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

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.

Study Overview

• Status: Recruiting
• Conditions: Obsessive-Compulsive Disorder (OCD)
• Intervention / Treatment: Behavioral: Cognitive-behavior therapy (psychological treatment)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carles Soriano-Mas, PhD; Phone Number: 2889 +34 260 65 75 00; Email: csoriano@idibell.cat

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • IDIBAPS
    • Contact: Luisa Lázaro, MD; Email: LLAZARO@clinic.cat
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Recruiting
      • IDIBELL
      • Contact: Carles Soriano-Mas, PhD; Phone Number: 2889 630835743; Email: csoriano@idibell.cat
    • Sant Boi De Llobregat, Barcelona, Spain, 08035
      • Recruiting
      • FIDMAG Germanes Hospitalàries
      • Contact: Edith Pomarol-Clotet, MD; Email: epomarol-clotet@fidmag.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT; Intensive CBT (20 sessions in 1 month)	Behavioral: Cognitive-behavior therapy (psychological treatment); Participants will receive up to 20 hours of manualized and structured CBT based on exposure and response prevention by experienced clinicians
No Intervention: Waiting-list

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obsessive-Compulsive Inventory-Revised	Obsessive-Compulsive Inventory-Revised is a self-report scale for assessing symptoms of Obsessive-Compulsive Disorder in adults. It consists of 18 questions that a person endorses on a 5-point Likert scale. Scores are generated by adding the item scores. The possible range of scores is 0-72. Mean score for persons with OCD is 28.0 (SD = 13.53). Recommended cutoff score is 21, with scores at or above this level indicating the likely presence of OCD.	Change from baseline to post-treatment (1 month)
Obsessive Compulsive Inventory-Child Version	Questionnaire assessing severity of obsessive-compulsive disorder symptoms children/adolescents. It is a 21-item self-report questionnaire, based on the 42-item adult version. Items are scored on a 3-point Likert scale. The measure is designed to evaluate obsessive-compulsive disorder in children between 7 and 17 years old. The total ranges from 0 to 42 points.	Change from baseline to post-treatment (1 month)
Children's Depression Inventory	The Children's Depression Inventory is a psychological assessment that rates the severity of symptoms related to depression or dysthymic disorder in children and adolescents. It is a 27-item scale that is self-rated and symptom-oriented. The 27 items on the assessment are grouped into five major factor areas. Patients rate themselves based on how they feel and think, with each statement being identified with a rating from 0 to 2.	Change from baseline to 1 month.
Spence Children's Anxiety Scale	The Spence Children's Anxiety Scale is a psychological questionnaire designed to identify symptoms of various anxiety disorders, specifically social phobia, obsessive-compulsive disorder, panic disorder/agorophobia, and other forms of anxiety, in children and adolescents between ages 8 and 15. There are 45 questions evaluating the frequency of certain anxiety symptoms, measured on a 0-3 scale from "never," "sometimes," often," to "always." A maximum score of 114 is possible on the child and parent-reported, and there are six subscales calculated within the final score. The total score is interpreted in different ways depending on the child's age and gender. For boys and girls ages 8-11, a total score of 40 and above or 50 and above is classified as elevated levels of anxiety, respectively. For boys and girls ages 12-15, a total score of 33 and above or 39 and above is classified as elevated, respectively.	Change from baseline to 1 month

Collaborators and Investigators

• Sponsor: Institut d'Investigació Biomèdica de Bellvitge
• Collaborators: Institut d'Investigacions Biomèdiques August Pi i Sunyer; FIDMAG Germanes Hospitalàries

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Neuroimaging; Functional magnetic resonance imaging; Obsessive compulsive disorder; Intensive cognitive-behavioral therapy; Response prediction; Response mechanisms
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Anxiety Disorders; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: HCB/2018/0681

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No