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

NCT02656784 | Completed DMC

• 1 other identifier: UESPI
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

OBSESSIVE COMPULSIVE DISORDER (OCD)

Outcome Measures

Primary Outcomes (1)

• The severity of OCD (Morphological and physiological changes in the brain)

  Data colected at 1st week, 6th week, 12th week. Scales used are Yale-Brown Obssessive Compulsive Scale and Symptoms of Checklist (Y-BOCS), Beck Depression Inventory (BDI), Beck Anxienty Inventory (BAI), Obsessive-Compulsive Beliefs Questionnaire-87 (OBQ-87), The Medical Outcomes Study 36 - Item Short Form Health Survery ( SF-36), Questionnare of Cognitive Distortions (CD-Quest), Subjective Units of Discomfort (SUDS) and MRI.

  12 weeks (3 months)

Secondary Outcomes (13)

• Quality of Life

  12 weeks

• Quality of Life

  1 year

• Cognitive Distortions

  12 weeks

• Cognitive Distortions

  1 year

• Severity of OCD

  12 weeks

Study Arms (3)

Trial-Based Cognitive Therapy (TBCT)

EXPERIMENTAL

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

Behavioral: Behavioral Therapy

Behavioral Therapy (ERP)

EXPERIMENTAL

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

Behavioral: Cognitive Therapy

Control Group

NO INTERVENTION

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 .

Interventions

Cognitive Therapy 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.

Also known as: Trial-based cognitive therapy

Behavioral Therapy (ERP)

Behavioral Therapy 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.

Also known as: Exposure and Response Prevention (ERP)

Trial-Based Cognitive Therapy (TBCT)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Estadual do PiauÍ: lead
• Federal University of Bahia: collaborator

Study Sites (1)

Piauí State University - UESPI

Teresina, Piauí, 64002-150, Brazil

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy; Behavior Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Eleonardo P Rodrigues, Psy MSc

  Piaui State University - Brazil - UESPI - Recruiting

  PRINCIPAL INVESTIGATOR

• Irismar R De Oliveira, PhD

  Bahia Federal University - Brazil - UFBA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effective Professor of Psychology Course. Coordinator of the Cognitive Neuroscience Laboratory.

Study Record Dates

• First Submitted: December 5, 2015
• First Posted: January 15, 2016
• Study Start: February 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: May 3, 2017
• Last Updated: June 22, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)