Condition category
Ear, Nose and Throat
Date applied
19/05/2010
Date assigned
19/05/2010
Last edited
08/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Vincent Deary

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4588; G0501875

Study information

Scientific title

Training a speech and language therapist in cognitive behavioural therapy to treat functional dysphonia: a randomised controlled trial

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

Newcastle amd North Tyneside REC approved on the 27th July 2007 (ref: 07/H0906/118)

Study design

Single centre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

29/10/2007

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 62

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

United Kingdom

Trial participating centre

Institute of Health and Society
Newcastle Upon Tyne
NE2 4AA
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Trust (UK)

Sponsor details

Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: G0501875)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/08/21016: No publications found in PubMed, verifying study status with principal investigator.