Generalized Anxiety DisorderCATSNCT00774150
Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study
A study testing Cognitive Behavioral Therapy and Client Centered Therapy in people with Generalized Anxiety Disorder and Separation Anxiety Disorder, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia
- What is being tested?
- Cognitive Behavioral Therapy and Client Centered Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinical diagnosis of DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and Social Phobia (SP)
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Transdisciplinary Studies of CBT for Anxiety in Youth
The purpose of this study is to investigate neurobehavioral, affective, and social processes that may influence and predict treatment response in pediatric anxiety disorders.
Read the 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.
- Being tested
- Cognitive Behavioral Therapy, Client Centered Therapy
- 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
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety, Separation, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
16 sessions of CBT
Client Centered TherapyBehavioural
16 sessions of CCT
| Study group | Role | What they receive |
|---|---|---|
| 1. Cognitive Behavioral Therapy | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy |
| 2. Client Centered Therapy | Active comparator | Not described Receives: Behavioral: Client Centered Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (1)
Cognitive and affective information processing will be measured using fMRI, pupil dilation/eye tracking, and event-related potential (ERP) assessment.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Neal Ryan, University of Pittsburgh
- Investigators
- Neal D Ryan, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774150
- Sponsor's protocol ID
- PRO07110273
- Other IDs
- P50MH080215-01A1
- Acronym
- CATS
- Status last verified
- Jul 2014
- First submitted
- 16 Oct 2008
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Westbrook CA, Schlund M, Silk JS, Forbes EE, Ryan ND, Dahl RE, McMakin DL, Kendall PC, Mannarino A, Ladouceur CD. The role of reward-related brain activity in response to treatment and later depression severity: data from a randomized controlled trial in early adolescents with anxiety disorders. Transl Psychiatry. 2025 Aug 16;15(1):286. doi: 10.1038/s41398-025-03388-2.
PubMed 40818984Tan 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.
PubMed 35679962Sequeira 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.
PubMed 33472390Ladouceur 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.
PubMed 29603219Silk 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.
PubMed 26983904
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdisciplinary Studies of CBT for Anxiety in Youth
- ClinicalTrials.gov ID
- NCT00774150
- Acronym / sponsor ID
- CATS / PRO07110273
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral Therapy |
| 2. Client Centered Therapy | Active comparator | Behavioral: Client Centered Therapy |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Clinical diagnosis of DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and Social Phobia (SP)
Key exclusion criteria (10 listed)
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy16 sessions of CBT | Behavioural | 1. Cognitive Behavioral Therapy |
| Client Centered Therapy16 sessions of CCT | Behavioural | 2. Client Centered Therapy |
Primary outcome
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.
Time frame: 16 weeks
1 secondary outcome
Cognitive and affective information processing will be measured using fMRI, pupil dilation/eye tracking, and event-related potential (ERP) assessment.
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
- Derived from this study: PubMed 40818984Westbrook CA, Schlund M, Silk JS, Forbes EE, Ryan ND, Dahl RE, McMakin DL, Kendall PC, Mannarino A, Ladouceur CD. The role of reward-related brain activity in response to treatment and later depression severity: data from a randomized controlled trial in early adolescents with anxiety disorders. Transl Psychiatry. 2025 Aug 16;15(1):286. doi: 10.1038/s41398-025-03388-2.
- Derived from this study: PubMed 35679962Tan 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.
- Derived from this study: PubMed 33472390Sequeira 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.
- Derived from this study: PubMed 29603219Ladouceur 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.
- Derived from this study: PubMed 26983904Silk 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.
Related trials for Generalized Anxiety Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruitingObservational study
BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders
Generalized Anxiety Disorder, Oxygenation Sensitive CMR
RecruitingPhase 3
A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder
RecruitingPhase 3
A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment
Generalized Anxiety Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal D Ryan, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Client Centered Therapy in people with Generalized Anxiety Disorder and Separation Anxiety Disorder, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00774150, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2014.