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Completed

NCT Number: NCT05094440

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

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).

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance Use Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campbell Family Mental Health Research Institute

Toronto, Ontario, M6J 1H1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Dialectical behavioral therapy skills training (DBT-ST)

Behavioral

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.

Other names: Pocket Skills

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient Health Questionnaire-9 (Depression Subscale; PHQ-9)

    Time frame: 14 days

    Level of depressive symptoms over the past 14 days. Minimum score: 0, maximum score 27. Higher scores mean worse outcome.

  2. Generalized Anxiety Disorder-7 (GAD-7) Scale

    Time frame: 14 days

    Level of generalized anxiety symptoms over the past 14 days. Minimum score: 0, maximum score 21. Higher scores mean worse outcome.

  3. Difficulties in Emotion Regulation Scale, Short Form (DERS-SF; Kaufmann et al., 2015)

    Time frame: 30 days

    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.

  4. WHO Disability Assessment Schedule Short Form (WHODAS 2.0)

    Time frame: 30 days

    Level of functional disability in the past month. Minimum score: 0, maximum score 48. Higher scores mean worse outcome.

  5. Mindful Attention and Awareness Scale (MAAS)

    Time frame: 30 days

    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).

  6. Suicidal Behaviors Questionnaire, Revised (SBQ-R; Osman et al., 2001)

    Time frame: 30 days

    Measure of suicidal ideation and behaviors over the past month. Minimum score: 3, maximum score: 18. Higher scores indicate worse outcome.

  7. Risky, Impulsive, and Self-Destructive Questionnaire (RISQ)

    Time frame: 30 days

    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)

  8. NIDA Assist

    Time frame: 30 days

    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).

  9. Daily Drinking Questionnaire (DDQ)

    Time frame: 30 days

    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).

Other outcomes

  1. Treatment Acceptability Questionnaire (TAQ; Hunsley, 1992)

    Time frame: 8 weeks

    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.

  2. Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)

    Time frame: 30 days

    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.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • University of Missouri, St. Louis

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2021
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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