Evaluation of a Cognitive Psychophysiological Treatment for Tourette Syndrome and Tic Disorders

NCT03225430 | Completed

• 1 other identifier: 340559
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

It is a randomized controlled trial to compare two behavioural treatments, namely CBIT and CoPs. This study would be the first head-to-head randomized trial between two established treatments rather than supportive counseling or wait-list control. Thirty-six adults and 36 children with TS/TD will be recruited into each of the two (CBIT, CoPs) modalities requiring a total recruitment of 72 adults and 72 children over 5 years, which permits, even for a small-medium effect size, a robust power calculation. Motor performance measures will give concurrent validity to changes pre-post in TS/TD motor processes. Recruitment of both males and females will permit sex comparisons. The participants meeting inclusion/exclusion criteria will be assessed at pre-post 1 month and 6 months following treatment on standardized tic scales and global assessment of functioning. Participants will be treated individually on a weekly basis by therapists with an allegiance to each modality and outcome assessed by masked evaluation. The treatments are manualized and will last 10 weeks with 4 weeks of home practice at post-treatment with 6-month follow-up assessment on all outcome measures, plus motor performance measures post-treatment. All treatment sessions will be audio-recorded and assessed with implementation of treatment integrity procedures scales. The hypotheses are that: (1) the CoPs group will show superiority in clinically significant improvement on standard tic scale score, global functioning and quality of life than the CBIT group; and (2) changes in recognized parameters on selected motor tests scored according to published norms will change towards normalization post CoPs but not post CBIT. The outcome data from the two treatments will be analyzed by a mixed linear model adaptation of repeated measures MANOVA and daily diary measures will allow for an additive time series design over the 10 weeks treatment session. This design will allow computation of the size of treatment effects at different stages of therapy. The study results will impact on the treatment of choice and access to treatment for tic disorders and on the conceptualization of tic disorders.

Conditions

Tic Disorder, Chronic Motor or Vocal; Tourette Syndrome in Children; Tourette Syndrome

Outcome Measures

Primary Outcomes (1)

• Yale Global Tic Severity Scale (YGTSS)

  The YGTSS is a clinician-rated scale used to assess change in tic severity and impairment due to tics.

  baseline

Secondary Outcomes (36)

• determine style of planning actions

  baseline

• measure effect of therapy in style of planning score

  change from baseline

• measure long term effect of therapy in style of planning score

  change from baseline at 6 months

• change in dimensions of perfectionism and use as a predictive variable of treatment issues

  baseline

• change in dimensions of perfectionism

  change from baseline

Other Outcomes (6)

• Intelligence and executive functioning screening assessment

  baseline

• Intelligence and executive functioning screening assessment

  change from baseline

• The Brief Inventory of Executive Function (BRIEF-A)

  baseline

Study Arms (2)

Comprehensive Behavioural Intervention

ACTIVE COMPARATOR

Participant will received psychoeducation about tic disorders, creating a tic hierarchy that will be revised during future sessions, introduce concept of function-based intervention, behavioral reward program, self-monitoring training, habit reversal training for their tics. They will received an introduction of relaxation techniques and diaphragmatic breathing exercise and an introduction of progressive muscle relaxation (PMR) exercise. They will received booster sessions for three months and he will do hierarchy review, inconvenience review, function-based intervention and competing response review, review of relaxation techniques and relapse prevention review.

Behavioral: Cognitive behavioural treatment for tics

Cognitive psychophysiological (CoPs)

EXPERIMENTAL

The participant will received a rational about the treatment and awareness training about tics and creating list of tics. He will identifying high and low risk situations provoking tics, do video record and make a list of inconveniences of tic. He will do a screening session of the video and muscle discrimination exercises. Worked on a situational profile with a Kelly's grill and beginning relaxation and breathing exercises. He will identifying style of planning and work on it to do an advantages and inconveniences list to adopt this style. Some behavioral and cognitive re structuration about style of planning and how to modifying. At the end, he will received a relapse prevention informations and how to generalize the learnings and a record of the therapy. Finally, he will have to practice all this techniques at home for four week and do a last session to discuss home practice and received strategies for the future.

Behavioral: Cognitive psychophysiological

Interventions

Cognitive behavioural treatment for tics BEHAVIORAL

Mainly based on the habit reversal treatment (HRT) and in addition to HRT components, they learn awareness training, relaxation, competing response, contingency management, and generalization training.

Also known as: CBIT

Comprehensive Behavioural Intervention

Cognitive psychophysiological BEHAVIORAL

Focus on the processes influencing thoughts and behaviors underlying tics.

Also known as: CoPs

Cognitive psychophysiological (CoPs)

Eligibility Criteria

• Age: 8 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• presenting a simple/complex tic for at least one year occurring daily. Those included in the TS group, age 8-12 or 18-65, had a diagnosis of TS as the principal presenting problem accompanied by vocal tics. Those included in the TD group presented a simple/complex tic (vocal or motor) for at least one year occurring daily.

You may not qualify if:

• any major medical history, head injury including sensori-motor impairment, history of autism, Intelligence Quotient (IQ)\<75; other psychiatric problem on Axis I or II requiring treatment (minor comorbidities were accepted), any neurological problems (e.g., Parkinson's, hemifacial spasms, Meige syndrome, sclerosis; Huntington's disease, Wilson's disease); currently receiving treatment from a psychologist, acupuncture, hypnotherapist, massotherapist; currently receiving psychotropic drugs non-relevant to TS or ADHD or abuse of alcohol or drugs.

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre de recherche de l'Institut universitaire en santé mentale de Montréal

Montreal East, Quebec, H1N 3V2, Canada

Location

MeSH Terms

Conditions

Tic Disorders; Tourette Syndrome

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders; Basal Ganglia Diseases; Brain Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessors will receive no information on participant history and psychopathology. All evaluation sessions will be audio-recorded for reliability and to ensure that treatment status is not divulged. The Assessors will be separated from the therapists by geographical location site and will sign agreements not to discuss cases in the study with any other team member. Child and adult participants will agree not to discuss treatment or therapy during evaluation. Management of assessors will be delegated to a separate clinical coordinator who will assume overall responsibility for evaluations and preempting any direct contact between the principal investigator and Co-investigators and the assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professeur titulaire

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 21, 2017
• Study Start: April 21, 2016
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)