Anxiety, Depression, Depression - Major Depressive Disorder, Mood Disorders, Stress
Conditions
Keywords
dialectical behavior therapy, internet interventions, co-developed interventions, feasibility study, digital health
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.
Interventions
BEHAVIORALdialectical 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.
Sponsors
University of Windsor
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Acceptability and Adherence Scale | 4 weeks and 8 weeks | 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. |
| Intervention Usability Scale | 4 weeks and 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Credibility and Expectancy Questionnaire | 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 | 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 | 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 | 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 | 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. |
Countries
Canada
Contacts
CONTACTAlexander Daros, Ph.D., C.Psych.
CONTACTRiad El-karout
Outcome results
None listed