INTERVENTIONALRECRUITINGNCT07088939

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

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-05-06

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: NA
Enrollment: 40 (ESTIMATED)
Start date: 2025-07-20
Sponsor: University of Windsor
Design: NA · SINGLE GROUP · TREATMENT
Locations: 1
Results record: Not present in registry snapshot

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

Depressive Disorder

Cannabinoids and active compounds

No governed compound link was found.

Medicines

No exact medicine-name link was found.

Interventions

What was registered

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 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.

secondary measures

Credibility and Expectancy Questionnaire

Time frame: Baseline

The Credibility and Expectancy Scale is used to assess whether participants had favorable opinions of the intervention and its potential effectiveness before starting treatment. In line with previous work, the first three items were used to evaluate credibility (using a 9-point Likert scale) whereas a single item (item 4) was used to evaluate expectancy of clinical improvement (using a 11-point Likert scale from 0% to 100%). The last two items are not scored.

Patient Health Questionnaire Depression Subscale

Time frame: Baseline, 4 weeks, and 8 weeks

The Patient Health Questionnaire Depression Subscale (PHQ-9) is a 9-item self-report measure used to assess depressive symptoms over the past two weeks. Items are rated on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). Items are summed to create a total score. Higher scores indicate greater depressive symptoms.

Generalized Anxiety Disorder 7 Questionnaire

Time frame: Baseline, 4 weeks, and 8 weeks

The Generalized Anxiety Disorder 7 Questionnaire (GAD7) is a 7-item self-report measure used to assess generalized anxiety symptoms over the past two weeks. Items are rated on a 4-point Likert scale from 0 (None at all) to 3 (Nearly Every Day). Items are summed to create a total score, with higher scores indicating greater symptoms.

World Health Organization Disability Assessment Schedule 2.0 Short Form

Time frame: Baseline, 4 weeks, and 8 weeks

The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) short form is a 12-item self-report measure assessing functional disability over the past month in several domains (cognition, mobility, self-care, getting along with others). Items are rated from 0 (none) to 4 (extreme or cannot do). Items are scored to create a total score. Higher scores indicate higher functional disability.

National Institute on Drug Abuse Assist for Alcohol and Substance Use

Time frame: Baseline, 4 weeks, and 8 weeks

The National Institute on Drug Abuse (NIDA) Assist is used to assess alcohol, smoking, and substance use involvement. This measure was used to assess alcohol, tobacco, cannabis, cocaine, amphetamine-type stimulants, inhalants, sedatives/sleeping pills, hallucinogens, and opioids. Each class of substance was rated for frequency over the past month using an ordinal scale: 0 (Never); 1 (Once or twice); 2 (3 or 4 times); 3 (5, 6, or 7 times); 4 (2 or 3 times a week); 5 (4 or 5 times a week); and 6 (Daily or almost daily). Ratings can be analyzed in terms of use at the binary level overall (indicating any substance used vs. no substances used) or at the class level (indicating one class was used vs. not used). Ratings can also be summed across substance classes with higher scores interpreted as greater frequencies of substance use.

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

Protocol only - no registry results posted

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

What was registered

dialectical behavior therapy

Population and criteria

Inclusion criteria

Exclusion criteria

primary measures

Treatment Acceptability and Adherence Scale

Intervention Usability Scale

secondary measures

Credibility and Expectancy Questionnaire

Patient Health Questionnaire Depression Subscale

Generalized Anxiety Disorder 7 Questionnaire

World Health Organization Disability Assessment Schedule 2.0 Short Form

National Institute on Drug Abuse Assist for Alcohol and Substance Use

other measures

Difficulties in Emotion Regulation Scale, Short Form

DBT Ways of Coping Checklist, Skills Subscale

Mindful Awareness and Attention Scale (MAAS)

Locally readable linked articles