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

Primary Purpose

Obsessive-Compulsive Disorder (OCD)

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cognitive-behavior therapy (psychological treatment)
Sponsored by
Institut d'Investigació Biomèdica de Bellvitge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obsessive-Compulsive Disorder (OCD) focused on measuring Obsessive compulsive disorder, Intensive cognitive-behavioral therapy, Neuroimaging, Response prediction, Response mechanisms, Functional magnetic resonance imaging

Eligibility Criteria

8 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • IDIBELLRecruiting
  • FIDMAG Germanes HospitalàriesRecruiting
  • IDIBAPSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CBT

Waiting-list

Arm Description

Intensive CBT (20 sessions in 1 month)

Waiting-list

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
July 30, 2019
Last Updated
February 28, 2023
Sponsor
Institut d'Investigació Biomèdica de Bellvitge
Collaborators
Institut d'Investigacions Biomèdiques August Pi i Sunyer, FIDMAG Germanes Hospitalàries
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1. Study Identification

Unique Protocol Identification Number
NCT04042038
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut d'Investigació Biomèdica de Bellvitge
Collaborators
Institut d'Investigacions Biomèdiques August Pi i Sunyer, FIDMAG Germanes Hospitalàries

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder (OCD)
Keywords
Obsessive compulsive disorder, Intensive cognitive-behavioral therapy, Neuroimaging, Response prediction, Response mechanisms, Functional magnetic resonance imaging

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT
Arm Type
Experimental
Arm Description
Intensive CBT (20 sessions in 1 month)
Arm Title
Waiting-list
Arm Type
No Intervention
Arm Description
Waiting-list
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavior therapy (psychological treatment)
Intervention Description
Participants will receive up to 20 hours of manualized and structured CBT based on exposure and response prevention by experienced clinicians
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive-Compulsive Scale
Description
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.
Time Frame
Change from baseline to post-treatment (1 month)
Title
Children´s Yale-Brown Obsessive-Compulsive Scale
Description
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).
Time Frame
Change from baseline to post-treatment (1 month)
Secondary Outcome Measure Information:
Title
Obsessive-Compulsive Inventory-Revised
Description
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.
Time Frame
Change from baseline to post-treatment (1 month)
Title
Obsessive Compulsive Inventory-Child Version
Description
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.
Time Frame
Change from baseline to post-treatment (1 month)
Title
Children's Depression Inventory
Description
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.
Time Frame
Change from baseline to 1 month.
Title
Spence Children's Anxiety Scale
Description
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.
Time Frame
Change from baseline to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: (same for Study 1 and Study 2): 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). Exclusion Criteria: (same for Study 1 and Study 2 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carles Soriano-Mas, PhD
Phone
+34 260 65 75 00
Ext
2889
Email
csoriano@idibell.cat
Facility Information:
Facility Name
IDIBELL
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carles Soriano-Mas, PhD
Phone
630835743
Ext
2889
Email
csoriano@idibell.cat
Facility Name
FIDMAG Germanes Hospitalàries
City
Sant Boi De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edith Pomarol-Clotet, MD
Email
epomarol-clotet@fidmag.com
Facility Name
IDIBAPS
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luisa Lázaro, MD
Email
LLAZARO@clinic.cat

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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