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Online Tool with Dialectical Behavior Therapy for Depression

N/A

Recruiting

Research Sponsored by University of Windsor

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 16 to 70

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will provide participants with an online tool that complements standard group therapy for Dialectical Behavior Therapy (DBT). The study will assess how well participants respond to this online tool and whether it

Who is the study for?

This trial is for individuals struggling with alcoholism, substance use disorders, depression, or anxiety. Participants should already be receiving standard group Dialectical Behavior Therapy (DBT) services and are interested in an additional online tool to support their treatment.

What is being tested?

The study tests an online adjunct intervention based on DBT skills training. It's designed to see if adding this tool to regular group therapy sessions helps people more than the therapy alone over a period of 12 weeks with assessments every 4 weeks.

What are the potential side effects?

Since the intervention is a non-medical online tool for behavior therapy, there are no direct physical side effects like you'd expect from medication. However, participants may experience emotional discomfort as they engage with therapeutic material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 16 and 70 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline only

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline only

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline only for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Severity of Dependence Scale

Secondary study objectives

Daily Drinking Questionnaire (DDQ)

Dialectical Behavioral Therapy Ways of Coping Checklist

Difficulties in Emotion Regulation Scale, Short Form (DERS-SF; Kaufmann et al., 2015)

+7 more

Other study objectives

Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)

Treatment Acceptability Questionnaire (TAQ; Hunsley, 1992)

Side effects data

From 2012 Phase 4 trial • 91 Patients • NCT00533117

Hospitalization or ED visitn

100%

80%

60%

40%

20%

Study treatment Arm

Dialectical Behavior Therapy With Fluoxetine

Supportive Therapy With Fluoxetine

Dialectical Behavior Therapy With Placebo

Supportive Therapy With Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Adjunct InterventionExperimental Treatment1 Intervention

The intervention is called Pocket Skills 2.0, which is a web-based dialectical behavior therapy skills training (DBT-ST) intervention. The content and material is based on the most recent Linehan (2014) DBT-ST manual. Pocket Skills 2.0 incorporates brief lessons using videos featuring Dr. Linehan herself, exercises involving interaction with the chatbot which allow for text input and selection of responses, and the ability to gain points and unlock additional content which increases user engagement. Pocket Skills is currently the only comprehensive and not-for-profit DBT-ST app available where the effectiveness has been evaluated in at least three research trials.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dialectical Behavior Therapy

2016

Completed Phase 4

~960

0 / 1Eligibility criteria met