The Pocket Skills Adjunct Project

NCT06402240 | Completed

• 1 other identifier: 166/2023
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Substance Use Disorders; Alcohol Use Disorder; Depression; Anxiety

Keywords

dialectical behavior therapy; substance use disorders; internet-delivered; adjunct intervention; alcohol use disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (10)

• Patient Health Questionnaire-9 (Depression Subscale; PHQ-9)

  14 days

• Generalized Anxiety Disorder-7 (GAD-7) Scale

  14 days

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

  30 days

• WHO Disability Assessment Schedule Short Form (WHODAS 2.0)

  30 days

• Mindful Attention and Awareness Scale (MAAS)

  30 days

Other Outcomes (2)

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

  Baseline only

• Treatment Acceptability Questionnaire (TAQ; Hunsley, 1992)

  30 days

Study Arms (1)

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.

Behavioral: Dialectical Behavior Therapy

Interventions

Dialectical Behavior Therapy BEHAVIORAL

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.

Adjunct Intervention

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Windsor: lead
• Centre for Addiction and Mental Health: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H1, Canada

Location

MeSH Terms

Conditions

Substance-Related Disorders; Alcoholism; Depression; Anxiety Disorders

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pragmatic single-arm clinical trial.

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: May 7, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: February 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)