ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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

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]

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

Social anxiety disorder

Condition category

Condition code

Mental Health

Anxiety

Physical Medicine / Rehabilitation

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]

Treatment: Other

Intervention code [2]

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]

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]

Pre-treatment and 12 months post-randomisation.

Secondary outcome [1]

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]