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

NCT ID: NCT02864589

Last Updated: 2018-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-01-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

I-HRT

Internet-delivered habit reversal training

Group Type: EXPERIMENTAL

Internet-delivered habit reversal training

Intervention Type: 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.

I-ERP

Internet-delivered exposure and response prevention

Group Type: EXPERIMENTAL

Internet-delivered exposure and response prevention

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

HRT, HR; ERP

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

David Mataix-Cols

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Mataix-Cols, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet, Department of Clinical Neuroscience

Locations

BUP CPF

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 30772854 (View on PubMed)

Other Identifiers

2015/938-31/4

Identifier Type: -

Identifier Source: org_study_id