Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 10, 2020
Open Peer Review Period: Jan 9, 2020 - Feb 12, 2020
Date Accepted: Mar 11, 2020
(closed for review but you can still tweet)
Daily electronic self-monitoring of subjective symptoms and skill- learning in borderline personality disorder – the mDIARY trial protocol: a pragmatic randomized controlled trial
ABSTRACT
Background:
Patient self-monitoring by mobile phones during psychotherapy can enhance overview of the psychotherapeutic progress by graphically displaying current and previous scores, providing feedback to the patient, delivering psychoeducative material, and providing timely data to the therapist or treatment team.
Objective:
The objective is to assess the effect of registering on a smartphone instead of using pen and paper during psychotherapy. There treatment performed is dialectical behaviour therapy.The psychiatric diagnosis treated is borderline personality disorder (BPD).The primary outcome is mean time needed to assimilate coping skills directed at emotion regualation. Secondary outcome is change in BPD symptom score as measured by Zanarini rating scale for BPD
Methods:
The study is a pragmatic randomised controlled multicenter trial.Recruiting through 5 Danish public general psychiatric outpatient treatment facilities.PAtients are randomly assigned, on 1:1 basis to til either mobile phone registration condition or pen and paper condition.Patients will conclude several self report questionnaires on symptom severity as well as assessment by trained raters on BPD severity. Survival analysis with shared frailty will be used to assess primary outcomes.
Results:
Recruitment for the study began june 2017. Inclusion into the study ended february 2019. The study is ongoing and scheduled to complete february 2020. 79 particiåants have been recruited from 5 different sites in Denmark. The alternative hypothesis of the study is that there will be an added affect of mobile phone registration during treatment.
Conclusions:
The RCT will contribute to the literature on effects of mobilephone self monitoring during psychiatric treatment. Clinical Trial: The Danish Ethics Committee in the Region of Southern Denmark [S-20160085]. The Danish Data protection Agency under the common Danish mental health databases of quality [2008-58-0035].
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