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Trial registered on ANZCTR


Registration number
ACTRN12621001087842
Ethics application status
Approved
Date submitted
20/07/2021
Date registered
18/08/2021
Date last updated
18/08/2021
Date data sharing statement initially provided
18/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the speech and psychological benefits of adding internet anxiety treatment to speech practice for adults who stutter
Scientific title
Investigating the speech and psychological benefits of adding internet anxiety treatment to speech practice for adults who stutter
Secondary ID [1] 304756 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SPAT: Speech and anxiety treatment
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stuttering 322802 0
Social anxiety disorder 322803 0
Condition category
Condition code
Mental Health 320391 320391 0 0
Anxiety
Physical Medicine / Rehabilitation 320392 320392 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Speech treatment
Arm 2: Speech treatment combined with an internet cognitive behaviour therapy program

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 treatment:
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. Speaking activities involve participants setting goals for their stuttering severity and fluency technique while talking to the treating speech pathologist.

For this trial participants will attend 12 x 1-hour weekly sessions of speech treatment with a speech pathologist. The sessions can be either in the clinic or by video conferencing (Zoom). The participant will have the option to attend sessions via Zoom or face to face. The focus of these sessions is to practice the fluency technique, to maintain control of stuttering and to make speech sound as natural as possible. 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.

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.

Randomisation:
At the end of the twelfth session, participants will be randomised to either the experimental group (offered immediate access to the internet CBT program for five months) or the control group (no immediate access to the internet CBT program).

Internet CBT treatment program:
The internet CBT program will guide participants through cognitive behaviour therapy with computer-based activities. This program has been designed to be standalone, that is without any assistance or interaction with 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 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, responses entered by clients for each page of the program and last login date and page of the program.
Intervention code [1] 321147 0
Treatment: Other
Intervention code [2] 321148 0
Behaviour
Comparator / control treatment
The control group will receive the speech restructuring treatment for stuttering component only.
The treatment will consist of 12 x 1 hour individual sessions with a speech pathologist.

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 randomistation.
Control group
Active

Outcomes
Primary outcome [1] 328242 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] 328242 0
Pre-treatment and 12 months post-randomisation.
Secondary outcome [1] 398228 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
will be the mean of scores for the week prior to each scheduled assessment.
Timepoint [1] 398228 0
Pre-treatment and 12 months post-randomisation.
Secondary outcome [2] 398229 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 [2] 398229 0
Pre-treatment and 12 months post-randomisation
Secondary outcome [3] 398230 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 [3] 398230 0
Pre-treatment and 12 months post-randomisation
Secondary outcome [4] 398231 0
Speaking situation avoidance.
Participants will record the frequency of their avoidance (never, rarely, sometimes, often or always) for the same speaking situations used to evaluate stuttering severity above.
Timepoint [4] 398231 0
Pre-treatment and 12 months post-randomisation.
Secondary outcome [5] 398232 0
Fear of negative social evaluation as evaluated by the Brief Fear of Negative Evaluation Scale-S.
Timepoint [5] 398232 0
Pre-treatment and 12 months post-randomisation
Secondary outcome [6] 398233 0
Social anxiety as assessed by the Social Phobia and Anxiety Inventory.
Timepoint [6] 398233 0
Pre-treatment and 12 months post-randomisation
Secondary outcome [7] 398234 0
Unhelpful thoughts and beliefs about stuttering as assessed by the questionnaire “Unhelpful Thoughts and Beliefs about Stuttering-6”.
Timepoint [7] 398234 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. Previous access to the Internet CBT program
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.
9. Neurodevelopmental disorder (e.g., diagnosis of developmental delay, i.e., autism spectrum disorder, down syndrome, intellectual disability and other genetic disorders)

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)
Allocation of participants to control or experimental group will be conducted by central randomisation generated by a computer. The researcher who recruits eligible participants into the trial will be unaware of group allocation at the time of recruitment.
Randomisation results will only be known by a researcher who will have no further contact with the participants such as for data collection post treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified block randomisation will be used to allocate participants to either 1) speech treatment only or 2) speech treatment and internet CBT.

Randomisation will be stratified by pre-treatment self-reported stuttering severity (low vs high) and treatment clinician.
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
Sample Size Calculation:
The total sample size will be 106. The number is derived on the basis of a two tailed test, .80 power, to detect a 30% decrease in the proportion of participants with social anxiety disorder at 12 months post randomisation in the speech restructuring plus Internet CBT group compared to the speech restructuring group.

Statistical Procedures and Analysis Plan:
Analysis of covariance will be used to compare treatment groups with respect to outcomes at 12 months post-randomisation. Data on outcomes prior to randomisation will be included as covariates in the analyses. Analysis by intention to treat will be conducted with last observation carried forward. Treatment effects will be reported as mean differences with 95% confidence intervals and p-values.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2021
Actual
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
106
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309127 0
Government body
Name [1] 309127 0
National Health and Medical Research Council
Country [1] 309127 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway, Ultimo, NSW, Australia, 2007
Country
Australia
Secondary sponsor category [1] 310076 0
None
Name [1] 310076 0
Address [1] 310076 0
Country [1] 310076 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308993 0
Human Research Ethics Executive Review Committees
Ethics committee address [1] 308993 0
Ethics committee country [1] 308993 0
Australia
Date submitted for ethics approval [1] 308993 0
17/02/2021
Approval date [1] 308993 0
13/04/2021
Ethics approval number [1] 308993 0
ETH21-5871

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

Contacts
Principal investigator
Name 112586 0
Prof Ross Menzies
Address 112586 0
Australian Stuttering Research Centre
University of Technology
15 Broadway, Ultimo, NSW 2007
Country 112586 0
Australia
Phone 112586 0
+61 02 95145314
Fax 112586 0
Email 112586 0
[email protected]
Contact person for public queries
Name 112587 0
Ross Menzies
Address 112587 0
Australian Stuttering Research Centre
University of Technology
15 Broadway, Ultimo, NSW 2007
Country 112587 0
Australia
Phone 112587 0
+61 02 95145314
Fax 112587 0
Email 112587 0
[email protected]
Contact person for scientific queries
Name 112588 0
Robyn Lowe
Address 112588 0
Australian Stuttering Research Centre
University of Technology
15 Broadway, Ultimo, NSW 2007
Country 112588 0
Australia
Phone 112588 0
+61 02 95145314
Fax 112588 0
Email 112588 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


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.