Dataset Information

The ONLINE-TICS Study Protocol: A Randomized Observer-Blind Clinical Trial to Demonstrate the Efficacy and Safety of Internet-Delivered Behavioral Treatment for Adults with Chronic Tic Disorders.

ABSTRACT: BACKGROUND:In recent years, behavioral therapy with comprehensive behavioral intervention for tics (CBIT) has been recognized as an effective and safe treatment in patients with Gilles de la Tourette syndrome. In Germany, however, dissemination of CBIT is restricted due to a considerable lack of well-trained therapists. The aim of this study is to overcome this deficiency by creating a new and sophisticated Internet-delivered CBIT (iCBIT) program. With this study, we want to demonstrate that iCBIT is superior to Internet-delivered psychoeducation and comparable to face-to-face CBIT. METHOD AND ANALYSIS:This is a multicenter, prospective, randomized, controlled, observer-blind clinical trial, which will be conducted at five sites in Germany (ONLINE-TICS). Over the course of 2?years, 160 adult patients with chronic tic disorders will be assigned to one of three treatment arms: iCBIT (n?=?72), online psychoeducation (n?=?72), or face-to-face CBIT (n?=?16). All treatments will consist of eighty therapy sessions over a period of 10?weeks and will follow the well-established CBIT manual by Woods and colleagues. The primary outcome measure will be the change in Yale Global Tic Severity Scale (YGTSS) at 1-week posttreatment. Secondary outcome measures include YGTSS change at 3 and 6?months, video- and self-ratings of tics as well as scales for psychiatric comorbidities assessed at each visit. The primary analysis will compare iCBIT to online psychoeducation using a mixed linear model with the YGTSS change as dependent variable. Secondary analyses will look at the comparison between iCBIT and face-to-face CBIT in a non-inferiority analysis. DISCUSSION:If iCBIT proves to be effective, it would be a considerable contribution to close the wide gap in treatment providers for tic disorders not only in Germany but also in several other countries, since this Internet-delivered therapy does not require the supervision of a therapist. In addition, iCBIT would be a cost-effective and readily available treatment alternative that guarantees high quality standard of CBIT. ETHICS AND DISSEMINATION:All institutional review boards approve the protocol. All participants will provide informed consent. There are no conflicts of interest. After study completion, the results will be published. STUDY REGISTRATION:ClinicalTrials.gov Identifier: NCT02413216.

SUBMITTER: Jakubovski E

PROVIDER: S-EPMC4928510 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The ONLINE-TICS Study Protocol: A Randomized Observer-Blind Clinical Trial to Demonstrate the Efficacy and Safety of Internet-Delivered Behavioral Treatment for Adults with Chronic Tic Disorders.

Jakubovski Ewgeni E Reichert Cornelia C Karch Annika A Buddensiek Nadine N Breuer Daniel D Müller-Vahl Kirsten K

Frontiers in psychiatry 20160630

<h4>Background</h4>In recent years, behavioral therapy with comprehensive behavioral intervention for tics (CBIT) has been recognized as an effective and safe treatment in patients with Gilles de la Tourette syndrome. In Germany, however, dissemination of CBIT is restricted due to a considerable lack of well-trained therapists. The aim of this study is to overcome this deficiency by creating a new and sophisticated Internet-delivered CBIT (iCBIT) program. With this study, we want to demonstrate ...[more]

PMID: 27445874

Similar Datasets

Project description:Background: Gilles de la Tourette syndrome (TS) is a chronic neuropsychiatric disorder characterized by motor and vocal tics. First-line treatments for tics are antipsychotics and tic-specific behavioral therapies. However, due to a lack of trained therapists and adverse events of antipsychotic medication many patients seek alternative treatment options including cannabis. Based on the favorable results obtained from case studies on different cannabis-based medicines as well as two small randomized controlled trials using delta-9-tetrahydrocannabinol (THC), we hypothesize that the cannabis extract nabiximols can be regarded as a promising new and safe treatment strategy in TS. Objective: To test in a double blind randomized clinical trial, whether treatment with the cannabis extract nabiximols is superior to placebo in patients with chronic tic disorders. Patients and Methods: This is a multicenter, randomized, double-blind, placebo controlled, parallel-group, phase IIIb trial, which aims to enroll 96 adult patients with chronic tic disorders (TS or chronic motor tic disorder) across 6 centers throughout Germany. Patients will be randomized with a 2:1 ratio into a nabiximols and a placebo arm. The primary efficacy endpoint is defined as tic reduction of at least 30% (compared to baseline) according to the Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS) after 13 weeks of treatment. In addition, several secondary endpoints will be assessed including changes in different psychiatric comorbidities, quality of life, driving ability, and safety assessments. Discussion: This will be the first large, controlled study investigating efficacy and safety of a cannabis-based medicine in patients with TS. Based on available data using different cannabis-based medicines, we expect not only a reduction of tics, but also an improvement of psychiatric comorbidities. If the cannabis extract nabiximols is proven to be safe and effective, it will be a valuable alternative treatment option. The results of this study will be of high health-economic relevance, because a substantial number of patients uses cannabis (illegally) as self-medication. Conclusion: The CANNA-TICS trial will clarify whether nabiximols is efficacious and safe in the treatment of patients with chronic tic disorders. Clinical Trial Registration: This trial is registered at clinicaltrialsregister.eu (Eudra-CT 2016-000564-42) and clinicaltrials.gov (NCT03087201).

Project description:BACKGROUND:Pain-related functional gastrointestinal disorders (P-FGIDs; eg, irritable bowel syndrome) are highly prevalent in children and associated with low quality of life, anxiety, and school absence. Treatment options are scarce, and there is a need for effective and accessible treatments. Internet-delivered cognitive behavior therapy (Internet-CBT) based on exposure exercises is effective for adult and adolescent irritable bowel syndrome, but it has not been evaluated for younger children. OBJECTIVE:The objective of this study was to assess acceptability, feasibility, and potential clinical efficacy of Internet-CBT for children with P-FGIDs. METHODS:This was a feasibility study with a within-group design. We included 31 children aged 8-12 years and diagnosed with P-FGID, according to the ROME III criteria. Mean duration of abdominal symptoms at baseline was 3.8 years (standard deviation [SD] 2.6). The treatment was therapist-guided and consisted of 10 weekly modules of exposure-based Internet-CBT. The children were instructed to provoke abdominal symptoms in a graded manner and to engage in previously avoided activities. The parents were taught to decrease their attention to their children's pain behaviors and to reinforce and support their work with the exposures. Assessments included treatment satisfaction, subjective treatment effect, gastrointestinal symptoms, quality of life, pain intensity, anxiety, depression, and school absence. Data were collected at pretreatment, posttreatment, and 6-month follow-up. Means, standard errors (SEs), and Cohen d effect sizes were estimated based on multi-level linear mixed models. RESULTS:Most children 25/31 (81%) completed 9 or 10 of the 10 treatment modules. Almost all children, 28/31 (90%), reported that the treatment had helped them to deal more effectively with their symptoms, and 27/31 (87%) children declared that their symptoms had improved during the treatment. Assessments from the parents were in accordance with the children's reports. No child or parent reported that the symptoms had worsened. We observed a large within-group effect size on the primary outcome measure, child-rated gastrointestinal symptoms from pretreatment to posttreatment (Cohen d=1.14, P<.001, 95% CI 0.69-1.61), and this effect size was maintained at 6-month follow-up (Cohen d=1.40, P<.001, 95% CI 1.04-1.81). We also observed significant improvements from pretreatment to posttreatment on a wide range of child- and parent-rated measures including quality of life, pain intensity, anxiety, depression, and school absence. All results remained stable or were further improved at 6-month follow-up. CONCLUSIONS:This study shows that children with longstanding P-FGIDs, and their parents, perceive exposure-based Internet-CBT as a helpful and feasible treatment. The included children improved significantly despite a long duration of abdominal symptoms before the intervention. The treatment shows potential to be highly effective for P-FGIDs. The results need to be confirmed in a randomized controlled trial (RCT).

Project description:BackgroundAmple studies have shown the effectiveness of internet-delivered cognitive behavioral therapy (iCBT) for anxiety disorders. These studies recruited their participants mainly from the community and, to a lesser extent, from within routine care services. Little is known about whether different recruitment strategies lead to different treatment effects.ObjectiveThis meta-analysis compared clinical results obtained in trials with recruitment from the community versus results obtained in trials with clinical service recruitment and explored factors that may mediate differences in treatment outcome.MethodsWe included randomized controlled trials in which the clinical effects of iCBT for anxiety disorders were compared with a control condition (waitlist controls or face-to-face cognitive behavioral therapy). We classified trials as open recruitment trials (recruitment from the community) or clinical service recruitment trials (recruitment through outpatient clinics). Pooled effect sizes based on measures examining anxiety symptoms, depressive symptoms, and quality of life were computed for each type of trial. Subgroup analyses examined whether clinical results from open recruitment trials differed from those obtained in clinical service recruitment trials. Additional analyses explored which demographic, clinical, and treatment-related factors contributed to differences in effect sizes of open recruitment versus clinical service recruitment trials.ResultsWe included 42 studies with 53 comparisons (43 open recruitment comparisons and 10 clinical recruitment comparisons). Analyses of anxiety measures revealed, first, that iCBT open recruitment studies with waitlist control comparators showed a significantly higher effect size for decrease in anxiety symptoms than did those with clinical recruitment (Q=10.09; P=.001). This association between recruitment method and effect size was no longer significant in a multivariate metaregression with treatment adherence and exclusion of patients with depressive symptoms entered as additional predictors of effect size. Second, effect size for decrease in anxiety symptoms did not differ significantly between clinical recruitment and open recruitment studies with face-to-face cognitive behavioral therapy comparators. The effects of open recruitment trials and clinical recruitment trials did not differ significantly for the secondary outcomes, compared with face-to-face cognitive behavioral therapy and waitlist controls.ConclusionsiCBT was effective in samples recruited in clinical practice, but effect sizes were smaller than those found in trials with an open recruitment method for studies with waitlist control comparators. Hence, for patients with anxiety disorders in routine care, the impact of iCBT may not be as positive as for study participants recruited from the community. The difference between open recruitment trials and clinical service recruitment trials might be partly explained by patients' greater therapy adherence in open recruitment trials and the stricter exclusion of patients with severe depressive symptoms in these studies. Since most trials in this meta-analysis applied an open recruitment method, more studies with routine care populations are needed to further validate these findings.

Dataset Information

The ONLINE-TICS Study Protocol: A Randomized Observer-Blind Clinical Trial to Demonstrate the Efficacy and Safety of Internet-Delivered Behavioral Treatment for Adults with Chronic Tic Disorders.

Publications

The ONLINE-TICS Study Protocol: A Randomized Observer-Blind Clinical Trial to Demonstrate the Efficacy and Safety of Internet-Delivered Behavioral Treatment for Adults with Chronic Tic Disorders.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets