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

NCT04594044 | Completed DMC

• 1 other identifier: 1-10-72-216-15
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Tic Disorder

Keywords

Habit reversal training; Exposure response prevention; Children and adolescents

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline,16 weeks, 24 weeks, 40 weeks, 68 weeks

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

Individual HRT and ERP

EXPERIMENTAL

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

Group HRT and ERP

EXPERIMENTAL

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

Interventions

tics training including habit reversal training and exposure response prevention 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; Individual HRT and ERP

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aarhus University Hospital: lead

Related Publications (1)

• 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.

  PMID: 33610169 DERIVED

MeSH Terms

Conditions

Tic Disorders

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Judith Nissen

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, senior researcher

Model Details: 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

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: November 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: July 21, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share