Neural Predictors and Neural Changes Associated With Cognitive Behavior Therapy for Obssesive Compulsive Disorder

NCT04042038 | Unknown

• 1 other identifier: HCB/2018/0681
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Obsessive-Compulsive Disorder (OCD)

Keywords

Obsessive compulsive disorder; Intensive cognitive-behavioral therapy; Neuroimaging; Response prediction; Response mechanisms; Functional magnetic resonance imaging

Outcome Measures

Primary Outcomes (2)

• Yale-Brown Obsessive-Compulsive Scale

  The Yale-Brown Obsessive-Compulsive Scale evaluates the severity of Obsessive Compulsive Disorder symptoms in adults. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms) (total range, 0 to 40), with separate subtotals for severity of obsessions and compulsions.

  Change from baseline to post-treatment (1 month)

• Children´s Yale-Brown Obsessive-Compulsive Scale

  The Children´s Yale-Brown Obsessive-Compulsive Scale evaluates the severity of Obsessive Compulsive Disorder symptoms in children/adolescents. The severity of the obsessions is rated on five Severity Items for Obsessions. Each of these five items is rated on a 5-point, ordinal scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = extreme. These values are anchored by a description for each score. The Obsessions Severity Score is obtained by adding the scores for items 1 through 5 (range = 0 to 20). There are five comparable Severity Items for Compulsions (items 6 through 10), which are also scored from 0 to 4. The Compulsions Severity Score is obtained by adding the scores of items 6 through 10 (range = 0 to 20). Summing the scores for all 10 items yields the CY-BOCS Total score (range = 0 to 40).

  Change from baseline to post-treatment (1 month)

Secondary Outcomes (4)

• Obsessive-Compulsive Inventory-Revised

  Change from baseline to post-treatment (1 month)

• Obsessive Compulsive Inventory-Child Version

  Change from baseline to post-treatment (1 month)

• Children's Depression Inventory

  Change from baseline to 1 month.

• Spence Children's Anxiety Scale

  Change from baseline to 1 month

Study Arms (2)

CBT

EXPERIMENTAL

Intensive CBT (20 sessions in 1 month)

Behavioral: Cognitive-behavior therapy (psychological treatment)

Waiting-list

NO INTERVENTION

Waiting-list

Interventions

Cognitive-behavior therapy (psychological treatment) BEHAVIORAL

Participants will receive up to 20 hours of manualized and structured CBT based on exposure and response prevention by experienced clinicians

CBT

Eligibility Criteria

• Age: 8 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Principal diagnosis of OCD;
• Y-BOCS or CYBOCS ≥ 16).
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Bellvitge: lead
• Institut d'Investigacions Biomèdiques August Pi i Sunyer: collaborator
• FIDMAG Germanes Hospitalàries: collaborator

Study Sites (3)

IDIBELL

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

FIDMAG Germanes Hospitalàries

Sant Boi de Llobregat, Barcelona, 08035, Spain

RECRUITING

IDIBAPS

Barcelona, 08036, Spain

RECRUITING

Related Publications (1)

• Hermida-Barros L, Garcia-Delgar B, Lera-Miguel S, Forcadell E, Moreno E, Prime-Tous M, Jaurrieta N, Segu X, Vilajosana E, Soriano-Mas C, de la Cruz LF, Vieta E, Radua J, Lazaro L, Fullana MA. Concentrated Cognitive-Behavior Therapy for Unmedicated Children and Adolescents With Obsessive-Compulsive Disorder in Routine Clinical Care: A Randomized Controlled Trial With a 6-Month Naturalistic Follow-up. Behav Ther. 2025 Jul;56(4):799-811. doi: 10.1016/j.beth.2025.01.001. Epub 2025 Jan 13.

  PMID: 40541379 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Carles Soriano-Mas, PhD

CONTACT

+34 260 65 75 00; csoriano@idibell.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 1, 2019
• Study Start: May 1, 2019
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

ES (3)