ClinicalTrials.gg
RecruitingNCT06458933Updated Apr 1, 2026

Testing Interventions for Borderline Personality Disorder.

A Phase 2 interventional study of Sage and Supportive Individual Psychotherapy in Borderline Personality Disorder, sponsored by York University. Recruiting at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by York University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
304
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

Borderline personality disorder (BPD) is a life-threatening, costly public health crisis affecting \~1-3% of North Americans, with 10% dying by suicide and annual healthcare costs of \~$63k (Canadian Dollars)/patient. Further, people with BPD's intimate relationships are highly disrupted, and their partners report elevated mental health problems but little access to treatment. Existing BPD treatments are resource-heavy, inaccessible, and 47% of people with BPD do not respond to them. These treatments also neglect relationship problems and intimate partner's mental health concerns, even though they are thought to play a key role in BPD maintenance. BPD interventions may produce stronger, quicker, and more durable outcomes if they incorporated partners to target both the emotional and relationship core of BPD. Moreover, incorporating partners into interventions may improve relationship outcomes and partner mental health without added resource investments.

Accordingly, members of our team developed Sage. Named after a plant that thrives in relationship with its ecosystem, Sage is a brief, 12-session conjoint intervention for people with BPD and their intimate partners that targets BPD, relationship conflict, and partner mental health. Our recent uncontrolled trial provides preliminary support for its efficacy.

As a next step in testing Sage, it is critical to utilize a Randomized Controlled Trial (RCT) design to identify if Sage is more efficacious than standard care that these couples typically receive; supportive individual psychotherapy (SIP) for people with BPD and their partners. The investigators propose to conduct the first RCT of Sage for couples wherein one member has BPD. The study will examine if Sage is more efficacious than SIP in improving BPD symptoms (primary outcome), as well as relationship conflict and partner mental health (secondary outcomes), as well as a range of other outcomes, from pre- to post-intervention, and post-intervention to follow-up. It will also investigate factors that influence treatment response, BPD severity, and related problems.

Up to 152 couples wherein one member has BPD will be randomized to receive Sage or SIP. Gold-standard measures of primary, secondary, and exploratory outcomes will be administered at baseline, mid-intervention, post-intervention, and a one-month, three- month, and six-month follow-up.

02

Conditions studied

  • Borderline Personality Disorder

Keywords

  • Borderline Personality Disorder
  • Relationship dysfunction
  • Couple therapy
  • Emotion dysregulation
03

In context

Borderline Personality Disorder

278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.

This study's planned enrollment of 304 is above the median of 70 across 221 interventional studies indexed under Borderline Personality Disorder.

Browse Borderline Personality Disorder studies →

Lead sponsor

York University is the lead sponsor of 51 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participant with borderline personality disorder (BPD) meets full diagnostic criteria for BPD (i.e., five or more BPD diagnostic criteria per the -5-TR)
  2. Both members are at least 19-years-old
  3. Both members consent to study participation
  4. Both members consent to a member of the research team contacting one of their provided emergency contacts if there are imminent safety concerns.
  5. Both members consent to having assessment interviews and treatment sessions audio- and video-recorded
  6. Both members members reside in Ontario (with no plan to leave the province during the course of the study)
  7. Both members members are fluent in English
  8. Both members are willing to receive emails about the study
  9. Both members have regular internet access from a private location for completion of study appointments

Exclusion criteria

EXCLUSION:

  1. Severe intimate partner violence in their relationship in the past year (Endorsement of severe intimate partner violence items on Conflict Tactics Scale-2)
  2. criteria A and B of schizophrenia, not better accounted for by BPD
  3. Hospitalization in the past year for mania, or mania in the past three months
  4. A substance/alcohol use disorder that is likely to require medical intervention (e.g., detoxification) to reduce use
  5. A medical condition that is likely to require hospitalization within the next year
  6. Scaled score below 70 on the Test of Premorbid Functioning, suggesting impaired intelligence and/or probable traumatic brain injury
  7. Either participant in the dyad is not able to show proof of identification upon request at any point throughout the study or is not able to provide an accurate phone number or address upon request.
  8. The individual with BPD is currently receiving an empirically-supported BPD treatment and is unwilling to pause the therapy for the duration of the active treatment phase
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
304 participants (estimated)

Study arms

  • Experimental
    Sage

    Immediately receives 12 sessions of a couple psychotherapy designed to treat borderline personality disorder (BPD) and enhances relationship functioning simultaneously.

    Behavioral: Sage

  • Active comparator
    SIP

    Immediately receives 12 individual sessions each (12 for people with borderline personality disorder (BPD), 12 for partners) of Supportive Individual Psychotherapy (SIP).

    Behavioral: Supportive Individual Psychotherapy

Interventions

  • BehavioralSage

    Sage is a 12-session manualized weekly intervention delivered to people with borderline personality disorder (BPD) and their intimate partners. The Sage intervention consists of three phases: Phase 1, orientation and safety which focuses on targeting destructive behaviours (e.g., suicide attempts and self harm engagement) by providing couples with safety strategies that target suicide risk/ crisis, education about BPD, the role of emotion dysregulation and intimate relationship dysfunction in maintaining it (\~three sessions). Next, Phase 2, communication and emotion skills entails couples learning communication skills and strategies for identifying, expressing, and regulating emotions (\~five sessions). Lastly, in Phase 3, cognitive skills and intervention termination, couples learn strategies to target negative cognitions that elicit emotion dysregulation and intimate relationship dysfunction (\~four sessions).

  • BehavioralSupportive Individual Psychotherapy

    Supportive Individual Psychotherapy (SIP) is a comparator in our control condition reflects enhanced usual care (i.e., supportive psychotherapy) for people with BPD. Both people with BPD and partners will receive SIP sessions separately over the course of 12 sessions, delivered by therapists. For both members of the couple, SIP will involve 12 sessions of a specific form of supportive psychotherapy based on client-centered, humanistic principles. This intervention involves creating a supportive therapeutic relationship, expressing empathy, and helping individuals feel understood. The SIP intervention is designed to support individuals in exploring their relationships and communication patterns as well as following the client's lead on what they want to work on.

06

What researchers measure

Primary outcomes

  1. Zanarini Rating Scale for BPD (ZAN-BPD)

    Interview measure of BPD severity. Scores range from 0 to 36, with higher scores reflecting higher severity of BPD symptoms.

    Time frame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

Secondary outcomes

  1. Conflict Resolution Scale

    Self-report measure of relationship conflict. Scores range from 0 to 52, with higher scores reflecting higher levels of conflict resolution.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  2. Depression, Anxiety, and Stress Scale- depression subscale (partners)

    Self-report measure of depression. Scores range from 0 to 21, with higher scores reflecting higher levels of depression.

    Time frame: It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  3. Generalized Anxiety Disorder 7 (GAD-7)

    Self-report measure of anxiety. Scores range from 0 to 21, with higher scores reflecting higher levels of anxiety.

    Time frame: It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  4. Kessler Psychological Distress Scale-10

    Self-report measure of psychological distress. Scores range from 10 to 50, with higher scores reflecting higher levels of psychological distress.

    Time frame: It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  5. Difficulties in Emotion Regulation Scale (DERS)

    Self-report measure of emotion dysregulation. Scores range from 36 to 180, with higher scores reflecting higher levels of emotion dysregulation.

    Time frame: It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  6. Addiction Severity Index

    Self-report measure of problematic alcohol or substance use. Scores vary across substances and items, but higher scores indicate higher levels of problematic substance use.

    Time frame: It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

Other outcomes

  1. Suicide Attempt Self-Injury Interview-modified

    Interview measure of frequency of self-injury and suicidal behaviours. Scores reflect the frequency of suicidal and self-injurious behaviour.

    Time frame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  2. Positive and Negative Affect Schedule (PANAS)- select subscales

    Self-report measure of anger, fear, guilt, sadness, fatigue, positive emotion, negative emotion. Score ranges vary across subscales, with higher scores reflecting higher levels of emotion.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and one, three, and six months after the intervention.

  3. Communication Patterns Questionnaire-23 item version

    Self-report measure of communication patterns

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  4. Borderline Symptom List- 23

    Self-report measure of BPD severity. Scores range from 0 to 92, with higher scores reflecting higher levels of BPD severity.

    Time frame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  5. Borderline Symptom List- 23-INFORMANT REPORT

    Informant-report measure of BPD severity Scores range from 0 to 92, with higher scores reflecting higher levels of partner's BPD severity.

    Time frame: It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  6. Humor Styles Questionnaire - affiliative subscale

    Self-report measure of humour and positive communication qualities. Scores range from 8 to 56, with higher scores reflecting higher levels of humour.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), 12 weeks, and 36 weeks.

  7. Perceived Relationship Quality Component

    Self-report measure of relationship satisfaction. Score ranges vary across subscales, with higher scores reflecting higher relationship quality.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  8. Couples Satisfaction Inventory- 16 item version

    Self-report measure of relationship satisfaction. Scores range from 0 to 81, with higher scores reflecting higher levels of relationship satisfaction.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  9. Sage skills use measure

    Use of Sage skills self-report measure, created for present study. Scores range from 0 to 60, with higher scores reflecting higher levels of Sage skill use.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  10. Sage skills use measure (in session)

    Use of Sage skills self-report measure, created for present study. Scores reflect the number of times a skill was used.

    Time frame: It will be administered to people with BPD and partners in the Sage condition at the beginning of every session.

  11. Feinberg Brief Co-Parenting Scale

    Self-report measure of co-parenting experiences. Scores range from 0 to 72, with higher scores reflecting higher levels positive co-parenting.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  12. Empathic accuracy measure

    Self and informant-report measure of one's own and one's partner's emotions. Scores for each emotion range from 1 to 5, with higher scores indicating higher levels of emotion.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  13. Working Alliance Inventory- Short form

    Self-report measure of working therapeutic alliance. Scores range from 12 to 60, with higher scores reflecting a stronger therapeutic alliance.

    Time frame: It will be administered to people with BPD and partners, as well as their therapists, approximately weekly from weeks one to 12.

  14. Posttraumatic Checklist-5 (PCL-5)

    Self-report measure of PTSD symptoms. Scores range from 0 to 80, with higher scores reflecting higher levels of PTSD severity.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  15. Informant Difficulties in Emotion Regulation Scale (DERS)

    Informant-report measure of emotion dysregulation. Scores range from 8 to 40, with higher scores reflecting higher levels of informant-reported emotion dysregulation.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  16. Depression, Anxiety, and Stress Scale- depression subscale (people with BPD)

    Self-report measure of depression. Scores range from 0 to 21, with higher scores reflecting higher levels of depression.

    Time frame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  17. Generalized Anxiety Disorder 7 (GAD-7)

    Self-report measure of anxiety. Scores range from 0 to 21, with higher scores reflecting higher levels of anxiety.

    Time frame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  18. Difficulties in Emotion Regulation Scale (DERS)

    Self-report measure of emotion dysregulation. Scores range from 36 to 180, with higher scores reflecting higher levels of emotion dysregulation.

    Time frame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  19. Experiences of Shame Scale

    Self-report measure of shame. Scores range from 25 to 100, with higher scores reflecting higher levels of shame.

    Time frame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  20. Impulsive Behaviour Scale

    Self-report measure of impulsive behaviour. Scores range from 25 to 125, with higher scores reflecting higher frequency of impulsive behaviour.

    Time frame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  21. Self Compassion Scale-Short form

    Self-report measure of self-compassion Scores range from 12 to 60, with higher scores reflecting higher levels of self-compassion.

    Time frame: It will be administered people with BPD at baseline (pre-intervention), 12 weeks, and 36 weeks.

  22. Multidimensional scale of perceived social support

    Self-report measure of perceived social support. Scores range from 1 to 7, with higher scores reflecting higher levels of perceived social support.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  23. Sexual functioning and satisfaction items

    Singular items measuring sexual functioning and satisfaction. Higher scores generally reflect higher sexual satisfaction or frequency of sexual activity.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  24. Break up items

    Singular items measuring whether the relationship has ended.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  25. Conflict tactics scale-2: Negotiation subscale

    Self-report measure of negotiation communication. Scores range from 0 to 36, with higher scores reflecting higher levels negotiation communication.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  26. Subjective emptiness scale

    Self-report measure of emptiness. Higher scores reflect higher emptiness.

    Time frame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  27. Inventory of Interpersonal Problems (IIP)- BPD subscale

    Self-report measure of interpersonal problems in BPD. Scores range from 0 to 72, with higher scores reflecting higher levels of interpersonal problems.

    Time frame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  28. Addiction Severity Index

    Self-report measure of problematic alcohol or substance use. Scores vary across substances and items, but higher scores indicate higher levels of problematic substance use.

    Time frame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  29. Kessler Psychological Distress Scale-10

    Self-report measure of psychological distress. Scores range from 10 to 50, with higher scores reflecting higher levels of psychological distress.

    Time frame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  30. Brief Inventory of Psychosocial Functioning

    Self-report measure of social functioning. Scores range from 0 to 44, with higher scores reflecting more difficulties in social functioning.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  31. Short Form (12) Health Survey

    Self-report measure of health

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  32. Barratt Impulsiveness Scale-11

    Self-report measure of impulsivity

    Time frame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  33. Columbia Suicide Severity Rating Scale- Suicidal Ideation section

    Interview measure of suicidal ideation. The presence and intensity of suicidal ideation are scored separately and range from 0 to 5 and 0 to 25, respectively, with higher scores reflecting higher severity.

    Time frame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  34. Dissociative Experiences Scale II

    Self-report measure of dissociation. Higher scores reflect higher levels of dissociation.

    Time frame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  35. Mental Health Utilization

    Qualitative interview of measure of mental health service utilization.

    Time frame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  36. Emergency Department Visits

    Interview of measure of frequency of emergency department visits and reasons for them.

    Time frame: It will be administered only to people with BPD at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  37. World Health Organization Quality of Life Items

    Three items measuring health, physical functioning, quality of life. Scores range from 1 to 5, with higher scores reflecting higher perceived health, work functioning or quality of life.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  38. Revised University of California-Los Angeles Loneliness Scale

    Self-report measure of loneliness Scores range from 20 to 80, with higher scores reflecting higher levels of loneliness.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  39. Emotion Regulation Questionnaire

    Measure of suppression and reappraisal emotion regulation strategy use. Scores range from 4 to 28 for suppression, and 6 to 42 for reappraisal, with higher scores reflecting higher emotion regulation strategy use.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  40. Relationship Questionnaire

    4-item measure of attachment. Each attachment style is rated on a scale from 1 to 7, with higher scores reflecting a higher measure of each attachment style.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  41. Mentalization Scale

    Self-report measure of mentalization. Scores range from 28 to 140.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  42. Interpersonal Needs Questionnaire

    Self-report measure of perceived burdensomeness and thwarted belongingness. Higher scores reflect higher levels of perceived burdensomeness and thwarted belongingness.

    Time frame: It will be administered people with BPD and partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  43. Test of Roles and Reactions in Dyads (TORRID)

    Self-report measure of roles partners of people with BPD play and their experiences in their relationship. Scores range depending on subscale, with higher scores reflecting higher identification with the role in question.

    Time frame: It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  44. Burden assessment scale

    Self-report measure of burden. Score ranges vary across subscales, with higher scores reflecting higher levels of burden.

    Time frame: It will be administered only to partners at baseline (pre-intervention), six weeks, 12 weeks, 16 weeks, 24 weeks, and 36 weeks.

  45. The Satisfaction With Therapy and Therapist Scale-Revised (STTS-R)

    Self-report measure of satisfaction with intervention and therapist. Scores range from 12 to 60, with higher scores reflecting higher levels of satisfaction with intervention and therapist.

    Time frame: It will be administered to people with BPD and partners at immediately after the intervention (12 weeks).

  46. Behavioural communication sample

    A videorecording of the couple discussing a problem in their relationship. The sample is then coded using a reliable and valid coding system for adaptive and maladaptive communication behaviours.

    Time frame: It will be administered to people with BPD and their partners in the Sage condition only at the first and last intervention session.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — De-identified data will be posted on a public, online data repository for the purpose of sharing it with the broader scientific community, to promote integrity and transparency in our research and allow other researchers to replicate our results from an open science framework. Demographic data will be shared only in grouped form for the entire sample (e.g., the average age of the sample, the frequencies of various racial/ethnic groups in the sample) except for participant's gender, which will be posted at the individual, rather than group, level.

Supporting information: Study protocol, Analytic code

Time frame: Following publication of primary study outcomes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2025 (actual). Primary completion is estimated for Dec 2029, 51 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2024
First posted
Jun 14, 2024
StartActual
Sep 1, 2025
Primary completionEst.
Dec 31, 2029
CompletionEst.
Mar 30, 2030
Last update
Apr 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06458933
Lead sponsor
York University
Collaborators
Centre for Addiction and Mental Health, Toronto Metropolitan University, University of Windsor, Kennesaw State University, University of Winnipeg, The Sashbear Foundation
Responsible party
Skye Fitzpatrick (Associate Professor, York University) — Principal investigator
First posted
Jun 14, 2024
Start date
Sep 1, 2025
Primary completion
Dec 31, 2029 (estimated)
Completion
Mar 30, 2030 (estimated)
Last update
Apr 1, 2026

Study contacts

Skye Fitzpatrick, PhD
Contact
skyefitz@yorku.ca
461-736-2100 ext. 66214

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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