Short summary

The study aims to evaluate if using an app to selfmonitor emotion, skill learning and stability improves the ability to learn skills in the psychiatric treatment of Borderline personality disorder(BPD). Patients with BPD are investigated at 5 sites in DK

Rationale

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 (5,6,7) . 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. Recent studies on pain management have suggested that mhealth solutions significantly increase compliance (9,10). 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 (8). 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.

STUDY OBJECTIVES

Monitoring of patients with BPD on mhealth diary devices needs to be explored and evaluated before they can be implemented in clinical practice. Hence, the specific objectives of the mDiary study are:

Primary objective

1. To examine whether patients randomized to using the Monsenso-app are quicker in assimilating DBT skills as compared to patients who are using the pen and paper version for self monitoring. The comparison will be difference in number of days until the relevant skills are learned - i.e. whether electronic diary cards take less days learn the skills

Patients using the app are hypothesized to quicker as compared to patients using the pen and paper version, due to better overview and easily assesible coaching videos on the phone.

Secondary objectives

2. To investigate whether patients using the app report a greater reduction in BPD-symptoms (e.g. less high-risk behavior, less self-harm), thus having a greater ability to regulate their emotions as compared to patients using the pen and paper version. This will be evaluted with the "Difficulty in emotion regulation scale" and "Borderline symptom list"  questionnaires (see table 2)

Patients using the app are hypothesized to experience greater reductions in symptoms and to be better at emotion regulation as compared to patients using the pen and paper version.

3. To investigate the summed weekly scores of positive emotions measured with an mhealth version of the PANAS questionnaire can predict improvements in outcome". 

Improvements in therapy outcomes are expected to correlate positively with positive affect scores. The paper version and app version of the PANAS are expected to show same reliability. 

Description of the cohort

Patients referred to treatment with Dialectical Behavioral Psychotherapy at oner of the 5 sites.

This is patients over 18 years of age, diagnosed with Borderline Personality Disorder

Collaborating researchers and departments

Department of Psychology, University of Southern Denmark

• Susanne S. Pedersen (Cand.psych., PhD), Professor
• Mia Beck Lichtenstein (Cand.Psych., PhD), Associate professor
• Stig Helweg-Jorgensen (Cand.psych.), PhD Student
• 3East Boys Intensive Program. McLean hospital, Harvard
• Alan E. Fruzzetti (PhD), program Director

Centre for Telepsychiatry, The Mental Health Services in the Region of Southern Denmark

• Mia Beck Lichtenstein (Cand.Psych., PhD), Research Unit leader
• Stig Helweg-Jorgensen (Cand.psych.), PhD Student

Odense University Hospital (DK)

• Susanne S. Pedersen (Cand.psych., PhD), Professor
• Svendborg Psychiatric Hospital, Svendborg (DK)
• Stig Helweg-Jorgensen (Cand.psych.), Clinical psychologist