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

NCT02864589 | Completed

• 1 other identifier: 2015/938-31/4
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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).

Conditions

Tourette's Disorder; Persistent (Chronic) Motor or Vocal Tic Disorder

Keywords

Tourette, Tic, Tics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Clinical Global Impression - Severity (CGI-S)

  Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up

• Clinical Global Impression - Improvement (CGI-I)

  Week 10; 3 months follow up; 6 months follow up; 12 months follow up

• Children's Global Assessment Scale (C-GAS)

  Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up

• Parent Tic Questionnaire (PTQ)

  Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up

• Premonitory urge for Tics Scale (PUTS)

  Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up

Study Arms (2)

I-HRT

EXPERIMENTAL

Internet-delivered habit reversal training

Behavioral: Internet-delivered habit reversal training

I-ERP

EXPERIMENTAL

Internet-delivered exposure and response prevention

Behavioral: Internet-delivered exposure and response prevention

Interventions

Internet-delivered habit reversal training BEHAVIORAL

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.

Also known as: HRT, HR

I-HRT

Internet-delivered exposure and response prevention BEHAVIORAL

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.

Also known as: ERP

I-ERP

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

BUP CPF

Stockholm, 113 30, Sweden

Location

Related Publications (1)

• Andren P, Aspvall K, Fernandez de la Cruz L, Wiktor P, Romano S, Andersson E, Murphy T, Isomura K, Serlachius E, Mataix-Cols D. Therapist-guided and parent-guided internet-delivered behaviour therapy for paediatric Tourette's disorder: a pilot randomised controlled trial with long-term follow-up. BMJ Open. 2019 Feb 15;9(2):e024685. doi: 10.1136/bmjopen-2018-024685.

  PMID: 30772854 DERIVED

MeSH Terms

Conditions

Tourette Syndrome; Bronchiolitis Obliterans Syndrome; Tic Disorders; Tics

Interventions

Hormone Replacement Therapy

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• David Mataix-Cols, Professor

  Karolinska Institutet, Department of Clinical Neuroscience

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 12, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 6, 2018

Record last verified: 2018-03

Locations

SE (1)