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

Anxiety Disorders Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02077205
• Other study ID #: no funding
• Status: Recruiting
• Phase: N/A
• First received: February 4, 2014
• Last updated: February 28, 2014
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: February 2014
• Source: Ruhr University of Bochum
• Contact: Silvia Schneider, Prof. Dr.
• Phone: +49 (0)234 32 - 23168
• Email: silvia.schneider[@]rub.de
• Is FDA regulated: No
• Health authority: Germany: Local ethics comittee of the faculty of Psychology
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 18 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• Manualised Cognitive Behavioral Therapy
16 Sessions of Manualised Cognitive Behavioral Therapy in a Routine Care Setting

Locations

Country	Name	City	State
Germany	Ruhr-University of Bochum, Department of Psychology, AE Klinische Kinder- und Jugendpsychologie	Bochum	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity rating of diagnosis (according to the Kinder-DIPS)		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)	No
Primary	Spence Children's Anxiety Scale (SCAS)		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)	No
Primary	Clinical Global Improvement Impression (CGI-I)		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)	No
Primary	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.	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)	No
Secondary	Depression as measured by the Short Moods and Feelings Questionnaire (SMFQ)		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)	No
Secondary	Strengths and Difficulties Questionnaire (SDQ)		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)	No