Clinical trial NCT06402240: The Pocket Skills Adjunct Project
Official title: Feasibility, Acceptability, and Potential Efficacy of an Adjunct Digital Health Solution to Standard Dialectical Behavior Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Alcohol Use Disorder
Depression
Anxiety
Keywords: dialectical behavior therapy
substance use disorders
internet-delivered
adjunct intervention
alcohol use disorder
Lead sponsor: University of Windsor
Sponsor class: OTHER
Collaborators: name: Centre for Addiction and Mental Health
First posted: 2024-05-07
Enrollment: 24
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pragmatic single-arm clinical trial.
Primary purpose: TREATMENT

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 (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.

Eligibility criteria: Inclusion Criteria:

1. Age 16 to 70
2. Fluency in English.
3. Understanding and willingness to comply with study requirements / capable of providing autonomous informed consent.
4. Smartphone or tablet capable of downloading and running the web application, or a computer with access to the internet.
5. Past year alcohol or substance use disorder
6. Use of alcohol or substance in the past month.
7. Starting DBT or has started DBT within the last 15 days.
8. Reports at least "contemplation" levels (score of 4+) of change with respect to substance use problems.

Exclusion Criteria:

1. Any known practical factors that would preclude participation (e.g., extended absences) in the study.
2. Acute psychiatric (e.g., psychosis, mania) or medical condition (including acute intoxication or withdrawal requiring medical attention) that precludes participation in this study.
3. Participation in another treatment/intervention study.

Primary outcomes:
measure: Severity of Dependence Scale
timeFrame: 30 days
Secondary outcomes:
measure: Patient Health Questionnaire-9 (Depression Subscale; PHQ-9)
timeFrame: 14 days
measure: Generalized Anxiety Disorder-7 (GAD-7) Scale
timeFrame: 14 days
measure: Difficulties in Emotion Regulation Scale, Short Form (DERS-SF; Kaufmann et al., 2015)
timeFrame: 30 days
measure: WHO Disability Assessment Schedule Short Form (WHODAS 2.0)
timeFrame: 30 days
measure: Mindful Attention and Awareness Scale (MAAS)
timeFrame: 30 days
measure: Suicidal Behaviors Questionnaire, Revised (SBQ-R; Osman et al., 2001)
timeFrame: 30 days
measure: Risky, Impulsive, and Self-Destructive Questionnaire (RISQ)
timeFrame: 30 days
measure: NIDA Assist
timeFrame: 30 days
measure: Daily Drinking Questionnaire (DDQ)
timeFrame: 30 days
measure: Dialectical Behavioral Therapy Ways of Coping Checklist
timeFrame: 30 days
Other outcomes:
measure: Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)
timeFrame: Baseline only
measure: Treatment Acceptability Questionnaire (TAQ; Hunsley, 1992)
timeFrame: 30 days
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
References: