Obsessive Compulsive Disorder OCD
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Referred to one of the participating sites for OCD treatment - Age 18 or above - Primary DSM-5 diagnosis of OCD (established by the SCID-I) - Moderate to severe OCD symptoms (expressed as a minimum score of 16 on the Yale Brown Obsessive Compulsive Scale (YBOCS) - Not currently using psychotropic medication, or on a stable dose for at least 12 weeks prior to randomisation with no plans to change the dose during the course of the study (this will be monitored during the study) - If CBT already has been received, treatment has ended at least 26 weeks before study participation.
Exclusion criteria
Exclusion criteria: - Suffering from a current psychotic disorder, organic mental disorder, substance use disorder or mental retardation. - No sufficient command of the Dutch language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Severity of OCD symptoms (Yale-Brown Obsessive Compulsive Scale (YBOCS)) o Responder status (decline on the YBOCS score of >= 35%) (yes/no) o Remission status (YBOCS | — |
Secondary
| Measure | Time frame |
|---|---|
| - T-1 weighted MRI, DTI, rs-fMRI and fMRI during symptom provocation (watching OCD related pictures) - Treatment history (Treatment Adherence Survey Patient version (TAS-P)) - Presence of tic disease (Tic symptom screening, optional: Yale Global Tic Severity Scale (YGTSS)) - Medication use (questionnaire regarding medication use) - Demographics (age, gender, marital status, level of education, occupation etc) - OCD subtype (YBOCS checklist) - Insight in OCD symptoms (Overvalued Ideas Scale (OVIS) and OVIS self rating (OVIS-SR)) - Severity of OCD symptoms (Yale-Brown Obsessive Compulsive Scale (YBOCS) and YBOCS self rating (YBOCS-SR) - Comorbidity (SCID 5, Becks Depression Inventory (BDI), Becks Anxiety Inventory (BAI), Autism Spectrum Quotient (AQ) - Quality of life (EuroQol) - Disability/impairment in work, social life or leisure activities and home life or family responsibilities (Sheehan disability scale (SDS)) - Relationship satisfaction (Relationship Satisfaction Scale (RSS)) - Treatment tolerability (Treatment Acceptability/Adherence Scale (TAAS)) - Treatment expectancy (Credibility and Expectancy Questionnaire (CEQ)) - Work alliance (Work Alliance Inventory Short Form client and therapist version (WAV)) - Treatment compliance (therapist will score their impression of patients compliance to treatment and homework assignments after two sessions on a visual analogue scale (VAS-scale) - Questionnaire regarding treatment after study participation - MRI eligibility screening - PhenX toolkit Handedness - Wechsler Abbreviated Scale of Intelligence IV- Short Form (WAIS-SF) (including block design, matrix reasoning, vocabulary, similarities) - Visual Spatial N-back: measures executive functioning (updating), probing the dorsal cognitive CSTC circuit. - Tower of London Task (ToL): measures executive functioning (planning), probing the dorsal cognitive CSTC circuit. - Stop-Signal Task (SST); probing the ventral cognitive CSTC circuit. | — |
Countries
Netherlands