Please select the arm or intervention descriptions that belong 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: Arm Label: meditation; Type: EXPERIMENTAL; Interventions: Behavioral: Central Meditation and Imagery Therapy | Arm Label: wait list; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Central Meditation and Imagery Therapy; Assigned to Arm(s): meditation
B: Arm Label: Non-Education; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Non-Education | Arm Label: Education; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Education | Intervention Type: BEHAVIORAL; Name: Education; Assigned to Arm(s): Education | Intervention Type: BEHAVIORAL; Name: Non-Education; Assigned to Arm(s): Non-Education
C: Arm Label: 1; Type: OTHER; Interventions: Drug: Naltrexone | Arm Label: 2; Type: OTHER; Interventions: Drug: Naltrexone | Arm Label: 3; Type: OTHER; Interventions: Drug: Naltrexone | Arm Label: 4; Type: OTHER; Interventions: Drug: Naltrexone | Intervention Type: DRUG; Name: Naltrexone; Assigned to Arm(s): 1, 2, 3, 4
D: Arm Label: App-Condition; Type: EXPERIMENTAL; Interventions: Device: Monsenso DBT-app and IT monitoring program | Arm Label: Paperdiary-condition; Type: ACTIVE_COMPARATOR; Interventions: Other: Paper diary sheet | Intervention Type: OTHER; Name: Paper diary sheet; Assigned to Arm(s): Paperdiary-condition | Intervention Type: DEVICE; Name: Monsenso DBT-app and IT monitoring program; Assigned to Arm(s): App-Condition

Answer: D