Training speech therapists in Cognitive Behavioural Therapy to treat Medically Unexplained Dysphonia: A Trial Platform

Lead Research Organisation: Newcastle University
Department Name: Inst of Health and Society

Abstract

Medically Unexplained Symptoms (MUS), i.e. physical symptoms in the absence of physical disease, account for up to 30% of medical consultations. For a substantial minority, symptoms develop into chronic and disabling conditions such as Chronic Fatigue Syndrome or Fibromyalgia. Currently the best treatment for these conditions is cognitive behavioural therapy (CBT). However CBT therapists are scarce, so there has been a move to teach CBT skills to other health professionals dealing with these conditions. This forms the background to our project. Our aim is to develop a CBT enhanced treatment package that can be delivered by Speech Therapists to improve the voice and quality of life in patients with Functional Dysphonia, an MUS where people experience unexplained voice loss or hoarseness. Our research brings together Britain‘s leading dysphonia research team with a MUS-specialized CBT therapist. We will initially develop and test the treatment in an study comparing standard voice therapy to CBT enhanced treatment in 62 patients. We will use these findings to design a much larger trial to further test the feasibility of passing on clinically useful CBT skills. A positive finding will have far reaching benefits not only for dysphonia but for the treatment of MUS in general.

Technical Summary

Functional dysphonia is the commonest disorder presenting to voice clinicians in the UK. It affects not only communication, but is also associated with anxiety, depression, poor general health and reduced quality of life. Voice therapy alone improves quality of speech but not these other factors. Our pilot study proved that training a Speech and Language Therapist (SLT) in cognitive behavioural therapy (CBT) skills is feasible within a relatively short timescale and that this seems effective in significantly improving voice and reducing distress. The study was limited by small numbers and baseline between group differences, but our findings support and inform the design of the proposed trial platform.

The overall objectives of the trial platform are: to refine and develop our CBT model of dysphonia; to refine and develop our prototype CBT training package and treatment of dysphonia by SLTs; to conduct a feasibility and exploratory efficacy study of the training and treatment; to use the data from this exploratory study to inform the design and power calculation of a definitive Phase 3 cluster-randomised trial (CRT) of this intervention. Phase 1 of the trial platform will consist of analyzing existing baseline data and collecting new baseline data to develop the CBT model, treatment and training packages. Phase 2 will be an exploratory randomised trial of the Phase 1 materials, where approximately 60 patients will be randomised to either speech therapy alone or speech therapy plus CBT. Both treatments will be manualised and delivered by the same therapist who will have received a brief training in CBT. Data collected at this stage will include the SLTs protocol adherence, the estimation of likely patient recruitment and attrition rates, the assessment of the reliability and responsiveness of a range of both voice and quality of life outcome measures. In Phase 3 the fellow will lead on utilizing the data from phases 1 and 2 to design a definitive cluster-randomised trial, if merited by the results from phase 2.

CBT has grade 1 evidence of its effectiveness in treating medically unexplained symptoms (MUS), but skilled practitioners are scarce. As MUS account for up to 30% of specialised medical referrals, the proposed study would be a substantial contribution to the assessment of the feasibility and effectiveness of targeting this population by providing brief CBT training interventions to non mental health professionals and would develop the fellow as a unique source of expertise in this burdensome area.

Publications

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Daniilidou P (2007) Cognitive behavioral therapy for functional dysphonia: a pilot study. in The Annals of otology, rhinology, and laryngology

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Deary V (2011) Reconsidering the role of psychosocial factors in functional dysphonia. in Current opinion in otolaryngology & head and neck surgery

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O'Hara J (2011) Relationship between fatigue, perfectionism, and functional dysphonia. in Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery

 
Description SLT Training
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
 
Description Action for M.E.
Amount £11,500 (GBP)
Organisation Action for M.E. 
Sector Charity/Non Profit
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 09/2012 
End 09/2014
 
Description NIHR Research for Patient Benefit (RfPB) Programme:
Amount £240,000 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 10/2013 
End 10/2015
 
Description NIHR-HTA
Amount £980,000 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 05/2011 
End 01/2015
 
Description Public Engagement and Impact Grant
Amount £2,850 (GBP)
Organisation Higher Education Funding Council for England (HEFCE) 
Sector Public
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 02/2012 
End 02/2013
 
Description CBT for Vaso-vagal Syncope (VVS) 
Organisation Royal Victoria Infirmary
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Hospitals 
PI Contribution PI on NIHR RfPB fto develop a novel CBT intervention for VVS
Collaborator Contribution New partnerships with consultants and psychologists which have lead to further projects
Impact NIHR grant application, not successful, but will recycle.
Start Year 2010
 
Description CBT for fear of falling in the elderly 
Organisation Newcastle University
Department Institute of Health and Society
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Designed a protocol for developing and delivering a complex intervention to target fear of falling in elderly population.
Collaborator Contribution Access to clinical population.
Impact This lead to a successful bid to the NIHR HTA targetted call for proposals in this area.
Start Year 2010
 
Description Chronic Fatigue Syndrome in adolescents 
Organisation King's College London
Department Institute of Psychiatry, Psychology & Neuroscience
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Worked with Professor Trudie Chalder in development and trial of CBT intervention for adolescents with chronic fatigue syndrome
Collaborator Contribution Clinical and research colloboration.
Impact Published results of trial this year. Also, with same collaborator, have published work on personality factors in development of chronic fatigue syndrome (see publications)
 
Description Development of Fatigue Intervention 
Organisation Newcastle University
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Co-applicant on an NIHR programme grant to develop fatigue services across various medical conditions.
Collaborator Contribution Has lead to access to and work relating to patients with Sjogrens disease which forms part of my PhD students work
Impact NIHR Programme Grant submission was not successful but the parners are now working on a sleep study in CFS/ME which has been the subject of a successful Action for ME Grant
Start Year 2011
 
Description Development of Fatigue Intervention 
Organisation Newcastle upon Tyne Hospitals NHS Foundation Trust
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution Co-applicant on an NIHR programme grant to develop fatigue services across various medical conditions.
Collaborator Contribution Has lead to access to and work relating to patients with Sjogrens disease which forms part of my PhD students work
Impact NIHR Programme Grant submission was not successful but the parners are now working on a sleep study in CFS/ME which has been the subject of a successful Action for ME Grant
Start Year 2011
 
Description Development of a theoretical model of mental health and well-being 
Organisation Northumbria University
Department School of Life Sciences Northumbria
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Co-applicant with input on health psychology aspects of grant to develop methodology to guide complex intervention development in life long well being.
Collaborator Contribution Access to clinical populations
Impact Submission of an MRC LLHW grant, not successful.
Start Year 2010
 
Description Development of personality theory 
Organisation University of Edinburgh
Department Psychology
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Working with Wendy Johnson to apply insights from Cognitive Behavioural theory and practice to personality theory.
Collaborator Contribution ideas
Impact So far only one short paper (see publications) , and one commentary piece in European Journal of Personality Volume 22 Issue 5, Pages 385 - 409 but ongoing
Start Year 2008
 
Description Food and Psychosocial Intervention for Head and Neck Cancer Survivors 
Organisation Durham University
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Development of the psychological part of the intervention protocol
Collaborator Contribution Access to new patient groups
Impact Submission of an NIHR RfPB grant application which was successful.
Start Year 2010
 
Description Sleep Snorer Intervention Development 
Organisation Durham University
Department School of Applied Social Sciences
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Complex Intervention Development Expertise and CBT skills
Collaborator Contribution Qualitative Expertise
Impact A patient and public involvement HEIF Grant.
Start Year 2012
 
Title CBT enhanced voice therapy for functional dysphonia. 
Description A CBT enhanced voice therapy intervention for patients suffering from functional dysphonia. Accompanied by patient treatment manual. 
Type Therapeutic Intervention - Psychological_Behavioural
Current Stage Of Development Small-scale adoption
Year Development Stage Completed 2009
Development Status Under active development_distribution
Clinical Trial? Yes
Impact Has become standard practice for therapist involved in trial, and CBT enhanced voice therapy is now routinely available to clients referred to the Freeman Hospital in Newcastle for functional dysphonia. 
URL http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=4588
 
Title Complex Intervention Development Methodology 
Description The complex intervention development methodology worked out in the course of this research is currently being used in an NIHR HTA Grant to develop interventions for fear of falling in older adults. We have also piloted this methodology in a group of head anmd neck cancer patients. 
Type Therapeutic Intervention - Psychological_Behavioural
Current Stage Of Development Initial development
Year Development Stage Completed 2012
Development Status Under active development_distribution
Clinical Trial? Yes
Impact has illuminated the phenomenon of fear of falling, currently being prepared for publication. 
URL http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=4588
 
Description CBT for SLTs workshops 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Health professionals
Results and Impact In conjunction with Freeman Hospital Speech Voice and Swallowing Clinic, Newcastle. As a result of the cognitive behavioural model and training package developed as part of research have delivered training workshops to speech and language therapists in region

Clear change in practice of speech and language therapists within my purview as evinced by clinical discussions
Year(s) Of Engagement Activity 2007,2008,2009,2010,2011
 
Description Medical Teaching 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Type Of Presentation Workshop Facilitator
Geographic Reach Local
Primary Audience Health professionals
Results and Impact Lectures to 1st year medical students on a CBT approach to the management of physical symptoms

Content of lecture will form part of examined curriculum
Year(s) Of Engagement Activity 2009,2010,2011,2012
 
Description SLT Teaching 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Type Of Presentation Workshop Facilitator
Geographic Reach Local
Primary Audience Health professionals
Results and Impact Workshops to SLTs on the CBT approach to the management of voiced disorders developed in the research.

Now part of core examined curriculum and clinical skills training
Year(s) Of Engagement Activity 2009,2010,2011,2012
 
Description Sage Centre Event 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Organised by the Sage Arts Centre in Newcastle Upon Tyne, a day for the public on Voice and Health in which I presented a lay version of the cognitive behavioural model developed as part of research.

Have been asked to contribute to training of Sage staff in future.
Year(s) Of Engagement Activity 2009