Using Smartphones for Selfmonitoring of Skill-use i Dialectical Behavior Therapy (mDIARY)
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|ClinicalTrials.gov Identifier: NCT03191565|
Recruitment Status : Enrolling by invitation
First Posted : June 19, 2017
Last Update Posted : April 20, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Borderline Personality Disorder Emotional Instability Skill, Coping||Other: Paper diary sheet Device: Monsenso DBT-app and IT monitoring program||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|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|
|Actual Study Start Date :||August 1, 2017|
|Estimated Primary Completion Date :||August 30, 2019|
|Estimated Study Completion Date :||August 30, 2019|
In this condition the intervention is that participants enter their skills-use and mood on a smartphone. They can follow their progress on graphs on the smartphone, get reminders to train skills, get psychoeducation about what the different emotion regulation coping skills can do, and how to do the skills. therapists can watch patient progress online, and review skill use together with the patients while in psychotherapy. The intervention is using a smartphone as an adjunct to the treatment.
Device: Monsenso DBT-app and IT monitoring program
Entering skill-use and symptoms on a smartphone with Monsenso DBT-app and IT monitoring program
Active Comparator: Paperdiary-condition
Patients are, weekly, given a paper diary sheet to fill out on a daily basis at home No prompting, no accumulative overview of progress. Patients are supposed to bring this paper to the weekly therapysession
Other: Paper diary sheet
Writing skill-use and symptoms on a week matrix type sheet
- Days/skill [ Time Frame: Daily measurements up to 1 year. (minimum 8 months.) ]Mean number of days required to learn a new DBT-skill
- Borderline symptoms [ Time Frame: Pre, post and monthly measurements up to 1 year (minimum 8 months) ]BPD symptoms according to the Martin Bohus BSL-23 scale
- Ability to emotionally regulate [ Time Frame: Pre, post and monthly measurements up to 1 year (Minimum 8 months) ]Emotion regulation ability according to the Kim Gratz DERS-scale
- Ratio of positive and negative emotion [ Time Frame: Weekly measurements up to 1 year (minimum 8 months) ]Assessment of ratio positive to negative emotion according to the PANAS-10 scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191565
|Glostrup DAT team. Psykiatrisk Ambulatorium|
|Copenhagen, Brøndby, Denmark, 2605|
|Haderslev DAT team|
|Haderslev, Denmark, 6100|
|Silkeborg DAT team, Psykiatriens Hus|
|Silkeborg, Denmark, 8600|
|Svendborg, Denmark, 5700|
|Vejle DAT- team, Psykiatrisk ambulatorium|
|Vejle, Denmark, 7100|
|Principal Investigator:||Stig Helweg-Jørgensen, PsyD||Region of Southern Denmark|