Management of social anxiety in clients who stutter
| ISRCTN | ISRCTN55065978 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55065978 |
| Protocol serial number | 12924 |
| Sponsor | NHS South Norfolk Clinical Commissioning Group (UK) |
| Funder | NIHR Research for Patient Benefit (RfPB) (UK); Grant Codes: PB-PG-0610-22225 |
- Submission date
- 05/07/2013
- Registration date
- 05/07/2013
- Last edited
- 29/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
About 1% of adults continue to experience stuttering (stammering) that began in childhood. For many of these adults, severe social anxiety (social phobia) is a serious problem. Social phobia involves a fear of situations where the person has to speak to others, in places such as work or education as well as social occasions, or where they fear that others will form negative views of them. This project aims to develop a new treatment for social phobia in adults who stutter. The treatment builds on the observation that, compared with an average person, people who are very socially anxious are more likely to focus on signs of disapproval in others (such as disapproving facial expressions). This tendency to look for negative signals is what causes and maintains the anxiety. Earlier research has shown that this tendency can be corrected by getting people with high levels of social anxiety to take part in a simple computer task. In previous studies, doing the task has lowered occurences of social anxiety disorder. If this treatment is to be used in the NHS for people who stutter, we must first make sure that it works, that it is safe and acceptable to people who use it, and whether it has any other benefits such as improving the speech fluency of people who stutter. We also need to know about its cost to the NHS. The study described here is a first step towards answering these questions.
Who can participate?
People aged 18 or over who stutter, who are not currently receiving speech treatment for their stutter (and have not been having such treatment in the past 6-12 months). Participants need to meet initial screening criteria about their stutter and their level of social anxiety, and must understand English to a level where they can make informed decisions about the study and understand the task instructions. They should not have been involved in other stuttering or social anxiety research in the previous 12 months. They should not have a mental disability. They should not be taking benzodiazepine medication (for anxiety), and if they are taking other mood-altering medication they need to be willing to continue to take these during the course of the study.
What does the study involve?
Participants would be randomly allocated to the treatment condition, the computer task (that is, the one that we think may improve social anxiety) or to a placebo (dummy) condition where they carry out a similar-looking computer task. We need to look at how people respond in both conditions because this is the only way that we can tell whether the treatment really works. The simple 5-minute computer task should be performed 8 times in a 4-week period. The task consists of a set of trials. On each trial, the person first sees a pair of faces presented very briefly. The faces then disappear and a letter appears in the place where one of the faces was previously. The person has to press a button as fast as possible to indicate what letter it was. Participants need to visit the University of East Anglia three times in a 5-month period, to have a conversation with a clinically-trained researcher, make a recording of their speech and fill in some questionnaires. Travel expenses up to a maximum of £55 per trip will be paid. If travelling to the University is inconvenient, it may be possible for the researcher to visit the participant instead.
What are the possible benefits and risks of participating?
Participants will receive a £20 gift voucher to thank them for participating. Although an individual participant may not benefit directly from taking part in the study, they would be contributing to the development of a potentially worthwhile treatment for people who stutter. It is possible that participants may become upset when talking about their experience of stuttering with the clinically-trained researcher.
Where is the study run from?
The University of East Anglia (UK)
When is the study starting and how long is it expected to run for?
May to November 2013
Who is funding the study?
The Research for Patient Benefit Programme of the National Institute for Health Research (NIHR), UK.
Who is the main contact?
Dr Jan McAllister
j.mcallister@uea.ac.uk
Contact information
Scientific
University of East Anglia
Norwich Research Park
Earlham Road
Norwich
NR4 7TJ
United Kingdom
| j.mcallister@uea.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Addressing social anxiety in adults who stutter: a pilot study |
| Study acronym | MOSAICS |
| Study objectives | This is a pilot study investigating the use of a computer task to treat social anxiety in adults who stutter. The mechanism of the intervention is attentional bias modification. The computer task trains people to pay less attention to disapproving faces. In earlier studies this approach has been shown to result in substantial decreases in social anxiety as measured on standard clinical assessments. |
| Ethics approval(s) | 12/EE/0272; First MREC approval date 06/08/2012 |
| Health condition(s) or problem(s) studied | Topic: Mental Health Research Network, Primary Care Research Network for England; Subtopic: Anxiety, Not Assigned; Disease: Anxiety, All Diseases |
| Intervention | Attentional bias modification. Participants carry out a computer task in which they see pairs of faces (one with a disapproving expression, the other neutral) followed by a probe letter to which they respond. In the treatment condition the letter always replaces the neutral face. In the placebo control condition the letter may replace either face. Each participant carries out 8 x 5-10 minute sessions in a 4-week period.; Follow Up Length: 4 month(s); Study Entry : Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure(s) |
Diagnostic and Statistical Manual, Structured Clinical Interview for DSM Disorders (DSM-IV SCID); Timepoint(s): Baseline, first follow-up (after 4 weeks), second follow-up (after 4 months). |
| Key secondary outcome measure(s) |
1. Attentional bias task; Timepoint(s): Baseline, first follow-up (after 4 weeks), second follow-up (after 4 months). |
| Completion date | 02/11/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Eighteen years of age or older 2. Stuttering rate greater than 2% syllables stuttered when measured over the telephone 3. Score of 19 or more on the Social Phobia Inventory 4. English proficiency to the level required for informed consent and taking part in the study. Target Gender: Male & Female ; Lower Age Limit 18 years |
| Key exclusion criteria | 1. Cognitive behavioural therapy (CBT) during the previous 6 months 2. Speech treatment during the previous 12 months 3. Involvement in stuttering or social anxiety research during the previous 12 months 4. Serious risk of self-harm, evaluated during interview at baseline 5. Intellectual disability 6. Current use of benzodiazepines 7. Unwillingness or inability to maintain a stable dose of any extant psychotropic medication for the duration of the trial |
| Date of first enrolment | 03/05/2013 |
| Date of final enrolment | 02/11/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
NR4 7TJ
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 | 22/10/2017 | 29/01/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/012019: Publication reference added
11/07/2016: No publications found, verifying study status with principal investigator.
