Group Therapy Versus Individual Therapy for Tourette Syndrome and Chronic Tic Disorder

• Sponsor: Aarhus University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04594044
• Collaborator: (none)
• Enrollment: 59
• Arms: 2
• Actual Duration (Months): 38

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Tic Disorder	Behavioral: tics training including habit reversal training and exposure response prevention	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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-upIn 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: Single (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
• Primary Purpose: Treatment
• Official Title: Group Therapy Versus Individual Therapy in Children and Adolescents With Tourette Syndrome and Chronic Tic Disorder
• Actual Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Dec 31, 2017
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Individual HRT and ERP Individual treatment with habit reversal training (HRT) and exposure response prevention (ERP) according to a protocol	Behavioral: tics training including habit reversal training and exposure response prevention; 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	Behavioral: tics training including habit reversal training and exposure response prevention; 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.

Outcome Measures

Primary Outcome Measures

1. Change of baseline Yale Global Tic Severity Scale (YGTSS) at 16 weeks, 24 weeks, 40 weeks and 68 weeks [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

Secondary Outcome Measures

1. Change of baseline Premonitory urge (PUTS) at 6 weeks, 16 weeks, 24 weeks, and 68 weeks [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

2. Change of baseline Beliefs About Tics Scale (BATS) at 6 weeks, 16 weeks, 24 weeks, and 68 weeks [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. Disorders that required immediate treatment

• psychotic disorder

• primary severe depression

• suicidal ideation or attempts

• primary severe anorexia nervosa

1. Disorders that makes participation difficult

• IQ below 70

• a life-time diagnosis of pervasive developmental disorder

1. Treatment with HRT or ERP during the last six months.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Aarhus University Hospital

Investigators

• Principal Investigator: Judith Nissen, Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Aarhus, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Judith Becker Nissen, MD, PhD, senior researcher, Aarhus University Hospital
• ClinicalTrials.gov Identifier: NCT04594044
• Other Study ID Numbers: 1-10-72-216-15
• First Posted: Oct 20, 2020
• Last Update Posted: Jul 21, 2021
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Judith Becker Nissen, MD, PhD, senior researcher, Aarhus University Hospital: Habit reversal training; Exposure response prevention; Children and adolescents
• Additional relevant MeSH terms: Tourette Syndrome; Tics; Tic Disorders

Study Results

No Results Posted as of Jul 21, 2021