Internet-based Cognitive Behavioral Therapy for Chronic Tic Disorder and Tourette's Disorder: a Feasibility Trial

NCT04908969 | Unknown

• 1 other identifier: 2020-00479
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Tic disorders, including Tourette's Disorder (TD) and Chronic Motor or Vocal Tic Disorder (CTD), are neurodevelopmental motor disorders characterised by motor and/or vocal tics. TD/CTD are impairing conditions with onset during childhood that often persist into adulthood. Behaviour therapy (BT) is an effective treatment for TD/CTD and is recommended as a first-line intervention in both in children and in adults. However, most adults with TD/CTD do not have access to BT due to a lack of trained professionals and geographical barriers. The objective of the study is to adapt and extend existing face-to-face BT treatment protocols for adults with TD/CTD to an internet-delivered format and evaluate its feasibility and preliminary efficacy. A total of 30 adult TD/CTD adult patients deemed eligible for the study through the recruitment process involving both psychologist and physician assessment will be enrolled in the project. The 8-modues treatment program, mainly based on exposure with response prevention with addition of other techniques will be made available for the participants in a secure treatment platform. The participants will keep in touch with a therapist using two-ways written communication in the same platform. The therapist's role will be to introduce the treatment and its modules, give feedback on the homework assignments and open the new modules as well as monitor the participants psychiatric symptoms and activity in the plattform. The measures will include tic severity secifically and disease severity in general, anxiety and depression symptoms, quality of life, treatment credibility and therapeutic alliance. The measures will be administrated at baseline, min- and post-tretment, as well at 3 and 12 months follow-up. Upon completion, this project will be the first crucial step towards the implementation of internet-delivered behaviour therapy (I-BT) for adults with TD/CTD in regular health care.

Conditions

Chronic Tic Disorder; Tourette Syndrome

Outcome Measures

Primary Outcomes (1)

• Yale Global Tic Severity Scale (YGTSS)

  The YGTSS is made up of a semi-structured interview, followed by a questionnaire where individuals are asked to rate the severity of their Tic symptoms (both motor and vocal) in domains such as: number, frequency, intensity, complexity, and interference. There is also an impairment scale, where the individual rates how the Tic impacts on their daily life and activities. The Total Tic Severity Score has a range of 0-50, and the Global Severity Score has a range of 0- 100. A higher score on all scales suggests a more severe Tic, or a greater impact the Tic has on the person's life. Only the total tic severity core will be used as the primary outcome.

  For the primary outcome: change between baseline and three months follow-up with one additional in-between measures at post-tretment. Two additional follow-up measures at 6- and 12-months.

Secondary Outcomes (7)

• Yale Global Tic Severity Scale (YGTSS) - impairment scale

  Change between baseline and three months follow-up with one additional in-between measure at post-tretment. Two additional follow-up measures at 6- and 12-months.

• Clinical Global Impression (CGI)

  Change between baseline and three months follow-up with one additional in-between measure at post-tretment. Two additional follow-up measures at 6- and 12-months.

• Global Assessment of Functioning (GAF)

  Change between baseline and three months follow-up with one additional in-between measure at post-tretment. Two additional follow-up measures at 6- and 12-months.

• Sheehan Disability Scale (SDS)

  Change between baseline and three months follow-up with one additional in-between measure at post-tretment. Two additional follow-up measures at 6- and 12-months.

• EuroQol 5-dimensions (EQ-5D)

  Change between baseline and three months follow-up with one additional in-between measure at post-tretment. Two additional follow-up measures at 6- and 12-months.

Other Outcomes (4)

• Internet Intervention Patient Adherence Scale for Guided Internet-Delivered Behavioural Interventions (iiPAS)

  Administered at mid- and post-treatment.

• Credibility/Expectancy Questionnaire (CEQ)

  In the 4th week of the treatment.

• Working Alliance Inventory Short-Revised (WAI-SR)

  In the 4th week of the treatment.

Interventions

Internet-delivered Cognitive Behavior Therapy for Chronic Tic Dosorder/Tourette Disorder BEHAVIORAL

The treatment will be provided through a secure internet platform designed for internet-administered treatments (BASS-4). In the treatment, the patient works through modules of self-help material, each ending in a short quiz with questions about the material. The treatment is supported by a therapist through text-based communication via the platform as well as occasional phone calls when needed. The central component in the treatment is exposure and response prevention (ERP). In ERP, the patient exposes her/himself to situations that trigger premonitory urges (a type of bodily sensation that precede the tic) while practicing to resist the tic. By doing this systematically and repeatedly, the patient gradually learns how to tolerate the premonitory urges and increase the ability to control and resist doing tics. Beyond ERP the treatment consists of other components such as applied relaxation, counter-movements and interventions to decrease stressors in the patient's everyday life.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant should
• be 18 years of age or older,
• fulfill diagnostic criteria for Tourette's Disorder (from now on referred to as Tourette Syndrome; TS) or Persistent (Chronic) Motor or Vocal Tic Disorder (CTD) according to the DSM-5 diagnostic criteria,
• have Total Tic Severity Score \[TTSS\] of \>15, or \>10 for individuals with motor or vocal tics only, in the past week as measured by the Yale Global Tic Severity Scale (YGTSS) (31) ,
• be able to read and communicate in Swedish and
• have regular access to a computer connected to the internet, sufficient technical skills to use the treatment platform, as well as a mobile phone to receive SMS.

You may not qualify if:

• organic brain disorders, intellectual disability, psychosis, bipolar disorder, autism spectrum disorder, anorexia nervosa, or substance use disorders,
• acute psychiatric problems such as severe depression or suicidal risk needing immediate psychiatric care,
• severe tics causing immediate risk to the patients or others and requiring urgent medical attention,
• previous CBT for tics of a minimum of 8 sessions with a qualified therapist within 12 months prior to assessment,
• simultaneous psychological treatment for TS or CTD
• initiation or adjustment of medication for tics within the last two months prior to assessment.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

OCD-clinic, Psykiatri Sydväst, Huddinge hospital

Huddinge, 14157, Sweden

Location

MeSH Terms

Conditions

Tic Disorders; Tourette Syndrome

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders; Basal Ganglia Diseases; Brain Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: April 15, 2021
• Primary Completion: June 23, 2023
• Study Completion: August 23, 2023
• Last Updated: October 28, 2022

Record last verified: 2022-10

Locations

SE (1)