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Behavioral Intervention

Exposure Therapy for Child Anxiety (IMPACT Trial)

N/A
Recruiting
Led By Jennifer Freeman, PhD
Research Sponsored by Bradley Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
primary or co-primary DSM-V diagnosis of anxiety or OCD
age 5-18 inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up in-treatment and follow-up (6-12 months)
Awards & highlights

IMPACT Trial Summary

This trial will compare the effectiveness of three different types of treatment for anxiety disorders in children and adolescents. The three types of treatment are cognitive behavioral therapy with exposure (CBT), patient-centered telehealth CBT (PCT-CBT; patient-centered telehealth closed as of 5/1/21), and traditional outpatient CBT. The trial will involve 379 participants who will be randomly assigned to one of the three treatment groups. The primary outcome measures will be the changes in the participants' anxiety symptoms, functioning, and quality of life from baseline to follow-up.

Who is the study for?
This trial is for children and teens aged 5-18 with anxiety or OCD, who need outpatient care. They must have had symptoms for at least 3 months and a stable parent or guardian to participate in treatment. It's not for those with certain psychiatric disorders, unstable medication use, acute suicidality, or other concurrent psychotherapy.Check my eligibility
What is being tested?
The study tests how well cognitive behavioral therapy (CBT) with exposure works when done at home or via telehealth compared to the traditional office-based approach. The goal is to see which method helps youth with anxiety more effectively and makes treatment easier to access.See study design
What are the potential side effects?
Since this trial involves psychological therapy rather than medication, typical medical side effects are not expected. However, participants may experience temporary increases in anxiety during exposure therapy as they face their fears.

IMPACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with anxiety or OCD as my main health issue.
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I am between the ages of 5 and 18.
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My symptoms have lasted for at least 3 months.
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I have been diagnosed with anxiety or OCD.
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My symptoms have lasted for at least 3 months.
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I am between the ages of 5 and 18.

IMPACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~in-treatment and follow-up (6-12 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and in-treatment and follow-up (6-12 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Children's Yale-Brown Obsessive-Compulsive Scale
Pediatric Anxiety Rating Scale
Secondary outcome measures
Affective Reactivity Index - Parent Version (ARI-P)
Affective Reactivity Index - Self Report (ARI-S)
Barriers to Treatment Questionnaire - Parent Version (BTQ-P)
+21 more

IMPACT Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: patient-centered telehealth CBTExperimental Treatment1 Intervention
60 minute telehealth exposure therapy with a PhD psychologist once per month and a 90 minute telehealth CBT with a mobile exposure coach three times per month for a total of four visits per month (once per week). Patient-centered telehealth was closed when the recruitment goal was met in May 2021.
Group II: patient-centered home CBTExperimental Treatment1 Intervention
60 minute office-based exposure therapy with a PhD psychologist once per month and a 90 minute community-based CBT with a mobile exposure coach three times per month for a total of four visits per month (once per week)
Group III: Provider-centeredActive Control1 Intervention
60 minute office-based exposure therapy with a PhD psychologist four times per month (once per week)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exposure Therapy
2016
N/A
~300

Find a Location

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER
557 Previous Clinical Trials
29,948,999 Total Patients Enrolled
Bradley HospitalLead Sponsor
16 Previous Clinical Trials
1,115 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
244 Patients Enrolled for Obsessive-Compulsive Disorder
Brown UniversityOTHER
458 Previous Clinical Trials
558,842 Total Patients Enrolled
8 Trials studying Obsessive-Compulsive Disorder
90 Patients Enrolled for Obsessive-Compulsive Disorder

Media Library

Exposure Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03528109 — N/A
Obsessive-Compulsive Disorder Research Study Groups: patient-centered home CBT, Provider-centered, patient-centered telehealth CBT
Obsessive-Compulsive Disorder Clinical Trial 2023: Exposure Therapy Highlights & Side Effects. Trial Name: NCT03528109 — N/A
Exposure Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03528109 — N/A
~5 spots leftby Jul 2024
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