Obsessive-compulsive disorder Mental and Behavioural Disorders Obsessive-compulsive disorder
Conditions
Interventions
The trial will consist of two arms. In the first arm, young people will receive cognitive behaviour therapy with a small dose of D-cycloserine (50 mg) given after sessions 3 to 12. In the second arm,
Sponsors
Institute of Psychiatry, Kings College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnosis of OCD 2. Aged 12 to 18 years 3. Either sex 4. Any ethnicity, religious background or sexual orientation 5. Referred to the National and Specialist OCD Clinic at Maudsley Hospital 6. If on medication, this should be stable for 12 weeks and not be changed during the course of the trial 7. Provision of written informed consent (patient and carer)
Exclusion criteria
Exclusion criteria: 1. Current diagnosis of psychosis, current alcohol or substance abuse/dependence 2. English too poor to engage in treatment 3. Severe disabling neurological disorder 4. Medical contraindication to cycloserine, including epilepsy and porphyria 5. A diagnosed global learning disability or pervasive developmental disorder 6. Characteristics interfering with completion of treatment, e.g. life threatening or unstable medical illness 7. Pregnancy 8. Not suitable for CBT (selective mutism, lack of insight or motivation for change)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Children's Yale Brown Obsessive Compulsive Scale (CYBOCS), a well-validated clinician administered measure of OCD severity. For each arm, this measure will be administered at the beginning of each session, and again at 3 months, 6 months and 12 months post-treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Diagnosis of OCD as determined with: 1.1. The Anxiety Disorders Interview Schedule for DSM-IV (ADIS), the Child Obsessive-Compulsive Inventory (ChOCI), child and parent versions 1.2. The Strengths and Difficulties Questionnaire (SDQ), child and parent versions 1.3. The Beck Depression Inventory for Youth (BDI-Y) 1.4. The Depression Anxiety and Stress Scale (DASS) for parents 1.5. The Family Accommodation Scale (FAS) 2. Additional ?process? variables include measures of trait anxiety (RCMAS), threat perception (CARBQ-C/P), subjective anxiety (SUDS ratings), behavioural avoidance tasks (BATs), physiological arousal (heart rate variability) and the Patient Exposure Adherence Scale (PEAS) 3. Behavioural Avoidance Task (BAT). A single task, single-step BAT will be administered. The task will be described to the child using standardised instructions. The BAT is an individually tailored task in which the young person is asked to expose him/herself to a situation that usually causes him/her significant distress or results in compulsive rituals. 4. Subjective units of distress (SUDS). Young people will be asked to rate their subjective distress at various time points during the BAT task, based on an 8-point Likert scale thermometer (0 = none to 8 = extreme). 5. Heart Rate Variability (HRV). HRV is a measure of the beat-to-beat variations in heart rate. It is calculated by analysing a time series of beat-to-beat intervals from a heart rate monitor. HRV is an indicator of autonomic arousal, and there is a known relationship between HRV and emotional arousal. HRV has been shown to be sensitive to the emotion of fear in most people. Therefore HRV will be used as a measure of physiological arousal in relation to the BAT task. HRV will be measured using a Polar heart rate monitor (FT80). A heart rate monitor consists of two elements: a chest strap transmitter and a wrist receiver (a sports watch). The chest strap has electrodes in contact with the skin to monitor electrical | — |
Countries
United Kingdom
Outcome results
None listed