Cognitive behavioural therapy (CBT) for dysphonia: a trial platform
| ISRCTN | ISRCTN20582523 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20582523 |
| Protocol serial number | 4588; G0501875 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Trust (UK) |
| Funder | Medical Research Council (MRC) (UK) (ref: 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 of protocol
Not provided at time of registration
Contact information
Mr Vincent Deary
Scientific
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
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
Psychological distress, measured using the Hospital Anxiety and Depression Scale (HADS). Outcomes will be taken at baseline, discharge and six months post-discharge |
| Key secondary outcome measure(s) |
1. Psychological distress, measured using the General Health Questionnaire |
| Completion date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 62 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 29/10/2007 |
| Date of final enrolment | 30/09/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Institute of Health and Society
Newcastle Upon Tyne
NE2 4AA
United Kingdom
NE2 4AA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/02/2018: Publication reference added.
