Daily Self-Monitoring of Symptoms and Skills Learning in Patients With Borderline Personality Disorder Through a Mobile Phone App: Protocol for a Pragmatic Randomized Controlled Trial.

backgroundPatient self-monitoring via mobile phones during psychotherapy can enhance and provide an overview of psychotherapeutic progress by graphically displaying current and previous symptom scores, providing feedback to the patient, delivering psychoeducative material, and providing timely data to the therapist or treatment team.

objectiveThis study will aim to assess the effects of using a mobile phone to self-monitor symptoms and acquire coping skills instead of using pen and paper during psychotherapy in patients with borderline personality disorder (BPD). Dialectical behavior therapy will be performed to treat BPD. The primary outcome is the mean time needed to learn coping skills directed at emotion regulation; the secondary outcome is changes in the BPD symptom score as measured by the Zanarini Rating Scale for Borderline Personality Disorder.

methodsThis study is a pragmatic, multicenter randomized controlled trial. Participants were recruited through five public general psychiatric outpatient treatment facilities in Denmark. Patients are randomly assigned, on a 1:1 basis, to either the mobile phone condition (using the Monsenso mDiary mobile app) or pen-and-paper condition. Patients will complete several self-report questionnaires on symptom severity; assessments by trained raters on BPD severity will be performed as well. Survival analysis with a shared frailty model will be used to assess the primary outcome.

resultsRecruitment began in June 2017 and was completed in February 2019 after 80 participants were recruited. The study ended in February 2020. It is expected that the benefits of mobile phone-based self-report compared to the pen-and-paper method will be demonstrated for skill learning speed and registration compliance. To our knowledge, this is the first trial exploring the impact of cloud-based mobile registration in BPD treatment.

conclusionsThis trial will report on the effectiveness of mobile phone-based self-monitoring during psychiatric treatment. It has the potential to contribute to evidence-based clinical practice since apps are already in use clinically.

trial registrationClinicalTrials.gov NCT03191565; https://clinicaltrials.gov/ct2/show/NCT03191565. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17737.