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

Not Applicable

Recruiting

• Conditions: Obsessive-Compulsive Disorder (OCD)
• Interventions: Behavioral: Cognitive-behavior therapy (psychological treatment)

• Registration Number: NCT04042038
• Lead Sponsor: Institut d'Investigació Biomèdica de Bellvitge

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.

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-07-30
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT	Cognitive-behavior therapy (psychological treatment)	Intensive CBT (20 sessions in 1 month)

Primary Outcome Measures

Name	Time	Method
Yale-Brown Obsessive-Compulsive Scale	Change from baseline to post-treatment (1 month)	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	Change from baseline to post-treatment (1 month)	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

Name	Time	Method
Obsessive-Compulsive Inventory-Revised	Change from baseline to post-treatment (1 month)	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	Change from baseline to post-treatment (1 month)	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	Change from baseline to 1 month.	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	Change from baseline to 1 month	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.

Trial Locations

Locations (3)

FIDMAG Germanes Hospitalàries; 🇪🇸 Sant Boi De Llobregat, Barcelona, Spain

IDIBAPS; 🇪🇸 Barcelona, Spain

IDIBELL; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain