- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01145261
The Relationship Between Emotional Regulation Strategies And Cognitive Behavioral Treatment Effectiveness In Childhood Anxiety Disorders: A Longitudinal Prospective Study
November 12, 2014 updated by: alan apter, Rabin Medical Center
The current study will focus on two phases of anxiety process: Generating Anxiety (reported, direct and physiological) and Emotional Regulation Strategies (Reappraisal, Mindfulness, Expressive Suppression and Rumination).
The claim is that better understanding of these phases in relation to CBT treatment will lead to better understanding of remission in anxiety and to better treatments in the future.
Objectives: To understand the relations between the four strategies of emotional regulation to anxiety disorder hence to understand the relation between these strategies to treatment effectiveness of children with anxiety disorder.
Methods: In phase one, clinically anxious adolescence before treatment (N=40) and healthy controls (N=40) will be compared.
Anxious adolescence are expected to have significantly higher levels of physical arousal and will use spontaneously more expressive suppression and rumination and less reappraisal and mindfulness then the healthy controls.
In phase two, clinically anxious adolescence (N=40) before and after 8-12 weeks of CBT treatment will be compared.
More specifically remitted patients will be compared with partially remitted patients.
Remitted patients are expected to show better improvement in the physical arousal, then partially remitted.
More, Decrease in levels of anxiety will be mediated by the four emotional regulation strategies, and the efficiency of using the Reappraisal will be higher.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
54
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Petach Tikva, Israel
- Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The anxious group: children who will present to the Anxiety Disorder Outpatient Clinic at Schneider Children's Hospital in Israel.
Description
Inclusion Criteria:
- anxious group: Clinical diagnosis of one or more of the following diagnoses: Generalized Anxiety Disorder, Social Anxiety, Separation Anxiety, panic disorder.
- non anxious group: do not meet the criteria for anxiety disorders as well as for any other mental disorder
Exclusion Criteria:
- anxious group: not treated during the study in any other treatment for anxiety disorders.Clinical diagnosis of one or more of the following diagnoses: psychosis, dyslexia, mental retardation, PTSD.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Anxiety
Children with anxiety disorders
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healthy controls
children without anxiety disorders
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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level of anxiety - by cgi and scared scales
Time Frame: 16 weeks
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16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alan Apter, MD, Director Department of Psychological Medicine Schneider Children's Medical Center of Israel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
June 15, 2010
First Submitted That Met QC Criteria
June 15, 2010
First Posted (Estimate)
June 16, 2010
Study Record Updates
Last Update Posted (Estimate)
November 13, 2014
Last Update Submitted That Met QC Criteria
November 12, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5846
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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