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

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.

Study Overview

• Status: Unknown
• Conditions: Anxiety Disorders
• Intervention / Treatment: Behavioral: Manualised Cognitive Behavioral Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44787
      • Recruiting
      • Ruhr-University of Bochum, Department of Psychology, AE Klinische Kinder- und Jugendpsychologie
      • Contact: Britta Bredenbröcker; Phone Number: +49 (0)234 32 - 23168; Email: britta.bredenbroecker@rub.de
      • Principal Investigator: Silvia Schneider, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manualised Cognitive Behavioral Therapy; Manualised Cognitive Behavioral Therapy in a Routine Care Setting	Behavioral: Manualised Cognitive Behavioral Therapy; 16 Sessions of Manualised Cognitive Behavioral Therapy in a Routine Care Setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: February 4, 2014
• First Submitted That Met QC Criteria: February 28, 2014
• First Posted (Estimate): March 4, 2014

Study Record Updates

• Last Update Posted (Estimate): March 4, 2014
• Last Update Submitted That Met QC Criteria: February 28, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Diagnostic and Statistical Manual of Mental Disorders-IV/-5: Anxiety Disorders in children
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: NO FUNDING (Registry Identifier: NO FUNDING)