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

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ClinicalTrials.gov Identifier: NCT02656784
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : June 22, 2017
Sponsor:
Collaborator:
Federal University of Bahia
Information provided by (Responsible Party):
Eleonardo Pereira Rodrigues, Universidade Estadual do PiauÍ

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.


Condition or disease Intervention/treatment Phase
OBSESSIVE COMPULSIVE DISORDER (OCD) Behavioral: Cognitive Therapy Behavioral: Behavioral Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Resonance Assessment in Magnetic Measurement of the Effect of Psychotherapy in Obsessive-compulsive Disorder in a Randomized Clinical Trial
Actual Study Start Date : February 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : May 3, 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 .



Primary Outcome Measures :
  1. The severity of OCD (Morphological and physiological changes in the brain) [ Time Frame: 12 weeks (3 months) ]
    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.


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 12 weeks ]
    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

  2. Quality of Life [ Time Frame: 1 year ]
    At follow-up, after three months, six months and one year. The scale used is SF-36

  3. Cognitive Distortions [ Time Frame: 12 weeks ]
    Data colected every week (during 12 weeks). The scale used is CD-Quest

  4. Cognitive Distortions [ Time Frame: 1 year ]
    At follow-up, after three months, six months and one year. The scale used is Cognitive Distortions Questionnaire.

  5. Severity of OCD [ Time Frame: 12 weeks ]
    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

  6. Severity of OCD [ Time Frame: 1 year ]
    At follow-up, after three months, six months and one year. The scale used is Y-BOCS.

  7. The Assessment of Depression [ Time Frame: 12 weeks ]
    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

  8. The Assessment of Depression [ Time Frame: 1 year ]
    At follow-up, after three months, six months and one year. The scale used is BDI

  9. The Assessment of Anxiety [ Time Frame: 12 weeks ]
    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

  10. The Assessment of Anxiety [ Time Frame: 1 year ]
    At follow-up, after three months, six months and one year. The scale used is BAI

  11. The Assessment of Magnetic Resonance (MRI) [ Time Frame: 15 weeks ]
    Data colected at zero week and 15th week. The scale used is MRI

  12. The Assessment of The Obssessive Beliefs [ Time Frame: 15 weeks ]
    Data colected at zero week and 15th week. The scale used is OBQ-87

  13. The level of Anxiety (Obssessive, Compulsive and Evitation Symptoms) [ Time Frame: 12 weeks ]
    Data colected every week (during 12 weeks). The scale used is SUDS



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656784


Locations
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Brazil
Piauí State University - UESPI
Teresina, Piauí, Brazil, 64002-150
Sponsors and Collaborators
Universidade Estadual do PiauÍ
Federal University of Bahia
Investigators
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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

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Responsible Party: Eleonardo Pereira Rodrigues, Effective Professor of Psychology Course. Coordinator of the Cognitive Neuroscience Laboratory., Universidade Estadual do PiauÍ
ClinicalTrials.gov Identifier: NCT02656784     History of Changes
Other Study ID Numbers: UESPI
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders