NCT07088939

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Jul 2025Aug 2026

First Submitted

Initial submission to the registry

July 16, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

July 20, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

July 16, 2025

Last Update Submit

April 30, 2026

Conditions

Keywords

dialectical behavior therapyinternet interventionsco-developed interventionsfeasibility studydigital health

Outcome Measures

Primary Outcomes (2)

  • Treatment Acceptability and Adherence Scale

    The Treatment Acceptability and Adherence Scale was used to assess ratings of perceived effectiveness, trustworthiness, and likelihood of adherence using a 7-point Likert scale from 1 (disagree strongly) to 7 (agree strongly). Items are summed to create a total score, with higher ratings indicating higher acceptability and adherence.

    4 weeks and 8 weeks

  • Intervention Usability Scale

    The Intervention Usability Scale is a 10-item measure to assess the ease of accessing and usability of the intervention. Items are rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). A total score is created by summing the items and higher ratings indicate higher usability of the intervention.

    4 weeks and 8 weeks

Secondary Outcomes (5)

  • Credibility and Expectancy Questionnaire

    Baseline

  • Patient Health Questionnaire Depression Subscale

    Baseline, 4 weeks, and 8 weeks

  • Generalized Anxiety Disorder 7 Questionnaire

    Baseline, 4 weeks, and 8 weeks

  • World Health Organization Disability Assessment Schedule 2.0 Short Form

    Baseline, 4 weeks, and 8 weeks

  • National Institute on Drug Abuse Assist for Alcohol and Substance Use

    Baseline, 4 weeks, and 8 weeks

Other Outcomes (3)

  • Difficulties in Emotion Regulation Scale, Short Form

    Baseline, 4 weeks, and 8 weeks

  • DBT Ways of Coping Checklist, Skills Subscale

    Baseline, 4 weeks, and 8 weeks

  • Mindful Awareness and Attention Scale (MAAS)

    Baseline, 4 weeks, and 8 weeks

Study Arms (1)

Internet-delivered, self-guided dialectical behavior therapy

EXPERIMENTAL

Treatment arm

Behavioral: dialectical behavior therapy

Interventions

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 introductory videos, interactive quizzes, practice and homework suggestions, as well as quotes and videos from individuals with lived experience. In preliminary testing, it was estimated to take approximately 8-10 hours to complete all material.

Internet-delivered, self-guided dialectical behavior therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Windsor

Windsor, Ontario, N9B 3P4, Canada

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersDepressionMood Disorders

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Alexander Daros, Ph.D., C.Psych.

CONTACT

Riad El-karout

CONTACT

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

Study Record Dates

First Submitted

July 16, 2025

First Posted

July 28, 2025

Study Start

July 20, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations