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Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study (CATS)

Primary Purpose

Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive Behavioral Therapy

Client Centered Therapy

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Neural correlates of pediatric anxiety disorder, Social correlates of pediatric anxiety disorder, Generalized Anxiety Disorder in pediatric populations, Separation Anxiety Disorder in pediatric populations, Social Phobia in pediatric populations

Eligibility Criteria

9 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Clinical diagnosis of DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and Social Phobia (SP)

Exclusion Criteria:

1. IQ below 70 as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI).
2. Requires current ongoing treatment with psychoactive medications including anxiolytics and antidepressants.
3. Acutely suicidal or at risk for harm to self or others. 4. Any motor impairments or eye-hand coordination problems 5. Persons not suited for fMRI procedures including those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, IUDs, metal braces, or other metal objects in their body, especially in the eye. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. Pregnancy, determined by pregnancy tests on post-menarcheal females.
6. History of head injury. 7. Neuromuscular or neurological disorder 8. Vision that is 20/40 and below that cannot be corrected by glasses or contacts.

Specific exclusion criteria for anxious participants includes:

Current comorbid diagnosis of: primary major depressive disorder (MDD) (subjects who have primary GAD with co-morbid MDD that is secondary in terms of course and functional impact are not excluded), obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), conduct disorder, substance abuse or dependence
Lifetime diagnosis of autism or Asperger syndrome, bipolar disorder, psychotic depression, schizophrenia, or schizoaffective disorder.

Specific exclusion criteria for controls includes:

Any current or lifetime DSM-IV diagnosis.
Having a parent with current or lifetime DSM-IV diagnosis of anxiety or mood disorders.

Sites / Locations

University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1. Cognitive Behavioral Therapy

2. Client Centered Therapy

Arm Description

Outcomes

Primary Outcome Measures

Evidence of therapy effects on anxiety symptoms are established by assessments of clinical status, symptoms, affective style, sleep,parent-child interactions using rating scales, self-report measures, and behavioral observations.

Secondary Outcome Measures

Cognitive and affective information processing will be measured using fMRI, pupil dilation/eye tracking, and event-related potential (ERP) assessment.

Full Information

NCT ID

NCT00774150

First Posted

October 16, 2008

Last Updated

July 17, 2014

Sponsor

University of Pittsburgh

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT00774150

Brief Title

Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study

Acronym

CATS

Official Title

Transdisciplinary Studies of CBT for Anxiety in Youth

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to investigate neurobehavioral, affective, and social processes that may influence and predict treatment response in pediatric anxiety disorders.

Detailed Description

This protocol proposes to study neurobehavioral and social correlates of treatment response in 200 youth (ages 9-13) with general anxiety disorder (GAD), separation anxiety disorder (SAD), and social phobia (SP). All youth with an anxiety disorder will receive 14 weeks of Cognitive Behavioral Therapy (CBT) or Client Centered Therapy (CCT) for child anxiety disorders. The study combines state-of-the-art measures from affective neuroscience, ecologically valid (EMA) measures of mood and behavior in natural environments, and measures of family and social context within a developmentally framed treatment study. The study design focuses on predictors and mechanisms of treatment response. This protocol will test key features of a "vigilance-avoidance" model focusing on hypotheses that pretreatment neural correlates of affective reactivity will predict treatment response and early changes in emotional processing will correlate with clinical response during treatment. In addition, the protocol examines how affective experiences within the family and social context are associated with treatment response and change across treatment, and how these are associated with and interact with neurobehavioral changes in affective functioning. Taken together these aspects of the study will advance understanding of the neurobehavioral, affective, and social processes that underpin treatment response in ways that will inform the design, refinement, and optimal developmental timing of cognitive behavioral treatments, and thus, decrease the morbidity, mortality, and lifetime impairments from these common disorders in youth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia

Keywords

Neural correlates of pediatric anxiety disorder, Social correlates of pediatric anxiety disorder, Generalized Anxiety Disorder in pediatric populations, Separation Anxiety Disorder in pediatric populations, Social Phobia in pediatric populations

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

194 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1. Cognitive Behavioral Therapy

Arm Type

Experimental

Arm Title

2. Client Centered Therapy

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy

Intervention Description

16 sessions of CBT

Intervention Type

Behavioral

Intervention Name(s)

Client Centered Therapy

Intervention Description

16 sessions of CCT

Primary Outcome Measure Information:

Title

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Cognitive and affective information processing will be measured using fMRI, pupil dilation/eye tracking, and event-related potential (ERP) assessment.

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and Social Phobia (SP) Exclusion Criteria: 1. IQ below 70 as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI). 2. Requires current ongoing treatment with psychoactive medications including anxiolytics and antidepressants. 3. Acutely suicidal or at risk for harm to self or others. 4. Any motor impairments or eye-hand coordination problems 5. Persons not suited for fMRI procedures including those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, IUDs, metal braces, or other metal objects in their body, especially in the eye. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. Pregnancy, determined by pregnancy tests on post-menarcheal females. 6. History of head injury. 7. Neuromuscular or neurological disorder 8. Vision that is 20/40 and below that cannot be corrected by glasses or contacts. Specific exclusion criteria for anxious participants includes: Current comorbid diagnosis of: primary major depressive disorder (MDD) (subjects who have primary GAD with co-morbid MDD that is secondary in terms of course and functional impact are not excluded), obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), conduct disorder, substance abuse or dependence Lifetime diagnosis of autism or Asperger syndrome, bipolar disorder, psychotic depression, schizophrenia, or schizoaffective disorder. Specific exclusion criteria for controls includes: Any current or lifetime DSM-IV diagnosis. Having a parent with current or lifetime DSM-IV diagnosis of anxiety or mood disorders.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neal D Ryan, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35679962

Citation

Tan PZ, Bylsma LM, Silk JS, Siegle GJ, Forbes EE, McMakin DL, Dahl RE, Ryan ND, Ladouceur CD. Neural indices of performance monitoring are associated with daily emotional functioning in youth with anxiety disorders: An ERP and EMA study. Int J Psychophysiol. 2022 Aug;178:34-42. doi: 10.1016/j.ijpsycho.2022.06.004. Epub 2022 Jun 6.

Results Reference

derived

PubMed Identifier

33472390

Citation

Sequeira SL, Silk JS, Ladouceur CD, Hanson JL, Ryan ND, Morgan JK, McMakin DL, Kendall PC, Dahl RE, Forbes EE. Association of Neural Reward Circuitry Function With Response to Psychotherapy in Youths With Anxiety Disorders. Am J Psychiatry. 2021 Apr 1;178(4):343-351. doi: 10.1176/appi.ajp.2020.20010094. Epub 2021 Jan 21.

Results Reference

derived

PubMed Identifier

29603219

Citation

Ladouceur CD, Tan PZ, Sharma V, Bylsma LM, Silk JS, Siegle GJ, Forbes EE, McMakin DL, Dahl RE, Kendall PC, Mannarino A, Ryan ND. Error-related brain activity in pediatric anxiety disorders remains elevated following individual therapy: a randomized clinical trial. J Child Psychol Psychiatry. 2018 Nov;59(11):1152-1161. doi: 10.1111/jcpp.12900. Epub 2018 Mar 30.

Results Reference

derived

PubMed Identifier

26983904

Citation

Silk JS, Tan PZ, Ladouceur CD, Meller S, Siegle GJ, McMakin DL, Forbes EE, Dahl RE, Kendall PC, Mannarino A, Ryan ND. A Randomized Clinical Trial Comparing Individual Cognitive Behavioral Therapy and Child-Centered Therapy for Child Anxiety Disorders. J Clin Child Adolesc Psychol. 2018 Jul-Aug;47(4):542-554. doi: 10.1080/15374416.2016.1138408. Epub 2016 Mar 16.

Results Reference

derived

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Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study

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