Table 2.
Assessment schedule.
| Study period | Screening | Baseline | Treatment: (a) iCBIT, (b) placebo, (c) Face-to-face CBIT | Follow-up visits/booster-treatmenta | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit | 1 | 1 | 2 | 3 | 4 | 5 | |||||||||
| Week | −4 −0 | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 8 | 10 | 11 | 17 | 23 | 29 | 35 |
| Treatment-session | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | Frequency individual, for face-to-face CBIT: max = 2 | ||||||
| General procedures | |||||||||||||||
| Written informed consent | X | ||||||||||||||
| Inclusion/exclusion criteria | X | ||||||||||||||
| Demographics | X | ||||||||||||||
| Medical and medication history | X | ||||||||||||||
| Intervention | |||||||||||||||
| Randomization | X | ||||||||||||||
| Complianceb | |||||||||||||||
| – Asking for compliance | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
| – Phone visits | X | X | |||||||||||||
| – Online check-ups | X | X | X | X | X | X | X | X | |||||||
| Psychometric assessment | |||||||||||||||
| Tics: | |||||||||||||||
| – YGTSS | X | X | X | X | X | X | |||||||||
| – ATQ | X | X | X | X | X | ||||||||||
| – MRVS | X | X | X | X | X | ||||||||||
| Severity of disease: CGI-S | X | X | X | X | X | X | |||||||||
| Improvement of disease: CGI-I | X | X | X | X | |||||||||||
| Premonitory urges: PUTS | X | X | X | X | X | ||||||||||
| Quality of life: GTS-QoL | X | X | X | X | X | ||||||||||
| Mood: BDI-II | X | X | X | X | X | ||||||||||
| Anxiety: BAI | X | X | X | X | X | ||||||||||
| ADHD: | |||||||||||||||
| – DSM-IV symptom list | X | ||||||||||||||
| – CAARS | X | X | X | X | X | ||||||||||
| OCD: Y-BOCS | X | X | X | X | X | ||||||||||
| Adverse events | |||||||||||||||
| Open question | X | X | X | X | |||||||||||
| Therapeutic alliance | |||||||||||||||
| WAI-SR | X | X | X | X | |||||||||||
YGTSS, Yale Global Tic Severity Scale; MRVS, Modified Rush Video-Based Tic Rating Scale; ATQ, Adult Tic Questionnaire; CGI-S, Clinical Global Impression–Severity Score; CGI-I, Clinical Global Impression-Improvement Score; PUTS, Premonitory Urge of Tics Scale; GTS-QoL, Gilles de la Tourette Syndrome-Quality of Life Scale; BDI-II, Beck Depression Inventory; ADHD, Attention Deficit Hyperactivity Disorder; CAARS, Conner’s Adult ADHD Rating Scale; OCD, Obsessive-Compulsive Disorder; Y-BOCS, Yale-Brown Obsessive-Compulsive Scale; BAI, Beck Anxiety Inventory, WAI-SR, Working Alliance Inventory-Short Revised.
aBooster-sessions: booster-session are optional. Frequency, scope, and number will vary individually in the iCBIT and placebo groups, in the face-to -face CBIT group up to two booster sessions a 60-min between week 11 and 35 are possible.
bCompliance: the compliance of patients in all treatment arms will be assessed during the telephone and in person visits. In the face-to-face CBIT treatment, arm compliance will also be determined via regular and full participation in the therapy sessions. In the iCBIT and placebo groups, the participation in the therapy session will be determined automatically by the online platform by collecting information on when, how long and where the patients were logged in.