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

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.

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.