NCT03191565: mDIARY

Using Smartphones for Selfmonitoring of Skill-use i Dialectical Behavior Therapy

Status unknown NA Last updated 25 November 2019

What this trial tests

NA trial testing Paper diary sheet in Borderline Personality Disorder in 78 participants. Status unknown.

Timeline

15 June 2017

Primary endpoint
30 December 2019

30 April 2020

Quick facts

Lead sponsor	Region of Southern Denmark
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	78
Start date	15 June 2017
Primary completion	30 December 2019
Estimated completion	30 April 2020
Sites	5 locations across Denmark

Drugs / interventions tested

• Paper diary sheet
• Monsenso DBT-app and IT monitoring program

Conditions studied

• Borderline Personality Disorder — all drugs for Borderline Personality Disorder →
• Emotional Instability — all drugs for Emotional Instability →
• Skill, Coping — all drugs for Skill, Coping →

Sponsor

Region of Southern Denmark

Who can join

18 and older, any sex, with Borderline Personality Disorder or Emotional Instability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Psychological therapies for people with borderline personality disorder.
   Storebø OJ, Stoffers-Winterling JM, Völlm BA, Kongerslev MT, et al · · 2020 · cited 208× · PMID 32368793 · DOI 10.1002/14651858.cd012955.pub2
2. Mobile Diary App Versus Paper-Based Diary Cards for Patients With Borderline Personality Disorder: Economic Evaluation.
   Laursen SL, Helweg-Jørgensen S, Langergaard A, Søndergaard J, et al · · 2021 · cited 14× · PMID 34762057 · DOI 10.2196/28874
3. Daily Self-Monitoring of Symptoms and Skills Learning in Patients With Borderline Personality Disorder Through a Mobile Phone App: Protocol for a Pragmatic Randomized Controlled Trial.
   Helweg-Jørgensen S, Beck Lichtenstein M, Fruzzetti AE, Møller Dahl C, et al · · 2020 · cited 11× · PMID 32449690 · DOI 10.2196/17737