Please select the eligibility criteria that correspond to the clinical trial below.
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
Brief Summary: 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.


Options:
A: Inclusion Criteria:

* Meet DSM-IV criteria for BPD
* Between 18-60 years of age
* Have had two parasuicide episodes in the past five years with one occurring in the past 3 months
* Have had OHIP coverage for 1 year or more
* Literate in English
* Provide informed consent to participate in the study

Exclusion Criteria:

* Current active substance dependence disorder
* Psychotic disorder,bipolar I disorder, or dementia
* Evidence of an organic brain syndrome or mental retardation
* A chronic or serious physical health problem that will require hospitalization within the next year (e.g. cancer)
* A medical condition that would preclude the psychiatric medication regimen in the GPM condition
* Definite plans to leave the province in the next 2 years
* Currently engaged in DBT or GPM at St. Michael's Hospital
B: Inclusion Criteria:

* Meets New Jersey definition of severe mental illness (SMI), which includes a DSM-IV diagnosis of an SMI; within the 3 to 6 months prior to study entry, functional limitations in major life activities that would be appropriate for the client's developmental stage; and within 2 years prior to study entry, two or more treatment episodes of greater intensity than outpatient services (such as inpatient, emergency, or partial hospitalization care, or a single episode lasting 3 months or more) OR a normal living situation disrupted to the point that supportive services were required to maintain the patient in their home or residence, or law enforcement officials were required to intervene
* DSM-IV Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression (as determined by Structured Clinical Interview)
* Diagnosis of current severe PTSD at baseline assessment (as determined by a score greater than 65 on a Clinician Administered PTSD Scale)
* Speaks English

Exclusion Criteria:

* Current diagnosis of alcohol or drug dependence
* Hospitalization or suicide attempt in the past 2 months
C: Inclusion Criteria:

* Must be admitted to DBT treatment at a psychiatric hospital treatment facility in Denmark
* Must meet the criteria for Emotionally unstable personality disorder
* Must be 18 yr.o.

Exclusion Criteria:

* Psychosis
* Schizophrenia
* Bipolar disorder
* IQ under 70
* Patients who do not have a working smartphone
* Demographic data on rejected patients will be collected
D: Inclusion Criteria:

* Age between 18 and 45 years
* Meets diagnostic criteria for borderline personality disorder and for active alcohol abuse or dependence
* At least average intelligence

Exclusion Criteria:

* Meets diagnostic criteria for schizophrenia, or schizoaffective disorder

Answer: C