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

Borderline Personality Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03191565
• Other study ID #: SDUSF-20216-56-(556)
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: April 30, 2020

Study information

• Verified date: November 2019
• Source: Region of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Est. completion date: April 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Emotional Instability
• Personality Disorders
• Skill, Coping

Intervention

Other:
• Paper diary sheet
Writing skill-use and symptoms on a week matrix type sheet

Device:
• Monsenso DBT-app and IT monitoring program
Entering skill-use and symptoms on a smartphone with Monsenso DBT-app and IT monitoring program

Locations

Country	Name	City	State
Denmark	Glostrup DAT team. Psykiatrisk Ambulatorium	Copenhagen	Brøndby
Denmark	Haderslev DAT team	Haderslev
Denmark	Silkeborg DAT team, Psykiatriens Hus	Silkeborg
Denmark	Lokalpsykiatrisk ambulatorium	Svendborg
Denmark	Vejle DAT- team, Psykiatrisk ambulatorium	Vejle

Sponsors (6)

Lead Sponsor	Collaborator
Region of Southern Denmark	Central Denmark Region, Innovation Fund Denmark, Mclean Hospital, Monsenso APS, Denmark, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (12)

Bedics 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. — View Citation

Burke 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. — View Citation

Faurholt-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. — View Citation

Faurholt-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. — View Citation

Klein 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. — View Citation

Linehan 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. Erratum in: Arch Gen Psychiatry. 2007 Dec;64(12):1401. — View Citation

Neacsiu 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. — View Citation

Stoffers JM, Völlm BA, Rücker G, Timmer A, Huband N, Lieb K. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD005652. doi: 10.1002/14651858.CD005652.pub2. Review. — View Citation

Stone 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. — View Citation

Torgersen S, Kringlen E, Cramer V. The prevalence of personality disorders in a community sample. Arch Gen Psychiatry. 2001 Jun;58(6):590-6. — View Citation

Torgersen S. [Paranoid schizophrenia, paranoid psychoses and personality disorders]. Tidsskr Nor Laegeforen. 2012 Apr 17;132(7):851-2. doi: 10.4045/tidsskr.12.0318. Norwegian. — View Citation

Turk 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days/skill	Mean number of days required to learn a new DBT-skill	Daily measurements up to 1 year. (minimum 8 months.)
Secondary	Borderline symptoms	BPD symptoms according to the ZAN-BPD	Pre, post and monthly measurements up to 1 year (minimum 8 months)
Secondary	Ability to emotionally regulate	Emotion regulation ability according to the Kim Gratz DERS-scale	Pre, post and monthly measurements up to 1 year (Minimum 8 months)
Secondary	Compliance to self registration	Days of compliant registration	Daily measurements up to 1 year (minimum 8 months)