An interventional study of Dialectical Behavior Therapy in Substance Use Disorders, Alcohol Use Disorder and Depression, sponsored by University of Windsor. Completed at 1 site in Canada. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by University of Windsor · Not applicable, Interventional, and Treatment
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Among 81 studies in Substance-Related Disorders with a site in Canada — 26 open to participants now, 29 under way, none of them phase 3. Substance-Related Disorders · Canada.
Among the 81 studies in Substance-Related Disorders with a site in Canada, this one is the 58th largest by enrollment of the 71 interventional ones that give a count, is one of 5 that started in 2024, is one of 52 with no phase, and was the 69th registered.
2,241 studies on the registry are indexed under Substance-Related Disorders; 410 are open to participants now.
Browse Substance-Related Disorders studies →26 of the 81 studies in Substance-Related Disorders with a site in Canada are open now. Recruiting first, the newest first:
Sunnybrook Health Sciences Centre · Sites in Canada
Ages 18–70
St. Joseph's Healthcare Hamilton · Sites in Canada
Ages 18–55
Centre for Addiction and Mental Health · Sites in Canada
Ages 18+
University Health Network, Toronto · Sites in Canada
Ages 18–85 · Healthy volunteers
Centre hospitalier de l'Université de Montréal (CHUM) · Sites in Canada
Ages 18–55
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 265 Substance-Related Disorders studies recruiting now, 130 (49%) set no upper age limit and 117 (44%) stop at 75 or younger; 55 take children under 18; 89 take healthy volunteers.
This study: 16 Years to 70 Years · 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.
81 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 5 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 24 is below the median of 108 across 1,843 interventional studies indexed under Substance-Related Disorders.
Median enrollment 74 across the 71 interventional studies, 520 across the 9 observational. Of the 47 that completed or were terminated, 4 (9%) have results posted.
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5 of 81 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 1 study filed under Substance-Related Disorders — fewer than ten, so there is no comparison to draw.
9 of the studies in Substance-Related Disorders with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04812613Ottawa Hospital Research InstituteTobacco-Concurrent Addictions in At-Risk Youth in Ottawa | 2026-12-31 |
| NCT05704582Ciusss de L'Est de l'Île de MontréalRCT Comparing Avatar Intervention to Supportive Intervention to Reduce Cannabis Use in Patients With Psychotic Disorders | 2027-01 |
| NCT07146633Centre for Addiction and Mental HealthEfficacy of an EMDR App for PTSD and SUD | 2027-01-30 |
| NCT03249428Ottawa Hospital Research InstituteCytisine vs Nicotine Replacement Therapy | 2027-03 |
| NCT06856161Fraser HealthA Novel Blood Test as a Biomarker in Mental Health | 2027-03-15 |
Add all 9 to your calendar (.ics) → With an account.
Among the 81 studies in Substance-Related Disorders with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study aims to provide access to an adjunct intervention alongside standard group DBT services to examine feasibility, acceptability, and potential added efficacy of the adjunct. The adjunct intervention is an online tool based on DBT skills training and was already evaluated as a self-guided intervention. Participants will complete a baseline session and be given immediate access to the adjunct intervention. Participants will be followed for 12 weeks and complete assessments every 4 weeks.
The purpose of this study is to evaluate the potential benefits of an optional add-on tool (i.e., an additional tool participants can use at the same time) alongside standard dialectical behavior therapy (DBT) group treatment (i.e., skills training). The adjunct tool is an online website that participants can use on any device connected to the internet and is also based on DBT.
The proposed study will be a single-arm pragmatic clinical trial aiming to recruit 30 participants over the course of 12 months. Participation in this research study includes a telephone screening visit, informed consent, and baseline assessment visit (conducted via video conferencing). Following the baseline assessment there will be three follow-up assessments completed remotely at weeks 4, 8, and 12.
The adjunct intervention is Pocket Skills 2.0, a skills training app based on dialectical behavior therapy. Participants receive access to this tool in conjunction with their start of standard dialectical behavior therapy. A member of the research team will help participants sign-in for the first time. The tool can be used in any internet browser on any device connected to the internet (e.g., computer, smartphone, tablet). Participants are expected to use the app at least twice a week.
At baseline, a brief interview is completed, along with some questionnaires online. Participants are also asked about the treatment they recently started/plan to start. The interview (40-60 minutes) will involve questions about background, treatment history, and current and past psychological symptoms, and history of substance use. The questionnaires ask a range of questions related to mood, and difficulties with functioning, among other questions. These questions should only take about 15-20 minutes to answer and should be completed within 24 hours.
Participants receive requests to complete additional questionnaires online on three additional occasions (week 4, 8, and 12). Links to the questionnaire package will be sent via email (or text) and they will involve questions about well-being as well as a chance to provide open-ended feedback on the app itself. These surveys will take roughly 15-20 minutes. After 12 weeks, participants are reimbursed for their time.
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.
The intervention is called Pocket Skills 2.0, which is a web-based dialectical behavior therapy skills training (DBT-ST) intervention. The content and material is based on the most recent Linehan (2014) DBT-ST manual. Pocket Skills 2.0 incorporates brief lessons using videos featuring Dr. Linehan herself, exercises involving interaction with the chatbot which allow for text input and selection of responses, and the ability to gain points and unlock additional content which increases user engagement. Pocket Skills is currently the only comprehensive and not-for-profit DBT-ST app available where the effectiveness has been evaluated in at least three research trials.
Behavioral: Dialectical Behavior Therapy
Dialectical behavior therapy (DBT) in its fully adherent form is a comprehensive intervention involving individual, group, and phone coaching sessions that addresses complex psychological conditions including suicidality, personality disorders, and post-traumatic stress disorder. Evidence for briefer formats incorporating the group skills training format have been successful for many types of conditions, which includes alcohol and substance use disorders. DBT skills training (DBT-ST) involves structured lessons for learning skills in 5 areas: mindfulness, emotion regulation, distress tolerance, interpersonal effectiveness, and addiction. The current intervention is an internet-delivered version of DBT-ST which aims to teach people the same 5 areas of skills in an online environment with a chatbot and interactive format.
Severity of Dependence Scale
Level of dependence on most problematic substance over past 30 days. Minimum score: 0, maximum score 15. Higher scores mean worse outcome.
Time frame: 30 days
Patient Health Questionnaire-9 (Depression Subscale; PHQ-9)
Level of depressive symptoms over the past 14 days. Minimum score: 0, maximum score 27. Higher scores mean worse outcome.
Time frame: 14 days
Generalized Anxiety Disorder-7 (GAD-7) Scale
Level of generalized anxiety symptoms over the past 14 days. Minimum score: 0, maximum score 21. Higher scores mean worse outcome.
Time frame: 14 days
Difficulties in Emotion Regulation Scale, Short Form (DERS-SF; Kaufmann et al., 2015)
Level of emotion dysregulation or the difficulty in changing unwanted emotions effectively in the past month. Minimum score: 18, maximum score 90. Higher scores mean worse outcome.
Time frame: 30 days
WHO Disability Assessment Schedule Short Form (WHODAS 2.0)
Level of functional disability in the past month. Minimum score: 0, maximum score 48. Higher scores mean worse outcome.
Time frame: 30 days
Mindful Attention and Awareness Scale (MAAS)
Measure of core mindfulness skills around awareness and acceptance, over the past month. Minimum score: 0, maximum score 6 (mean score on 15 items). Higher scores indicate more positive outcome (e.g., more mindful awareness).
Time frame: 30 days
Suicidal Behaviors Questionnaire, Revised (SBQ-R; Osman et al., 2001)
Measure of suicidal ideation and behaviors over the past month. Minimum score: 3, maximum score: 18. Higher scores indicate worse outcome.
Time frame: 30 days
Risky, Impulsive, and Self-Destructive Questionnaire (RISQ)
Measure of risky and impulsive behavior, past month. Only subscales pertaining to sexual behavior and general reckless behavior will be used. Minimum score: 0, Maximum score: 40. Higher scores indicate worse outcome (e.g., more impulsive and/or risky behaviors)
Time frame: 30 days
NIDA Assist
Assesses the frequency of non-alcohol substance use over the past month. Minimum score per item: never used substance; maximum score per item: used substance daily or almost daily. Higher scores indicate worse outcome (e.g., more substance use).
Time frame: 30 days
Daily Drinking Questionnaire (DDQ)
Assesses the frequency and quantity of alcohol use and binge drinking episodes over the past month. Minimum score: no alcoholic drinks on specific day; Maximum score: 15+ drinks on a specific day. Higher scores indicate worse outcome (E.g., more alcoholic drinks consumed).
Time frame: 30 days
Dialectical Behavioral Therapy Ways of Coping Checklist
Assesses the frequency and intensity of using DBT skills in the past month. Investigators will use the DBT skills subscale only with an average score of 38 items presented. Higher scores indicate greater use of DBT skills.
Time frame: 30 days
Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)
Measure of treatment credibility and expectancy for interventions. Minimum score: 4; Maximum score: 56; Higher scores mean participants perceive the intervention to provide expected benefits and/or improvements.
Time frame: Baseline only
Treatment Acceptability Questionnaire (TAQ; Hunsley, 1992)
Whether or not the treatment is seen as acceptable and helpful with respect to current symptoms/problems. Minimum score: 6, maximum score: 42. Higher scores indicate better treatment acceptability and positive perceptions of the treatment.
Time frame: 30 days
Plan to share: Yes — Deidentified data can be shared upon request. An open-access database will be created to store data within 2 years of study completion.
No publications or documents are linked to this record.
Ran from Jan 2024 to primary completion in Dec 2024, 11 months.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's 11 months is below that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Windsor