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

NCT ID: NCT04594044

Last Updated: 2021-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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

Conditions

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Chronic Tic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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

Study Groups

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Individual HRT and ERP

Individual treatment with habit reversal training (HRT) and exposure response prevention (ERP) according to a protocol

Group Type EXPERIMENTAL

tics training including habit reversal training and exposure response prevention

Intervention Type BEHAVIORAL

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.

Group HRT and ERP

Group treatment with habit reversal training (HRT) and exposure response prevention (ERP) according to a protocol

Group Type EXPERIMENTAL

tics training including habit reversal training and exposure response prevention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
2. Disorders that makes participation difficult

* IQ below 70
* a life-time diagnosis of pervasive developmental disorder
3. Treatment with HRT or ERP during the last six months.
Minimum Eligible Age

9 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Judith Becker Nissen

MD, PhD, senior researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judith Nissen

Role: PRINCIPAL_INVESTIGATOR

Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Aarhus, Denmark

References

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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.

Reference Type DERIVED
PMID: 33610169 (View on PubMed)

Other Identifiers

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1-10-72-216-15

Identifier Type: -

Identifier Source: org_study_id

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