NCT02810171

Brief Summary

Anxiety is among the most prevalent, costly and disabling illnesses and tends emerge early in childhood. Cognitive behavioral therapy (CBT) is the first-line treatment for early life anxiety, but as many as 40% of young patients who receive CBT fail to get better. The proposed study will examine brain changes marking positive response to CBT for anxiety and how these changes may differ in children compared adolescents. By helping us to understand how CBT works, this study will pave the way for new treatments to stop anxiety early.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2021

Completed
Last Updated

December 20, 2021

Status Verified

July 1, 2021

Enrollment Period

4.6 years

First QC Date

June 20, 2016

Last Update Submit

December 4, 2021

Conditions

Anxiety DisordersSocial Anxiety DisorderSocial PhobiaGeneralized Anxiety DisorderSeparation Anxiety DisorderSpecific PhobiaPhobiaAgoraphobiaPanic DisorderPanic AttackAnxiety

Keywords

anxietysocial anxiety disordergeneralized anxiety disorderphobiasfearsworry

Outcome Measures

Primary Outcomes (1)

  • Brain function/structure as assessed by Magnetic Resonance Imaging scans

    Pre- to post-CBT changes in functional, connectivity and structural MRI measures of brain networks relevant for anxiety. Brain regions include the amygdala, anterior insula, dorsal anterior cingulate cortex (dACC) and ventrolateral prefrontal cortex (vlPFC). Functional activation and connectivity of these brain regions are assessed using simple computer tasks performed during MRI scanning. Tasks engage threat reactivity, self-regulatory control and the interaction of these processes. Structural connections between regions will be measured using a MRI technique that measures water diffusion in the brain.

    Baseline and 12-weeks

Secondary Outcomes (1)

  • Pediatric Anxiety Rating Scale

    weeks 0, 3, 6, 9, 12

Study Arms (3)

Cognitive Behavioral Therapy

ACTIVE COMPARATOR
Behavioral: Cognitive Behavioral Therapy

Relaxation Therapy

OTHER
Behavioral: Relaxation Therapy

No Intervention: Healthy youth only

NO INTERVENTION

Healthy control participants, matched to gender and age with anxiety patients, will be enrolled. These healthy participants will be scanned with fMRI before and after \~16 weeks, but without any intervention (i.e., no therapy).

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

A therapy which teaches patients coping skills to manage anxiety and gradually yet repeatedly exposes patients to anxiety-provoking thoughts and situations until the anxiety habituates/diminishes.

Also known as: CBT
Cognitive Behavioral Therapy
Relaxation TherapyBEHAVIORAL

An active control therapy with minimal effects on anxiety symptoms. If randomized to this therapy, participants will have the option to cross-over to CBT once the relaxation therapy arms has been completed.

Relaxation Therapy

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age 7.0 - 17.99 years
  • Parent or guardian able and willing to give informed consent
  • Ability to tolerate small, enclosed spaces

You may not qualify if:

  • No metals, implants or metallic substances within or on the body (e.g., orthodontic braces)
  • Vision equal to or better than 20/30 on a Snelling chart, with correction if necessary
  • Not currently taking any psychotropic medication or receiving any psychotherapy (stable doses of stimulants allowable for anxiety subjects with comorbid attention deficit hyperactivity disorder) or receiving hormone therapy other than birth control
  • No lifetime diagnoses of psychotic disorder, mental retardation or autism
  • No history of current substance/alcohol abuse/dependence
  • No evidence of suicidal intentions or behaviors in the past 6 months
  • No history of serious medical or neurological illness
  • If post-pubertal female, not pregnant
  • Clinically significant anxiety as determined by structured clinical interview
  • Past history of major depressive episodes are allowable
  • Past history substance/alcohol abuse allowable if in remission for at least 1 year
  • Obsessive-compulsive disorder symptoms are acceptable if not the primary source of interference or distress
  • Anxiety must be primary concern, still bothersome, and CBT for anxiety determined to be appropriate treatment
  • No history of past or current mental illness as determined by structured clinical interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (3)

  • Bilek EL, Iturra-Mena AM, Becker HC, Phan KL, Monk CS, Fitzgerald KD. Exposure-Focused Cognitive-Behavioral Therapy for Youth Anxiety Disorders: Superiority Over Relaxation-Based Comparator and Predictors of Response. JAACAP Open. 2025 Apr 25;3(4):1161-1176. doi: 10.1016/j.jaacop.2025.04.003. eCollection 2025 Dec.

    PMID: 41367992DERIVED

  • Diaz DE, Russman Block SR, Becker HC, Phan KL, Monk CS, Fitzgerald KD. Neural Substrates of Emotion Processing and Cognitive Control Over Emotion in Youth Anxiety: An RDoC-Informed Study Across the Clinical to Nonclinical Continuum of Severity. J Am Acad Child Adolesc Psychiatry. 2025 Apr;64(4):488-498. doi: 10.1016/j.jaac.2024.06.010. Epub 2024 Jul 24.

    PMID: 39059719DERIVED

  • Rueppel M, Mannella KA, Fitzgerald KD, Schroder HS. Post-error slowing in anxiety and obsessive-compulsive disorders. Cogn Affect Behav Neurosci. 2022 Jun;22(3):610-624. doi: 10.3758/s13415-021-00976-9. Epub 2021 Dec 29.

    PMID: 34966981DERIVED

MeSH Terms

Conditions

Anxiety DisordersPhobia, SocialGeneralized Anxiety DisorderAnxiety, SeparationPhobia, SpecificPhobic DisordersAgoraphobiaPanic Disorder

Interventions

Cognitive Behavioral TherapyRelaxation Therapy

Condition Hierarchy (Ancestors)

Mental DisordersNeurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesMind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Kate D. Fitzgerald, M.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chair, Department of Psychology, Professor of Psychology

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 22, 2016

Study Start

December 1, 2016

Primary Completion

July 1, 2021

Study Completion

November 12, 2021

Last Updated

December 20, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

Anonymized data will be shared with the National Database for Autism Research (NDAR) and the Research Domain Criteria Database (RDoCdb).

Locations

US(1)