Recruitment barriers in a double-blinded RCT study. Music therapy for negative symptoms in schizophrenia

Background: The research program aims at verifying if music therapy can reduce negative symptoms for patients suffering from schizophrenia. It is a close cooperation between Aalborg University Hospital, Psychiatry and Aalborg University, DK. A `close to` biomedical design is applied to approve recommendation of music therapy as part of standard treatment for this population.
Method: The study is a national study with a randomized, controlled, double-blinded design aiming at including 120 participants due to power calculations. A thorough screening procedure done by the same person/s for all participants determines, if the referred patients meet the inclusion criteria. Participants, knowing about two conditions of music therapy activities, will be randomized to either an experimental condition 1) 25 weekly sessions of music therapy with an educated music therapist - or a control condition 2) 25 weekly sessions of being together with a care person listening to music playing lists developed by music therapists. Both conditions are called music therapy activities. Participants, screening person/s and statstic research members are blinded.
Challenges: The recruitment processes started March 2016 and should originally terminate at July 2018. 28 participants are included October 2017, not 70-80 as expected. This is due to massive recruitement barriers which count organizational problems, problems in finding suited participants, problems concerning professionals protecting the patients, logistical problems and problems concerning installing a new IT-system in the Health Care System during the period of recruiting participants. In the lecture these barriers and our Applied solutions will be presented in detail.