terms of use data arrIBA
Creators: name: Visser
Publisher: name: Zenodo
Year: 2024
Subjects: subject: Obsessive-compulsive disorder

description: Alternative Treatment to Reduce Chronicity in OCD: Research Into Brain Response and Adequacy of Treatment (arrIBA)

ClinicalTrials.gov identifier NCT03929081

Principal Investigator: H. Visser PhD

 

Study Overview

Brief Summary

In this study (a multicentre randomized controlled non-inferiority trial) the effectiveness and neurobiological working mechanism of the Inference Based Approach (IBA), a new psychotherapy for people with Obsessive-Compulsive Disorder (OCD), was compared to that of Cognitive Behavioral Therapy (CBT). 

Adult patients with OCD (N=197) were randomly allocated to treatment with 20 sessions IBA or 20 sessions CBT. A subsample (N=86) and 43 healthy controls also participated in the imaging study and underwent fMRI and cognitive tests. fMRI took place pretreatment and post treatment. Healthy controls just 

Severity of OCD, as measured with the Yale Brown Obsessive Compulsive Scale (YBOCS) was the primary outcome measure. Assessments took place at baseline, post treatment and 6 and 12 months after the end of treatment. 

Datacollection took place between 2019 and 2023

 

 

 

Inclusion Criteria:

Participants



Referred to one of the participating sites for OCD treatment

Age 18 or above

Primary Diagnostic Statistical Manual (DSM)-5 diagnosis of OCD (established by the Structured Clinical Interview for DSM-5 (SCID)

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 for OCD, treatment has ended at least 26 weeks before study participation.


Controls

- Age 18 or above

Exclusion Criteria:

Patients



Suffering from a current psychotic disorder, organic mental disorder, substance use disorder or mental retardation

No sufficient command of the Dutch language


 

 

Main study parameters/endpoints: Clinical measures (e.g. severity of OCD symptoms, disease insight), neurocognitive capabilities (performance on neuropsychological tests), neural correlates on brain structure (i.e. white matter integrity, grey matter volume) and brain function (i.e., activation and connectivity during resting state and symptom provocation) using 3 Tesla magnetic resonance imaging.

Study parameters:

                   Clinical assessments

-          Current and lifetime primary diagnosis of OCD and comorbidity (SCID-5), including age at disease onset.

-          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 (responderstatus plus posttest YBOCS ≤ 8) (yes/no)

-          Insight in OCD symptoms (Overvalued Ideas Scale (OVIS))

-          Comorbidity (SCID-5, Yale Global Tic Severity Scale (YGTSS)

-          Treatment history (questionnaire regarding current and lifetime psychotherapy and medication use)

-          Current medication use (questionnaire regarding current medication use)

-          Illness duration at start of treatment (SCID-5)

-          Questionnaire regarding feared consequences

 

Self-report questionnaires

-          Demographics (age, gender, marital status, number of children and siblings, physical health, level of education and occupation) 

-          OCD subtype (YBOCS symptom checklist)

-          Severity of OCD symptoms (Yale-Brown Obsessive Compulsive Scale self-report questionnaire (YBOCS-SR) & Obsessive Compulsive Inventory-Revised (OCI-R))

-          Insight in OCD symptoms (Overvalued Ideas Scale self-report questionnaire (OVIS-SR))

-          Comorbidity (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 (WAI-Short Form))

-          Treatment compliance (therapist will score their impression of patients compliance to treatment and homework assignments after session 10 and 20 on a scale from 0 - 100 

-          Questionnaire regarding treatment after study participation

 

Tasks

Confidence Accuracy Task: measures the accuracy of the confidences in one’s own performance on a visual perception task.  

 

 

Study outcomes exclusively for participants of the imaging part

These assessments will take place at the Amsterdam UMC (location VUmc) by a trained (neuro)psychologist, within one week of the clinical assessments.

 

Interviews

-          MRI eligibility screening

Self-report questionnaires

-          PhenX Toolkit for Hand Dominance Measure (Dutch) (PTHD)

NeuroimagingScans will be performed on a 3 Tesla whole-body scanner, equipped with a 32 channel phased-array head coil. Images will be acquired with optimized and standardized sequences for:                                                                               a. high resolution 3D T1 weighted structural imaging with 1 mm isotropic             resolution             b. multi-shell diffusion weighted imaging (DWI) based on 73 high b-values: 25      in the first shell (b1000), and 24 in the 2 higher shells (b2000 and b3000) with         2,5 mm isotropic resolution, and 7 unweighted (b=0 s/mm2) scans                     c. resting-state fMRI (10 minutes, eyes closed): 272 volumes with 3.3 mm           isotropic resolution.                                                                                                      d. fMRI during symptom provocation (9 minutes). We will implement a 19            second on-off block-design task with OCD related (subtypes: symmetry, check  and wash), general fearful and neutral pictures being presented during 3                seconds each. These stimuli will be adopted from an OCD-specific emotion      regulation paradigm (De Wit et al., 2015) and from the International Affective         Picture System (IAPS; Lang, Bradley & Cuthbert, 2008). Participants are             instructed to attend to these pictures, and to perform a simple task to assure       attendance. To prevent habituation to the stimuli (repetition effects), different  versions will be used for the pre- and posttreatment scanning session. The    order of these two versions will be counterbalanced across patients. Directly        before and after the symptom provocation task, participants will rate their level    of distress. Additionally, after scanning, participants will rate their level of             distress provoked by each individual picture on a 5 point      scale.

Computerized tasks

IQ assessment:

-          Wechsler Abbreviated Scale of Intelligence IV- Short Form (WAIS-SF) (including block design, matrix reasoning, vocabulary, similarities)Neurobehavioral:

-          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.