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ID
Source
Brief title
Health condition
Pediatric obsessive-compulsive disorder, OCD
Sponsors and support
AMC
Intervention
Outcome measures
Primary outcome
OCD severity, measured with the Children Yale–Brown Obsessive Compulsive Scale (CY-BOCS; Scahill et al., 1997)
Secondary outcome
- Interpretation bias, measured with a recognition task (Eysenck, Mogg, May, Richards, & Mathews, 1991; Salemink & van den Hout, 2010) and the Obsessive Belief Questionnaire – Child version (OBQ-CV; Coles et al., 2010; Wolters et al., 2011)
- Comorbid problems:
o Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2001; Verhulst & Van der Ende, 1997)
o Youth Self Report (YSR; Achenbach & Rescorla, 2001; Verhulst & Van der Ende, 1997)
o Children’s Depression Inventory (CDI; Timbremont & Braet, 2004)
- General functioning: CGAS score (DSM-IV)
Background summary
The aim of the present study is to improve treatment for children with OCD by adding an online Cognitive Bias Modification–Interpretation (CBM-I) training to cognitive behavioural therapy (CBT). The CBM-I training is offered as the first step in treatment, followed by CBT. CBM-I is compared with a waitlist condition also followed by CBT. Advantages of CBM-I compared with existing interventions are: the CBM-I training is relatively short (4 weeks), it can start during a natural waitlist that usually exists (before a therapist is available), CBM-I is motivating for the patient, can be completed at home, is cheap and easy to implement.
The first research question is: Does CBM-I result in a decrease of obsessive-compulsive complaints compared to the waitlist condition? The second research question is: Is there a favourable effect of the CBM-I training (compared to the waitlist condition) on subsequent CBT?
If CBM-I leads to a significant improvement in OCD severity and/or if CBM positively affects the effect of CBT, than adding a pre-treatment CBM-I training to CBT may result in more effective treatment for children with OCD, an early start of treatment (no/shorter waitlist period), and a reduction of the costs of treatment.
Study objective
The aim of the present study is to improve treatment for children with OCD by adding an online Cognitive Bias Modification-Interpretation (CBM-I) training as a pre-treatment to cognitive behavioural therapy (CBT). CBM-I is compared with a waitlist condition also followed by CBT.
The first hypothesis is that CBM-I results in a decrease of obsessive-compulsive complaints compared to the waitlist condition.
The second hypothesis is that CBM-I has a favourable effect (compared to the waitlist condition) on subsequent CBT.
Study design
Assessment T0: pre-CBM / pre-waitlist (week 0)
- OCD severity (CY-BOCS)
- Interpretation bias (OBQ-CV; recognition task)
- Comorbidity (CBCL, YSR, CDI)
- General functioning (CGAS)
Assessment T1: post-CBM / post-waitlist & start CBT (week 4)
- OCD severity (CY-BOCS)
- Interpretation bias (OBQ-CV; recognition task)
- OCD severity (CY-BOCS)
- Interpretation bias (OBQ-CV; recognition task)
- Comorbidity (CBCL, YSR, CDI)
- General functioning (CGAS)
Assessment T2: CBT, 4th session (week 8)
- OCD severity (CY-BOCS)
Assessment T3: CBT, 8th session (week 12)
- OCD severity (CY-BOCS)
Assessment T4: CBT, 12th session (week 16)
- OCD severity (CY-BOCS)
Assessment T5: post-CBT, 16th session (week 20)
- OCD severity (CY-BOCS)
- Comorbidity (CBCL, YSR, CDI)
- General functioning (CGAS)
Intervention
A Cognitive Bias Modification – Interpretation (CBM-I) training (12 sessions in 4 weeks) is compared with a waitlist control condition (4 weeks without treatment). The CBM-I procedure (Mathews & Mackintosh, 2000) is adapted for children with OCD.
After the CBM-I training / waitlist period, all participants receive cognitive behavioural treatment (16 weekly sessions, protocol ‘Bedwing je dwang’/‘Control your OCD’, De Haan & Wolters, 2009).
Meibergdreef 9
L.H. Wolters
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5662242
l.h.wolters@amsterdamumc.nl
Meibergdreef 9
L.H. Wolters
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5662242
l.h.wolters@amsterdamumc.nl
Inclusion criteria
- Age: 8-18 jaar
- Primary diagnosis: obsessive-compulsive disorder
- CY-BOCS score >=16
- IQ >=80
- medication (SSRI): stable
Exclusion criteria
- Recent state-of-the-art cognitive behavioral therapy for OCS (within 3 months)
- Psychosis
- Drugs- or alcohol abuse
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL4073 |
| NTR-old | NTR4275 |
| Other | Fonds NutsOhra: 1204-035 : METC: NL44055.018.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |