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

NCT03191565 | Unknown DMC

• 1 other identifier: SDUSF-20216-56-(556)
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 5

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.

Conditions

Borderline Personality Disorder; Emotional Instability; Skill, Coping

Keywords

mhealth; self-monitoring; Outcome monitoring

Outcome Measures

Primary Outcomes (1)

• Days/skill

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

  Daily measurements up to 1 year. (minimum 8 months.)

Secondary Outcomes (3)

• Borderline symptoms

  Pre, post and monthly measurements up to 1 year (minimum 8 months)

• Ability to emotionally regulate

  Pre, post and monthly measurements up to 1 year (Minimum 8 months)

• Compliance to self registration

  Daily measurements up to 1 year (minimum 8 months)

Study Arms (2)

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.

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

Other: Paper diary sheet

Interventions

Paper diary sheet OTHER

Writing skill-use and symptoms on a week matrix type sheet

Paperdiary-condition

Monsenso DBT-app and IT monitoring program DEVICE

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

App-Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Psychosis
• Schizophrenia
• Bipolar disorder
• IQ under 70
• Patients who do not have a working smartphone
• Demographic data on rejected patients will be collected

Sponsors & Collaborators

• Region of Southern Denmark: lead
• University of Southern Denmark: collaborator
• Innovation Fund Denmark: collaborator
• Monsenso: collaborator
• Mclean Hospital: collaborator
• Central Denmark Region: collaborator

Study Sites (5)

Glostrup DAT team. Psykiatrisk Ambulatorium

Copenhagen, Brøndby, 2605, Denmark

Location

Haderslev DAT team

Haderslev, 6100, Denmark

Location

Silkeborg DAT team, Psykiatriens Hus

Silkeborg, 8600, Denmark

Location

Lokalpsykiatrisk ambulatorium

Svendborg, 5700, Denmark

Location

Vejle DAT- team, Psykiatrisk ambulatorium

Vejle, 7100, Denmark

Location

Related Publications (15)

• 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.

  PMID: 11386989 BACKGROUND

• 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. No abstract available. Norwegian.

  PMID: 22511105 BACKGROUND

• Stoffers 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.

  PMID: 22895952 BACKGROUND

• 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. doi: 10.1016/s0304-3959(03)00040-x.

  PMID: 12855344 BACKGROUND

• 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.

  PMID: 26395972 BACKGROUND

• 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.

  PMID: 22936524 BACKGROUND

• 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.

  PMID: 22704741 BACKGROUND

• 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.

  PMID: 26220802 BACKGROUND

• 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. doi: 10.1001/archpsyc.63.7.757.

  PMID: 16818865 BACKGROUND

• 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.

  PMID: 24974307 BACKGROUND

• 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.

  PMID: 22642526 BACKGROUND

• 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.

  PMID: 24295464 BACKGROUND

• Laursen 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.

  PMID: 34762057 DERIVED

• Helweg-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.

  PMID: 32449690 DERIVED

• Storebo 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.

  PMID: 32368793 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Stig Helweg-Jørgensen, PsyD

  Region of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: June 19, 2017
• Study Start: June 15, 2017
• Primary Completion: December 30, 2019
• Study Completion: April 30, 2020
• Last Updated: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

DK (5)