- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04594044
Group Therapy Versus Individual Therapy for Tourette Syndrome and Chronic Tic Disorder
Group Therapy Versus Individual Therapy in Children and Adolescents With Tourette Syndrome and Chronic Tic Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic tic disorder (CTD) may have a huge impact on life quality. Habit Reversal Training (HRT) and Exposure Response Prevention (ERP) are known to be effective therapeutic modalities. Little is known about the effect of group therapy, the effect of combining HRT and ERP training, and of the long-term effect of treatment. This study therefore wanted to examine the effect of a combined treatment using both HRT and ERP in children and adolescents with CTD. The participants were randomized to treatment either in groups or in an individual setting. The parents were included in the training programme. The participants were asked to fulfill questionnaires concerning anxiety, mood, life quality, their thoughts about tics and the experienced premonitory urge. Furthermore, they were interviewed with the semistructured interview Yale Global Tic Severity Scale (YGTSS).
Data was obtained from patient files as to examine possible predictors of both acute and long-term treatment effects. The evaluators were a specialized psychologist and a child and adolescent psychiatrist with several years of experience in diagnosing, evaluating and treating tic disorders. A random sample of 10% were audiotaped and evaluated by another rater with extensive experience and expertise in the use of the YGTSS. The evaluator was not blinded to the treatment allocation, yet not involved in the treatment of the patient, and blinded to any previous evaluations
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A primary diagnosis of either Tourette syndrome or a chronic motor/vocal tics disorder
- Moderate or greater severity corresponding to a total score on the Yale Global Tic Severity Scale (YGTSS) higher than 13 (higher than nine if only motor or vocal tics were described)
Exclusion Criteria:
Disorders that required immediate treatment
- psychotic disorder
- primary severe depression
- suicidal ideation or attempts
- primary severe anorexia nervosa
Disorders that makes participation difficult
- IQ below 70
- a life-time diagnosis of pervasive developmental disorder
- Treatment with HRT or ERP during the last six months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Individual HRT and ERP
Individual treatment with habit reversal training (HRT) and exposure response prevention (ERP) according to a protocol
|
In an open randomized controlled study, youth were randomized to either individualized, or group treatment.
Both therapies included nine sessions, and the parents were offered one group-session.
|
Experimental: Group HRT and ERP
Group treatment with habit reversal training (HRT) and exposure response prevention (ERP) according to a protocol
|
In an open randomized controlled study, youth were randomized to either individualized, or group treatment.
Both therapies included nine sessions, and the parents were offered one group-session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of baseline Yale Global Tic Severity Scale (YGTSS) at 16 weeks, 24 weeks, 40 weeks and 68 weeks
Time Frame: Baseline,16 weeks, 24 weeks, 40 weeks, 68 weeks
|
Measures the change in Total tic score and functional impairment at different end points on the Yale Global Tic Severity Scale (unabbreviated scale title).
Interval 0-100, high score means a worse outcome
|
Baseline,16 weeks, 24 weeks, 40 weeks, 68 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of baseline Premonitory urge (PUTS) at 6 weeks, 16 weeks, 24 weeks, and 68 weeks
Time Frame: Baseline, 6 weeks, 16 weeks, 24 weeks, 68 weeks
|
Measures the change of baseline premonitory urge score at different end points on the Premonitory Urge scale (unabbreviated scale title).
Interval 1-4, high score means a worse outcome
|
Baseline, 6 weeks, 16 weeks, 24 weeks, 68 weeks
|
Change of baseline Beliefs About Tics Scale (BATS) at 6 weeks, 16 weeks, 24 weeks, and 68 weeks
Time Frame: Baseline, 6 weeks, 16 weeks, 24 weeks, 68 weeks
|
Measures the change of baseline Beliefs About Tics Scale score at different end points on the Beliefs About Tics Scale (unabbreviated scale title).
Interval 1-4, high score means a worse outcome
|
Baseline, 6 weeks, 16 weeks, 24 weeks, 68 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Judith Nissen, Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Aarhus, Denmark
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Tourette Syndrome
- Tic Disorders
- Tics
Other Study ID Numbers
- 1-10-72-216-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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