The Relationship Between Emotional Regulation Strategies And Cognitive Behavioral Treatment Effectiveness In Childhood Anxiety Disorders: A Longitudinal Prospective Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
alan apter, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01145261
First received: June 15, 2010
Last updated: November 22, 2012
Last verified: November 2012
  Purpose

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.


Condition
Anxiety

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Relationship Between Emotional Regulation Strategies And Cognitive Behavioral Treatment Effectiveness In Childhood Anxiety Disorders: A Longitudinal Prospective Study

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • level of anxiety - by cgi and scared scales [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Anxiety
Children with anxiety disorders
healthy controls
children without anxiety disorders

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145261

Contacts
Contact: Alan Apter, MD +972-3-9253232 ext Non eapter@clalit.org.il

Locations
Israel
Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine Recruiting
Petach Tikva, Israel
Contact: Alan Apter, MD       eapter@clalit.org.il   
Sub-Investigator: Yael Tadmor-Zisman         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Alan Apter, MD Director Department of Psychological Medicine Schneider Children's Medical Center of Israel
  More Information

No publications provided

Responsible Party: alan apter, Director Department of Psychological Medicine Schneider Children's Medical Center of Israel, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01145261     History of Changes
Other Study ID Numbers: 5846
Study First Received: June 15, 2010
Last Updated: November 22, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Rabin Medical Center:
Anxiety,
Emotional Regulation

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 19, 2014