NCT02077205

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 4, 2014

Status Verified

February 1, 2014

Enrollment Period

2.4 years

First QC Date

February 4, 2014

Last Update Submit

February 28, 2014

Conditions

Anxiety Disorders

Keywords

Diagnostic and Statistical Manual of Mental Disorders-IV/-5: Anxiety Disorders in children

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • 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)

Study Arms (1)

Manualised Cognitive Behavioral Therapy

EXPERIMENTAL

Manualised Cognitive Behavioral Therapy in a Routine Care Setting

Behavioral: Manualised Cognitive Behavioral Therapy

Interventions

Manualised Cognitive Behavioral TherapyBEHAVIORAL

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

Manualised Cognitive Behavioral Therapy

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Other primary diagnoses
  • Significant intellectual impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bochum, North Rhine-Westphalia, 44787, Germany

RECRUITING

Related Publications (1)

  • Krause K, Zhang XC, Schneider S. Long-Term Effectiveness of Cognitive Behavioral Therapy in Routine Outpatient Care for Youth with Anxiety Disorders. Psychother Psychosom. 2024;93(3):181-190. doi: 10.1159/000537932. Epub 2024 Apr 12.

    PMID: 38615662DERIVED

MeSH Terms

Conditions

Anxiety DisordersDisease

Condition Hierarchy (Ancestors)

Mental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Silvia Schneider, Prof. Dr.

CONTACT

+49 (0)234 32 - 23168silvia.schneider@rub.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 4, 2014

First Posted

March 4, 2014

Study Start

January 1, 2012

Primary Completion

June 1, 2014

Study Completion

December 1, 2015

Last Updated

March 4, 2014

Record last verified: 2014-02

Locations

DE(1)