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

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Brief Title

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

Official Title

Internet-based Behaviour Therapy for Tourette's Disorder and Chronic Tic Disorder: A Feasibility Study

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).
    

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.
    


Study Type

Interventional


Primary Outcome

Yale Global Tic Severity Scale (YGTSS)

Secondary Outcome

 Clinical Global Impression - Severity (CGI-S)

Condition

Tourette's Disorder

Intervention

Internet-delivered habit reversal training

Study Arms / Comparison Groups

 I-HRT
Description:  Internet-delivered habit reversal training

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

23

Start Date

August 2016

Completion Date

January 2018

Primary Completion Date

January 2018

Eligibility 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.
      

Gender

All

Ages

7 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

David Mataix-Cols, Professor, , 

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT02864589

Organization ID

2015/938-31/4


Responsible Party

Principal Investigator

Study Sponsor

Karolinska Institutet


Study Sponsor

David Mataix-Cols, Professor, Principal Investigator, Karolinska Institutet, Department of Clinical Neuroscience


Verification Date

March 2018