NCT01145261

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2010

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

1.7 years

First QC Date

June 15, 2010

Last Update Submit

November 12, 2014

Conditions

Keywords

Anxiety,Emotional Regulation

Outcome Measures

Primary Outcomes (1)

  • level of anxiety - by cgi and scared scales

    16 weeks

Study Arms (2)

Anxiety

Children with anxiety disorders

healthy controls

children without anxiety disorders

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The anxious group: children who will present to the Anxiety Disorder Outpatient Clinic at Schneider Children's Hospital in Israel.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine

Petah Tikva, Israel, Israel

Location

MeSH Terms

Conditions

Anxiety DisordersEmotional Regulation

Condition Hierarchy (Ancestors)

Mental DisordersSelf-ControlSocial BehaviorBehavior

Study Officials

  • Alan Apter, MD

    Director Department of Psychological Medicine Schneider Children's Medical Center of Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Department of Psychological Medicine Schneider Children's Medical Center of Israel

Study Record Dates

First Submitted

June 15, 2010

First Posted

June 16, 2010

Study Start

September 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations