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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).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I-HRT | Experimental | Internet-delivered habit reversal training |
|
| I-ERP | Experimental | Internet-delivered exposure and response prevention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Mataix-Cols, Professor | Karolinska Institutet, Department of Clinical Neuroscience | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BUP CPF | Stockholm | 113 30 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30772854 | Derived | 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. |
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| ID | Term |
|---|---|
| D005879 | Tourette Syndrome |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D013981 | Tic Disorders |
| D020323 | Tics |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020249 | Hormone Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
|
| 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. |
|
|
| 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 |
| 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 |
| Obsessive-Compulsive Inventory - Child version (OCI-CV). | Week 0; 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 |
| 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 - Child version (EWSAS-C) | Week 0; 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 credibility scale | Week 3 |
| Treatment satisfaction scale | Week 10 |
| Safety Monitoring Uniform Report Form (SMURF) | Week 5; week 10 |
| Internet Intervention Patient Adherence Scale (iiPAS) | Week 5; week 10 |
| Parental strategy scale | Week 10 |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |