Internet-based Behaviour Therapy for Tourette's Disorder and Chronic Tic Disorder
Primary Purpose
Tourette's Disorder, Persistent (Chronic) Motor or Vocal Tic Disorder
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-delivered habit reversal training
Internet-delivered exposure and response prevention
Sponsored by
About this trial
This is an interventional treatment trial for Tourette's Disorder focused on measuring Tourette, Tic, Tics
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.
Sites / Locations
- BUP CPF
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
I-HRT
I-ERP
Arm Description
Internet-delivered habit reversal training
Internet-delivered exposure and response prevention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Clinical Global Impression - Severity (CGI-S)
Clinical Global Impression - Improvement (CGI-I)
Children's Global Assessment Scale (C-GAS)
Parent Tic Questionnaire (PTQ)
Premonitory urge for Tics Scale (PUTS)
Gilles de la Tourette Syndrome Quality of Life Scale (GTS-QOL).
Obsessive-Compulsive Inventory - Child version (OCI-CV).
Children's Depression Inventory - Short version (CDI-S), with additional suicidality item
Mood and Feeling Questionnaire - Short version (MFQ)
Education, Work and Social Adjustment Scale - Child version (EWSAS-C)
Education, Work and Social Adjustment Scale - Parent version (EWSAS-P)
Treatment credibility scale
Treatment satisfaction scale
Safety Monitoring Uniform Report Form (SMURF)
Internet Intervention Patient Adherence Scale (iiPAS)
Parental strategy scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02864589
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette's Disorder, Persistent (Chronic) Motor or Vocal Tic Disorder
Keywords
Tourette, Tic, Tics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I-HRT
Arm Type
Experimental
Arm Description
Internet-delivered habit reversal training
Arm Title
I-ERP
Arm Type
Experimental
Arm Description
Internet-delivered exposure and response prevention
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered habit reversal training
Other Intervention Name(s)
HRT, HR
Intervention Description
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
Intervention Name(s)
Internet-delivered exposure and response prevention
Other Intervention Name(s)
ERP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Yale Global Tic Severity Scale (YGTSS)
Description
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.
Time Frame
Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Secondary Outcome Measure Information:
Title
Clinical Global Impression - Severity (CGI-S)
Time Frame
Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Title
Clinical Global Impression - Improvement (CGI-I)
Time Frame
Week 10; 3 months follow up; 6 months follow up; 12 months follow up
Title
Children's Global Assessment Scale (C-GAS)
Time Frame
Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Title
Parent Tic Questionnaire (PTQ)
Time Frame
Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Title
Premonitory urge for Tics Scale (PUTS)
Time Frame
Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Title
Gilles de la Tourette Syndrome Quality of Life Scale (GTS-QOL).
Time Frame
Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Title
Obsessive-Compulsive Inventory - Child version (OCI-CV).
Time Frame
Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Title
Children's Depression Inventory - Short version (CDI-S), with additional suicidality item
Time Frame
Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Title
Mood and Feeling Questionnaire - Short version (MFQ)
Time Frame
Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Title
Education, Work and Social Adjustment Scale - Child version (EWSAS-C)
Time Frame
Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Title
Education, Work and Social Adjustment Scale - Parent version (EWSAS-P)
Time Frame
Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Title
Treatment credibility scale
Time Frame
Week 3
Title
Treatment satisfaction scale
Time Frame
Week 10
Title
Safety Monitoring Uniform Report Form (SMURF)
Time Frame
Week 5; week 10
Title
Internet Intervention Patient Adherence Scale (iiPAS)
Time Frame
Week 5; week 10
Title
Parental strategy scale
Time Frame
Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mataix-Cols, Professor
Organizational Affiliation
Karolinska Institutet, Department of Clinical Neuroscience
Official's Role
Principal Investigator
Facility Information:
Facility Name
BUP CPF
City
Stockholm
ZIP/Postal Code
113 30
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30772854
Citation
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.
Results Reference
derived
Learn more about this trial
Internet-based Behaviour Therapy for Tourette's Disorder and Chronic Tic Disorder
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