Behavioral Intervention

Dialectical behavioral therapy for Type 2 Diabetes

Q: Is the minimum age threshold for enrolment into this clinical research 18 years or older?

<p>The enrollment criteria for this research project <a href="https://www.withpower.com/clinical-trials/all">all</a>ows individuals aged between 14 and 17 to participate. To further contextualize, there are 195 clinical trials available to minors while 1077 have been designed with elderly people in mind.</p>

University of Calgary, Calgary, Canada

Targeting 2 different conditionsDialectical behavioral therapy +1 moreN/AWaitlist AvailableResearch Sponsored by University of Manitoba

Eligibility Criteria Checklist

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

Must have

signs of mild-moderate depression (PHQ-9 score 5-19)

Be younger than 18 years old

Must not have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upone week at week 16 and week 32

Awards & highlights

No Placebo-Only Group

Study Summary

This trial is testing a new therapy to help improve quality of life and weight management in youth at risk for type 2 diabetes.

Eligible Conditions

Prevention
Type 2 Diabetes

Eligibility Criteria

Inclusion Criteria

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

Select...

You have mild to moderate depression, as measured by a questionnaire called the PHQ-9, with a score between 5 and 19.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one week at week 16 and week 32

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one week at week 16 and week 32

This trial's timeline: 3 weeks for screening, Varies for treatment, and one week at week 16 and week 32 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to the intervention

Enrollment rates

Retention for follow up measurements

Secondary outcome measures

Barriers for lifestyle change

DBT benefits and challenges

DBT skills training

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Lifestyle aloneExperimental Treatment1 Intervention

Participants will receive 2 lifestyle sessions per week, one 90 minutes in length and the other 60 minutes for 16 weeks.

Group II: DBT + lifestyleExperimental Treatment2 Interventions

Participants will receive 90 minutes of dialectical behavioral therapy and 60 minutes of lifestyle sessions each week for 16 weeks.

Group III: ControlActive Control1 Intervention

Participants will be included in baseline, endpoint and follow up measurements, but will receive no form of intervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dialectical behavioral therapy

2019

N/A

~40

Lifestyle

2016

Completed Phase 4

~8600

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

University of ManitobaLead Sponsor

565 Previous Clinical Trials

194,658 Total Patients Enrolled

Diabetes CanadaOTHER

7 Previous Clinical Trials

772 Total Patients Enrolled

Children's Hospital Research Institute of Manitoba (CHRIM)UNKNOWN

1 Previous Clinical Trials

40 Total Patients Enrolled

Media Library

Dialectical Behavioral Therapy (DBT) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05338944 — N/A

Type 2 Diabetes Research Study Groups: DBT + lifestyle, Lifestyle alone, Control

Type 2 Diabetes Clinical Trial 2023: Dialectical Behavioral Therapy (DBT) Highlights & Side Effects. Trial Name: NCT05338944 — N/A

Dialectical Behavioral Therapy (DBT) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05338944 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently available for this trial?

"The clinical trial, which was first proposed on January 1st 2023 and last amended October 5th 2022, is actively seeking participants."

Answered by AI

Who qualifies to participate in this clinical experiment?

"This study seeks 15 volunteers between 14 and 17 years old who present with prevention, a BMI z-score greater than 1.6, willingness to commit to the trial's procedures as well as evidence of mild-moderate depression (PHQ-9 score 5-19)."

Answered by AI

How many individuals are currently enrolled in this research endeavor?

"That is accurate. According to the information on clinicaltrials.gov, this research project has been accepting recruits since 1/1/2023 and was most recently updated on 10/5/2022. The trial seeks 15 individuals from a single location."

Answered by AI

Is the minimum age threshold for enrolment into this clinical research 18 years or older?

"The enrollment criteria for this research project allows individuals aged between 14 and 17 to participate. To further contextualize, there are 195 clinical trials available to minors while 1077 have been designed with elderly people in mind."

Answered by AI

What objectives is this clinical trial aiming to accomplish?

"This research study has two primary outcomes that will be assessed over a duration of 32 weeks. These are enrollment rates and patient-centeredness, which is evaluated using focus groups and feedback forms. Secondary objectives include evaluating delivery of the behavioural intervention, barriers for lifestyle change (gathered through photovoice participation at 16 weeks), as well as other mental health co-morbidities related to self-regulation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DBT to Enhance Health Behaviour Change for Adolescents Living With Obesity

Jon McGavock 2023. "DBT to Enhance Health Behaviour Change for Adolescents Living With Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05338944.