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Internet-based Behaviour Therapy for Tourette's Disorder and Chronic Tic Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02864589
Recruitment Status : Completed
First Posted : August 12, 2016
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
David Mataix-Cols, Karolinska Institutet

Brief Summary:
The purpose of this study is to evaluate the feasibility and acceptability of two different modalities of therapist-guided Internet-delivered behaviour therapy (IBT) for children and adolescents (7-17 years) with Tourette's Disorder (TD) or Persistent (Chronic) Motor or Vocal Tic Disorder (PTD).

Condition or disease Intervention/treatment Phase
Tourette's Disorder Persistent (Chronic) Motor or Vocal Tic Disorder Behavioral: Internet-delivered habit reversal training Behavioral: Internet-delivered exposure and response prevention Not Applicable

Detailed Description:

The primary objective of this study is to evaluate the feasibility and acceptability of two different modalities of therapist-guided Internet-delivered behaviour therapy (IBT) for children and adolescents (7-17 years) with Tourette's Disorder (TD) or Persistent (Chronic) Motor or Vocal Tic Disorder (PTD). The two modalities of IBT are habit reversal training (HRT) and exposure and response prevention (ERP). Secondary objectives are to evaluate whether IBT can decrease tic frequency and tic-related impairment, and, as both HRT and ERP have been proven efficacious in treating TD/PTD face-to-face, are any of the two treatments better suited to be delivered via the internet?

The design of the study is a randomized-controlled trial with 20 participants. Participants will be stratified by ADHD/ADD status.

The treatment duration is 10 weeks.

Feasibility and acceptability will be assumed if:

  • The two treatments can be successfully adapted to a therapist guided internet-delivered format (technical feasibility)
  • Patients/parents are willing to try the offered treatment modalities
  • Participants complete the active parts of the treatment
  • Referrers are open to the idea of internet-delivered treatment for TD or PTD
  • We can recruit sufficient numbers of patients for a fully powered efficacy trial

Regarding the secondary objective, the primary outcome is tic severity measured by the Yale Global Tic Severity Scale (YGTSS). Participants will be assessed directly after treatment (post), and at 3, 6 and 12 months after treatment. Assessments at post-treatment and 3 month follow up will be performed by assessors blinded to the treatment condition. After 3 months, we will naturalistically follow up patients up to 12 months after the end of treatment. Data collection will finish 12 months after treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Internet-based Behaviour Therapy for Tourette's Disorder and Chronic Tic Disorder: A Feasibility Study
Study Start Date : August 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: I-HRT
Internet-delivered habit reversal training
Behavioral: Internet-delivered habit reversal training
The I-HRT group will receive a 10-week therapist-guided, parent-assisted, Internet-delivered behavioural treatment. The treatment is based on existing literature on habit reversal training (i.e. Woods, D.W. (2008). Managing Tourette syndrome: A behavioral intervention for children and adults therapist guide. OUP, USA.) with added interactive features as videos and illustrations. In short, the participants practice to become more aware of their tics and inhibit them by performing competing responses (movements). The treatment is therapist guided: the participants have regular (up to 5 days a week) contact with a personally assigned therapist via written text in the platform and occasionally via the telephone. The children and parents have separate logins and access partly different content.
Other Name: HRT, HR

Experimental: I-ERP
Internet-delivered exposure and response prevention
Behavioral: Internet-delivered exposure and response prevention
The I-ERP group receives a 10-week therapist-guided, parent-assisted, Internet-delivered behavioural treatment. The treatment is based on existing literature on exposure and response prevention (i.e. Verdellen, C. et al. (2011). Tics: Therapist manual & workbook for children. Boom, Amsterd.) with added interactive features as videos and illustrations. In short, the participants practice to suppress their tics for longer and longer times, at the same time as premonitory urges are intentionally provoked. The treatment is therapist-guided: the children and parents have regular (up to 5 days a week) contact with a personally assigned therapist via written text in the platform and occasionally via the telephone. The children and parents have separate logins and access partly different content.
Other Name: ERP




Primary Outcome Measures :
  1. Yale Global Tic Severity Scale (YGTSS) [ Time Frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up ]
    Change in tic severity (motor and/or vocal tics) from week 0 (pre treatment) to week 10 (post treatment), 3 months follow up (after post treatment), 6 months follow up and 12 months follow up.


Secondary Outcome Measures :
  1. Clinical Global Impression - Severity (CGI-S) [ Time Frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up ]
  2. Clinical Global Impression - Improvement (CGI-I) [ Time Frame: Week 10; 3 months follow up; 6 months follow up; 12 months follow up ]
  3. Children's Global Assessment Scale (C-GAS) [ Time Frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up ]
  4. Parent Tic Questionnaire (PTQ) [ Time Frame: Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up ]
  5. Premonitory urge for Tics Scale (PUTS) [ Time Frame: Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up ]
  6. Gilles de la Tourette Syndrome Quality of Life Scale (GTS-QOL). [ Time Frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up ]
  7. Obsessive-Compulsive Inventory - Child version (OCI-CV). [ Time Frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up ]
  8. Children's Depression Inventory - Short version (CDI-S), with additional suicidality item [ Time Frame: Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up ]
  9. Mood and Feeling Questionnaire - Short version (MFQ) [ Time Frame: Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up ]
  10. Education, Work and Social Adjustment Scale - Child version (EWSAS-C) [ Time Frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up ]
  11. Education, Work and Social Adjustment Scale - Parent version (EWSAS-P) [ Time Frame: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up ]
  12. Treatment credibility scale [ Time Frame: Week 3 ]
  13. Treatment satisfaction scale [ Time Frame: Week 10 ]
  14. Safety Monitoring Uniform Report Form (SMURF) [ Time Frame: Week 5; week 10 ]
  15. Internet Intervention Patient Adherence Scale (iiPAS) [ Time Frame: Week 5; week 10 ]
  16. Parental strategy scale [ Time Frame: Week 10 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fulfill DSM-5 diagnostic criteria for Tourette's Disorder or Persistent (Chronic) Motor or Vocal Tic Disorder (PTD).
  • >15 (TD) or >10 (PTD) on Yale Global Tic Severity Scale (Impairment not included).
  • Both child and parent are able to read and communicate in Swedish.
  • Regular access to a computer and the Internet.
  • Parent availability to support their child throughout the treatment.

Exclusion Criteria:

  • Acute psychiatric problems such as severe depression, suicidal risk, substance abuse or another psychiatric disorder that could interfere with treatment.
  • Lifetime history of global learning disability, pervasive developmental disorder, psychosis, bipolar disorder or organic brain disorder.
  • Severe tics causing immediate risk to the patients or others and requiring urgent medical attention.
  • Previous behavioural therapy (HRT or ERP), minimum 8 sessions with qualified therapist, within the last 12 months prior to assessment.
  • Simultaneous psychological treatment for tic disorder.
  • Initiation or adjustment of any psychotropic medication for tics within the last 6 weeks prior to assessment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864589


Locations
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Sweden
BUP CPF
Stockholm, Sweden, 113 30
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: David Mataix-Cols, Professor Karolinska Institutet, Department of Clinical Neuroscience
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Mataix-Cols, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02864589    
Other Study ID Numbers: 2015/938-31/4
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by David Mataix-Cols, Karolinska Institutet:
Tourette, Tic, Tics
Additional relevant MeSH terms:
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Tics
Tic Disorders
Tourette Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders
Basal Ganglia Diseases
Brain Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn