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A Dialectical Behavioral Therapy Digital Health Solution for Outpatients Seeking Support for Substance Use

Feasibility, Acceptability, and Efficacy of a Dialectical Behavioral Therapy Digital Health Solution in the CAMH Rainbow/COMPASS Service

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05094440
Enrollment
76
Registered
2021-10-26
Start date
2021-11-08
Completion date
2023-05-31
Last updated
2023-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder, Substance Use Disorders

Keywords

dialectical behavior therapy, digital health

Brief 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 (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.

Interventions

BEHAVIORALDialectical 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 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.

Sponsors

University of Missouri, St. Louis
CollaboratorOTHER
Centre for Addiction and Mental Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. 18-65 years of age 2. Fluency in English 3. Understanding and willingness to comply with study requirements 4. Referred to Addictions Program at CAMH or seeking treatment from the community and currently waiting for psychosocial services 5. Smartphone, tablet, or computer with access to the Internet 6. Reports at least contemplation levels of wanting to reduce substance use 7. Use of target substance in past month 8. Alcohol or substance use disorder in the past year

Exclusion criteria

1. Any known practical factor that would preclude participation (e.g., extended absences) 2. Untreated or unstable severe psychiatric or medical disorder that precludes participation in the study (e.g., acute suicidality, untreated psychosis) 3. Participation in another treatment/intervention study

Design outcomes

Primary

MeasureTime frameDescription
Severity of Dependence Scale30 daysLevel of dependence on most problematic substance over past 30 days. Minimum score: 0, maximum score 15. Higher scores mean worse outcome.

Secondary

MeasureTime frameDescription
Risky, Impulsive, and Self-Destructive Questionnaire (RISQ)30 daysMeasure 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)
NIDA Assist30 daysAssesses 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).
Patient Health Questionnaire-9 (Depression Subscale; PHQ-9)14 daysLevel of depressive symptoms over the past 14 days. Minimum score: 0, maximum score 27. Higher scores mean worse outcome.
Generalized Anxiety Disorder-7 (GAD-7) Scale14 daysLevel of generalized anxiety symptoms over the past 14 days. Minimum score: 0, maximum score 21. Higher scores mean worse outcome.
Difficulties in Emotion Regulation Scale, Short Form (DERS-SF; Kaufmann et al., 2015)30 daysLevel 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.
Suicidal Behaviors Questionnaire, Revised (SBQ-R; Osman et al., 2001)30 daysMeasure of suicidal ideation and behaviors over the past month. Minimum score: 3, maximum score: 18. Higher scores indicate worse outcome.
Daily Drinking Questionnaire (DDQ)30 daysAssesses 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).
WHO Disability Assessment Schedule Short Form (WHODAS 2.0)30 daysLevel of functional disability in the past month. Minimum score: 0, maximum score 48. Higher scores mean worse outcome.
Mindful Attention and Awareness Scale (MAAS)30 daysMeasure 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).

Other

MeasureTime frameDescription
Treatment Acceptability Questionnaire (TAQ; Hunsley, 1992)8 weeksWhether 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.
Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)30 daysMeasure 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026