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Trial registered on ANZCTR


Registration number
ACTRN12616001146482
Ethics application status
Approved
Date submitted
27/07/2016
Date registered
23/08/2016
Date last updated
24/02/2022
Date data sharing statement initially provided
21/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the psychological and speech effects of adding Internet anxiety treatment to speech restructuring treatment with adults who stutter.
Scientific title
Investigating the psychological and speech effects of adding Internet anxiety treatment to speech restructuring treatment with adults who stutter.
Secondary ID [1] 289774 0
NHMRC APP1101682
Universal Trial Number (UTN)
U1111-1184-9387
Trial acronym
SPAT: Speech and anxiety treatment
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stuttering 299654 0
Social anxiety disorder 299656 0
Condition category
Condition code
Mental Health 299601 299601 0 0
Anxiety
Physical Medicine / Rehabilitation 299862 299862 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm1: Face to face speech treatment
Arm 2: Face to face speech treatment combined with Internet cognitive behaviour therapy

This study is a randomised controlled trial of speech restructuring treatment for stuttering compared with speech restructuring treatment for stuttering combined with an Internet Cognitive Behaviour Therapy (CBT) Program.
Speech pathologists with experience treating adults who stutter will administer the speech restructuring treatment.
The speech restructuring treatment involves teaching participants to speak using a ‘fluency technique’ which controls stuttering. This fluency technique, which is learnt by imitating a video Training Model, requires participants to initially speak in a slow and exaggerated manner and then to gradually make this speech sound more natural while still controlling stuttering. The speech pathologist provides instruction and feedback to the participants during this process.
To learn this technique, participants will receive individual instruction from a speech pathologist for two hours. During this stage, participants also learn to use a stuttering severity rating scale where ‘0’ = ‘no stuttering’ and ‘8’ = ‘extremely severe stuttering’, so that they can evaluate their stuttering on an on-going basis.
Participants then attend the clinic as part of a group of adults who stutter for three consecutive 8-hour days. Groups will consist of a maximum of six participants. The focus of these three days is to practice the fluency technique, to maintain control of stuttering and to make speech sound as natural as possible. During this stage of the treatment participants will also learn to use a fluency technique rating scale, where ‘0’ = ‘no technique’ and ‘8’ = ‘training model’ to describe and evaluate how their speech sounds to others. Speaking activities involve participants setting goals for their stuttering severity and fluency technique while talking to the treating speech pathologists, student speech pathologists and other participants involved in the study. There will be no opportunity to discuss any anxiety associated with stuttering either in the clinic or in everyday environments. The focus is solely on practising and perfecting a technique to control stuttering.
Student speech pathologists will assist the participants with their speech practice tasks. At all times the students will be directly supervised by the qualified speech pathologists.
The stuttering treatment described above will be available only once.
At the end of the third group day, participants will be randomised to either the experimental group (offered immediate access to the Internet CBT program for five months) or control group (no immediate access to the Internet CBT program).
The Internet CBT program will guide participants through cognitive behaviour therapy with computer-based activities. This will be without the assistance of a live clinician. The Internet CBT program is divided into seven modules. Participants complete the prescribed activities associated with each module before progressing to the next module. The first step of the program involves developing an individualised profile for each participant. This is achieved by having the participant complete an online battery of assessments, including the Fear of Negative Evaluation scale, the Depression Anxiety Stress Scales, and the Unhelpful Thoughts and Beliefs About Stuttering scale. These assessments are designed to comprehensively identify destructive and irrational cognitions common to those who stutter, such as “people focus on every word I say,” “I won’t be able to keep a job if I stutter,” and “everyone in the room will hear me stutter.” The resultant profile is then used to design appropriate activities for each participant throughout the program. Instructions for each activity are given both in text on the screen and with pre-recorded spoken instructions from a psychologist with more than 20 years experience treating anxiety. Participants work through the activities at their own pace.
Activities include behavioural experiments, cognitive restructuring, attention training, writing tasks.

Participants will have access to the Internet CBT program for 5 months. Research has shown this to be adequate time to complete the program. Participants work at their own pace through each of the modules. The time spent working through each module varies depending on participant responses to the initial questionnaires.

Adherence to the speech treatment component is monitored by attendance and progress which will be documented by the speech pathologists. Progress notes will be documented for each participant.
Adherence to the Internet CBT program is monitored by data collected by the program. The data includes time of log-in, number of log-ins, time spent on each page and responses entered by clients for each page of the program.
Intervention code [1] 295429 0
Treatment: Other
Intervention code [2] 295663 0
Behaviour
Comparator / control treatment
Speech restructuring treatment for stuttering consists of two hours of individual treatment with a speech pathologist followed by three consecutive 8-hour days of speech practice with a speech pathologist and a group of participants.
Groups will consist of a maximum of six participants at any time.
The speech treatment described above will be available only once.
Participants randomised to the control group (speech restructuring treatment only) will be given access to the Internet CBT program when outcome data have been collected 12 months after randomisation,
Control group
Active

Outcomes
Primary outcome [1] 299073 0
Social anxiety disorder diagnosis as assessed by the Anxiety and Related Disorders Interview Schedule for DSM-V (ADIS-V)
Presence or absence of social anxiety disorder.
Timepoint [1] 299073 0
Pre-treatment and 12 months post-randomisation.
Secondary outcome [1] 326063 0
Percentage of syllables stuttered.
At each assessment we will make two 10-minute audio recordings of participants’ speech over the phone. These recordings will be of conversations between the participant and an unfamiliar person who will be a research assistant calling them at an unscheduled time from the research centre. A blinded speech pathologist will measure percent syllables stuttered from the audio recordings, using the customary button press device for this purpose.
Timepoint [1] 326063 0
Pre-treatment and 12 months post-randomisation
Secondary outcome [2] 326064 0
Self-reported stuttering severity.
Participants will report severity ratings of their stuttering using a standard nine-point scale where 0 = no stuttering, 1 = extremely mild stuttering, and 8 = extremely severe stuttering. The following procedure is designed to capture the known variability of stuttering severity across different times and situations. At each scheduled assessment, participants will; (1) document their typical and highest stuttering severity for eight situations identified as representative of their daily lifestyle, such as work meetings, talking on the telephone, conversing with family members, and speaking in social situations. The outcome measure will be the mean of scores for the week prior to each scheduled assessment.
Timepoint [2] 326064 0
Pre-treatment and 12 months post-randomisation
Secondary outcome [3] 326065 0
Satisfaction with communication in everyday speaking situations.
Participants will report satisfaction with their communication in everyday speaking situations on a rating scale were 1 = extremely satisfied and 9 = extremely dissatisfied.
Timepoint [3] 326065 0
Pre-treatment and 12 months post-randomisation
Secondary outcome [4] 326066 0
Overall Assessment of Speakers Experience of Stuttering
Participants will document their personal experience of stuttering by completing the Overall Assessment of Speakers Experience of Stuttering questionnaire.
Timepoint [4] 326066 0
Pre-treatment and 12 months post-randomisation
Secondary outcome [5] 326067 0
Speaking situation avoidance.
Participants will record the frequency of their avoidance (never, sometimes or usually) for the same speaking situations used to evaluate stuttering severity above.
Timepoint [5] 326067 0
Pre-treatment and 12 months post-randomisation
Secondary outcome [6] 326068 0
Fear of negative social evaluation as evaluated by the Brief Fear of Negative Evaluation Scale-S.
Timepoint [6] 326068 0
Pre-treatment and 12 months post-randomisation
Secondary outcome [7] 326069 0
Social anxiety as assessed by the Social Phobia and Anxiety Inventory.
Timepoint [7] 326069 0
Pre-treatment and 12 months post-randomisation
Secondary outcome [8] 326070 0
Unhelpful thoughts and beliefs about stuttering as assessed by the questionnaire “Unhelpful Thoughts and Beliefs about Stuttering-6”.
Timepoint [8] 326070 0
Pre-treatment and 12 months post-randomisation

Eligibility
Key inclusion criteria
1. Adults who stutter aged 18 years and older
2. Above cut-off score of 15 on the Brief Fear of Negative Evaluation-S
3. Functional English (writing, reading, speaking)
4. Uninterrupted access to a computer with Internet access at least on a weekly basis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Treatment for anxiety or depression from a mental health professional during the previous 12 months
2. Access to the Internet CBT program during the previous 12 months
3. Treatment for stuttering during the previous 6 months
4. Onset of stuttering at age 12 years or older
5. Onset of stuttering due to a known conversion or any other psychological disorder
6. Unwilling to maintain a stable dose of medication for any psychological problems.
7. Risk of self-harm as assessed by BDI-II criteria
8. A neurological speech-motor disorder for example cerebral palsy, Parkinson’s disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Stratified randomisation using percentage of syllables stuttered. Criterion is above or below five percent syllables stuttered.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
With 53 participants in each group we will have greater than 80% power to detect a 30% decreased proportion of participants with social anxiety disorder diagnosis at 12 months post-randomisation in the speech restructuring + Internet CBT group compared to the speech restructuring group. This calculation allows for a 10% drop-out rate and is based on a 5% level of significance.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Covid 19 impacted the conduct of the trial, as per the treatment protocol, and the current study was suspended.
A new trial was designed however the treatment protocol differed significantly to the treatment protocol for this study so a new trial has been registered.
Date of first participant enrolment
Anticipated
29/05/2017
Actual
29/05/2017
Date of last participant enrolment
Anticipated
31/12/2020
Actual
17/02/2020
Date of last data collection
Anticipated
17/02/2021
Actual
Sample size
Target
106
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294154 0
Government body
Name [1] 294154 0
National Health and Medical Research Council
Country [1] 294154 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown, NSW, Australia, 2050
Country
Australia
Secondary sponsor category [1] 292985 0
None
Name [1] 292985 0
Address [1] 292985 0
Country [1] 292985 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295563 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 295563 0
Ethics committee country [1] 295563 0
Australia
Date submitted for ethics approval [1] 295563 0
18/04/2016
Approval date [1] 295563 0
09/06/2016
Ethics approval number [1] 295563 0
2016/393
Ethics committee name [2] 302250 0
UTS Human Research Ethics Committee
Ethics committee address [2] 302250 0
Ethics committee country [2] 302250 0
Australia
Date submitted for ethics approval [2] 302250 0
28/09/2015
Approval date [2] 302250 0
13/12/2018
Ethics approval number [2] 302250 0
UTS HREC REF NO. ETH18-2932

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67098 0
Prof Ross Menzies
Address 67098 0
Australian Stuttering Research Centre
Graduate School of Health
University of Technology
Building 1, Level 13
15 Broadway, Ultimo, NSW 2007
Country 67098 0
Australia
Phone 67098 0
+61 2 9514 5314
Fax 67098 0
N/A
Email 67098 0
[email protected]
Contact person for public queries
Name 67099 0
Ross Menzies
Address 67099 0
Australian Stuttering Research Centre
Graduate School of Health
University of Technology
Building 1, Level 13
15 Broadway, Ultimo, NSW 2007
Country 67099 0
Australia
Phone 67099 0
+61 2 9514 5314
Fax 67099 0
N/A
Email 67099 0
[email protected]
Contact person for scientific queries
Name 67100 0
Ross Menzies
Address 67100 0
Australian Stuttering Research Centre
Graduate School of Health
University of Technology
Building 1, Level 13
15 Broadway, Ultimo, NSW 2007
Country 67100 0
Australia
Phone 67100 0
+61 2 9514 5314
Fax 67100 0
N/A
Email 67100 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data will be made available as ethical approval has not extended to this level of disclosure.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.