Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000761763
Ethics application status
Approved
Date submitted
11/05/2022
Date registered
27/05/2022
Date last updated
7/07/2023
Date data sharing statement initially provided
27/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing psychological treatment services for adults who stutter: Online social anxiety treatment versus standard community treatment services.
Scientific title
Comparing psychological treatment services for adults who stutter: Online social anxiety treatment versus standard community treatment services.
Secondary ID [1] 307082 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stuttering 326244 0
Social anxiety 326455 0
Condition category
Condition code
Mental Health 323546 323546 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a randomised controlled trial investigating the quality of life, psychological benefits and speech outcomes of an online social anxiety treatment in comparison to standard clinical practice in the community for adults who stutter.

Participants will be randomised to one of two groups:
Online cognitive behaviour treatment or standard psychological services available in the community.

The online cognitive behaviour treatment involves an internet program, known as iGlebe. The iGlebe program is a cognitive behaviour therapy program for social anxiety with people who stutter. The treatment is completely online without any input from live clinicians.
iGlebe has seven modules. Participants complete the prescribed activities associated with each module before progressing to the next module. The first stage of the program involves developing an individualised profile for each participant. This is achieved by having the participant complete an online battery of assessments, The Unhelpful Thoughts and Beliefs About Stuttering scale, Avoidance of Speaking Situations questionnaire, The Fear of Negative Evaluation scale, and the Depression, Anxiety and Stress Scales. 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 specific and individualised 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, and writing tasks.

Participants have access to iGlebe 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 can vary depending on participant responses to the initial questionnaires and the time they spend working on the activities and tasks. Participants can choose to repeat tasks as well. It is recommended that participants log into the program at least weekly. The teaching components for each module is expected to take between 1 and 2 hours depending on the module.

Adherence to iGlebe will be provided from data generated within the program and consists of dates of first login, date of login for each new module, date and page of last login.

Intervention code [1] 323536 0
Treatment: Other
Comparator / control treatment
The control condition is standard psychological services available in the community.
Control participants will be provided with options for psychological treatment services in their area including telehealth options. The treatment services will include private and community health services. Participants will also be able to choose their own service that is available within the community.
The treatment provided by community service providers will be as per the service, practice or clinician deems necessary and appropriate for the participant.

Adherence to standard care available in the community will be generated from a questionnaire provided to participants at the final data point. The questionnaire asks whether the participant sought services; the type of support received, for example, assessment only, placed on a waiting list or treatment; the amount of time in treatment; where treatment was provided, for example, public health, private, helpline; professional who provided treatment; and a brief description of the treatment.

Control group
Active

Outcomes
Primary outcome [1] 331298 0
Quality of life as assessed by the Overall Assessment of The Speaker's Experience of Stuttering (OASES) - total score. (Yaruss & Quesal, 2016).
Timepoint [1] 331298 0
Pre-treatment
12 months post randomisation.
Secondary outcome [1] 409463 0
Beck Depression Inventory – II (BDI-II). (Beck, Steer, & Brown, 1996).

Timepoint [1] 409463 0
Pre-treatment
12 months post randomisation
Secondary outcome [2] 409464 0
Typical Stuttering Severity: 11 point scale where 0= no stuttering and 10 = extremely severe stuttering.
Timepoint [2] 409464 0
Pre-treatment
12 months post randomisation
Secondary outcome [3] 409465 0
Worst Stuttering Severity: 11 point scale where 0= no stuttering and 10 = extremely severe stuttering.
Timepoint [3] 409465 0
Pre-treatment
12 months post randomisation
Secondary outcome [4] 409466 0
Social Phobia Anxiety Inventory (SPAI) (Turner, Beidel, Dancu, & Stanley, 1989)
Timepoint [4] 409466 0
Pre-treatment
12 months post randomisation
Secondary outcome [5] 409467 0
Avoidance of speaking situations: assessed with 55 response questionnaire.
Timepoint [5] 409467 0
Pre-treatment
12 months post randomisation
Secondary outcome [6] 409468 0
Brief Fear of Negative Evaluation (BFNE-S) (Carleton, Collimore, McCabe, & Antony, 2011; Rodebaugh et al., 2004; Weeks et al., 2005)
Timepoint [6] 409468 0
Pre-treatment
12 months post randomisation
Secondary outcome [7] 409469 0
Unhelpful Thoughts and Beliefs about Stuttering scale (UTBAS) – 6 items scale (Iverach, Heard, Lowe, O’Brian, Packman, & Onslow, 2016).
Timepoint [7] 409469 0
Pre-treatment
12 months post randomisation
Secondary outcome [8] 409470 0
Satisfaction with communication in everyday speaking situation (SCESS) (Karimi, Onslow, Jones, O’Brian, Packman, Menzies, Reilly, Sommer, & Jelcic-Jakšic, 2018)
Timepoint [8] 409470 0
Pre-treatment
12 months post randomisation
Secondary outcome [9] 409471 0
Depression, Anxiety, and Stress scales (DASS) (Psychology Foundation of Australia, 2013).
Timepoint [9] 409471 0
Pre-treatment
12 months post randomisation
Secondary outcome [10] 409559 0
Social Anxiety Disorder diagnosis as assessed using the Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5). Social anxiety disorder subscale.
Timepoint [10] 409559 0
Pre-treatment
12 months post treatment

Eligibility
Key inclusion criteria
• 18 years and over
• Formal diagnosis of stuttering by a speech pathologist via clinical interview over phone
• Australian resident/citizen
• Willingness to give written consent and willingness to participate and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Treatment for anxiety or depression from a mental health professional in the previous 12 months (not including assessment or less than 3 hours of contact)
• Prior use of iGlebe in previous 12 months
• Unwillingness or inability to stabilise prescribed psychological medication for duration of the trial
• Risk of self-harm as assessed by the Beck Depression Inventory (such excluded participants will be referred for psychological care).

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 schedule generated off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A medium effect size of 0.5 SD assuming 20% dropout, 80% power, 5% level of significance, ANCOVA and within-person correlation of 0.57 would require 106 participants in total or 53 per group.
Continuous outcomes including QoL will be compared between treatment groups using an analysis of covariance (ANCOVA) by adjusting for pre-treatment values of outcome in question ,e.g., QoL. Treatment effect will be measured by the mean difference between groups and reported along with 95% confidence intervals and p-value.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/06/2022
Actual
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
31/05/2025
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] 311391 0
Government body
Name [1] 311391 0
National Health and Medical Research Council
Country [1] 311391 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway Ultimo, NSW 2007
Country
Australia
Secondary sponsor category [1] 312781 0
None
Name [1] 312781 0
Address [1] 312781 0
Country [1] 312781 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310874 0
University of Technology Sydney Human Research Ethics Committee
Ethics committee address [1] 310874 0
15 Broadway Ultimo, NSW 2007
Ethics committee country [1] 310874 0
Australia
Date submitted for ethics approval [1] 310874 0
18/11/2021
Approval date [1] 310874 0
08/04/2022
Ethics approval number [1] 310874 0
UTS HREC REF NO. ETH21-6514

Summary
Brief summary
Aim
The aim of this project is to determine if adults who stutter have superior quality of life (QOL), psychological well being, and speech functionality following 5 months access to an online social anxiety treatment for adults who stutter, known as iGlebe, compared to standard psychological services in the community.
Objectives
Primary objective: To compare quality of life with adults who stutter pre­-treatment and 12 months post­-treatment who have been randomly allocated to iGlebe or standard community practice, using the Overall Assessment of the Speaker's Experience of Stuttering (OASES).
We are comparing the outcomes of participants from two groups: an online cognitive behaviour therapy program for social anxiety and standard psychological services in the community.
Standard community care may consist of various service provisions, varying in cost, for example, private service providers or community health services. Participants in the standard care group can choose whichever option suits their individual circumstances.

Secondary objectives: To measure levels of speech related anxiety and speech functionality pre-­treatment and 12 months post-­treatment for adults who stutter and who have been randomly allocated to iGlebe or standard psychological services in the community.
Measures include self­-reported stuttering severity, situation avoidance and a range of anxiety measures.

Hypotheses
1. Participants who receive treatment with iGlebe will demonstrate significant improvements in Quality of life as measured by the Overall Assessment of the Speakers Experience of Stuttering (OASES), total score, at 12 months post­ randomisation compared to standard community services.
2. Participants who receive iGlebe will demonstrate significantly greater improvements in social anxiety than participants in the standard care group.
3. Participants who receive iGlebe will report significantly lower self-­reported stuttering severity ratings than participants in the standard care group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119182 0
Prof Ross Menzies
Address 119182 0
Australian Stuttering Research Centre
University of Technology Sydney
Level 13, Building One,
15 Broadway, Ultimo NSW 2007
Country 119182 0
Australia
Phone 119182 0
+61 02 9514 5314
Fax 119182 0
Email 119182 0
[email protected]
Contact person for public queries
Name 119183 0
A/Prof Robyn Lowe
Address 119183 0
Australian Stuttering Research Centre
University of Technology Sydney
Level 13, Building One,
15 Broadway, Ultimo NSW 2007
Country 119183 0
Australia
Phone 119183 0
+61 02 9514 5314
Fax 119183 0
Email 119183 0
[email protected]
Contact person for scientific queries
Name 119184 0
Prof Ross Menzies
Address 119184 0
Australian Stuttering Research Centre
University of Technology Sydney
Level 13, Building One,
15 Broadway, Ultimo NSW 2007
Country 119184 0
Australia
Phone 119184 0
+61 02 9514 5314
Fax 119184 0
Email 119184 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.