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

Not Applicable

Completed

• Conditions: Tourette's Disorder; Persistent (Chronic) Motor or Vocal Tic Disorder
• Interventions: Behavioral: Internet-delivered habit reversal training; Behavioral: Internet-delivered exposure and response prevention

• Registration Number: NCT02864589
• Lead Sponsor: 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).

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-12
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-05
• Last Update Posted: 2018-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I-HRT	Internet-delivered habit reversal training	Internet-delivered habit reversal training
I-ERP	Internet-delivered exposure and response prevention	Internet-delivered exposure and response prevention

Primary Outcome Measures

Name	Time	Method
Yale Global Tic Severity Scale (YGTSS)	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

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

Trial Locations

Locations (1)

BUP CPF; 🇸🇪 Stockholm, Sweden