Substance Use DisordersNCT06402240
The Pocket Skills Adjunct Project
A study testing Dialectical Behavior Therapy in people with Substance Use Disorders and Alcohol Use Disorder, run by University of Windsor at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Substance Use Disorders, Alcohol Use Disorder, Depression
- What is being tested?
- Dialectical Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2024to 1 Feb 2025
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 16 to 70
- Fluency in English.
- Understanding and willingness to comply with study requirements / capable of providing autonomous informed consent.
- Smartphone or tablet capable of downloading and running the web application, or a computer with access to the internet.
- Past year alcohol or substance use disorder
- Use of alcohol or substance in the past month.
- Starting DBT or has started DBT within the last 15 days.
- Reports at least "contemplation" levels (score of 4+) of change with respect to substance use problems.
Who cannot join
- Any known practical factors that would preclude participation (e.g., extended absences) in the study.
- Acute psychiatric (e.g., psychosis, mania) or medical condition (including acute intoxication or withdrawal requiring medical attention) that precludes participation in this study.
- Participation in another treatment/intervention study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Acceptability, and Potential Efficacy of an Adjunct Digital Health Solution to Standard Dialectical Behavior Therapy
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.
Read the detailed description
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.
- Conditions
- Substance Use Disorders, Alcohol Use Disorder, Depression, Anxiety
- Being tested
- Dialectical Behavior Therapy
- Keywords
- dialectical behavior therapy, substance use disorders, internet-delivered, adjunct intervention, alcohol use disorder
- Medical subject headings
- Substance-Related Disorders, Alcoholism, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical Behavior TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Adjunct Intervention | Experimental | 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. Receives: Behavioral: Dialectical Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pragmatic single-arm clinical trial.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Windsor
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Addiction and Mental Health
- Responsible party
- Principal investigator, Alexander Daros, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402240
- Sponsor's protocol ID
- 166/2023
- Status last verified
- Mar 2025
- First submitted
- 5 Jan 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data can be shared upon request. An open-access database will be created to store data within 2 years of study completion.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Potential Efficacy of an Adjunct Digital Health Solution to Standard Dialectical Behavior Therapy
- ClinicalTrials.gov ID
- NCT06402240
- Acronym / sponsor ID
- 166/2023
- Conditions
- Substance Use Disorders, Alcohol Use Disorder, Depression, Anxiety
- Keywords
- dialectical behavior therapy, substance use disorders, internet-delivered, adjunct intervention, alcohol use disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of WindsorUniversity, hospital or other
- Collaborators
- Centre for Addiction and Mental Health
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 7 May 2024 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pragmatic single-arm clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Adjunct Intervention | Experimental | Behavioral: Dialectical Behavior TherapyThe 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. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age 16 to 70
- Fluency in English.
- Understanding and willingness to comply with study requirements / capable of providing autonomous informed consent.
- Smartphone or tablet capable of downloading and running the web application, or a computer with access to the internet.
- Past year alcohol or substance use disorder
Key exclusion criteria (3 listed)
- Any known practical factors that would preclude participation (e.g., extended absences) in the study.
- Acute psychiatric (e.g., psychosis, mania) or medical condition (including acute intoxication or withdrawal requiring medical attention) that precludes participation in this study.
- Participation in another treatment/intervention study.
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 |
|---|---|---|
| Dialectical Behavior TherapyDialectical 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. | Behavioural | Adjunct Intervention |
Primary outcome
Severity of Dependence Scale
Time frame: 30 days
Level of dependence on most problematic substance over past 30 days. Minimum score: 0, maximum score 15. Higher scores mean worse outcome.
10 secondary outcomes
Patient Health Questionnaire-9 (Depression Subscale; PHQ-9)
Time frame: 14 days
Generalized Anxiety Disorder-7 (GAD-7) Scale
Time frame: 14 days
Difficulties in Emotion Regulation Scale, Short Form (DERS-SF; Kaufmann et al., 2015)
Time frame: 30 days
WHO Disability Assessment Schedule Short Form (WHODAS 2.0)
Time frame: 30 days
Mindful Attention and Awareness Scale (MAAS)
Time frame: 30 days
Suicidal Behaviors Questionnaire, Revised (SBQ-R; Osman et al., 2001)
Time frame: 30 days
Risky, Impulsive, and Self-Destructive Questionnaire (RISQ)
Time frame: 30 days
NIDA Assist
Time frame: 30 days
Daily Drinking Questionnaire (DDQ)
Time frame: 30 days
Dialectical Behavioral Therapy Ways of Coping Checklist
Time frame: 30 days
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 2 Apr 2025.
- Individual participant dataSharing planned: Yes. Deidentified data can be shared upon request. An open-access database will be created to store data within 2 years of study completion.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical Behavior Therapy in people with Substance Use Disorders and Alcohol Use Disorder, run by University of Windsor 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 8 inclusion and 3 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 2 Apr 2025. 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?
Severity of Dependence Scale (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2025.