NCT06402240

The Pocket Skills Adjunct Project

Feasibility, Acceptability, and Potential Efficacy of an Adjunct Digital Health Solution to Standard Dialectical Behavior Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Windsor · Academic / Other
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
BEHAVIORAL	Dialectical Behavior Therapy	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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-12-31
• Completion: 2025-02-01
• First posted: 2024-05-07
• Last updated: 2025-04-02

Locations

1 site across 1 country: Canada