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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03191565
Recruitment Status : Unknown
Verified November 2019 by Stig Helweg-Jørgensen, Region of Southern Denmark.
Recruitment status was:  Active, not recruiting
First Posted : June 19, 2017
Last Update Posted : November 25, 2019
University of Southern Denmark
Innovation Fund Denmark
Monsenso APS, Denmark
Mclean Hospital
Central Denmark Region
Information provided by (Responsible Party):
Stig Helweg-Jørgensen, Region of Southern Denmark

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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 : June 15, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: App-Condition
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

Primary Outcome Measures :
  1. Days/skill [ Time Frame: Daily measurements up to 1 year. (minimum 8 months.) ]
    Mean number of days required to learn a new DBT-skill

Secondary Outcome Measures :
  1. Borderline symptoms [ Time Frame: Pre, post and monthly measurements up to 1 year (minimum 8 months) ]
    BPD symptoms according to the ZAN-BPD

  2. 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

  3. Compliance to self registration [ Time Frame: Daily measurements up to 1 year (minimum 8 months) ]
    Days of compliant registration

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03191565

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Glostrup DAT team. Psykiatrisk Ambulatorium
Copenhagen, Brøndby, Denmark, 2605
Haderslev DAT team
Haderslev, Denmark, 6100
Silkeborg DAT team, Psykiatriens Hus
Silkeborg, Denmark, 8600
Lokalpsykiatrisk ambulatorium
Svendborg, Denmark, 5700
Vejle DAT- team, Psykiatrisk ambulatorium
Vejle, Denmark, 7100
Sponsors and Collaborators
Region of Southern Denmark
University of Southern Denmark
Innovation Fund Denmark
Monsenso APS, Denmark
Mclean Hospital
Central Denmark Region
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Principal Investigator: Stig Helweg-Jørgensen, PsyD Region of Southern Denmark

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Stig Helweg-Jørgensen, Principal investigator, Region of Southern Denmark Identifier: NCT03191565    
Other Study ID Numbers: SDUSF-20216-56-(556)
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After receiving permission from the participants, individual data will be shared with the individual therapist who is treating the patient, but only data regarding for their own clients, so they can follow therapy-progress. De-identified data will be shared with researcher doing the economic evaluation, August 2019. According to danish data protection law this researcher will need a Data processor approval through The danish Data protection agency.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stig Helweg-Jørgensen, Region of Southern Denmark:
Outcome monitoring
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders