Tourette SyndromePhase 2NCT02247206
VoIP Delivered Behavior Therapy for Tourette Syndrome
A Phase 2 study testing Behavior Therapy for Tics (CBIT) in people with Tourette Syndrome and Chronic Tic Disorder, run by University of Wisconsin, Milwaukee at 1 site in United States.
Trial summary
The purpose of this research is to examine the preliminary efficacy, feasibility, and acceptability of Voice over Internet Protocol delivered behavior therapy for Tourette Syndrome through in a randomized waitlist-controlled trial. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Tourette Syndrome, Chronic Tic Disorder
- What is being tested?
- Behavior Therapy for Tics (CBIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Nov 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Resides in the state of Wisconsin
- Ages 8-17
- Meets DSM-IV-TR diagnostic criteria for Chronic Tic Disorder (CMVT or TS)
- Clinical global Impressions - Severity Score greater than or equal to 4 (moderately ill)
- YGTSS Total Score greater than or equal to 14 and less than 30 OR Total Score greater than or equal to 10 and less than 20 if CTD with motor tics only
- Unmedicated or on stable medication treatment for tics, OCD, ADHD, anxiety, and/or depressive disorder for at least 6 weeks, with no planned changes for duration of study participation
- Fluent English speaker
Who cannot join
- YGTSS Total Tic Score > 30 (for any score exceeding 30 on the YGTSS, the research team determined the appropriateness of the patient's participation in the study, taking into account the patient's global functioning)
- WASI-Vocab subtest T-Score < 37
- DSM-IV substance abuse or dependence or Conduct Disorder within the past 3 months
- Lifetime DSM-IV diagnosis of Pervasive developmental disorder, Mania, or Psychotic Disorder
- Any serious psychiatric, psychosocial, or neurological condition requiring immediate treatment other than that provided in the current
- Previous treatment with HRT for tics (four or more sessions)
- Lack of a functional, and accessible home computer, and high speed (i.e., cable/DSL) internet connection
- Refusal to sign a release of information form for the child's local primary care physician, mental health professional, or neurologist.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Milwaukee Psychology Department
Milwaukee, Wisconsin, 53211
About this study
Official title: Voice Over Internet Protocol Delivered Behavior Therapy for Tourette Syndrome
The purpose of this research is to examine the preliminary efficacy, feasibility, and acceptability of Voice over Internet Protocol delivered behavior therapy for Tourette Syndrome through in a randomized waitlist-controlled trial.
Read the detailed description
A Comprehensive Behavioral Intervention for Tics (CBIT) is an emerging treatment for children with Tourette Syndrome (TS) and has been shown to be efficacious in separate randomized trials with children and adults; however, many families of children with TS are prevented from accessing it due to limited availability of adequately trained treatment providers. Recent research has shown that videoconference-delivered CBIT is as effective as face to face delivery, and that both modalities are efficacious. Despite its effectiveness, traditional videoconferencing has limitations including lack of portability, ease of access, the need for third party clinics, and cost. A newer, more convenient alternative to increase access is the use of Voice over Internet Protocol (VoIP) transmission, allowing for the direct delivery of CBIT to patients' homes.
Therefore the objective of this study (the final phase of a three-phase project) is to establish the preliminary efficacy of VoIP-modified CBIT for reducing tics in children with TS relative to a waitlist-control. Twenty children (ages 9-17) with TS or Chronic Tic Disorder as a primary diagnosis will be recruited for a randomized, observer-blind, waitlist controlled trial of VoIP-delivered CBIT. Participants will be randomly assigned to 8 weekly sessions of CBIT-VoIP over a 10-week acute treatment period, or waitlist control condition. As an exploratory aim, the current study will investigate potential correlates of treatment outcome, including home computer equipment available (i.e., web camera type, microphone type, internet upload speed, and type of internet connection), prior computer experience, and comfort with study computer equipment.
- Conditions
- Tourette Syndrome, Chronic Tic Disorder
- Being tested
- Behavior Therapy for Tics (CBIT)
- Keywords
- Tourette Syndrome, tic disorders, behavior therapy, web-based videoconferencing, VoIP
- Medical subject headings
- Tourette Syndrome, Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior Therapy for Tics (CBIT)Behavioural
Also called Comprehensive Behavioral Intervention for Tics (CBIT), Habit Reversal Training (HRT)
CBIT is an 8-session 10-week behavioral treatment for chronic tic disorders, including Tourette Syndrome. The first two sessions are 90 minutes, with subsequent sessions lasting 60 minutes. The treatment consists of Habit Reversal Training (awareness training, competing response training, and social support), and function-based assessment to reduce the impact of environmental or other stimuli on tic severity. The treatment also consists of relaxation techniques to reduce tic-related stress and tension, and behavioral rewards to motivate treatment compliance.
| Study group | Role | What they receive |
|---|---|---|
| Behavior Therapy for Tics (CBIT) | Experimental | The child 1) learns to become more aware of any sensations, or urges that may trigger tics, and 2) learn some other behavior (competing response) to do every time he/she feels the urge to tic. The child's parent is trained to provide prompts and praise for use of the competing response. The parent and family also receive psychoeducation about tics, and learn ways to reduce the impact of environmental stimuli on tic severity. The child learns relaxation techniques to reduce stress and make it easier for him/her to resist his or her tics. Prior to treatment sessions, the parent and child spend about 10 minutes discussing with the therapist any problematic issues he/she is having. At the end of treatment sessions the child is assigned some tasks to practice prior to the next session. Receives: Behavioral: Behavior Therapy for Tics (CBIT) |
| Waitlist-control Group | No intervention | Participants in the waitlist-control group, do not receive behavior therapy for tics or any other treatment during the 10-week acute treatment period. Instead they child are placed on a waitlist to receive videoconference-delivered treatment following the end of the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Yale Global Tic Severity Scale (YGTSS) total tic severity scores at 10 weeks
The YGTSS is a clinician-rated tic severity measure, featuring a total severity score, with a rating from 0 to 50, and independent subtotals for motor and vocal tics each with ratings from 0 to 25. It also features a tic-related 0-50 point impairment scale.
Measured: Baseline, 10-week (post-treatment)
Secondary outcomes (2)
Change from baseline on the Clinical Global Impressions-Severity scale at 10 weeks
The CGI-S is a clinician-rated measure of patient global impairment.
Measured: Baseline, 10-week (post-treatment)
Treatment response rate using the Clinical Global Impressions-Improvement scale at 10 weeks
The CGI-I is a rating of patient improvement compared to baseline. Scores of Much (2) or Very Much (1) Improved indicate positive treatment response in this study.
Measured: 10-week (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startDec 2012
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Utah
- Responsible party
- Principal investigator, Emily Ricketts, University of Wisconsin, Milwaukee
- Investigators
- Emily J Ricketts, PhD, Principal investigator, University of Wisconsin, MilwaukeeDouglas W Woods, PhD, Study director, Texas A&M UniversityMichael B Himle, PhD, Study chair, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247206
- Sponsor's protocol ID
- MIL105611
- Other IDs
- F31MH096375-01, 5F31MH096375-02
- Status last verified
- Sep 2014
- First submitted
- 15 Sep 2014
- Last updated
- 23 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice Over Internet Protocol Delivered Behavior Therapy for Tourette Syndrome
- ClinicalTrials.gov ID
- NCT02247206
- Acronym / sponsor ID
- MIL105611
- Conditions
- Tourette Syndrome, Chronic Tic Disorder
- Keywords
- Tourette Syndrome, tic disorders, behavior therapy, web-based videoconferencing, VoIP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Utah
- Study start
- Dec 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to examine the preliminary efficacy, feasibility, and acceptability of Voice over Internet Protocol delivered behavior therapy for Tourette Syndrome through in a randomized waitlist-controlled trial.
Detailed description
A Comprehensive Behavioral Intervention for Tics (CBIT) is an emerging treatment for children with Tourette Syndrome (TS) and has been shown to be efficacious in separate randomized trials with children and adults; however, many families of children with TS are prevented from accessing it due to limited availability of adequately trained treatment providers. Recent research has shown that videoconference-delivered CBIT is as effective as face to face delivery, and that both modalities are efficacious. Despite its effectiveness, traditional videoconferencing has limitations including lack of portability, ease of access, the need for third party clinics, and cost. A newer, more convenient alternative to increase access is the use of Voice over Internet Protocol (VoIP) transmission, allowing for the direct delivery of CBIT to patients' homes.
Therefore the objective of this study (the final phase of a three-phase project) is to establish the preliminary efficacy of VoIP-modified CBIT for reducing tics in children with TS relative to a waitlist-control. Twenty children (ages 9-17) with TS or Chronic Tic Disorder as a primary diagnosis will be recruited for a randomized, observer-blind, waitlist controlled trial of VoIP-delivered CBIT. Participants will be randomly assigned to 8 weekly sessions of CBIT-VoIP over a 10-week acute treatment period, or waitlist control condition. As an exploratory aim, the current study will investigate potential correlates of treatment outcome, including home computer equipment available (i.e., web camera type, microphone type, internet upload speed, and type of internet connection), prior computer experience, and comfort with study computer equipment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavior Therapy for Tics (CBIT) | Experimental | Behavioral: Behavior Therapy for Tics (CBIT)The child 1) learns to become more aware of any sensations, or urges that may trigger tics, and 2) learn some other behavior (competing response) to do every time he/she feels the urge to tic. The child's parent is trained to provide prompts and praise for use of the competing response. The parent and family also receive psychoeducation about tics, and learn ways to reduce the impact of environmental stimuli on tic severity. The child learns relaxation techniques to reduce stress and make it easier for him/her to resist his or her tics. Prior to treatment sessions, the parent and child spend about 10 minutes discussing with the therapist any problematic issues he/she is having. At the end of treatment sessions the child is assigned some tasks to practice prior to the next session. |
| Waitlist-control Group | No intervention | –Participants in the waitlist-control group, do not receive behavior therapy for tics or any other treatment during the 10-week acute treatment period. Instead they child are placed on a waitlist to receive videoconference-delivered treatment following the end of the study period. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Resides in the state of Wisconsin
- Ages 8-17
- Meets DSM-IV-TR diagnostic criteria for Chronic Tic Disorder (CMVT or TS)
- Clinical global Impressions - Severity Score greater than or equal to 4 (moderately ill)
- YGTSS Total Score greater than or equal to 14 and less than 30 OR Total Score greater than or equal to 10 and less than 20 if CTD with motor tics only
Key exclusion criteria (8 listed)
- YGTSS Total Tic Score > 30 (for any score exceeding 30 on the YGTSS, the research team determined the appropriateness of the patient's participation in the study, taking into account the patient's global functioning)
- WASI-Vocab subtest T-Score < 37
- DSM-IV substance abuse or dependence or Conduct Disorder within the past 3 months
- Lifetime DSM-IV diagnosis of Pervasive developmental disorder, Mania, or Psychotic Disorder
- Any serious psychiatric, psychosocial, or neurological condition requiring immediate treatment other than that provided in the current
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavior Therapy for Tics (CBIT)Also: Comprehensive Behavioral Intervention for Tics (CBIT), Habit Reversal Training (HRT)CBIT is an 8-session 10-week behavioral treatment for chronic tic disorders, including Tourette Syndrome. The first two sessions are 90 minutes, with subsequent sessions lasting 60 minutes. The treatment consists of Habit Reversal Training (awareness training, competing response training, and social support), and function-based assessment to reduce the impact of environmental or other stimuli on tic severity. The treatment also consists of relaxation techniques to reduce tic-related stress and tension, and behavioral rewards to motivate treatment compliance. | Behavioural | Behavior Therapy for Tics (CBIT) |
Primary outcome
Change from baseline in Yale Global Tic Severity Scale (YGTSS) total tic severity scores at 10 weeks
Time frame: Baseline, 10-week (post-treatment)
The YGTSS is a clinician-rated tic severity measure, featuring a total severity score, with a rating from 0 to 50, and independent subtotals for motor and vocal tics each with ratings from 0 to 25. It also features a tic-related 0-50 point impairment scale.
2 secondary outcomes
Change from baseline on the Clinical Global Impressions-Severity scale at 10 weeks
Time frame: Baseline, 10-week (post-treatment)
Treatment response rate using the Clinical Global Impressions-Improvement scale at 10 weeks
Time frame: 10-week (post-treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily J Ricketts, PhD principal investigator
University of Wisconsin, Milwaukee
Douglas W Woods, PhD study director
Texas A&M University
Michael B Himle, PhD study chair
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Behavior Therapy for Tics (CBIT) in people with Tourette Syndrome and Chronic Tic Disorder, run by University of Wisconsin, Milwaukee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Yale Global Tic Severity Scale (YGTSS) total tic severity scores at 10 weeks (time frame: Baseline, 10-week (post-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2014.