Clinical trial NCT04042038: Neural Predictors and Neural Changes Associated With Cognitive Behavior Therapy for Obssesive Compulsive Disorder
Official title: Neural Predictors and Neural Changes Associated With Cognitive Behavior Therapy for Obssesive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obsessive-Compulsive Disorder (OCD)
Keywords: Obsessive compulsive disorder
Intensive cognitive-behavioral therapy
Neuroimaging
Response prediction
Response mechanisms
Functional magnetic resonance imaging
Lead sponsor: Institut d'Investigació Biomèdica de Bellvitge
Sponsor class: OTHER
Collaborators: name: Institut d'Investigacions Biomèdiques August Pi i Sunyer
name: FIDMAG Germanes Hospitalàries
First posted: 2019-08-01
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two separate (but methodologically identical) RCTs will be conducted, one in a sample of children/adolescents with OCD (study 1) and another in a sample of adults with OCD (study 2). Within each study, one group of age and gender-matched healthy controls will also serve as a comparison group at baseline (clinical and neuroimaging assessment). Within each study, after baseline assessment, OCD participants will be randomized to either intensive CBT or waiting list for one month. Then, OCD participants will be assessed again (clinical and neuroimaging assessment).
Primary purpose: BASIC_SCIENCE

Brief summary: The goals of the project are 1) to understand what are the neural mechanisms involved in the psychological treatment of obsessive-compulsive disorder (OCD) in children/adolescents and adults, 2) to assess potential differences in the neural mechanisms involved in the psychological treatment of OCD between children/adolescents and adults, and 3) to assess the effectiveness of intensive CBT for children/adolescents and adults with OCD.

Detailed description: Obsessive-compulsive disorder (OCD) is a frequent and disabling disorder. Cognitive-behavior therapy (CBT) is the best treatment option available for OCD, although it achieves optimum results in less than half of the patients. The investigators will investigate the main neural circuits that predict CBT outcome in OCD and the neural changes associated with CBT in two separate randomized controlled trials (RCTs), one in an adult sample and another in a pediatric sample. In this two RCTs, OCD participants will be randomized to either intensive CBT (20 sessions in 1 month) by a experienced clinician or a waiting-list control (WLC) and will be assessed (by a blind assessor) and scanned before and after CBT. Patients will be offered CBT if they have been randomized to the WLC. At baseline, the investigators will also compare OCD patients with a group of healthy controls (HC). Secondary goals of the project include 1) assessing potential differences between children/adolescents and adults in the neural mechanisms involved in CBT for OCD; 2) assess the effectiveness of intensive CBT for children/adolescents and adults.

Eligibility criteria: Inclusion Criteria: (same for Study 1 and Study 2):

1. Principal diagnosis of OCD;
2. Y-BOCS or CYBOCS ≥ 16).
3. No current psychotropic medication (except benzodiacepines for sleep). 4 ) Age between 8 and 17 years (Study 1) and between 18 and 60 years (Study 2).

Exclusion Criteria: (same for Study 1 and Study 2

1. Current major depression or current/past psychosis, bipolar disorder or substance abuse.
2. Developmental disorders (including autistic spectrum disorders).
3. To be pregnant or during breastfeeding
4. Current CBT; nt.
5. Any severe medical disorder ;
6. Any contraindication for neuroimaging

Primary outcomes:
measure: Yale-Brown Obsessive-Compulsive Scale
timeFrame: Change from baseline to post-treatment (1 month)
measure: Children´s Yale-Brown Obsessive-Compulsive Scale
timeFrame: Change from baseline to post-treatment (1 month)
Secondary outcomes:
measure: Obsessive-Compulsive Inventory-Revised
timeFrame: Change from baseline to post-treatment (1 month)
measure: Obsessive Compulsive Inventory-Child Version
timeFrame: Change from baseline to post-treatment (1 month)
measure: Children's Depression Inventory
timeFrame: Change from baseline to 1 month.
measure: Spence Children's Anxiety Scale
timeFrame: Change from baseline to 1 month
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: IDIBELL
state: Barcelona
city: Sant Boi De Llobregat
country: Spain
facility: FIDMAG Germanes Hospitalàries
state: Barcelona
city: Barcelona
country: Spain
facility: IDIBAPS
Study officials:
References: