The Efficacy of TBCT Compared to ERP in the Treatment of OCD Patients, by the Assessment of Magnetic Resonance.

NCT ID: NCT02656784

Last Updated: 2017-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-05-03

Brief Summary

This is a sample made up of ninety-six adult individuals of both sexes to be divided into three groups: the experimental group of thirty-two patients with OCD who will be undergone Trial-Based Cognitive Therapy; the gold standard, with thirty-two people with OCD subject Exposure and Response Prevention and the control group of thirty-two healthy individuals. Interviews and therapeutic intervention occur in private practices researchers or medical schools accredited by UESPI.

Experimental group: Will be eligible adults of both sexes with educational level equal to or higher education complete primary, aged between 18 and 60 years with OCD diagnosis confirmed according to criteria DSM-IV (APA, 1994). It is going to be excluded patients who had previously undergone treatment behavioral psychotherapy or cognitive-behavioral approach.

Detailed Description

OBJECTIVES

Evaluate the effectiveness of Trial-Based Cognitive Therapy (TBCT) compared to Exposure and Response Prevention (ERP) in the treatment of OCD patients, by neuroimaging tests such as MRI.

1. Describe the neuroanatomical profile of the sample participants before and after the psychotherapeutic intervention by MRI;

2. Compare the profile neuroanatomical between the experimental group and the control group by MRI;

3. Identify possible neuroanatomical differences in the participating sample of pre and post-treatment, both among individuals and among psychotherapeutic intervention groups;

4. To investigate associations between the results of MRI scans and indexes the scales currently used to assess severity of OCD.

Conditions

OBSESSIVE COMPULSIVE DISORDER (OCD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Trial-Based Cognitive Therapy (TBCT)

Trial-Based Cognitive Therapy (TBCT) is a three-level, three-phase, case formulation approach, based on the work of Franz Kafka "The Trial" and developed by Professor Irismar Reis de Oliveira at Federal University of Bahia, Brazil. TBCT's foundation is in cognitive therapy (CT); however, it has a unique approach to conceptualization and techniques that make it a distinct intervention in modifying patients' core beliefs, especially those about the self. All individuals in the group will be submitted to MRI

Group Type: EXPERIMENTAL

Behavioral Therapy

Intervention Type: BEHAVIORAL

The Behavioral therapy employs the technique of Exposure and Response Prevention ( ERP ).The technique involves directly exposing patients to recall stimulation of obsessive thoughts and prevent them from performing the compulsive rituals. All the individuals will be submitted to MRI.

Behavioral Therapy (ERP)

The Behavioral Therapy is an intervention of first choice for treatment of OCD , which employs the technique of Exposure and Response Prevention (ERP) , considered the gold standard to the disorder. The technique involves directly exposing patients to recall stimulation of obsessive thoughts and prevent them from performing the compulsive rituals. All individuals in the group will be submitted to MRI

Group Type: EXPERIMENTAL

Cognitive Therapy

Intervention Type: BEHAVIORAL

Trial-Based Cognitive Therapy (TBCT) is a three-level, three-phase, case formulation approach. TBCT's foundation is in cognitive therapy (CT); however, it has a unique approach to conceptualization and techniques that make it a distinct intervention in modifying patients' core beliefs, especially those about the self. All the individuals will be submitted to MRI.

Control Group

The control group consisted of individuals without OCD, matched with the experimental group in terms of gender,age and education. In this group are not included in individuals in psychotherapeutic care and with a history of neurological or psychiatric disorder; however, all them will be submitted to MRI .

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Therapy

Trial-Based Cognitive Therapy (TBCT) is a three-level, three-phase, case formulation approach. TBCT's foundation is in cognitive therapy (CT); however, it has a unique approach to conceptualization and techniques that make it a distinct intervention in modifying patients' core beliefs, especially those about the self. All the individuals will be submitted to MRI.

Intervention Type: BEHAVIORAL

Behavioral Therapy

The Behavioral therapy employs the technique of Exposure and Response Prevention ( ERP ).The technique involves directly exposing patients to recall stimulation of obsessive thoughts and prevent them from performing the compulsive rituals. All the individuals will be submitted to MRI.

Intervention Type: BEHAVIORAL

Other Intervention Names

Trial-based cognitive therapy; Exposure and Response Prevention (ERP)

Eligibility Criteria

Inclusion Criteria

• Will be eligible adults of both sexes with educational level equal to or higher education complete primary, aged between 18 and 60 years with OCD diagnosis confirmed according to criteria DSM-IV

Exclusion Criteria

• It is going to be excluded patients who had previously undergone treatment behavioral psychotherapy or cognitive-behavioral approach.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Bahia

OTHER

Sponsor Role: collaborator

Universidade Estadual do PiauÍ

OTHER

Sponsor Role: lead

Responsible Party

Eleonardo Pereira Rodrigues

Effective Professor of Psychology Course. Coordinator of the Cognitive Neuroscience Laboratory.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eleonardo P Rodrigues, Psy MSc

Role: PRINCIPAL_INVESTIGATOR

Piaui State University - Brazil - UESPI - Recruiting

Irismar R De Oliveira, PhD

Role: STUDY_DIRECTOR

Bahia Federal University - Brazil - UFBA

Locations

Piauí State University - UESPI

Teresina, Piauí, Brazil

Countries

Brazil

Other Identifiers

UESPI

Identifier Type: -

Identifier Source: org_study_id