Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
100

Summary

Conditions
  • Borderline Personality Disorder
  • Emotional Instability
  • Skill, Coping
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

BACKGROUND Borderline personality disorder It is estimated that 1-5% of the Scandinavian population meets the criteria for borderline personality disorder (BPD). General consensus regarding estimates for the western world population, is that around 1,5% of the population meets criteria for BPD. Life...

BACKGROUND Borderline personality disorder It is estimated that 1-5% of the Scandinavian population meets the criteria for borderline personality disorder (BPD). General consensus regarding estimates for the western world population, is that around 1,5% of the population meets criteria for BPD. Lifetime prevalence will be estimated as 3 times as high (about 5%). The percentage for clinical populations is considerably higher and is estimated to be around 28% (range 9.3 to 46.3 % of patients in different current studies) of all psychiatric patients meeting this diagnosis. BDP is characterized by an instability across a number of domains: Mood, interpersonal relationships, self-image, impulse- and behavioral control. Generally, these BDP manifestations are attributed to a lack of ability to emotionally regulate. Patients with BDP have a four times increased risk of premature death compared to the general population, emphasizing the need for appropriate treatment. Treatment of borderline personality disorder Dialectical behavior therapy (DBT) has shown good clinical efficacy and is regarded as one of the most well researched evidence-based treatments for BPD. The DBT treatment centers around the learning of a predefined set of behavioral skills, targeting lack of emotional, mental and behavioral self-control. These skills are trained in group and individual therapy. In standard clinical practice, evaluation of a patient's progress in learning skills is left to the clinician's subjective memory and evaluation of weekly data. Self-monitoring of skill use and accompanying changes in suicidality, self-harm, and emotional reactivity have traditionally been done by means of paper diaries. Technological advances in self-monitoring might reduce the burden on the patient, increase data quality and generate new opportunities for registration (8). Recent studies on pain management have suggested that mhealth solutions significantly increase compliance. Studies using electronic diaries in the treatment of bipolar disorders, in pain- and weight management, and in patients treated with chemo-therapy have also shown promising results. DBT skills have been shown to mediate improvements in BPD defining behaviors. However, no randomized studies to date have examined if a mobile phone-/mhealth solution could speed up the time it takes for patients to assimilate the DBT-skills, while at the same time serving the function of filling out diary cards for the treatment of BDP. Regarding the time series part of the study, a single pilot study of ecological momentary assessment (EMA) has demonstrated significant differences in fluctuations of positive and negative affect on a daily basis when comparing major depressive disorder to BPD. Hence, this lends promise that a purpose-designed mobile phone application aimed at collecting DBT-diary data will produce time-efficient and valid data of higher quality than traditional paper-registrations. This will also at the same time generate objective outcome data, thus collecting multimodal data. Both self report and passive sensor data. The exact same sensor data have been shown to have value in predicting manic episodes in bipolar patients. When starting an mhealth-supported session, it is possible to view the EMA data (for content, see Table 1), self-rated daily assessments, monthly questionnaires together with the therapist. The mDiary system will automatically generate chosen relevant questionnaires at a selected ratio, making the research data-collection much easier. The patient and the therapist can also get access to phone sensor data, such as activity level, phone use, internet use and minutes of communication on phone as well. The increased overview provided by diarycard-, sensor- and questionnaire data can also be useful when evaluating and discussing patient cases at staff meetings or during therapist supervision.

Tracking Information

NCT #
NCT03191565
Collaborators
  • University of Southern Denmark
  • Innovation Fund Denmark
  • Monsenso APS, Denmark
  • Mclean Hospital
  • Central Denmark Region
Investigators
Principal Investigator: Stig Helweg-Jørgensen, PsyD Region of Southern Denmark