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DBT Techniques by E-mail for Patients With BPD

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
iDBT
In-Person DBT
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Borderline Personality Disorder, Treatment, Barriers to Treatment, Psychotherapy, Dialectal Behavioural Therapy, Online

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Hotel Dieu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iDBT Treatments

In-Person DBT Treatments

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Self-Assessment Questionnaire (SAQ) Changes
Self assessment questionnaire
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).

Secondary Outcome Measures

Full Information

First Posted
July 21, 2020
Last Updated
July 27, 2020
Sponsor
Queen's University
Collaborators
Online PsychoTherapy Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04493580
Brief Title
DBT Techniques by E-mail for Patients With BPD
Official Title
Effectiveness of Delivering Dialectical Behavioral Therapy Techniques by E-mail in Patients With Borderline Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
April 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
Online PsychoTherapy Clinic

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
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).
Detailed Description
Dialectal Behavioural Therapy: Since 1995, the Personality Disorders Service in Kingston, Ontario, Canada, has developed psychotherapeutic programs that have integrated a range of modalities for the treatment of individuals presenting with borderline personality disorders. Currently, a range of therapy groups is offered, including a weekly skills-building group that is structured to offer the basic DBT curriculum, titled Managing Powerful Emotions (MPE). This MPE curriculum includes Mindfulness, Distress Tolerance, Emotion Regulation, and Interpersonal Effectiveness. MPE has been offered since 2000 as a first-line treatment for individuals who are diagnosed with BPD. The Personality Disorders Service offers more advanced therapy groups for individuals who have completed the MPE and wish to continue seeking treatment modalities. One of the most intensive therapy programs offered is the Chrysalis Day Treatment Program (CDTP). To participate in the CDTP, an individual must 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. This integrated form of psychotherapy is extremely effective, especially for individuals suffering from more severe and prolonged symptomatology and trauma histories. Recruitment: 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). Inclusion criteria included participants being between the ages of 18 and 65 years at study inception, a diagnosis of borderline personality disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) guidelines. Moreover, participants were required to have the competence to consent and participate, the ability to speak and read English, and have consistent and reliable access to the internet. Participants were excluded from the study if they were experiencing acute hypomanic or manic episodes, acute psychosis, severe alcohol or substance use disorder, or were currently receiving DBT. Individuals who were referred to the program were provided with an information sheet about the study comparing the effectiveness of online treatment to in-person treatment, and those who consented were included in the study. The in-person group served as a control group. Measurement Scales: Each individual participating in the study completed a pre- and post-program Self-Assessment Questionnaire (SAQ) and Difficulties in Emotion Regulation Scale (DERS) (Weiss, Gratz, & Lavender, 2015). The DERS is a 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 behaviours), impulse (difficulty controlling impulses), awareness (lack of emotional awareness), strategies (lack of access to emotion regulation strategies) and clarity (lack of emotional clarity). It was explained to all participants on the consent form and also as part of the first session of both the in-person and electronic groups that the program was created for helping individuals to learn useful skills and strategies for managing their emotions and behaviours, and that it was not a crisis service. iDBT participants were informed that their online therapist would read their emails once a week and thus would not be in a position to respond to crises, such as suicidal impulses or behaviours. Participants were informed that in the case of an emergency, they were to either attend their local emergency department, call emergency services, or call their local crisis line. Therapy Programs: The therapy program had a duration of 15 weeks, with one DBT session per week. During each online session, participants were individually sent approximately 30-40 PowerPoint slides. These slides included general information on a particular topic, an overview of skills related to the issue being covered, and homework sheets to be completed and returned to their therapists. Therapists involved were a psychiatry resident, a psychologist, and a registered nurse who also facilitated the in-person groups. The content and format of the online program directly corresponded with that of the in-person group. Participants in the online program were asked to send their homework sheets back to the therapists by a specific day each week. The following day, the therapist would email individualized feedback regarding the homework submitted and send the next week's PowerPoint slides, information sheets, and homework. To be eligible to receive the next week's materials, participants were required to send in their homework before the deadline. If the homework was not returned, a reminder email was sent. If more than two sessions were missed, participants were excluded from the program. Ethical Considerations and Confidentiality: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
Borderline Personality Disorder, Treatment, Barriers to Treatment, Psychotherapy, Dialectal Behavioural Therapy, Online

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iDBT Treatments
Arm Type
Experimental
Arm Description
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.
Arm Title
In-Person DBT Treatments
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
iDBT
Intervention Description
Electronic DBT sessions designed to mirror in-person DBT.
Intervention Type
Behavioral
Intervention Name(s)
In-Person DBT
Intervention Description
In-person DBT
Primary Outcome Measure Information:
Title
Self-Assessment Questionnaire (SAQ) Changes
Description
Self assessment questionnaire
Time Frame
Week 1, Week 15
Title
Difficulties in Emotion Regulation Scale (DERS) Changes
Description
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).
Time Frame
Week 1, Week 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Acute hypomanic/manic episodes Acute psychosis Severe alcohol or substance use disorder Currently receiving DBT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazanin Alavi
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
33835936
Citation
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.
Results Reference
derived

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DBT Techniques by E-mail for Patients With BPD

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