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

Not Applicable

• Conditions: Anxiety Disorders
• Interventions: Behavioral: Manualised Cognitive Behavioral Therapy

• Registration Number: NCT02077205
• Lead Sponsor: Ruhr University of Bochum

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2014-02
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-28
• Last Update Submitted: 2014-02-28
• Study First Posted: 2014-03-04
• Last Update Posted: 2014-03-04
• Primary Completion: 2014-06
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Manualised Cognitive Behavioral Therapy	Manualised Cognitive Behavioral Therapy	Manualised Cognitive Behavioral Therapy in a Routine Care Setting

Primary Outcome Measures

Name	Time	Method
Interference rating as assessed by the "Beurteilung der Beeinträchtigung/ Einschränkung des Patienten" (BEE)	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)	The German questionnaire "Beurteilung der Beeinträchtigung/ Einschränkung des Patienten" (BEE) assesses the degree of interference.
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)
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)
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)

Secondary Outcome Measures

Name	Time	Method
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)
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)

Trial Locations

Locations (1)

Ruhr-University of Bochum, Department of Psychology, AE Klinische Kinder- und Jugendpsychologie; 🇩🇪 Bochum, Nordrhein-Westfalen, Germany