Cognitive behavioural therapy (CBT) for dysphonia: a trial platform

ISRCTN	ISRCTN20582523
DOI	https://doi.org/10.1186/ISRCTN20582523
Secondary identifying numbers	4588; G0501875

Submission date: 19/05/2010
Registration date: 19/05/2010
Last edited: 12/02/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Mr Vincent Deary
Scientific

Institute of Health and Society
21-23 Claremont Place
Newcastle Upon Tyne
NE2 4AA
United Kingdom

ORCID ID	0000-0001-6115-9259

Study information

Study design	Single-centre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Training a speech and language therapist in cognitive behavioural therapy to treat functional dysphonia: a randomised controlled trial
Study acronym	CBT for dysphonia
Study hypothesis	The principle purpose of this trial is to see if giving a speech and language therapist a brief training in cognitive behavioural therapy (CBT), and then having that therapist deliver CBT "enhanced" voice therapy, can improve the quality of life of people suffering from medically unexplained hoarseness and voice loss. This voice problem, known as "functional dysphonia", is associated with increased anxiety and depression, and with poor general health. Voice therapy alone improves voice, but seems to have no impact on this associated distress. Our hypothesis therefore is that the addition of CBT skills to conventional voice therapy will improve anxiety and depression in this patient group more than voice therapy alone.
Ethics approval(s)	Newcastle amd North Tyneside REC, 27/07/2007, ref: 07/H0906/118
Condition	Topic: Ear; Subtopic: Ear (all Subtopics); Disease: Ear, nose & throat
Intervention	Voice Therapy: This "treatment as usual" will aim to be as close to standard voice therapy practice as possible. Patients will be offered 6 - 8 sessions, weekly to fortnightly, of approximately one hour's voice therapy. This represents an average length of a voice therapy course in the UK. The content will typically have the following elements: 1. Voice care and education on use 2. Elimination of voice misuse and abuse 3. Breath control, breathing and speaking coordination Voice Therapy plus CBT: The approximate number and timing of sessions will be the same as in the voice therapy alone arm. The treatment will be couched within an overarching CBT framework, the key component of this being that an explanatory model of the patient's condition will be collaboratively established, and the key factors maintaining both vocal problems and distress will be identified. This model will then be used to structure the treatment. Length of treatment will be six to eight sessions, fortnightly and patients will be followed up to six months post-discharge from treatment.
Intervention type	Other
Primary outcome measure	Psychological distress, measured using the Hospital Anxiety and Depression Scale (HADS). Outcomes will be taken at baseline, discharge and six months post-discharge
Secondary outcome measures	1. Psychological distress, measured using the General Health Questionnaire 2. The Chalder Fatigue Scale 3. The Work and Social Adjustment Scale 4. Voice, measured using the Voice Performance Questionnaire (VPQ) Outcomes will be taken at baseline, discharge and six months post-discharge.
Overall study start date	29/10/2007
Overall study end date	30/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned sample size: 62
Participant inclusion criteria	1. Patients of either sex who are over 16 years 2. Diagnosed by an expert speech and language therapist as having functional dysphonia 3. Clinical assessment involving larygoscope to exclude other causes
Participant exclusion criteria	1. Previous experience of cognitive behavioural therapy (CBT) for voice problem 2. Acute or ongoing serious medical illness 3. Suffer from a severe mental health problem (for example major depression, psychotic illnesses, or alcohol dependence) 4. Learning disability 5. Vocal condition that does not merit a full course of treatment 6. Score of less than 1 on a standardised measure of voice quality (the Grade, Roughness, Breathiness, Aesthenia, Strain [GRBAS] Scale) 7. Do not speak English
Recruitment start date	29/10/2007
Recruitment end date	30/09/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Health and Society

Newcastle Upon Tyne
NE2 4AA
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Trust (UK)
Hospital/treatment centre

Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom

Website	http://www.newcastle-hospitals.org.uk/
"ROR"	https://ror.org/05p40t847

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) (ref: G0501875)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2018		Yes	No

Editorial Notes

12/02/2018: Publication reference added.