Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402240
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-01-05
Brief Title:
The Pocket Skills Adjunct Project
Sponsor:
University of Windsor
Organization:
University of Windsor
Study Overview
Official Title:
Feasibility Acceptability and Potential Efficacy of an Adjunct Digital Health Solution to Standard Dialectical Behavior Therapy
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The purpose of this study is to evaluate the potential benefits of an optional add-on tool ie an additional tool you can use at the same time alongside standard dialectical behavior therapy DBT group treatment ie 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 20 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 eg 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 startedplan 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
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 20 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 eg 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 startedplan 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None