Study design
anxiety
DEL, DER
SCD-Well was a multi-center, randomized, controlled, superiority trial with two intervention arms: an 8-week CMBAS and a structurally matched HSMP. Randomisation to one of the two groups was performed at a ratio of 1:1. Participants were assessed at three visits: pre-intervention at baseline (V1), post-intervention (V2), and at follow-up 6 months after randomisation (V3). The primary outcome of the SCD-Well trial was mean change in anxiety symptoms from V1 to V2 [The intervention was delivered at four European sites (Barcelona, Cologne, London, and Lyon). Written informed consent was obtained from all participants after the procedures had been explained to them and prior to participation. The multi-centre SCD-Well trial received ethics approval from the committees and regulatory agencies of all centres: London, UK (Queen Square Research Ethics Committee: n° 17/LO/0056 and Health Research Authority National Health Service, IRAS project ID: 213008); Lyon, France (Comité de Protection des Personnes Sud-Est II Groupement Hospitalier Est: n° 2016-30-1 and Agence Nationale de Sécurité du Médicament et des Produits de Santé: IDRCB 2016-A01298-43); Cologne, Germany (Ethikkommission der Medizinischen Fakultät der Universität zu Köln: n° 17–059); and Barcelona, Spain (Comité Etico de Investigacion Clinica del Hospital Clinic de Barcelona: n° HCB/2017/0062). The SCD-Well trial was performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.