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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2023-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obsessive-Compulsive Disorder (OCD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CBT

Intensive CBT (20 sessions in 1 month)

Group Type EXPERIMENTAL

Cognitive-behavior therapy (psychological treatment)

Intervention Type BEHAVIORAL

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

Waiting-list

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

8 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes