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CBT vs IPT for Anxiety and Obesity in Teens (ASSET Trial)

N/A
Recruiting
Research Sponsored by The Metis Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
12-17-year-old adolescent girls
Anxiety symptoms: 32 or higher on State Trait Anxiety Inventory for Children-Trait Scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post treatment
Awards & highlights

ASSET Trial Summary

This trial will explore whether interpersonal therapy or cognitive behavioral therapy is better for reducing anxiety symptoms, preventing excess weight gain, and reducing cardio-metabolic risk in adolescent girls with above-average weight and elevated anxiety.

Who is the study for?
This trial is for girls aged 12-17 who are overweight (BMI ≥ 75th percentile) and have anxiety (scoring ≥32 on a specific anxiety scale). It's not open to those with psychiatric disorders that could affect participation, current psychotherapy or mood/weight medications, medical conditions, or if pregnant/breastfeeding.Check my eligibility
What is being tested?
Project ASSET compares two therapies for anxious and overweight teens: Interpersonal Psychotherapy (IPT) versus Cognitive Behavioral Therapy (CBT). The goal is to see which better reduces anxiety, prevents weight gain, and lowers heart disease risk. This pilot will also assess the study's broader application.See study design
What are the potential side effects?
While this trial focuses on therapy without medication, side effects might include discomfort discussing personal issues or feeling upset after sessions. However, these therapies typically don't have physical side effects like drugs do.

ASSET Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a girl aged between 12 and 17.
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My anxiety score is 32 or higher on a specific test.

ASSET Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intervention Fidelity and Acceptability
Secondary outcome measures
Body Composition Measurement
Cardiometabolic Functioning
Collection of Metabolic Markers
+5 more

ASSET Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Interpersonal Psychotherapy (IPT)Experimental Treatment1 Intervention
Interpersonal Psychotherapy program adapted for the prevention of excessive weight gain. Involves one initial 1.5-hour individual session, and 12 weekly 90-minute group sessions.
Group II: Cognitive-Behavioral Therapy (CBT)Active Control1 Intervention
The CBT program will match the delivery format and dose of the IPT program. There will be one initial 1.5-hour individual session, and 12 weekly 90-minute group sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interpersonal Psychotherapy (IPT)
2006
Completed Phase 2
~190

Find a Location

Who is running the clinical trial?

Colorado State UniversityOTHER
125 Previous Clinical Trials
38,319 Total Patients Enrolled
1 Trials studying Anxiety
5 Patients Enrolled for Anxiety
The Metis FoundationLead Sponsor
8 Previous Clinical Trials
216 Total Patients Enrolled

Media Library

Cognitive Behavioral Theory (CBT) Clinical Trial Eligibility Overview. Trial Name: NCT05038033 — N/A
Anxiety Research Study Groups: Interpersonal Psychotherapy (IPT), Cognitive-Behavioral Therapy (CBT)
Anxiety Clinical Trial 2023: Cognitive Behavioral Theory (CBT) Highlights & Side Effects. Trial Name: NCT05038033 — N/A
Cognitive Behavioral Theory (CBT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05038033 — N/A

Frequently Asked Questions

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

Is there capacity for more participants in this trial?

"Affirmative. The publicly available information through clinicaltrials.gov attests to the fact that this trial is still actively recruiting participants, with 40 needed from two different locations. This research project was first posted on February 22nd 2021 and has been updated as recently as August 31st 2021."

Answered by AI

Is it possible for me to participate in this experiment?

"This trial is enrolling 40 young women between the ages of 12 and 17 who are considered overweight. To be accepted, applicants must have an anxiety score of 32 or higher on the State Trait Anxiety Inventory for Children-Trait Scale."

Answered by AI

How many individuals are receiving treatment from this trial?

"Yes, the clinicaltrials.gov database confirms that this medical study is seeking volunteers. It was first made available on February 22nd 2021 and has been recently updated on August 31st 2021. A total of 40 participants are necessary to be recruited from two different centers."

Answered by AI

Is this experiment including elderly participants exceeding 75 years of age?

"This trial has a limited age range, only admitting patients within the 12-17 year old bracket. In comparison to other trials hosted on clinicaltrials.gov, there are 714 studies for minors and 1905 studies that accept seniors as their subjects."

Answered by AI

Who else is applying?

What state do they live in?
Wyoming
Maryland
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
What site did they apply to?
Uniformed Services University
Recent research and studies
clinicaltrials.govStudy
Addressing Anxiety and Stress for Healthier Eating in Teens
2021. "Addressing Anxiety and Stress for Healthier Eating in Teens". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05038033.
All > Mental Illness > Overweight
~0 spots leftby May 2024
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