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

The Resonance Assessment in Magnetic Measurement of the Effect of Psychotherapy in Obsessive-compulsive Disorder in a Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: OBSESSIVE COMPULSIVE DISORDER (OCD)
• Intervention / Treatment: Behavioral: Behavioral Therapy; Behavioral: Cognitive Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Piauí
    • Teresina, Piauí, Brazil, 64002-150
      • Piauí State University - UESPI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.; Other Names: Exposure and Response Prevention (ERP)
Experimental: 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	Behavioral: 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.; Other Names: Trial-based cognitive therapy
No Intervention: 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Data colected at 1st week and 12th week and, at follow-up, after three months, six months and one year. The scale used is SF-36	12 weeks
Quality of Life	At follow-up, after three months, six months and one year. The scale used is SF-36	1 year
Cognitive Distortions	Data colected every week (during 12 weeks). The scale used is CD-Quest	12 weeks
Cognitive Distortions	At follow-up, after three months, six months and one year. The scale used is Cognitive Distortions Questionnaire.	1 year
Severity of OCD	Data colected at 1st week, 6th week and 12th week and, at follow-up, after three months, six months and one year. The scale used is Y-BOCS	12 weeks
Severity of OCD	At follow-up, after three months, six months and one year. The scale used is Y-BOCS.	1 year
The Assessment of Depression	Data colected at 1st week, 6th week and 12th week and, at follow-up, after three months, six months and one year. The scale used is BDI	12 weeks
The Assessment of Depression	At follow-up, after three months, six months and one year. The scale used is BDI	1 year
The Assessment of Anxiety	Data colected at 1st week, 6th week and 12th week and, at follow-up, after three months, six months and one year. The scale used is BAI	12 weeks
The Assessment of Anxiety	At follow-up, after three months, six months and one year. The scale used is BAI	1 year
The Assessment of Magnetic Resonance (MRI)	Data colected at zero week and 15th week. The scale used is MRI	15 weeks
The Assessment of The Obssessive Beliefs	Data colected at zero week and 15th week. The scale used is OBQ-87	15 weeks
The level of Anxiety (Obssessive, Compulsive and Evitation Symptoms)	Data colected every week (during 12 weeks). The scale used is SUDS	12 weeks

Collaborators and Investigators

• Sponsor: Universidade Estadual do PiauÍ
• Collaborators: Federal University of Bahia
• Investigators: Principal Investigator: Eleonardo P Rodrigues, Psy MSc, Piaui State University - Brazil - UESPI - Recruiting; Study Director: Irismar R De Oliveira, PhD, Bahia Federal University - Brazil - UFBA

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): May 3, 2017

Study Registration Dates

• First Submitted: December 5, 2015
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimate): January 15, 2016

Study Record Updates

• Last Update Posted (Actual): June 22, 2017
• Last Update Submitted That Met QC Criteria: June 21, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: UESPI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No