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

NCT ID: NCT03225430

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-21
• Study Completion Date: 2021-09-01

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.

Detailed Description

Tics are defined as repetitive non-voluntary contractions of functionally related groups of skeletal muscles in one or more parts of the body. Gilles de la Tourette's syndrome (TS) forms a separate diagnostic category with multiple tics including vocal (phonic) tics occurring several times per day, for at least 1 year with onset before age 18. Persistent (chronic) tic disorder (TD) may involve a single motor or vocal tic. Tics peak around age 11 but can persist into adulthood with a prevalence of 1% and if untreated cause significant impairment. The current treatment guidelines for managing the tics recommend a Behavioural treatment, "habit reversal", which focuses on reversing the tic habit, now developed as a Comprehensive Behavioural Intervention for Tics (CBIT). CBIT involves multiple stages including awareness, relaxation, contingency training, positive reinforcement for not do the tic and the practice of a competing response antagonistic to the tic. A recent large scale multisite study compared CBIT with supportive therapy and found a significantly greater decrease in adults and children tics treated with CBIT. However, in both adult and child studies, 48-62% of samples were classified as non-responders. Effect sizes were medium (Cohen's d´= 0.55 - 0.68) compared to supportive therapy with mean tic decrease of 25-30% and samples remained symptomatic at follow-up. Research over the last 10 years (funded by the CIHR) have led to elaboration of a cognitive behavioural psychophysiological model of treatment (CoPs) of tic disorders. The CoPs is multi-modal and targets cognitive, behavioural and physiological processes characteristic of tic disorders rather than focusing on reversing the actual tic at onset. In the last funding period 2009-2013 the investigators have successfully applied the program to all subtypes and severity of adults with TS/TD both with and without comorbidity and compared outcome with a natural waitlist control. Results showed a clinically significant reduction of tic frequency following CoPs (Cohen's d- 1.43-2.34), maintained at 6-month follow-up. Validity of the CoPs model was supported by a change in behavioural and psychosocial as well as tic symptom measures post-treatment and at 6-month follow-up, and a post-treatment normalization of participants' performance on neuropsychological and electrophysiological measures.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Comprehensive Behavioural Intervention

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.

Group Type: ACTIVE_COMPARATOR

Cognitive behavioural treatment for tics

Intervention Type: 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.

Cognitive psychophysiological (CoPs)

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.

Group Type: EXPERIMENTAL

Cognitive psychophysiological

Intervention Type: BEHAVIORAL

Focus on the processes influencing thoughts and behaviors underlying tics.

Interventions

Cognitive behavioural treatment for tics

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.

Intervention Type: BEHAVIORAL

Cognitive psychophysiological

Focus on the processes influencing thoughts and behaviors underlying tics.

Intervention Type: BEHAVIORAL

Other Intervention Names

CBIT; CoPs

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Frederick Aardema

Professeur titulaire

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Montreal East, Quebec, Canada

Countries

Canada

Other Identifiers

340559

Identifier Type: -

Identifier Source: org_study_id