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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145261
• Other study ID #: 5846
• Status: Completed
• Phase: N/A
• First received: June 15, 2010
• Last updated: November 12, 2014
• Start date: September 2011
• Est. completion date: May 2013

Study information

• Verified date: November 2014
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of anxiety - by cgi and scared scales		16 weeks	No