An interventional study of dialectical behavior therapy in Depression - Major Depressive Disorder, Anxiety and Depression, sponsored by University of Windsor. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by University of Windsor · Not applicable, Interventional, and Treatment
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Among 532 studies in Depression with a site in Canada — 107 open to participants now, 124 under way, 7 of them phase 3. Depression · Canada.
Among the 532 studies in Depression with a site in Canada, this one is the 336th largest by enrollment of the 487 interventional ones that give a count, is one of 40 that started in 2025, is one of 334 with no phase, and was the 503rd registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →107 of the 532 studies in Depression with a site in Canada are open now. Recruiting first, the newest first:
Lawson Research Institute of St. Joseph's · Sites in Canada
Ages 18+
Eli Lilly and Company · Sites in Canada, United States, Australia and 12 more countries
Ages 18–75
University of Regina · Sites in Canada
Ages 18+
University of Toronto · Sites in Canada
Ages 18+
Lakshmi N Yatham · Sites in Canada
Ages 19–65
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
532 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 45 · Phase 3 55 · Phase 4 37
First in 1997; this study’s year is marked. 40 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 41 is below the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 76 across the 487 interventional studies, 262 across the 45 observational. Of the 345 that completed or were terminated, 45 (13%) have results posted.
This tab as a report to print or save as PDF → With an account.
59 of 532 have an industry lead sponsor. The 10 most frequent:
University of Windsor is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
University of Windsor has 3 studies filed under Depression — fewer than ten, so there is no comparison to draw.
35 of the studies in Depression with a site in Canada that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06963021Phase 3Neurocrine BiosciencesNBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) | 2027-07 |
| NCT05543681IGC Pharma, LLCClinical Trial on Agitation in Alzheimer's Dementia | 2026-11 |
| NCT07313657Bruyère Health Research Institute.Improving Care and Mental Well-Being for Adults With Heart Failure | 2026-11-30 |
| NCT05543720University Health Network, TorontoEvaluation of Nurse-led Integrated Care of Complex Patients Facilitated By Telemonitoring: The SMaRT Study | 2026-12 |
| NCT06745349University of ReginaThe Sleep Course: An Online Sleep Intervention for Adults With Self-reported Sleep Difficulties | 2026-12 |
Add all 35 to your calendar (.ics) → With an account.
Among the 532 studies in Depression with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Dialectical behavior therapy (DBT) is a comprehensive, third-wave psychological intervention designed for patients with complex and severe behavioral, emotional, and interpersonal dysfunction. DBT has since been adapted to shorter, briefer, "skills training" formats, which have been effective for a number of mild-to-moderate mental health conditions, including depression and anxiety. Moreover, internet-delivered formats of DBT (iDBT) have similarly started to build support for their effectiveness, although there are fewer studies on digital formats. One study found that over 12 weeks, iDBT was deemed acceptable (e.g., 50% of participants were still active after 4 weeks) and there were improvements in multiple symptom domains, such as depression, anxiety, suicidality, functional disability, as well as alcohol and substance dependence.
In the current study, the investigators will examine the feasibility, acceptability, and potential efficacy of a new iDBT intervention, packaged as an online e-learning skills course, with adult participants. The study is a pilot trial as iDBT has never been tested in this format through formal research. Thus, this pilot study aims to examine whether this course is usable, practical, and potentially useful to others in the future. The investigators will recruit up to 40 individuals with mild-to-moderate depression and anxiety for an 8-week study. Following a phone screen to determine eligibility, participants will complete a baseline session where they will provide consent, complete a brief interview and questionnaires, and register for the e-learning skills course. Over the course of 8 weeks, participants will be exposed to material adapted from a DBT manual in a self-guided manner. Participants will complete follow-up assessments at 4 and 8 weeks.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
This study's enrollment of 41 is below the median of 81 across 7,066 interventional studies indexed under Depression.
Browse Depression studies →University of Windsor is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment arm
Behavioral: dialectical behavior therapy
This internet-delivered dialectical behavior therapy (iDBT) intervention consists of an e-learning course with 4 modules based on the 4 areas of skills training in dialectical behavior therapy: mindfulness, emotion regulation, distress tolerance, and interpersonal effectiveness. Participants can work through the modules at a self-guided pace to learn more than 30 specific skills using psychoeducational materials. The intervention incorporates psychoeducational elements of skills training with introductory videos, interactive quizzes, practice and homework suggestions, as well as quotes and videos from individuals with lived experience. In preliminary testing, it was estimated to take approximately 8-10 hours to complete all material.
Treatment Acceptability and Adherence Scale
The Treatment Acceptability and Adherence Scale was used to assess ratings of perceived effectiveness, trustworthiness, and likelihood of adherence using a 7-point Likert scale from 1 (disagree strongly) to 7 (agree strongly). Items are summed to create a total score, with higher ratings indicating higher acceptability and adherence.
Time frame: 4 weeks and 8 weeks
Intervention Usability Scale
The Intervention Usability Scale is a 10-item measure to assess the ease of accessing and usability of the intervention. Items are rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). A total score is created by summing the items and higher ratings indicate higher usability of the intervention.
Time frame: 4 weeks and 8 weeks
Credibility and Expectancy Questionnaire
The Credibility and Expectancy Scale is used to assess whether participants had favorable opinions of the intervention and its potential effectiveness before starting treatment. In line with previous work, the first three items were used to evaluate credibility (using a 9-point Likert scale) whereas a single item (item 4) was used to evaluate expectancy of clinical improvement (using a 11-point Likert scale from 0% to 100%). The last two items are not scored.
Time frame: Baseline
Patient Health Questionnaire Depression Subscale
The Patient Health Questionnaire Depression Subscale (PHQ-9) is a 9-item self-report measure used to assess depressive symptoms over the past two weeks. Items are rated on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). Items are summed to create a total score. Higher scores indicate greater depressive symptoms.
Time frame: Baseline, 4 weeks, and 8 weeks
Generalized Anxiety Disorder 7 Questionnaire
The Generalized Anxiety Disorder 7 Questionnaire (GAD7) is a 7-item self-report measure used to assess generalized anxiety symptoms over the past two weeks. Items are rated on a 4-point Likert scale from 0 (None at all) to 3 (Nearly Every Day). Items are summed to create a total score, with higher scores indicating greater symptoms.
Time frame: Baseline, 4 weeks, and 8 weeks
World Health Organization Disability Assessment Schedule 2.0 Short Form
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) short form is a 12-item self-report measure assessing functional disability over the past month in several domains (cognition, mobility, self-care, getting along with others). Items are rated from 0 (none) to 4 (extreme or cannot do). Items are scored to create a total score. Higher scores indicate higher functional disability.
Time frame: Baseline, 4 weeks, and 8 weeks
National Institute on Drug Abuse Assist for Alcohol and Substance Use
The National Institute on Drug Abuse (NIDA) Assist is used to assess alcohol, smoking, and substance use involvement. This measure was used to assess alcohol, tobacco, cannabis, cocaine, amphetamine-type stimulants, inhalants, sedatives/sleeping pills, hallucinogens, and opioids. Each class of substance was rated for frequency over the past month using an ordinal scale: 0 (Never); 1 (Once or twice); 2 (3 or 4 times); 3 (5, 6, or 7 times); 4 (2 or 3 times a week); 5 (4 or 5 times a week); and 6 (Daily or almost daily). Ratings can be analyzed in terms of use at the binary level overall (indicating any substance used vs. no substances used) or at the class level (indicating one class was used vs. not used). Ratings can also be summed across substance classes with higher scores interpreted as greater frequencies of substance use.
Time frame: Baseline, 4 weeks, and 8 weeks
Difficulties in Emotion Regulation Scale, Short Form
The Difficulties in Emotion Regulation Scale, Short Form (DERS-16; Kaufman et al., 2016) is a 16-item self-report measure, with excellent internal consistency, assessing emotion dysregulation based on a six-facet model first described by Gratz and Roemer (2004). Items are rated on a 5-point Likert scale from 1 (Almost Never) to 5 (Almost Always) and a total score is derived from summing the items (after reverse- scoring certain items). Higher scores reflect greater difficulties regulating emotions.
Time frame: Baseline, 4 weeks, and 8 weeks
DBT Ways of Coping Checklist, Skills Subscale
The DBT Ways of Coping Checklist (Neacsiu et al., 2010) is a 59-item self-report measure that assesses the frequency of maladaptive and adaptive skills used to manage difficult situations over the past month, with good internal consistency and test-retest reliability. In this study, the investigators only use the 38-item adaptive skills subscale, which includes skillful behaviors often learned in DBT without using DBT-specific language. Items were rated on a 4-point Likert scale from 0 (Never Used) to 3 (Regularly Used).
Time frame: Baseline, 4 weeks, and 8 weeks
Mindful Awareness and Attention Scale (MAAS)
The Mindful Awareness and Attention Scale (MAAS) is a 15-item measure of mindful attention and awareness, which is a primary target of DBT skills training. Items were rated on a 6-point Likert scale from 1 (Almost Never) to 6 (Almost Always). Higher scores reflect higher levels of dispositional mindfulness ability.
Time frame: Baseline, 4 weeks, and 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2025 to primary completion in Jul 2026, 12 months.
Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 12 months is below that.
Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University of Windsor