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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

Must not have

Other primary or co-primary psychiatric disorder which requires initiation of other active current treatment

Treatment with psychotropic medication that is not stable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up in-treatment and follow-up (6-12 months)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am starting treatment for another major mental health condition.

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My psychotropic medication dose is changing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ in-treatment and follow-up (6-12 months)

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

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

Primary study objectives

Children's Yale-Brown Obsessive-Compulsive Scale

Pediatric Anxiety Rating Scale

Secondary study objectives

Affective Reactivity Index - Parent Version (ARI-P)

Affective Reactivity Index - Self Report (ARI-S)

Barriers to Treatment Questionnaire - Parent Version (BTQ-P)

+21 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: 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

0 / 8Eligibility criteria met