Clinical trial NCT05520398: Neural Mechanisms of Obsessive-compulsive Disorder (OCD) Treatment Failure
Official title: Cognitive and Neural Networks in Psychiatry (CNNP): Neural Mechanisms of Obsessive-compulsive Disorder (OCD) Treatment Failure (ERP in Silico)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with obsessive-compulsive disorder (OCD)

Brief summary: The aim of this study is to understand why patients with obsessive-compulsive disorder (OCD) fail in therapy.

To understand the neural mechanisms involved in exposure therapy that support success and clinical improvement in order to improve therapy outcomes for OCD patients.

Detailed description: A course of therapy is recommended for individuals with obsessive-compulsive disorder (OCD). It is usually a type of cognitive behavioural therapy (CBT) with exposure and response prevention (ERP).

In this study the investigators assess patients pre-therapy and post-therapy evaluating symptom severity (measured by the Y-BOCS) and decision-making (measured by online questionnaires and computer-based behavioural tasks).

To examine how decisions are formed in patients undergoing OCD CBT, how behaviour changes after a non-pharmacological therapy module and how it is associated to the alleviation of OCD symptoms.

The study, which will recruit 90 patients, is based at University College London - Wellcome Centre for Human Neuroimaging. This study is a part of the Cognitive and Neural Networks in Psychiatry (CNNP) study.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of obsessive-compulsive disorder (OCD)
* Fluent in written and spoken English
* Normal/corrected to normal vision
* Expecting to start OCD therapy

Exclusion Criteria:

* Autism spectrum disorder, psychosis, schizophrenia, addiction, substance abuse, bipolar, hoarding, or Tourette disorder
* Hearing conditions: tinnitus, ear inflammation, hearing sensitivity, hearing loss, requires hearing aids
* Colour blindness
* Severe learning disabilities

Primary outcomes:
measure: Yale-Brown obsessive compulsive scale (Y-BOCS)
timeFrame: 3 - 9 months
measure: Decision making and learning tasks
timeFrame: 3 - 9 months
Secondary outcomes:
measure: Patient EX/RP Adherence Scale (PEAS)
timeFrame: 3 - 9 months
measure: Short form of Obsessive Beliefs Questionnaire (OBQ)
timeFrame: 3 - 9 months
measure: Brief Experiential Avoidance Questionnaire (BEAQ)
timeFrame: 3 - 9 months
measure: International Cognitive Ability Resource (ICAR16)
timeFrame: 3 - 9 months
measure: Worry Domains Questionnaire - Short Form (WDQ-SF)
timeFrame: 3 - 9 months
measure: The World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
timeFrame: 3 - 9 months
measure: Sheehan Disability Scale (SDS)
timeFrame: 3 - 9 months
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 3 - 9 months
measure: Zung Self-Rating Depression Scale (SDS)
timeFrame: 3 - 9 months
measure: Anxiety Sensitivity Index (ASI-3)
timeFrame: 3 - 9 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Max Planck UCL Centre for Computational Psychiatry and Ageing Research
Study officials:
affiliation: University College, London
name: Tobias Hauser, PhD
role: PRINCIPAL_INVESTIGATOR
References: