Sacristan-Martin, Olga
Santed, Miguel A.
Garcia-Campayo, Javier
Duncan, Larissa G.
Bardacke, Nancy
Fernandez-Alonso, Carmen
Garcia-Sacristan, Gloria
Garcia-Sacristan, Diana
Barcelo-Soler, Alberto
Montero-Marin, Jesus
Funding for this research was provided by:
Instituto de Investigación Sanitaria Aragón (G-99426132)
Article History
Received: 1 April 2019
Accepted: 21 September 2019
First Online: 28 November 2019
Ethics approval and consent to participate
: Written informed consent will be obtained from participants before their baseline assessment and group assignment. Before they give consent, participants will be provided with general information about the objectives and characteristics of the study. They will also be informed that participation in the study is voluntary, that they can choose to withdraw at any time, and are guaranteed to continue to receive the care considered most appropriate by their PC midwife and obstetrician regardless of study participation. The study follows Helsinki Convention norms and posterior modifications, and the Declaration of Madrid of the World Psychiatric Association. For ethical reasons, patients allocated to the TAU arm will be offered the option to attend mindfulness and compassion training after the trial is finished. Participants’ data will be encrypted and stored according to the 2018 New European Data Protection Law. Ethical approval was obtained from the ethics committee of the hospital that coordinates the 11 PC centers belonging to that hospital clinical area (the Research Commission from the University Hospital “Rio Hortega,” reference approval number: 50/2014/04). In the Spanish National Health System, when approval is received from the hospital ethical committee, a trial can be conducted in all PC centers belonging to that hospital clinical area.
: Not applicable.
: NB is the developer of MBCP and leads the not-for-profit Mindful Birthing and Parenting Foundation (MBPF) that offers professional training in MBCP. She is the author of a related book and app/guided audio meditation materials for which she receives royalties. LGD is an unpaid member of the MBPF board of directors and is conducting other Institutional Review Board approved research on MBCP funded by the Mind & Life Institute. The other authors declare they have no competing interests.