Anxiety DisordersNCT02077205
Manualised Cognitive Behavioral Therapy of Anxiety Disorders in Children and Adolescents in Routine Care Setting
A study testing Manualised Cognitive Behavioral Therapy in people with Anxiety Disorders, run by Ruhr University of Bochum at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Manualised Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Other primary diagnoses
- Significant intellectual impairment
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Ruhr-University of Bochum, Department of Psychology, AE Klinische Kinder- und Jugendpsychologie
Bochum, North Rhine-Westphalia, 44787
Britta Bredenbröcker, +49 (0)234 32 - 23168, britta.bredenbroecker@rub.de
Silvia Schneider, Prof. Dr.
About this study
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.
- Conditions
- Anxiety Disorders
- Being tested
- Manualised Cognitive Behavioral Therapy
- Keywords
- Diagnostic and Statistical Manual of Mental Disorders-IV/-5: Anxiety Disorders in children
- Medical subject headings
- Anxiety Disorders, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manualised Cognitive Behavioral TherapyBehavioural
16 Sessions of Manualised Cognitive Behavioral Therapy in a Routine Care Setting
| Study group | Role | What they receive |
|---|---|---|
| Manualised Cognitive Behavioral Therapy | Experimental | Manualised Cognitive Behavioral Therapy in a Routine Care Setting Receives: Behavioral: Manualised Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity rating of diagnosis (according to the Kinder-DIPS)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startJan 2012
- Primary completionJun 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Silvia Schneider, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077205
- Sponsor's protocol ID
- no funding
- Status last verified
- Feb 2014
- First submitted
- 4 Feb 2014
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38615662
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manualised Cognitive Behavioral Therapy of Anxiety Disorders in Children and Adolescents in Routine Care Setting
- ClinicalTrials.gov ID
- NCT02077205
- Acronym / sponsor ID
- no funding
- Conditions
- Anxiety Disorders
- Keywords
- Diagnostic and Statistical Manual of Mental Disorders-IV/-5: Anxiety Disorders in children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Manualised Cognitive Behavioral Therapy | Experimental | Behavioral: Manualised Cognitive Behavioral TherapyManualised Cognitive Behavioral Therapy in a Routine Care Setting |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Children and adolescents aged 4-18 years
- Primary diagnosis of an anxiety disorder:
Key exclusion criteria (2 listed)
- Other primary diagnoses
- Significant intellectual impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manualised Cognitive Behavioral Therapy16 Sessions of Manualised Cognitive Behavioral Therapy in a Routine Care Setting | Behavioural | Manualised Cognitive Behavioral Therapy |
Primary outcome
Severity rating of diagnosis (according to the Kinder-DIPS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Depression as measured by the Short Moods and Feelings Questionnaire (SMFQ)
Time frame: 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)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
- Derived from this study: PubMed 38615662Krause 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manualised Cognitive Behavioral Therapy in people with Anxiety Disorders, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Schneider, Prof. Dr. (+49 (0)234 32 - 23168, silvia.schneider@rub.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity rating of diagnosis (according to the Kinder-DIPS) (time frame: 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02077205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.