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Inference Based Approach (IBA): towards personalized care for OCD patients ;A randomized non-inferiority controlled trial into the effectiveness and working mechanisms of IBA in comparison to CBT.

Inference Based Approach (IBA): towards personalized care for OCD patients ;A randomized non-inferiority controlled trial into the effectiveness and working mechanisms of IBA in comparison to CBT. - arrIBA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49344
Enrollment
246
Registered
2019-03-20
Start date
2019-05-23
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive Compulsive Disorder OCD

Interventions

The IBA treatment, a focused form of psychotherapy consists of twenty 45-minutes sessions, delivered weekly and carried out as specified in a session-by-session IBA protocol, containing standardized

Sponsors

GGZ Centraal (Amersfoort)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)