Clinical trial NCT02077205: Manualised Cognitive Behavioral Therapy of Anxiety Disorders in Children and Adolescents in Routine Care Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorders
Keywords: Diagnostic and Statistical Manual of Mental Disorders-IV/-5: Anxiety Disorders in children
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Severity rating of diagnosis (according to the Kinder-DIPS)
timeFrame: 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)
measure: Spence Children's Anxiety Scale (SCAS)
timeFrame: 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)
measure: Clinical Global Improvement Impression (CGI-I)
timeFrame: 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)
measure: Interference rating as assessed by the "Beurteilung der Beeinträchtigung/ Einschränkung des Patienten" (BEE)
timeFrame: 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 outcomes:
measure: Depression as measured by the Short Moods and Feelings Questionnaire (SMFQ)
timeFrame: 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)
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 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)
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Ruhr-University of Bochum, Department of Psychology, AE Klinische Kinder- und Jugendpsychologie
state: Nordrhein-Westfalen
Study officials:
References: