Borderline Personality DisorderNCT04493580
DBT Techniques by E-mail for Patients With BPD
A study testing iDBT and In-Person DBT in people with Borderline Personality Disorder, run by Dr. Nazanin Alavi at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- iDBT and In-Person DBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2014to 1 Apr 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute hypomanic/manic episodes
- Acute psychosis
- Severe alcohol or substance use disorder
- Currently receiving DBT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Delivering Dialectical Behavioral Therapy Techniques by E-mail in Patients With Borderline Personality Disorder
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).
Read the 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.
- Conditions
- Borderline Personality Disorder
- Being tested
- iDBT, In-Person DBT
- Keywords
- Borderline Personality Disorder, Treatment, Barriers to Treatment, Psychotherapy, Dialectal Behavioural Therapy, Online
- 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.
iDBTBehavioural
Electronic DBT sessions designed to mirror in-person DBT.
In-Person DBTBehavioural
In-person DBT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: In-Person DBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Assessment Questionnaire (SAQ) Changes
Self assessment questionnaire
Measured: 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).
Measured: Week 1, Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Apr 2014
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Nazanin Alavi
- Sponsor type
- University, hospital or other
- Collaborators
- Online PsychoTherapy Clinic
- Responsible party
- Sponsor-investigator, Dr. Nazanin Alavi, Queen's University
- Investigators
- Nazanin Alavi, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493580
- Sponsor's protocol ID
- PSIY-391-13
- Status last verified
- Apr 2024
- First submitted
- 21 Jul 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 33835936
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Delivering Dialectical Behavioral Therapy Techniques by E-mail in Patients With Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT04493580
- Acronym / sponsor ID
- PSIY-391-13
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline Personality Disorder, Treatment, Barriers to Treatment, Psychotherapy, Dialectal Behavioural Therapy, Online
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Dr. Nazanin AlaviUniversity, hospital or other
- Collaborators
- Online PsychoTherapy Clinic
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 30 Jul 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| iDBT Treatments | Experimental | Behavioral: iDBT15 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. |
| In-Person DBT Treatments | Active comparator | Behavioral: In-Person DBTWeekly 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Acute hypomanic/manic episodes
- Acute psychosis
- Severe alcohol or substance use disorder
- Currently receiving DBT
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 |
|---|---|---|
| iDBTElectronic DBT sessions designed to mirror in-person DBT. | Behavioural | iDBT Treatments |
| In-Person DBTIn-person DBT | Behavioural | In-Person DBT Treatments |
Primary outcome
Self-Assessment Questionnaire (SAQ) Changes
Time frame: Week 1, Week 15
Self assessment questionnaire
Difficulties in Emotion Regulation Scale (DERS) Changes
Time frame: Week 1, Week 15
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 33835936Alavi 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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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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.
Nazanin Alavi principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iDBT and In-Person DBT in people with Borderline Personality Disorder, run by Dr. Nazanin Alavi at 1 site in Canada.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-Assessment Questionnaire (SAQ) Changes (time frame: Week 1, Week 15). The study lists 2 primary outcomes in all. 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 NCT04493580, which also lists 1 linked publication.
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 10 Apr 2024; AzTrials last refreshed its copy on 28 Oct 2026.