Group Therapy Versus Individual Therapy for Tourette Syndrome and Chronic Tic Disorder
Primary Purpose
Chronic Tic Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tics training including habit reversal training and exposure response prevention
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Tic Disorder focused on measuring Habit reversal training, Exposure response prevention, Children and adolescents
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Individual HRT and ERP
Group HRT and ERP
Arm Description
Individual treatment with habit reversal training (HRT) and exposure response prevention (ERP) according to a protocol
Group treatment with habit reversal training (HRT) and exposure response prevention (ERP) according to a protocol
Outcomes
Primary Outcome Measures
Change of baseline Yale Global Tic Severity Scale (YGTSS) at 16 weeks, 24 weeks, 40 weeks and 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
Secondary Outcome Measures
Change of baseline Premonitory urge (PUTS) at 6 weeks, 16 weeks, 24 weeks, and 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
Change of baseline Beliefs About Tics Scale (BATS) at 6 weeks, 16 weeks, 24 weeks, and 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
Full Information
NCT ID
NCT04594044
First Posted
October 13, 2020
Last Updated
July 20, 2021
Sponsor
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04594044
Brief Title
Group Therapy Versus Individual Therapy for Tourette Syndrome and Chronic Tic Disorder
Official Title
Group Therapy Versus Individual Therapy in Children and Adolescents With Tourette Syndrome and Chronic Tic Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic tic disorder (CTD) may have a huge impact on life quality. Habit Reversal Training (HRT) and Exposure Response Prevention (ERP) are effective therapeutic modalities. This study examined the effect of a combined treatment using both HRT and ERP in children and adolescents with CTD. The treatment outcome was examined as an individual treatment compared to a group setting. There was no control group. The study examined both acute outcome and outcome at one year of follow-up. Predictive factors for treatment outcome were evaluated.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Tic Disorder
Keywords
Habit reversal training, Exposure response prevention, Children and adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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. Treatment effect was evaluated after 8 and 9 months, and after one year of follow-up
Masking
Outcomes Assessor
Masking Description
Evaluations of treatment response were made by an independent evaluator who was not blinded to the treatment allocation, yet not involved in the treatment of the patient, and blinded to any previous evaluations. 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
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Individual HRT and ERP
Arm Type
Experimental
Arm Description
Individual treatment with habit reversal training (HRT) and exposure response prevention (ERP) according to a protocol
Arm Title
Group HRT and ERP
Arm Type
Experimental
Arm Description
Group treatment with habit reversal training (HRT) and exposure response prevention (ERP) according to a protocol
Intervention Type
Behavioral
Intervention Name(s)
tics training including habit reversal training and exposure response prevention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of baseline Yale Global Tic Severity Scale (YGTSS) at 16 weeks, 24 weeks, 40 weeks and 68 weeks
Description
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
Time Frame
Baseline,16 weeks, 24 weeks, 40 weeks, 68 weeks
Secondary Outcome Measure Information:
Title
Change of baseline Premonitory urge (PUTS) at 6 weeks, 16 weeks, 24 weeks, and 68 weeks
Description
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
Time Frame
Baseline, 6 weeks, 16 weeks, 24 weeks, 68 weeks
Title
Change of baseline Beliefs About Tics Scale (BATS) at 6 weeks, 16 weeks, 24 weeks, and 68 weeks
Description
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
Time Frame
Baseline, 6 weeks, 16 weeks, 24 weeks, 68 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Nissen
Organizational Affiliation
Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Aarhus, Denmark
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
In accordance to Danish law, personal data cannot be shared
Citations:
PubMed Identifier
33610169
Citation
Nissen JB, Carlsen AH, Thomsen PH. One-year outcome of manualised behavior therapy of chronic tic disorders in children and adolescents. Child Adolesc Psychiatry Ment Health. 2021 Feb 20;15(1):9. doi: 10.1186/s13034-021-00362-w.
Results Reference
derived
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Group Therapy Versus Individual Therapy for Tourette Syndrome and Chronic Tic Disorder
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