Pediatric Anxiety DisordersFCPANCT02631785
Fear Conditioning, Extinction and Its Recall in Anxious Youth
A study testing Cognitive Behavioral Therapy in people with Pediatric Anxiety Disorders, run by University of Haifa at 2 sites in Israel.
Trial summary
The proposed research aims to isolate brain-based information-processing mechanisms implicated in perturbed fear learning and extinction characteristic of pediatric anxiety. The study will focus on the therapeutic relevance of dysfunction in fear learning and extinction for treatment by examining the associations… Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Anxiety Disorders
- What is being tested?
- Cognitive Behavioral Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesIsrael
- Study dates
- Feb 2016to Feb 2020
- 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 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- diagnosis of Separation Anxiety Disorder, Social Phobia or Generalized Anxiety Disorder.
- healthy volunteers
Who cannot join
- other psychiatry diagnose (not include depression and ADHD)
- currently in psychological treatment
- psychiatry medication
- Control group:
- any psychiatry diagnose.
- currently in psychological treatment
- psychiatry medication
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
University of Haifa
Haifa
Tomer Shechner, phd
Weizmann Institue of Science
Rehovot
Ronny Paz
About this study
Official title: Fear Conditioning, Extinction and Its Recall in Anxious Youth: Identifying Neuro- Cognitive Abnormalities and Their Relation to Pediatric Anxiety Treatment Outcomes
The proposed research aims to isolate brain-based information-processing mechanisms implicated in perturbed fear learning and extinction characteristic of pediatric anxiety.
The study will focus on the therapeutic relevance of dysfunction in fear learning and extinction for treatment by examining the associations between brain functioning and response to exposure intervention in anxious children.
Read the detailed description
Anxiety disorders are the most common form of pediatric psychopathology, affecting 5 - 20% of children and adolescents. Despite therapeutic advances, treatment-resistance remains high, and progress towards early detection of at-risk populations and more effective treatments has stalled. Although some anxiety disorders are transient, recent studies suggest that pediatric anxiety disorders commonly persist into adulthood. Because anxiety disorders are costly and debilitating conditions that are very often associated with other severe psychopathology such as substance abuse, depression and suicidality, there is an imperative need to identify risk and resilience factors that moderate pediatric anxiety and improve treatment.
Fear conditioning and resistance to extinction are two domains that have been implicated in the etiology and maintenance of anxiety disorders. Indeed, one of the most effective treatment for pediatric and adult anxiety disorders, exposure therapy, relies profoundly on extinction learning. The proposed research plan will investigate the neural correlates of aberrant fear conditioning and extinction processes in children and adolescents with anxiety disorders.
The proposed research aims to isolate brain-based information-processing mechanisms implicated in perturbed fear learning and extinction characteristic of pediatric anxiety. A fMRI study using a novel age-appropriate fear conditioning-extinction paradigm are proposed. The study will delineate perturbed psychological and psychophysiological response to fear conditioning and isolate neuro-cognitive mechanisms mediating extinction recall in anxious and non-anxious children. Three weeks after completing fear conditioning and extinction task in the psychophysiology lab, participants will return to complete an fMRI extinction-recall task quantifying responses to extinguished CS blends. Two major hypotheses will be examined: a) anxious children will exhibit perturbations during extinction as measured by psychophysiology indexes and self-reported fear compared to non-anxious children; b) less activation in ventromedial prefrontal cortex (vmPFC) is expected in anxious, relative to healthy, children during extinction-recall. Furthermore, the study will focus on the therapeutic relevance of dysfunction in fear learning and extinction for treatment by examining the associations between vmPFC function and response to exposure intervention in anxious children. Lower levels of vmPFC activation prior to exposure therapy and larger pre-to-post-treatment changes in vmPFC activity are expected to be associated with better response to exposure therapy.
- Conditions
- Pediatric Anxiety Disorders
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- ANXIETY, CBT, fMRI, Fear conditioning, Fear extinction
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyOther
Also called CBT
Psychologists will deliver the "COPING CAT" treatment for reducing anxiety symptoms. It is a manualized treatment that was extensively used before. The treatment will include 10- 14 sessions, mostly individual but also two parents meetings. All the treatments will occur in the Department of Psychology in Haifa University as a part of a clinical trial. The treatment will take place in a room that was designed for this purpose fully equipped with cameras, microphone and double sided mirror. All sessions will be audio and video recorded and will be closely monitored by the PI. To increase protocol adherence and verify the adequacy of the treatment delivered, all clinicians will complete routine forms with the content of each session.
| Study group | Role | What they receive |
|---|---|---|
| Anxious group | Experimental | Youth diagnosed with anxiety disorder will receive Cognitive Behavioral Therapy for reducing anxiety symptoms. Receives: Other: Cognitive Behavioral Therapy |
| Control group | No intervention | Healthy youth will be recruited for comparison but their participant in the study will not include intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI Bold signal
analysis of brain activation
Measured: 2 years
Secondary outcomes (6)
Autonomous measures- skin conductance response (SCR)
skin conductance response (SCR) will be recorded from the participant's hand using two standard electrodes attached to the participants' palm.
Measured: 2 years
Self report of anxiety
participants will rate their level of fear during watching stimuli
Measured: 2 years
Autonomous measures-Fear-Potentiated Startle
will be measured through electromyography (EMG) of the eye-blink reflex following a puff of air to the forehead.
Measured: 2 years
Anxiety symptom- SCARED
- The Screen for Child Anxiety Related Emotional Disorders (SCARED) - the SCARED is a self-report measure that assesses different types of anxiety based on criteria in the DSM-IV. Specifically, the SCARED was developed as a screening tool for generalized anxiety disorder, separation anxiety disorder, panic disorder, social phobia, and school phobia. The SCARED has been reported to have robust reliability and validly (Birmaher et al., 1997).
Measured: 2 years
Anxiety symptoms- ADIS
The Anxiety Disorder Interview Schedule (ADIS) - is a well validated semi-structured diagnostic interview, suitable for measuring all anxiety disorders as listed in the DSM-IV as well as mood disorders and attention deficit hyperactivity disorder, in children from 7-17 years of age (Silverman \& Albano, 1996). The interview has two versions, one for children (ADIS-C) and one for parents (ADIS-P), and both have good inter-rater and high test-retest reliability (Silverman, Saavedra, \& Pina, 2001). In standard ADIS procedures, a child receive a diagnosis when a specified amount of criteria are met the child or parent reports substantial interference (4 or higher on a scale from 0 to 8). The combined diagnosis represents a sum of the diagnoses of the child and the parent interview
Measured: 2 years
Anxiety symptoms- CGI
Clinical Global Impression scale (CGI). The CGI scale requires clinicians to rate the overall severity of their patient's illness at the time of assessment relative to the clinician's experience with patients having the same diagnosis. This scale yields three different measures: severity of illness, global improvement, and the efficacy index. The ratings range from 1 (very much improved) to 7 (very much worse) (Busner \& Targum, 2007).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2020 (estimated)
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 Pediatric Anxiety DisordersStudies of the same condition, open and under way.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- HaEmek Medical Center, Israel, Weizmann Institute of Science
- Responsible party
- Principal investigator, Tomer Shechner, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631785
- Sponsor's protocol ID
- 97-15
- Other IDs
- 1377/14, 618534
- Acronym
- FCPA
- Status last verified
- Dec 2015
- First submitted
- 2 Dec 2015
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Beesdo K, Knappe S, Pine DS. Anxiety and anxiety disorders in children and adolescents: developmental issues and implications for DSM-V. Psychiatr Clin North Am. 2009 Sep;32(3):483-524. doi: 10.1016/j.psc.2009.06.002.
PubMed 19716988Shechner T, Hong M, Britton JC, Pine DS, Fox NA. Fear conditioning and extinction across development: evidence from human studies and animal models. Biol Psychol. 2014 Jul;100:1-12. doi: 10.1016/j.biopsycho.2014.04.001. Epub 2014 Apr 16.
PubMed 24746848Shechner T, Britton JC, Ronkin EG, Jarcho JM, Mash JA, Michalska KJ, Leibenluft E, Pine DS. Fear conditioning and extinction in anxious and nonanxious youth and adults: examining a novel developmentally appropriate fear-conditioning task. Depress Anxiety. 2015 Apr;32(4):277-88. doi: 10.1002/da.22318. Epub 2014 Nov 27.
PubMed 25427438Walkup JT, Albano AM, Piacentini J, Birmaher B, Compton SN, Sherrill JT, Ginsburg GS, Rynn MA, McCracken J, Waslick B, Iyengar S, March JS, Kendall PC. Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety. N Engl J Med. 2008 Dec 25;359(26):2753-66. doi: 10.1056/NEJMoa0804633. Epub 2008 Oct 30.
PubMed 18974308Britton JC, Grillon C, Lissek S, Norcross MA, Szuhany KL, Chen G, Ernst M, Nelson EE, Leibenluft E, Shechner T, Pine DS. Response to learned threat: An FMRI study in adolescent and adult anxiety. Am J Psychiatry. 2013 Oct;170(10):1195-204. doi: 10.1176/appi.ajp.2013.12050651.
PubMed 23929092
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fear Conditioning, Extinction and Its Recall in Anxious Youth: Identifying Neuro- Cognitive Abnormalities and Their Relation to Pediatric Anxiety Treatment Outcomes
- ClinicalTrials.gov ID
- NCT02631785
- Acronym / sponsor ID
- FCPA / 97-15
- Conditions
- Pediatric Anxiety Disorders
- Keywords
- ANXIETY, CBT, fMRI, Fear conditioning, Fear extinction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- HaEmek Medical Center, Israel, Weizmann Institute of Science
- Study start
- Feb 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 16 Dec 2015 (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 proposed research aims to isolate brain-based information-processing mechanisms implicated in perturbed fear learning and extinction characteristic of pediatric anxiety.
The study will focus on the therapeutic relevance of dysfunction in fear learning and extinction for treatment by examining the associations between brain functioning and response to exposure intervention in anxious children.
Detailed description
Anxiety disorders are the most common form of pediatric psychopathology, affecting 5 - 20% of children and adolescents. Despite therapeutic advances, treatment-resistance remains high, and progress towards early detection of at-risk populations and more effective treatments has stalled. Although some anxiety disorders are transient, recent studies suggest that pediatric anxiety disorders commonly persist into adulthood. Because anxiety disorders are costly and debilitating conditions that are very often associated with other severe psychopathology such as substance abuse, depression and suicidality, there is an imperative need to identify risk and resilience factors that moderate pediatric anxiety and improve treatment.
Fear conditioning and resistance to extinction are two domains that have been implicated in the etiology and maintenance of anxiety disorders. Indeed, one of the most effective treatment for pediatric and adult anxiety disorders, exposure therapy, relies profoundly on extinction learning. The proposed research plan will investigate the neural correlates of aberrant fear conditioning and extinction processes in children and adolescents with anxiety disorders.
The proposed research aims to isolate brain-based information-processing mechanisms implicated in perturbed fear learning and extinction characteristic of pediatric anxiety. A fMRI study using a novel age-appropriate fear conditioning-extinction paradigm are proposed. The study will delineate perturbed psychological and psychophysiological response to fear conditioning and isolate neuro-cognitive mechanisms mediating extinction recall in anxious and non-anxious children. Three weeks after completing fear conditioning and extinction task in the psychophysiology lab, participants will return to complete an fMRI extinction-recall task quantifying responses to extinguished CS blends. Two major hypotheses will be examined: a) anxious children will exhibit perturbations during extinction as measured by psychophysiology indexes and self-reported fear compared to non-anxious children; b) less activation in ventromedial prefrontal cortex (vmPFC) is expected in anxious, relative to healthy, children during extinction-recall. Furthermore, the study will focus on the therapeutic relevance of dysfunction in fear learning and extinction for treatment by examining the associations between vmPFC function and response to exposure intervention in anxious children. Lower levels of vmPFC activation prior to exposure therapy and larger pre-to-post-treatment changes in vmPFC activity are expected to be associated with better response to exposure therapy.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anxious group | Experimental | Other: Cognitive Behavioral TherapyYouth diagnosed with anxiety disorder will receive Cognitive Behavioral Therapy for reducing anxiety symptoms. |
| Control group | No intervention | –Healthy youth will be recruited for comparison but their participant in the study will not include intervention. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- diagnosis of Separation Anxiety Disorder, Social Phobia or Generalized Anxiety Disorder.
- healthy volunteers
Key exclusion criteria (7 listed)
- other psychiatry diagnose (not include depression and ADHD)
- currently in psychological treatment
- psychiatry medication
- any psychiatry diagnose.
- currently in psychological treatment
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 TherapyAlso: CBTPsychologists will deliver the "COPING CAT" treatment for reducing anxiety symptoms. It is a manualized treatment that was extensively used before. The treatment will include 10- 14 sessions, mostly individual but also two parents meetings. All the treatments will occur in the Department of Psychology in Haifa University as a part of a clinical trial. The treatment will take place in a room that was designed for this purpose fully equipped with cameras, microphone and double sided mirror. All sessions will be audio and video recorded and will be closely monitored by the PI. To increase protocol adherence and verify the adequacy of the treatment delivered, all clinicians will complete routine forms with the content of each session. | Other | Anxious group |
Primary outcome
fMRI Bold signal
Time frame: 2 years
analysis of brain activation
6 secondary outcomes
Autonomous measures- skin conductance response (SCR)
Time frame: 2 years
Self report of anxiety
Time frame: 2 years
Autonomous measures-Fear-Potentiated Startle
Time frame: 2 years
Anxiety symptom- SCARED
Time frame: 2 years
Anxiety symptoms- ADIS
Time frame: 2 years
Anxiety symptoms- CGI
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
- Background: PubMed 19716988Beesdo K, Knappe S, Pine DS. Anxiety and anxiety disorders in children and adolescents: developmental issues and implications for DSM-V. Psychiatr Clin North Am. 2009 Sep;32(3):483-524. doi: 10.1016/j.psc.2009.06.002.
- Background: PubMed 24746848Shechner T, Hong M, Britton JC, Pine DS, Fox NA. Fear conditioning and extinction across development: evidence from human studies and animal models. Biol Psychol. 2014 Jul;100:1-12. doi: 10.1016/j.biopsycho.2014.04.001. Epub 2014 Apr 16.
- Background: PubMed 25427438Shechner T, Britton JC, Ronkin EG, Jarcho JM, Mash JA, Michalska KJ, Leibenluft E, Pine DS. Fear conditioning and extinction in anxious and nonanxious youth and adults: examining a novel developmentally appropriate fear-conditioning task. Depress Anxiety. 2015 Apr;32(4):277-88. doi: 10.1002/da.22318. Epub 2014 Nov 27.
- Background: PubMed 18974308Walkup JT, Albano AM, Piacentini J, Birmaher B, Compton SN, Sherrill JT, Ginsburg GS, Rynn MA, McCracken J, Waslick B, Iyengar S, March JS, Kendall PC. Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety. N Engl J Med. 2008 Dec 25;359(26):2753-66. doi: 10.1056/NEJMoa0804633. Epub 2008 Oct 30.
- Results publication: PubMed 23929092Britton JC, Grillon C, Lissek S, Norcross MA, Szuhany KL, Chen G, Ernst M, Nelson EE, Leibenluft E, Shechner T, Pine DS. Response to learned threat: An FMRI study in adolescent and adult anxiety. Am J Psychiatry. 2013 Oct;170(10):1195-204. doi: 10.1176/appi.ajp.2013.12050651.
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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.
2 sites 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 in people with Pediatric Anxiety Disorders, run by University of Haifa at 2 sites in Israel.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomer Shechner, PHD (97248249660, tshechner@psy.haifa.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI Bold signal (time frame: 2 years). 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 NCT02631785, 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 16 Dec 2015.