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Recruiting NCT07088939

Feasibility and Acceptability of an E-learning Dialectical Behavior Therapy Skills Course

No phase Interventional Depression - Major Depressive Disorder Anxiety Depression Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: dialectical behavior therapy.
Who it may be relevant to
Registry conditions: Depression - Major Depressive Disorder, Anxiety, Depression, Stress. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Feasibility and Acceptability of a Self-guided Internet-delivered Dialectical Behavior Therapy Intervention for Adults With Mental Health Challenges

Overview

Dialectical behavior therapy (DBT) is a comprehensive, third-wave psychological intervention designed for patients with complex and severe behavioral, emotional, and interpersonal dysfunction. DBT has since been adapted to shorter, briefer, "skills training" formats, which have been effective for a number of mild-to-moderate mental health conditions, including depression and anxiety. Moreover, internet-delivered formats of DBT (iDBT) have similarly started to build support for their effectiveness, although there are fewer studies on digital formats. One study found that over 12 weeks, iDBT was deemed acceptable (e.g., 50% of participants were still active after 4 weeks) and there were improvements in multiple symptom domains, such as depression, anxiety, suicidality, functional disability, as well as alcohol and substance dependence. In the current study, the investigators will examine the feasibility, acceptability, and potential efficacy of a new iDBT intervention, packaged as an online e-learning skills course, with adult participants. The study is a pilot trial as iDBT has never been tested in this format through formal research. Thus, this pilot study aims to examine whether this course is usable, practical, and potentially useful to others in the future. The investigators will recruit up to 40 individuals with mild-to-moderate depression and anxiety for an 8-week study. Following a phone screen to determine eligibility, participants will complete a baseline session where they will provide consent, complete a brief interview and questionnaires, and register for the e-learning skills course. Over the course of 8 weeks, participants will be exposed to material adapted from a DBT manual in a self-guided manner. Participants will complete follow-up assessments at 4 and 8 weeks.

Interventions

  • Behavioral dialectical behavior therapy
    This internet-delivered dialectical behavior therapy (iDBT) intervention consists of an e-learning course with 4 modules based on the 4 areas of skills training in dialectical behavior therapy: mindfulness, emotion regulation, distress tolerance, and interpersonal effectiveness. Participants can work through the modules at a self-guided pace to learn more than 30 specific skills using psychoeducational materials. The intervention incorporates psychoeducational elements of skills training with in

Primary outcome measures

  • Treatment Acceptability and Adherence Scale [Time frame: 4 weeks and 8 weeks]
  • Intervention Usability Scale [Time frame: 4 weeks and 8 weeks]
Secondary outcome measures (5)
  • Credibility and Expectancy Questionnaire [Time frame: Baseline]
  • Patient Health Questionnaire Depression Subscale [Time frame: Baseline, 4 weeks, and 8 weeks]
  • Generalized Anxiety Disorder 7 Questionnaire [Time frame: Baseline, 4 weeks, and 8 weeks]
  • World Health Organization Disability Assessment Schedule 2.0 Short Form [Time frame: Baseline, 4 weeks, and 8 weeks]
  • National Institute on Drug Abuse Assist for Alcohol and Substance Use [Time frame: Baseline, 4 weeks, and 8 weeks]

Eligibility criteria

Inclusion criteria

  • Ages 18 years old and up.
  • Reside in Ontario.
  • Fluent in English.
  • Able to provide autonomous informed consent
  • Reports at least mild depression and/or anxiety symptoms
  • Not currently receiving any psychotherapy or psychosocial interventions.
  • Have access to the internet

Exclusion criteria

  • Practical (e.g., scheduling), acute psychiatric (e.g., suicidal ideation nearly every day, recent hospitalization for mental health reasons), or medical reasons (e.g., upcoming surgery, medical procedure, head injury).
  • Not meeting one or more of the above inclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • University of Windsor — Windsor

Identifiers

NCT: NCT07088939 · 25-025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗