Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Gävlegatan 22, 113 30, Stockholm, Sweden.
Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.
Trials. 2021 Sep 30;22(1):669. doi: 10.1186/s13063-021-05592-z.
Treatment guidelines recommend behaviour therapy (BT) for patients with Tourette syndrome (TS) and chronic tic disorder (CTD). However, BT is rarely accessible due to limited availability of trained therapists and long travel distances to specialist clinics. Internet-delivered BT has the potential of overcoming these barriers through remote delivery of treatment with minimal therapist support. In the current protocol, we outline the design and methods of a randomised controlled trial (RCT) evaluating an internet-delivered BT programme referred to as BIP TIC. The trial's primary objective is to determine the clinical efficacy of BIP TIC for reducing tic severity in young people with TS/CTD, compared with an active control intervention. Secondary objectives are to investigate the 12-month durability of the treatment effects and to perform a health economic evaluation of the intervention.
In this single-blind superiority RCT, 220 participants (9-17 years) with TS/CTD throughout Sweden will be randomised to 10-12 weeks of either therapist-supported internet-delivered BT based on exposure with response prevention (BIP TIC) or therapist-supported internet-delivered education. Data will be collected at baseline, 3 and 5 weeks into the treatment, at post-treatment, and 3, 6, and 12 months post-treatment. The primary endpoint is the 3-month follow-up. The primary outcome is tic severity as measured by the Yale Global Tic Severity Scale - Total Tic Severity Score. Treatment response is operationalised as scores of "Very much improved" or "Much improved" on the Clinical Global Impression - Improvement scale, administered at the primary endpoint. Outcome assessors will be blind to treatment condition at all assessment points. A health economic evaluation of BIP TIC will be performed, both in the short term (primary endpoint) and the long term (12-month follow-up). There are no planned interim analyses.
Participant recruitment started on 26 April 2019 and finished on 9 April 2021. The total number of included participants was 221. The final participant is expected to reach the primary endpoint in September 2021 and the 12-month follow-up in June 2022. Data analysis for the primary objective will commence after the last participant reaches the primary endpoint.
ClinicalTrials.gov NCT03916055 . Registered on 16 April 2019.
治疗指南建议对抽动秽语综合征（TS）和慢性抽动障碍（CTD）患者采用行为疗法（BT）。然而，由于训练有素的治疗师数量有限，以及前往专科诊所的长途旅行，BT 很少能够获得。通过远程提供治疗，互联网提供的 BT 有可能克服这些障碍，同时最大限度地减少治疗师的支持。在当前的方案中，我们概述了一项随机对照试验（RCT）的设计和方法，该试验评估了一种称为 BIP TIC 的互联网提供的 BT 方案。该试验的主要目的是确定 BIP TIC 在降低 TS/CTD 青少年的抽动严重程度方面与积极对照干预相比的临床疗效。次要目标是调查治疗效果的 12 个月持久性，并对干预措施进行健康经济评估。
在这项单盲优效 RCT 中，瑞典各地的 220 名 TS/CTD 患者（9-17 岁）将被随机分配到 10-12 周的治疗中，一组接受基于暴露和反应预防的治疗师支持的互联网提供的 BT（BIP TIC），另一组接受治疗师支持的互联网提供的教育。数据将在基线、治疗的第 3 周和第 5 周、治疗后、治疗后 3 个月、6 个月和 12 个月进行收集。主要终点是 3 个月随访。主要结局是耶鲁总体抽动严重程度量表-总抽动严重程度评分测量的抽动严重程度。治疗反应的操作性定义是在主要终点时使用临床总体印象-改善量表评定为“非常改善”或“明显改善”。在所有评估点，结局评估者都将对治疗条件保持盲态。将在短期（主要终点）和长期（12 个月随访）对 BIP TIC 进行健康经济评估。没有计划进行中期分析。
参与者招募于 2019 年 4 月 26 日开始，2021 年 4 月 9 日结束。总共纳入了 221 名参与者。预计最后一名参与者将在 2021 年 9 月达到主要终点，并在 2022 年 6 月达到 12 个月的随访。主要目标的数据分析将在最后一名参与者达到主要终点后开始。
ClinicalTrials.gov NCT03916055。注册于 2019 年 4 月 16 日。
