NCT04493580

Brief Summary

Purpose: The aim of the current study was to evaluate the efficacy of online Dialectical Behavioural Therapy (e-DBT) in the treatment of individuals with symptoms of borderline personality disorder (BPD). Method: Study participants diagnosed with BPD were offered treatment options of either online or in-person format of a DBT skills-building program. During each session, participants were provided with both the material and feedback regarding their previous week's homework. e-DBT protocol and content was designed to mirror in-person content. Participants were assessed by using a Self-Assessment Questionnaire (SAQ) and Difficulties in Emotion Regulation Scale (DERS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

4 years

First QC Date

July 21, 2020

Last Update Submit

April 8, 2024

Conditions

Keywords

Borderline Personality DisorderTreatmentBarriers to TreatmentPsychotherapyDialectal Behavioural TherapyOnline

Outcome Measures

Primary Outcomes (2)

  • Self-Assessment Questionnaire (SAQ) Changes

    Self assessment questionnaire

    Week 1, Week 15

  • Difficulties in Emotion Regulation Scale (DERS) Changes

    Self-report tool designed to obtain an overall measure of the difficulty respondents have with various aspects of emotion regulation. The DERS not only provides an overall score of difficulties with emotion regulation, but assesses the following six specific factors related to emotion dysregulation: non-acceptance (non-acceptance of emotional responses), goals (difficulty engaging in goal-oriented behaviors), impulse (difficulty controlling impulses), awareness (lack of emotional awareness), strategies (lack of access to emotion regulation strategies) and clarity (lack of emotional clarity).

    Week 1, Week 15

Study Arms (2)

iDBT Treatments

EXPERIMENTAL

15 weekly DBT sessions. During each session, participants will be sent 30-40 PowerPoint slides including general information on particular topic, overview of skills, and homework sheets to be completed and returned to therapists. Therapists involved will be a psychiatry resident, a psychologist, and a registered nurse who will also facilitate the in-person groups. The content and format of the online program will directly corresponded with that of the in-person group. Participants will be asked to send their homework sheets back to therapists by a specific day each week. The following day, the therapist will email feedback regarding the homework submitted and send next week's PowerPoint slides, information sheets, and homework. In order to be eligible to receive the materials, participants are required to send in homework prior to deadline. If homework was not returned, reminder email will be sent. If more than two sessions are missed, participants are excluded from the program.

Behavioral: iDBT

In-Person DBT Treatments

ACTIVE COMPARATOR

Weekly skills-building groups titled Managing Powerful Emotions (MPE) includes Mindfulness, Distress Tolerance, Emotion Regulation, and Interpersonal Effectiveness. Personality Disorders Service offers more advanced therapy groups for individuals who have successfully completed MPE and wish to continue seeking treatment modalities. Chrysalis Day Treatment Program (CDTP) is for an individual who has progress through two prior phases. In phase one, individuals will participate in a DBT-informed skill-building group (MPE). Once completed, the individual will progress to phase two which includes attending a psychotherapy group, incorporating DBT skills-building. Finally, in phase three, individuals who wish to participate in a more advanced and complex psychological treatment program, apply to participate in CDTP. The CDTP is an intensive day treatment program integrating DBT skills-building, psychodynamic psychotherapy, and a range of other group therapy modalities.

Behavioral: In-Person DBT

Interventions

iDBTBEHAVIORAL

Electronic DBT sessions designed to mirror in-person DBT.

iDBT Treatments
In-Person DBTBEHAVIORAL

In-person DBT

In-Person DBT Treatments

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Borderline Personality Disorder Diagnosis via DSM-5 Guidelines
  • Competence to consent and participate
  • Ability to speak and read English
  • Consistent and reliable access to the internet

You may not qualify if:

  • Acute hypomanic/manic episodes
  • Acute psychosis
  • Severe alcohol or substance use disorder
  • Currently receiving DBT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G3, Canada

Location

Related Publications (1)

  • Alavi N, Stephenson C, Rivera M. Effectiveness of Delivering Dialectical Behavioral Therapy Techniques by Email in Patients With Borderline Personality Disorder: Nonrandomized Controlled Trial. JMIR Ment Health. 2021 Apr 30;8(4):e27308. doi: 10.2196/27308.

Related Links

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Study Officials

  • Nazanin Alavi

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Individuals who were referred to the Personality Disorders Service in Kingston, Ontario, Canada, with a diagnosis of BPD by a psychiatrist or family physician were offered the opportunity to either select in-person DBT skills-building program groups (MPE) or an online format of the program (iDBT).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, Assistant Professor

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 30, 2020

Study Start

April 1, 2014

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Only the therapists involved in the patients' care had access to the participants' information. The data for variables under study were entered anonymously into a database separate from the clinical file. This study was approved by the Research and Ethics Board of Queen's University, Canada.

Locations