Alcohol Use DisorderNCT05094440
A Dialectical Behavioral Therapy Digital Health Solution for Outpatients Seeking Support for Substance Use
A study testing Dialectical behavioral therapy skills training (DBT-ST) in people with Alcohol Use Disorder and Substance Use Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The purpose of this study is to compare the feasibility, acceptability, and efficacy of a dialectical behavior therapy skills training webapp known as "Pocket Skills" in outpatients and community members seeking treatment for substance use, across those who receive immediate versus delayed access to the intervention… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder, Substance Use Disorders
- What is being tested?
- Dialectical behavioral therapy skills training (DBT-ST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- 8 Nov 2021to 31 May 2023
- 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
- 18-65 years of age
- Fluency in English
- Understanding and willingness to comply with study requirements
- Referred to Addictions Program at CAMH or seeking treatment from the community and currently waiting for psychosocial services
- Smartphone, tablet, or computer with access to the Internet
- Reports at least "contemplation" levels of wanting to reduce substance use
- Use of target substance in past month
- Alcohol or substance use disorder in the past year
Who cannot join
- Any known practical factor that would preclude participation (e.g., extended absences)
- Untreated or unstable severe psychiatric or medical disorder that precludes participation in the study (e.g., acute suicidality, untreated psychosis)
- Participation in another treatment/intervention study
Trial locations and contacts
1 site in 1 country.
Canada1 site
Campbell Family Mental Health Research Institute
Toronto, Ontario, M6J 1H1
About this study
Official title: Feasibility, Acceptability, and Efficacy of a Dialectical Behavioral Therapy Digital Health Solution in the CAMH Rainbow/COMPASS Service
The purpose of this study is to compare the feasibility, acceptability, and efficacy of a dialectical behavior therapy skills training webapp known as "Pocket Skills" in outpatients and community members seeking treatment for substance use, across those who receive immediate versus delayed access to the intervention (e.g., a waitlist control condition).
Read the detailed description
Seventy adult outpatients and community members seeking treatment for substance use from the Centre for Addiction and Mental Health Addictions Program will be randomized to receive immediate or delayed (1 month) access to a web-based DBT skills training intervention called Pocket Skills in addition to standard care. Participants will complete interviews and questionnaires at baseline. Following baseline, participants complete questionnaires at months 1, 2, and 3 months. Measures will assess alcohol and drug consumption, substance use disorder symptoms, and other clinical features.
- Conditions
- Alcohol Use Disorder, Substance Use Disorders
- Being tested
- Dialectical behavioral therapy skills training (DBT-ST)
- Keywords
- dialectical behavior therapy, digital health
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical behavioral therapy skills training (DBT-ST)Behavioural
Also called Pocket Skills
Pocket Skills is a dialectical behavior therapy skills training (DBT-ST) webapp that includes video lessons, an interactive chatbot AI coach, and in-app exercises to practice DBT skills. The delivery of the app will occur primarily over 1 month, followed by 2 months of follow-up, and will be supplemented with a walk through manual and links to DBT worksheets.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment | Experimental | Pocket Skills is a dialectical behavior therapy skills training (DBT-ST) webapp that includes video lessons, an interactive chatbot AI coach, and in-app exercises to practice DBT skills. The delivery of the app intervention will be primarily monitored for one month, but followed for up to 3 months, and will be supplemented with a walk through manual and links to DBT worksheets. The intervention will be delivered in conjunction with treatment as usual which includes standard psychosocial care (e.g., assessments, group, and individual programming) as part of the Addictions Program or greater community. Receives: Behavioral: Dialectical behavioral therapy skills training (DBT-ST) |
| Waitlist and Delayed Treatment | Active comparator | Waitlist control whereby outpatients or members of the community will wait 1 month (4 weeks) to receive the intervention and then receive the Pocket Skills webapp for the subsequent 2 months (8 weeks). The waitlist period and subsequent intervention will be delivered in conjunction with treatment as usual which includes standard psychosocial care (e.g., assessments, group, and individual programming) as part of the Addictions Program. Receives: Behavioral: Dialectical behavioral therapy skills training (DBT-ST) |
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 (9)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start8 Nov 2021
- Primary completion31 May 2023
- Study completion31 May 2023
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 Alcohol Use 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Missouri, St. Louis
- Responsible party
- Principal investigator, Lena Quilty, Centre for Addiction and Mental Health
- Investigators
- Lena C. Quilty, Ph.D., Principal investigator, Campbell Family Mental Health Research Institute, CAMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094440
- Sponsor's protocol ID
- 016/2021
- Status last verified
- Sep 2023
- First submitted
- 14 Oct 2021
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Daros AR, Guimond TH, Yager C, Palermo EH, Wilks CR, Quilty LC. Feasibility, Acceptability, and Potential Efficacy of a Self-Guided Internet-Delivered Dialectical Behavior Therapy Intervention for Substance Use Disorders: Randomized Controlled Trial. JMIR Ment Health. 2024 Jan 16;11:e50399. doi: 10.2196/50399.
PubMed 38227362
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Efficacy of a Dialectical Behavioral Therapy Digital Health Solution in the CAMH Rainbow/COMPASS Service
- ClinicalTrials.gov ID
- NCT05094440
- Acronym / sponsor ID
- 016/2021
- Conditions
- Alcohol Use Disorder, Substance Use Disorders
- Keywords
- dialectical behavior therapy, digital health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- University of Missouri, St. Louis
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 26 Oct 2021 (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.
The purpose of this study is to compare the feasibility, acceptability, and efficacy of a dialectical behavior therapy skills training webapp known as "Pocket Skills" in outpatients and community members seeking treatment for substance use, across those who receive immediate versus delayed access to the intervention (e.g., a waitlist control condition).
Detailed description
Seventy adult outpatients and community members seeking treatment for substance use from the Centre for Addiction and Mental Health Addictions Program will be randomized to receive immediate or delayed (1 month) access to a web-based DBT skills training intervention called Pocket Skills in addition to standard care. Participants will complete interviews and questionnaires at baseline. Following baseline, participants complete questionnaires at months 1, 2, and 3 months. Measures will assess alcohol and drug consumption, substance use disorder symptoms, and other clinical features.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Experimental | Behavioral: Dialectical behavioral therapy skills training (DBT-ST)Pocket Skills is a dialectical behavior therapy skills training (DBT-ST) webapp that includes video lessons, an interactive chatbot AI coach, and in-app exercises to practice DBT skills. The delivery of the app intervention will be primarily monitored for one month, but followed for up to 3 months, and will be supplemented with a walk through manual and links to DBT worksheets. The intervention will be delivered in conjunction with treatment as usual which includes standard psychosocial care (e.g., assessments, group, and individual programming) as part of the Addictions Program or greater community. |
| Waitlist and Delayed Treatment | Active comparator | Behavioral: Dialectical behavioral therapy skills training (DBT-ST)Waitlist control whereby outpatients or members of the community will wait 1 month (4 weeks) to receive the intervention and then receive the Pocket Skills webapp for the subsequent 2 months (8 weeks). The waitlist period and subsequent intervention will be delivered in conjunction with treatment as usual which includes standard psychosocial care (e.g., assessments, group, and individual programming) as part of the Addictions Program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-65 years of age
- Fluency in English
- Understanding and willingness to comply with study requirements
- Referred to Addictions Program at CAMH or seeking treatment from the community and currently waiting for psychosocial services
- Smartphone, tablet, or computer with access to the Internet
Key exclusion criteria (3 listed)
- Any known practical factor that would preclude participation (e.g., extended absences)
- Untreated or unstable severe psychiatric or medical disorder that precludes participation in the study (e.g., acute suicidality, untreated psychosis)
- 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 behavioral therapy skills training (DBT-ST)Also: Pocket SkillsPocket Skills is a dialectical behavior therapy skills training (DBT-ST) webapp that includes video lessons, an interactive chatbot AI coach, and in-app exercises to practice DBT skills. The delivery of the app will occur primarily over 1 month, followed by 2 months of follow-up, and will be supplemented with a walk through manual and links to DBT worksheets. | Behavioural | Immediate Treatment, Waitlist and Delayed Treatment |
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.
9 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
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 15 Sep 2023.
- Derived from this study: PubMed 38227362Daros AR, Guimond TH, Yager C, Palermo EH, Wilks CR, Quilty LC. Feasibility, Acceptability, and Potential Efficacy of a Self-Guided Internet-Delivered Dialectical Behavior Therapy Intervention for Substance Use Disorders: Randomized Controlled Trial. JMIR Ment Health. 2024 Jan 16;11:e50399. doi: 10.2196/50399.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
- Study webpageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Lena C. Quilty, Ph.D. principal investigator
Campbell Family Mental Health Research Institute, CAMH
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 behavioral therapy skills training (DBT-ST) in people with Alcohol Use Disorder and Substance Use Disorders, run by Centre for Addiction and Mental Health 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 15 Sep 2023. 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?
On the ClinicalTrials.gov record for NCT05094440, 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 15 Sep 2023; AzTrials last refreshed its copy on 31 Oct 2026.