Borderline Personality DisordermDIARYNCT03191565
Using Smartphones for Selfmonitoring of Skill-use i Dialectical Behavior Therapy
A study testing Paper diary sheet and Monsenso DBT-app and IT monitoring program in people with Borderline Personality Disorder and Emotional Instability, run by Region of Southern Denmark at 5 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Personality Disorder, Emotional Instability, Skill, Coping
- What is being tested?
- Paper diary sheet and Monsenso DBT-app and IT monitoring program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 5 sitesDenmark
- Study dates
- 15 Jun 2017to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Psychosis
- Schizophrenia
- Bipolar disorder
- IQ under 70
- Patients who do not have a working smartphone
- Demographic data on rejected patients will be collected
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Glostrup DAT team. Psykiatrisk Ambulatorium
Copenhagen, Brøndby, 2605
Haderslev DAT team
Haderslev, 6100
Silkeborg DAT team, Psykiatriens Hus
Silkeborg, 8600
Lokalpsykiatrisk ambulatorium
Svendborg, 5700
Vejle DAT- team, Psykiatrisk ambulatorium
Vejle, 7100
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- Paper diary sheet, Monsenso DBT-app and IT monitoring program
- Keywords
- mhealth, self-monitoring, Outcome monitoring
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paper diary sheetOther
Writing skill-use and symptoms on a week matrix type sheet
Monsenso DBT-app and IT monitoring programDevice
Entering skill-use and symptoms on a smartphone with Monsenso DBT-app and IT monitoring program
| Study group | Role | What they receive |
|---|---|---|
| App-Condition | Experimental | 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. Receives: Device: Monsenso DBT-app and IT monitoring program |
| Paperdiary-condition | Active comparator | 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 Receives: Other: Paper diary sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days/skill
Mean number of days required to learn a new DBT-skill
Measured: Daily measurements up to 1 year. (minimum 8 months.)
Secondary outcomes (3)
Borderline symptoms
BPD symptoms according to the ZAN-BPD
Measured: Pre, post and monthly measurements up to 1 year (minimum 8 months)
Ability to emotionally regulate
Emotion regulation ability according to the Kim Gratz DERS-scale
Measured: Pre, post and monthly measurements up to 1 year (Minimum 8 months)
Compliance to self registration
Days of compliant registration
Measured: Daily measurements up to 1 year (minimum 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start15 Jun 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Innovation Fund Denmark, Monsenso, Mclean Hospital, Central Denmark Region
- Responsible party
- Principal investigator, Stig Helweg-Jørgensen, Region of Southern Denmark
- Investigators
- Stig Helweg-Jørgensen, PsyD, Principal investigator, Region of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191565
- Sponsor's protocol ID
- SDUSF-20216-56-(556)
- Acronym
- mDIARY
- Status last verified
- Nov 2019
- First submitted
- 24 Mar 2017
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Torgersen S, Kringlen E, Cramer V. The prevalence of personality disorders in a community sample. Arch Gen Psychiatry. 2001 Jun;58(6):590-6. doi: 10.1001/archpsyc.58.6.590.
PubMed 11386989Torgersen S. [Paranoid schizophrenia, paranoid psychoses and personality disorders]. Tidsskr Nor Laegeforen. 2012 Apr 17;132(7):851-2. doi: 10.4045/tidsskr.12.0318. No abstract available. Norwegian.
PubMed 22511105Stoffers JM, Vollm BA, Rucker G, Timmer A, Huband N, Lieb K. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD005652. doi: 10.1002/14651858.CD005652.pub2.
PubMed 22895952Stone AA, Broderick JE, Schwartz JE, Shiffman S, Litcher-Kelly L, Calvanese P. Intensive momentary reporting of pain with an electronic diary: reactivity, compliance, and patient satisfaction. Pain. 2003 Jul;104(1-2):343-51. doi: 10.1016/s0304-3959(03)00040-x.
PubMed 12855344Faurholt-Jepsen M, Vinberg M, Frost M, Christensen EM, Bardram JE, Kessing LV. Smartphone data as an electronic biomarker of illness activity in bipolar disorder. Bipolar Disord. 2015 Nov;17(7):715-28. doi: 10.1111/bdi.12332. Epub 2015 Sep 23.
PubMed 26395972Turk MW, Elci OU, Wang J, Sereika SM, Ewing LJ, Acharya SD, Glanz K, Burke LE. Self-monitoring as a mediator of weight loss in the SMART randomized clinical trial. Int J Behav Med. 2013 Dec;20(4):556-61. doi: 10.1007/s12529-012-9259-9.
PubMed 22936524Burke LE, Styn MA, Sereika SM, Conroy MB, Ye L, Glanz K, Sevick MA, Ewing LJ. Using mHealth technology to enhance self-monitoring for weight loss: a randomized trial. Am J Prev Med. 2012 Jul;43(1):20-6. doi: 10.1016/j.amepre.2012.03.016.
PubMed 22704741Faurholt-Jepsen M, Frost M, Ritz C, Christensen EM, Jacoby AS, Mikkelsen RL, Knorr U, Bardram JE, Vinberg M, Kessing LV. Daily electronic self-monitoring in bipolar disorder using smartphones - the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial. Psychol Med. 2015 Oct;45(13):2691-704. doi: 10.1017/S0033291715000410. Epub 2015 Jul 29.
PubMed 26220802Linehan MM, Comtois KA, Murray AM, Brown MZ, Gallop RJ, Heard HL, Korslund KE, Tutek DA, Reynolds SK, Lindenboim N. Two-year randomized controlled trial and follow-up of dialectical behavior therapy vs therapy by experts for suicidal behaviors and borderline personality disorder. Arch Gen Psychiatry. 2006 Jul;63(7):757-66. doi: 10.1001/archpsyc.63.7.757.
PubMed 16818865Neacsiu AD, Eberle JW, Kramer R, Wiesmann T, Linehan MM. Dialectical behavior therapy skills for transdiagnostic emotion dysregulation: a pilot randomized controlled trial. Behav Res Ther. 2014 Aug;59:40-51. doi: 10.1016/j.brat.2014.05.005. Epub 2014 May 27.
PubMed 24974307Bedics JD, Atkins DC, Comtois KA, Linehan MM. Weekly therapist ratings of the therapeutic relationship and patient introject during the course of dialectical behavioral therapy for the treatment of borderline personality disorder. Psychotherapy (Chic). 2012 Jun;49(2):231-40. doi: 10.1037/a0028254.
PubMed 22642526Klein AS, Skinner JB, Hawley KM. Targeting binge eating through components of dialectical behavior therapy: preliminary outcomes for individually supported diary card self-monitoring versus group-based DBT. Psychotherapy (Chic). 2013 Dec;50(4):543-52. doi: 10.1037/a0033130.
PubMed 24295464Laursen SL, Helweg-Jorgensen S, Langergaard A, Sondergaard J, Sorensen SS, Mathiasen K, Lichtenstein MB, Ehlers LH. Mobile Diary App Versus Paper-Based Diary Cards for Patients With Borderline Personality Disorder: Economic Evaluation. J Med Internet Res. 2021 Nov 11;23(11):e28874. doi: 10.2196/28874.
PubMed 34762057Helweg-Jorgensen S, Beck Lichtenstein M, Fruzzetti AE, Moller Dahl C, Pedersen SS. 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. JMIR Res Protoc. 2020 May 25;9(5):e17737. doi: 10.2196/17737.
PubMed 32449690Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
PubMed 32368793
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03191565
- Acronym / sponsor ID
- mDIARY / SDUSF-20216-56-(556)
- Keywords
- mhealth, self-monitoring, Outcome monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Region of Southern DenmarkUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Innovation Fund Denmark, Monsenso, Mclean Hospital, Central Denmark Region
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App-Condition | Experimental | Device: Monsenso DBT-app and IT monitoring programIn 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. |
| Paperdiary-condition | Active comparator | Other: Paper diary sheetPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Psychosis
- Schizophrenia
- Bipolar disorder
- IQ under 70
- Patients who do not have a working smartphone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paper diary sheetWriting skill-use and symptoms on a week matrix type sheet | Other | Paperdiary-condition |
| Monsenso DBT-app and IT monitoring programEntering skill-use and symptoms on a smartphone with Monsenso DBT-app and IT monitoring program | Device | App-Condition |
Primary outcome
Days/skill
Time frame: Daily measurements up to 1 year. (minimum 8 months.)
Mean number of days required to learn a new DBT-skill
3 secondary outcomes
Borderline symptoms
Time frame: Pre, post and monthly measurements up to 1 year (minimum 8 months)
Ability to emotionally regulate
Time frame: Pre, post and monthly measurements up to 1 year (Minimum 8 months)
Compliance to self registration
Time frame: Daily measurements up to 1 year (minimum 8 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Background: PubMed 11386989Torgersen S, Kringlen E, Cramer V. The prevalence of personality disorders in a community sample. Arch Gen Psychiatry. 2001 Jun;58(6):590-6. doi: 10.1001/archpsyc.58.6.590.
- Background: PubMed 22511105Torgersen S. [Paranoid schizophrenia, paranoid psychoses and personality disorders]. Tidsskr Nor Laegeforen. 2012 Apr 17;132(7):851-2. doi: 10.4045/tidsskr.12.0318. No abstract available. Norwegian.
- Background: PubMed 22895952Stoffers JM, Vollm BA, Rucker G, Timmer A, Huband N, Lieb K. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD005652. doi: 10.1002/14651858.CD005652.pub2.
- Background: PubMed 12855344Stone AA, Broderick JE, Schwartz JE, Shiffman S, Litcher-Kelly L, Calvanese P. Intensive momentary reporting of pain with an electronic diary: reactivity, compliance, and patient satisfaction. Pain. 2003 Jul;104(1-2):343-51. doi: 10.1016/s0304-3959(03)00040-x.
- Background: PubMed 26395972Faurholt-Jepsen M, Vinberg M, Frost M, Christensen EM, Bardram JE, Kessing LV. Smartphone data as an electronic biomarker of illness activity in bipolar disorder. Bipolar Disord. 2015 Nov;17(7):715-28. doi: 10.1111/bdi.12332. Epub 2015 Sep 23.
- Background: PubMed 22936524Turk MW, Elci OU, Wang J, Sereika SM, Ewing LJ, Acharya SD, Glanz K, Burke LE. Self-monitoring as a mediator of weight loss in the SMART randomized clinical trial. Int J Behav Med. 2013 Dec;20(4):556-61. doi: 10.1007/s12529-012-9259-9.
- Background: PubMed 22704741Burke LE, Styn MA, Sereika SM, Conroy MB, Ye L, Glanz K, Sevick MA, Ewing LJ. Using mHealth technology to enhance self-monitoring for weight loss: a randomized trial. Am J Prev Med. 2012 Jul;43(1):20-6. doi: 10.1016/j.amepre.2012.03.016.
- Background: PubMed 26220802Faurholt-Jepsen M, Frost M, Ritz C, Christensen EM, Jacoby AS, Mikkelsen RL, Knorr U, Bardram JE, Vinberg M, Kessing LV. Daily electronic self-monitoring in bipolar disorder using smartphones - the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial. Psychol Med. 2015 Oct;45(13):2691-704. doi: 10.1017/S0033291715000410. Epub 2015 Jul 29.
- Background: PubMed 16818865Linehan MM, Comtois KA, Murray AM, Brown MZ, Gallop RJ, Heard HL, Korslund KE, Tutek DA, Reynolds SK, Lindenboim N. Two-year randomized controlled trial and follow-up of dialectical behavior therapy vs therapy by experts for suicidal behaviors and borderline personality disorder. Arch Gen Psychiatry. 2006 Jul;63(7):757-66. doi: 10.1001/archpsyc.63.7.757.
- Background: PubMed 24974307Neacsiu AD, Eberle JW, Kramer R, Wiesmann T, Linehan MM. Dialectical behavior therapy skills for transdiagnostic emotion dysregulation: a pilot randomized controlled trial. Behav Res Ther. 2014 Aug;59:40-51. doi: 10.1016/j.brat.2014.05.005. Epub 2014 May 27.
- Background: PubMed 22642526Bedics JD, Atkins DC, Comtois KA, Linehan MM. Weekly therapist ratings of the therapeutic relationship and patient introject during the course of dialectical behavioral therapy for the treatment of borderline personality disorder. Psychotherapy (Chic). 2012 Jun;49(2):231-40. doi: 10.1037/a0028254.
- Background: PubMed 24295464Klein AS, Skinner JB, Hawley KM. Targeting binge eating through components of dialectical behavior therapy: preliminary outcomes for individually supported diary card self-monitoring versus group-based DBT. Psychotherapy (Chic). 2013 Dec;50(4):543-52. doi: 10.1037/a0033130.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stig Helweg-Jørgensen, PsyD principal investigator
Region of Southern Denmark
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paper diary sheet and Monsenso DBT-app and IT monitoring program in people with Borderline Personality Disorder and Emotional Instability, run by Region of Southern Denmark at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days/skill (time frame: Daily measurements up to 1 year. (minimum 8 months.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03191565, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.