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

Primary Purpose

Borderline Personality Disorder, Emotional Instability, Skill, Coping

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Paper diary sheet
Monsenso DBT-app and IT monitoring program
Sponsored by
Region of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Borderline Personality Disorder focused on measuring mhealth, self-monitoring, Outcome monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Glostrup DAT team. Psykiatrisk Ambulatorium
  • Haderslev DAT team
  • Silkeborg DAT team, Psykiatriens Hus
  • Lokalpsykiatrisk ambulatorium
  • Vejle DAT- team, Psykiatrisk ambulatorium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

App-Condition

Paperdiary-condition

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Days/skill
Mean number of days required to learn a new DBT-skill

Secondary Outcome Measures

Borderline symptoms
BPD symptoms according to the ZAN-BPD
Ability to emotionally regulate
Emotion regulation ability according to the Kim Gratz DERS-scale
Compliance to self registration
Days of compliant registration

Full Information

First Posted
March 24, 2017
Last Updated
November 21, 2019
Sponsor
Region of Southern Denmark
Collaborators
University of Southern Denmark, Innovation Fund Denmark, Monsenso APS, Denmark, Mclean Hospital, Central Denmark Region
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1. Study Identification

Unique Protocol Identification Number
NCT03191565
Brief Title
Using Smartphones for Selfmonitoring of Skill-use i Dialectical Behavior Therapy
Acronym
mDIARY
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region of Southern Denmark
Collaborators
University of Southern Denmark, Innovation Fund Denmark, Monsenso APS, Denmark, Mclean Hospital, Central Denmark Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
BACKGROUND Borderline personality disorder It is estimated that 1-5% of the Scandinavian population meets the criteria for borderline personality disorder (BPD). General consensus regarding estimates for the western world population, is that around 1,5% of the population meets criteria for BPD. Lifetime prevalence will be estimated as 3 times as high (about 5%). The percentage for clinical populations is considerably higher and is estimated to be around 28% (range 9.3 to 46.3 % of patients in different current studies) of all psychiatric patients meeting this diagnosis. BDP is characterized by an instability across a number of domains: Mood, interpersonal relationships, self-image, impulse- and behavioral control. Generally, these BDP manifestations are attributed to a lack of ability to emotionally regulate. Patients with BDP have a four times increased risk of premature death compared to the general population, emphasizing the need for appropriate treatment. Treatment of borderline personality disorder Dialectical behavior therapy (DBT) has shown good clinical efficacy and is regarded as one of the most well researched evidence-based treatments for BPD. The DBT treatment centers around the learning of a predefined set of behavioral skills, targeting lack of emotional, mental and behavioral self-control. These skills are trained in group and individual therapy. In standard clinical practice, evaluation of a patient's progress in learning skills is left to the clinician's subjective memory and evaluation of weekly data. Self-monitoring of skill use and accompanying changes in suicidality, self-harm, and emotional reactivity have traditionally been done by means of paper diaries. Technological advances in self-monitoring might reduce the burden on the patient, increase data quality and generate new opportunities for registration (8). Recent studies on pain management have suggested that mhealth solutions significantly increase compliance. Studies using electronic diaries in the treatment of bipolar disorders, in pain- and weight management, and in patients treated with chemo-therapy have also shown promising results. DBT skills have been shown to mediate improvements in BPD defining behaviors. However, no randomized studies to date have examined if a mobile phone-/mhealth solution could speed up the time it takes for patients to assimilate the DBT-skills, while at the same time serving the function of filling out diary cards for the treatment of BDP. Regarding the time series part of the study, a single pilot study of ecological momentary assessment (EMA) has demonstrated significant differences in fluctuations of positive and negative affect on a daily basis when comparing major depressive disorder to BPD. Hence, this lends promise that a purpose-designed mobile phone application aimed at collecting DBT-diary data will produce time-efficient and valid data of higher quality than traditional paper-registrations. This will also at the same time generate objective outcome data, thus collecting multimodal data. Both self report and passive sensor data. The exact same sensor data have been shown to have value in predicting manic episodes in bipolar patients. When starting an mhealth-supported session, it is possible to view the EMA data (for content, see Table 1), self-rated daily assessments, monthly questionnaires together with the therapist. The mDiary system will automatically generate chosen relevant questionnaires at a selected ratio, making the research data-collection much easier. The patient and the therapist can also get access to phone sensor data, such as activity level, phone use, internet use and minutes of communication on phone as well. The increased overview provided by diarycard-, sensor- and questionnaire data can also be useful when evaluating and discussing patient cases at staff meetings or during therapist supervision.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, Emotional Instability, Skill, Coping
Keywords
mhealth, self-monitoring, Outcome monitoring

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
App-Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Paperdiary-condition
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Paper diary sheet
Intervention Description
Writing skill-use and symptoms on a week matrix type sheet
Intervention Type
Device
Intervention Name(s)
Monsenso DBT-app and IT monitoring program
Intervention Description
Entering skill-use and symptoms on a smartphone with Monsenso DBT-app and IT monitoring program
Primary Outcome Measure Information:
Title
Days/skill
Description
Mean number of days required to learn a new DBT-skill
Time Frame
Daily measurements up to 1 year. (minimum 8 months.)
Secondary Outcome Measure Information:
Title
Borderline symptoms
Description
BPD symptoms according to the ZAN-BPD
Time Frame
Pre, post and monthly measurements up to 1 year (minimum 8 months)
Title
Ability to emotionally regulate
Description
Emotion regulation ability according to the Kim Gratz DERS-scale
Time Frame
Pre, post and monthly measurements up to 1 year (Minimum 8 months)
Title
Compliance to self registration
Description
Days of compliant registration
Time Frame
Daily measurements up to 1 year (minimum 8 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stig Helweg-Jørgensen, PsyD
Organizational Affiliation
Region of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glostrup DAT team. Psykiatrisk Ambulatorium
City
Copenhagen
State/Province
Brøndby
ZIP/Postal Code
2605
Country
Denmark
Facility Name
Haderslev DAT team
City
Haderslev
ZIP/Postal Code
6100
Country
Denmark
Facility Name
Silkeborg DAT team, Psykiatriens Hus
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
Facility Name
Lokalpsykiatrisk ambulatorium
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark
Facility Name
Vejle DAT- team, Psykiatrisk ambulatorium
City
Vejle
ZIP/Postal Code
7100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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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Using Smartphones for Selfmonitoring of Skill-use i Dialectical Behavior Therapy

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