Mediators and moderators of cognitive behavioral therapy for childhood anxiety disorders: information processing, emotion regulation and stress reactivity
| ISRCTN | ISRCTN46352117 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46352117 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/09/2006
- Registration date
- 26/09/2006
- Last edited
- 06/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr F Boer
Scientific
Scientific
Academic Medical Center (AMC)
Department of Child and Adolescent Psychiatry/de Bascule
PO Box 12474
Amsterdam
1100 AL
Netherlands
| Phone | +31 (0)20 5663383 |
|---|---|
| f.boer@amc.uva.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Mediators and moderators of cognitive behavioral therapy for childhood anxiety disorders: information processing, emotion regulation and stress reactivity |
| Study objectives | 1. Changes in outcome measures of anxiety can be partly explained by changes in: a. self-reported thoughts b. selective attention and by changes in fear relevant cognitive schema's 2. Changes in outcome measures of anxiety can be partly explained by changes in: a. self-reported emotion regulation strategies b. processes of attention regulation and by changes in underlying schema's of 'perceived control' 3. Effortful control will moderate the treatment effect 4. Executive functions will moderate the relation between mediators and the treatment effect. The treatment effect will be larger when executive functions are more developed 5. Stress-reactivity will moderate the treatment effect 6. Stress-reactivity is a vulnerability factor for developing an anxiety disorder and is an effect of an anxiety disorder 7. Part of the variance in treatment effect can be explained by family characteristics (parents psychopathology and parenting style) and characteristics of the therapist |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Anxiety disorders |
| Intervention | Group one: 12 sessions of Cognitive Behavioural Therapy (CBT) according to the Coping Cat manual. Four measure points: before therapy, after eight sessions, after therapy and after 12 week follow-up period. Group two: Eight week Waiting List (WL) group. Children will receive the same therapy as group one after the waiting period. Five measure points: before waiting list, before therapy, after eight sessions of therapy, after therapy and after 12 week follow-up period |
| Intervention type | Other |
| Primary outcome measure | 1. Effect of treatment (diagnosis of anxiety disorder and scores on anxiety questionnaires) 2. Mediating effect of information processing 3. Mediating effect of emotion regulation 4. Moderating effect of effortful control, executive functions and stress-reactivity |
| Secondary outcome measures | 1. Correlation between explicit and implicit measures 2. Development of implicit measures |
| Overall study start date | 01/09/2006 |
| Completion date | 01/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 145 |
| Key inclusion criteria | 1. Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) anxiety disorder as primary diagnosis 2. Age between seven and 18 years 3. Intelligence Quotient (IQ) more than or equal to 80 4. Informed consent from parents and child |
| Key exclusion criteria | 1. Psychosis 2. Obsessive compulsive disorder as primary disorder 3. Post-traumatic stress disorder as primary disorder 4. Acute stress disorder 5. Drug and/or alcohol problems 6. Selective mutism 7. Current treatment with Selective Serotonin Reuptake Inhibitor (SSRI) or treatment with SSRI within half a year before inclusion 8. Psychotherapeutic treatment within the last half year |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 01/09/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 AL
Netherlands
1100 AL
Netherlands
Sponsor information
Academic Medical Center
University/education
University/education
PO Box 22660
Amsterdam
1100 DD
Netherlands
| Website | https://www.amc.nl/web/Zorg.htm |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
University/education
Universiteit van Amsterdam
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Amsterdam, UvA
- Location
- Netherlands
Accare (The Netherlands)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Location
- Netherlands
Academic Medical Center (AMC) (The Netherlands)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Academic Medical Center, AMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2013 | 06/01/2021 | Yes | No |
Editorial Notes
06/01/2021: Publication reference and total final enrolment added.
