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Trial registered on ANZCTR


Registration number
ACTRN12623000824662
Ethics application status
Approved
Date submitted
29/05/2023
Date registered
1/08/2023
Date last updated
1/08/2023
Date data sharing statement initially provided
1/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Combined Habit Reversal Training and Acceptance and Commitment
Therapy for Treatment of Tics in Tourette Syndrome
Scientific title
Combined Habit Reversal Training and Acceptance and Commitment
Therapy for Treatment of Tics in Tourette Syndrome
Secondary ID [1] 309777 0
Nil known.
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Tic disorder 330181 0
Tourette Syndrome 330182 0
Condition category
Condition code
Neurological 327057 327057 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study uses a behavioural intervention for the treatment of tics combining Habit Reversal Therapy, an established and evidence-based treatment for tics, with Acceptance and Commitment Therapy, an empirically-based psychological intervention that uses acceptance and mindfulness strategies to increase psychological flexibility. HRT is a behavioural approach to the treatment of tics and other habit disorders. The treatment model is based on the rationale that tic reduction is possible through tic awareness and training in performing a physically competing response, in order to prevent or interrupt the occurrence of tics. It involves several therapeutic components including a function-based assessment, awareness training, relaxation training and competing response training. ACT is a modern, empirically-based psychological intervention grouped under the “third wave of cognitive behavioural therapy”. The model employs six core processes that assist in developing increased psychological flexibility. Treatment sessions will incorporate the core ACT processes, such as mindfulness and defusion, with the overarching aim of fostering acceptance of tic urges and helping patients deal more effectively with the unpleasant emotional states. Participants will be encouraged to complete homework and exercises between sessions which consists of completing self-monitoring worksheets (counting tics) once a day for 30-60 minutes and doing 2-5 minute relaxation exercises daily.

This combined behavioural intervention will be administered by a trained psychologist over eight, weekly, 1-hour sessions. The sessions will be conducted individually and face-to-face at the Perron Institute clinic in Nedlands, WA. Two 1-hour booster sessions will be provided at 1 and 2 months following completion of the eight-week treatment program. Booster sessions will involve a review and consolidation of learned techniques.
Intervention code [1] 326213 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334917 0
Yale Global Tic Severity Scale
Timepoint [1] 334917 0
Pre-treatment (baseline)
Immediately post-completion of treatment program
3 months post-completion of treatment program
6 months post-completion of treatment program
9 months post-completion of treatment program
12 months post-completion of treatment program
Secondary outcome [1] 422422 0
Tic severity using the Modified Rush Video Rating Scale (Goetz et al., 1999)
Timepoint [1] 422422 0
Pre-treatment (baseline)
Immediately post-completion of treatment program
3 months post-completion of treatment program
6 months post-completion of treatment program
9 months post-completion of treatment program
12 months post-completion of treatment program
Secondary outcome [2] 422423 0
Quality of Life assessed using the Short-Form 36
Timepoint [2] 422423 0
Pre-treatment (baseline)
Immediately post-completion of treatment program
3 months post-completion of treatment program
6 months post-completion of treatment program
9 months post-completion of treatment program
12 months post-completion of treatment program
Secondary outcome [3] 422424 0
Work and Social Adjustment Scale (WSAS)
Timepoint [3] 422424 0
Pre-treatment (baseline)
Immediately post-completion of treatment program
3 months post-completion of treatment program
6 months post-completion of treatment program
9 months post-completion of treatment program
12 months post-completion of treatment program
Secondary outcome [4] 422425 0
Depression, Anxiety and Stress Scale (DASS21)
Timepoint [4] 422425 0
Pre-treatment (baseline)
Immediately post-completion of treatment program
3 months post-completion of treatment program
6 months post-completion of treatment program
9 months post-completion of treatment program
12 months post-completion of treatment program
Secondary outcome [5] 422426 0
Yale Brown Obsession and Compulsion Scale (YBOCS)
Timepoint [5] 422426 0
Pre-treatment (baseline)
Immediately post-completion of treatment program
3 months post-completion of treatment program
6 months post-completion of treatment program
9 months post-completion of treatment program
12 months post-completion of treatment program

Eligibility
Key inclusion criteria
• Adults aged 16 years and over
• Diagnosis of Tourette Syndrome or another Chronic Tic Disorder
• Comorbidities such as obsessive-compulsive disorder (OCD), anxiety disorders and Attention-Deficit Hyperactivity Disorder (ADHD) will be permitted providing that the tics are the primary concern for the participant and the co-occurring disorder is stable.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Moderate to severe cognitive dysfunction
• Severe psychiatric condition (such as severe depression, psychosis, suicidality or substance abuse)
• Other medical or neurological comorbidities that may interfere with treatment
• History of 4 or more sessions of a similar behavioural therapy for tics (to ensure the participant is naïve to the treatment techniques)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive analysis will include means, standard deviations, and characteristics at baseline.
Comparisons will be made between pre-treatment, post-treatment and follow-up scores using repeated-measures ANOVA with a two-sided significance level of 0.05. Corrections will be made for multiple testing. Correlational analyses will be conducted using scores on the YGTSS and the Modified Video Rush Scale to assess convergent validity across the subjective and objective measures of tics. The primary aim of the study will be investigated through comparisons of pre-treatment, post-treatment and follow-up YGTSS scores using repeated-measures ANOVA. The secondary aims of the study will be investigated by comparing pre-treatment, post-treatment and follow-up scores on the DASS21 depression scale, DASS21 anxiety scale, DASS21 stress scale, SF-36, WSAS and the YBOCS using repeated-measures ANOVA.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/09/2018
Date of last participant enrolment
Anticipated
Actual
3/05/2021
Date of last data collection
Anticipated
Actual
25/08/2022
Sample size
Target
10
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 24814 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 40464 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 313960 0
Other
Name [1] 313960 0
Perron Institute
Country [1] 313960 0
Australia
Primary sponsor type
Other
Name
Perron Institute
Address
G Floor, RR Block, QEII Medical Cente, 8 Verdun street, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 315831 0
None
Name [1] 315831 0
Address [1] 315831 0
Country [1] 315831 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313097 0
Bellberry Human Research Ethic Committee Limited
Ethics committee address [1] 313097 0
Ethics committee country [1] 313097 0
Australia
Date submitted for ethics approval [1] 313097 0
18/06/2018
Approval date [1] 313097 0
12/07/2018
Ethics approval number [1] 313097 0
2018-05-312

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

Contacts
Principal investigator
Name 126994 0
A/Prof Rick Stell
Address 126994 0
G Floor, RR Block, QEII Medical Centre, 8 Verdun street, Nedlands WA 6009
Country 126994 0
Australia
Phone 126994 0
+61 8 6457 0200
Fax 126994 0
+61 8 6457 0281
Email 126994 0
rick.stell@health.wa.gov.au
Contact person for public queries
Name 126995 0
Jennifer Eisenhauer
Address 126995 0
G Floor, RR Block, QEII Medical Centre, 8 Verdun street, Nedlands WA 6009
Country 126995 0
Australia
Phone 126995 0
+61 8 6457 0207
Fax 126995 0
+61 8 6457 0281
Email 126995 0
jenny.eisenhauer@perron.uwa.edu.au
Contact person for scientific queries
Name 126996 0
Jennifer Eisenhauer
Address 126996 0
G Floor, RR Block, QEII Medical Centre, 8 Verdun street, Nedlands WA 6009
Country 126996 0
Australia
Phone 126996 0
+61 8 64570207
Fax 126996 0
Email 126996 0
jenny.eisenhauer@perron.uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is confidential.


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.