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

Tourette's Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864589
• Other study ID #: 2015/938-31/4
• Status: Completed
• Phase: N/A
• First received: August 9, 2016
• Last updated: March 5, 2018
• Start date: August 2016
• Est. completion date: January 2018

Study information

• Verified date: March 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Persistent (Chronic) Motor or Vocal Tic Disorder
• Tic Disorders
• Tics
• Tourette Syndrome
• Tourette's Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	BUP CPF	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale Global Tic Severity Scale (YGTSS)	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.	Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Secondary	Clinical Global Impression - Severity (CGI-S)		Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Secondary	Clinical Global Impression - Improvement (CGI-I)		Week 10; 3 months follow up; 6 months follow up; 12 months follow up
Secondary	Children's Global Assessment Scale (C-GAS)		Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Secondary	Parent Tic Questionnaire (PTQ)		Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Secondary	Premonitory urge for Tics Scale (PUTS)		Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Secondary	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
Secondary	Obsessive-Compulsive Inventory - Child version (OCI-CV).		Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Treatment credibility scale		Week 3
Secondary	Treatment satisfaction scale		Week 10
Secondary	Safety Monitoring Uniform Report Form (SMURF)		Week 5; week 10
Secondary	Internet Intervention Patient Adherence Scale (iiPAS)		Week 5; week 10
Secondary	Parental strategy scale		Week 10