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Manualised Cognitive Behavioral Therapy of Anxiety Disorders in Children and Adolescents in Routine Care Setting

Primary Purpose

Anxiety Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Manualised Cognitive Behavioral Therapy
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Diagnostic and Statistical Manual of Mental Disorders-IV/-5: Anxiety Disorders in children

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children and adolescents aged 4-18 years

  • Primary diagnosis of an anxiety disorder:

    1. Generalized Anxiety Disorder
    2. Social Phobia
    3. Separation Anxiety Disorder
    4. Panic Disorder +/- Agoraphobia
    5. Specific Phobia

Exclusion Criteria:

  • Other primary diagnoses
  • Significant intellectual impairment

Sites / Locations

  • Ruhr-University of Bochum, Department of Psychology, AE Klinische Kinder- und JugendpsychologieRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Manualised Cognitive Behavioral Therapy

Arm Description

Manualised Cognitive Behavioral Therapy in a Routine Care Setting

Outcomes

Primary Outcome Measures

Severity rating of diagnosis (according to the Kinder-DIPS)
Spence Children's Anxiety Scale (SCAS)
Clinical Global Improvement Impression (CGI-I)
Interference rating as assessed by the "Beurteilung der Beeinträchtigung/ Einschränkung des Patienten" (BEE)
The German questionnaire "Beurteilung der Beeinträchtigung/ Einschränkung des Patienten" (BEE) assesses the degree of interference.

Secondary Outcome Measures

Depression as measured by the Short Moods and Feelings Questionnaire (SMFQ)
Strengths and Difficulties Questionnaire (SDQ)

Full Information

First Posted
February 4, 2014
Last Updated
February 28, 2014
Sponsor
Ruhr University of Bochum
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1. Study Identification

Unique Protocol Identification Number
NCT02077205
Brief Title
Manualised Cognitive Behavioral Therapy of Anxiety Disorders in Children and Adolescents in Routine Care Setting
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Manualised Cognitive Behavioral Therapy for children and adolescents with anxiety disorders is evaluated in a routine care setting to evaluate the efficacy of the intervention. Children and adolescents receive manualized Cognitive Behavioral Therapy for anxiety disorder. It is expected, that the intervention will result in less anxiety / lower scores on the primary and secondary outcome measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Diagnostic and Statistical Manual of Mental Disorders-IV/-5: Anxiety Disorders in children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manualised Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Manualised Cognitive Behavioral Therapy in a Routine Care Setting
Intervention Type
Behavioral
Intervention Name(s)
Manualised Cognitive Behavioral Therapy
Intervention Description
16 Sessions of Manualised Cognitive Behavioral Therapy in a Routine Care Setting
Primary Outcome Measure Information:
Title
Severity rating of diagnosis (according to the Kinder-DIPS)
Time Frame
Changes in severity rating from pre- to post-assessment (post-assessment takes place 30 weeks after the pre-assessment on average) and to 6-month-follow-up (which takes place about 6 months after the post-assessment)
Title
Spence Children's Anxiety Scale (SCAS)
Time Frame
Changes on the SCAS from pre- to post-assessment (post-assessment takes place 30 weeks after the pre-assessment on average) and to 6-month-follow-up (which takes place about 6 months after the post-assessment)
Title
Clinical Global Improvement Impression (CGI-I)
Time Frame
Changes on the CGI-I from post-assessment (post-assessment takes place 30 weeks after the pre-assessment on average) to 6-month-follow-up (which takes place about 6 months after the post-assessment)
Title
Interference rating as assessed by the "Beurteilung der Beeinträchtigung/ Einschränkung des Patienten" (BEE)
Description
The German questionnaire "Beurteilung der Beeinträchtigung/ Einschränkung des Patienten" (BEE) assesses the degree of interference.
Time Frame
Changes in interference rating from pre- to post-assessment (post-assessment takes place 30 weeks after the pre-assessment on average) and to 6-month-follow-up (which takes place about 6 months after the post-assessment)
Secondary Outcome Measure Information:
Title
Depression as measured by the Short Moods and Feelings Questionnaire (SMFQ)
Time Frame
Changes in the SMFQ from pre- to post-assessment (post-assessment takes place 30 weeks after the pre-assessment on average) and to 6-month-follow-up (which takes place about 6 months after the post-assessment)
Title
Strengths and Difficulties Questionnaire (SDQ)
Time Frame
Changes on the SDQ from pre- to post-assessment (post-assessment takes place 30 weeks after the pre-assessment on average) and to 6-month-follow-up (which takes place about 6 months after the post-assessment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children and adolescents aged 4-18 years Primary diagnosis of an anxiety disorder: Generalized Anxiety Disorder Social Phobia Separation Anxiety Disorder Panic Disorder +/- Agoraphobia Specific Phobia Exclusion Criteria: Other primary diagnoses Significant intellectual impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Schneider, Prof. Dr.
Phone
+49 (0)234 32 - 23168
Email
silvia.schneider@rub.de
Facility Information:
Facility Name
Ruhr-University of Bochum, Department of Psychology, AE Klinische Kinder- und Jugendpsychologie
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44787
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Britta Bredenbröcker
Phone
+49 (0)234 32 - 23168
Email
britta.bredenbroecker@rub.de
First Name & Middle Initial & Last Name & Degree
Silvia Schneider, Prof. Dr.

12. IPD Sharing Statement

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Manualised Cognitive Behavioral Therapy of Anxiety Disorders in Children and Adolescents in Routine Care Setting

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