary to evaluate the efficacy of such intervention. The objective of this paper is to present the design of a randomised controlled trial aiming at evaluating the efficacy of an integrated treatment of VR and CBT on dizziness, physical function, psychological complaints and quality of life in persons with persistent dizziness. Methods/Design: The randomised controlled trial is an assessor-blinded block randomised parallel-group design, with a 6- and 12- month follow-up. The study includes 125 participants from Bergen (Norway) and surrounding areas. Included participants present with persistent dizziness lasting at least 3 months, triggered or exacerbated by movement. All participants receive a one-session treatment (Brief Intervention) with VR before being randomised into a control-group or an intervention-group. The intervention-group will further be offered an eight-session treatment integrating VR and CBT. The primary outcomes in the study are the dizziness handicap inventory and preferred gait velocity. Discussion: Previous studies combining these treatments have been of varying methodological quality, with small samples, and long-term effects have not been maintained. In addition, only the CBT has been administered in supervised sessions, with VR offered as home-exercises. The current study focuses on the integrated treatment, sufficiently powered sample size, and a standardised treatment program evaluated by validated outcomes using a standardised assessment protocol. Trial registration: The study was registered at www.clinicaltrials.gov (NCT02655575) on January 14th 2016. Keywords: Protocol, RCT, persistent dizziness, vestibular rehabilitation, cognitive behaviour therapy, dizziness handicap inventory, gait velocity, rehabilitation

Download Full-text

Is tepid sponging more effective than paracetamol at relieving fever in febrile children in hot tropical climates? a mini review

Ghana Medical Journal ◽

10.4314/gmj.v55i1.9 ◽

2021 ◽

Vol 55 (1) ◽

pp. 60-68

Author(s):

Samuel Akyirem ◽

Irene F. Bossman

Keyword(s):

Controlled Trial ◽

Meta Analysis ◽

Outcome Data ◽

Systematic Review Methodology ◽

Post Intervention ◽

Eligibility Criteria ◽

Randomised Controlled ◽

Tropical Climates ◽

New Evidence ◽

Significant Health

Background: Childhood fever remains a significant health problem because of the convulsion risk it poses to the child as well as the parental anxiety it provokes. Tepid sponging of such children remains commonplace in tropical climates despite the lack of evidence to support it.Objective: To evaluate the effectiveness of tepid sponging in hot tropical climatesMethods: NICE systematic review methodology was used. Medline and EMBASE were searched from their inception to date. Eligibility criteria included a) studies of randomised controlled trial (RCT) design b) children aged 2 to 120 months c) the use of tepid sponging alone in one arm and paracetamol in the other arm of the experiment. Eligible studies were critically appraised with NICE risk of bias tool. The outcome of interest was the number of afebrile children 2 hours after intervention. The outcome data from eligible studies were pooled for meta-analysis using random effects.Findings: Out of the 201 papers retrieved from the electronic search, two studies met the inclusion criteria. The meta-analysis found that tepid sponging was less effective than paracetamol at relieving fever two hours post-intervention (RR=0.25, 95% CI 0.08-0.79]).Conclusion: Tepid sponging was not effective against fever. There is the need to modify existing local clinical protocols to reflect the new evidence and international guidelines.

Download Full-text

Evaluating the effectiveness of a ‘real-world’ shared reading intervention for preschool children and their families: A randomised controlled trial.

10.31234/osf.io/habg9 ◽

2018 ◽

Author(s):

Jamie Lingwood ◽

Josie Billington ◽

Caroline F Rowland

Keyword(s):

Randomised Controlled Trial ◽

Reading Interventions ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Shared Reading ◽

Control Group ◽

Post Intervention ◽

Reading Groups ◽

Randomised Controlled

Background: Shared reading interventions can impact positively on preschool children’s language development and on their caregiver’s attitudes/behaviours towards reading. However, a number of barriers may discourage families from engaging with these interventions, particularly families from lower socioeconomic (SES) backgrounds. We investigated how families from such backgrounds responded to an intervention designed explicitly to overcome these barriers. Methods: In a pre-registered cluster randomised controlled trial, 85 lower SES families and their 3- to 4-year old children from 10 different preschools were randomly allocated to take part in The Reader’s Shared Reading programme (intervention) or an existing ‘Story Time’ group at a library (control), once a week for eight weeks. Three outcome measures were assessed at baseline and post-intervention: (i) attendance, (ii) enjoyment of the reading groups, and (iii) caregivers’ knowledge of, attitudes and behaviours towards reading. A fourth, - children’s vocabulary - was assessed at baseline and four weeks post-intervention. Results: Families were significantly more likely to attend the intervention group and rated them more favourably, compared to the control group. However, there were no significant effects on caregivers’ knowledge, attitudes and behaviours, or on children’s language. Conclusion: The intervention was only successful in engaging families from disadvantaged backgrounds in shared reading. Implications for the use, duration and intensity of shared reading interventions are discussed.

Download Full-text