Pervasive Computing Paradigms for Mental Health by Pietro Cipresso & Silvia Serino & Daniela Villani

Author:Pietro Cipresso & Silvia Serino & Daniela Villani
Language: eng
Format: epub
ISBN: 9783030258726
Publisher: Springer International Publishing

2 Method

2.1 Design

The study presents preliminary data from a three-armed, simple-blinded, randomized controlled clinical trial with a dismantling design. Nine participants were randomly allocated to one of the three experimental conditions: Internet-based Global protocol condition (IGc), Internet-based BA protocol condition (IBAc), Internet-based PPs protocol condition (IPPc). This study is ongoing, and we are continuing to recruit participants. The participants’ randomization was stratified according to levels of severity of depression symptomatology. Therefore, the randomization to each condition was carried out within each stratum in order to ensure that all the levels of depression were equally represented in the three intervention conditions. This study is being conducted following the CONSORT statement (Consolidated Standards of Reporting Trials, http://​www.​consort-statement.​org) [33, 34], CONSORT-EHEALTH guidelines [35] and the SPIRIT guidelines (Standard Protocol Items: Recommendations for Interventional Trials) [36, 37]. The study has been approved by the Ethics Committee of University Jaume I (Castellon, Spain, approval number: 4/2017). The trial is registered at clinicalstrials.gov as NCT03159715.

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