Borderline Personality Disorder Clinical Trial
Official title:
The mDIARY Study: Using Smartphones for Daily Selfmonitoring of Skilluse and Outcome in Dialectical Behavior Therapy With Borderline Personality Disorder: A Combined RCT and Timeseries Study
BACKGROUND: Borderline Personality Disorder (BPD) is a serious and debilitating mental
disease characterized by difficulties with emotion regulation that leads to unstable and
self- destructive behavior and relationships. The prevalence of BPD is between 1% and 5% in
the Scandinavian population with similar prevalence rates found in US epidemiologic surveys.
BPD increases the risk for suicide by 4-fold, while patients with comorbid BDP and tendency
to self-harm have a further 2-fold attenuated risk. BDP is difficult to treat, and even more
difficult when co-occurring with other disorders. Dialectical Behavior Therapy (DBT) is the
best validated treatment for BPD, showing medium to large effect sizes as compared to
treatment as usual for anger, parasuicidality (suicide attempts without an intention to die)
and poor mental health. DBT uses self-monitoring as the mainstay of treatment, which helps
patients regulate their emotions by means of emotional regulating skills, and reduce problem
behavior. Self-monitoring has traditionally been done by means of daily paper diaries. The
latest developments in smartphone applications have generated alternatives for ecological
momentary assessments of problematic behavior that even prompt patients to practice skills
targeting emotion regulation. An example of this is Monsenso's DBT self-monitoring mHealth
application (mHealth means mobile health, public health supported by mobile phones). Such
applications may enhance treatment success in BPD patients, as they are available to patients
at all times.
OBJECTIVES: To evaluate the Monsenso's mHealth app with respect to clinical efficacy as an
adjunct to DBT-psychotherapy treatment and utility as a way to measure outcomes in BPD
patients.
METHODS: The study will be a 2-year multi center, randomized controlled trial. In both
conditions patients will be followed for one year. Self report data of DBT-skills-use,
positive and negative affect, Standardised self report questionnaires on Emotion regulation
ability; functioning; borderline symptoms. will be given pre, post and every month. The
treatment arm (n=50) will receive the mHealth app that includes coaching suggestions and
instructed how to use it. The control arm (n=50) will only use a pen and paper based
self-monitoring, as traditionally used in DBT-treatment.
STUDY ENDPOINTS: Primary: mean number of days passed per new DBT-Skill learned. Secondary:
Borderline personality disorder(BPD)-symptoms, Emotion regulation ability, ratio
positive/negative affect.
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.
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