Back to resultsThe Efficacy of TBCT Compared to ERP in the Treatment of OCD Patients, by the Assessment of Magnetic Resonance.
Primary Purpose
OBSESSIVE COMPULSIVE DISORDER (OCD)
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cognitive Therapy
Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for OBSESSIVE COMPULSIVE DISORDER (OCD)
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.
Sites / Locations
- Piauí State University - UESPI
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Trial-Based Cognitive Therapy (TBCT)
Behavioral Therapy (ERP)
Control Group
Arm Description
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
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
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 .
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Quality of Life
At follow-up, after three months, six months and one year. The scale used is SF-36
Cognitive Distortions
Data colected every week (during 12 weeks). The scale used is CD-Quest
Cognitive Distortions
At follow-up, after three months, six months and one year. The scale used is Cognitive Distortions Questionnaire.
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
Severity of OCD
At follow-up, after three months, six months and one year. The scale used is Y-BOCS.
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
The Assessment of Depression
At follow-up, after three months, six months and one year. The scale used is BDI
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
The Assessment of Anxiety
At follow-up, after three months, six months and one year. The scale used is BAI
The Assessment of Magnetic Resonance (MRI)
Data colected at zero week and 15th week. The scale used is MRI
The Assessment of The Obssessive Beliefs
Data colected at zero week and 15th week. The scale used is OBQ-87
The level of Anxiety (Obssessive, Compulsive and Evitation Symptoms)
Data colected every week (during 12 weeks). The scale used is SUDS
Full Information
NCT ID
NCT02656784
First Posted
December 5, 2015
Last Updated
June 21, 2017
Sponsor
Universidade Estadual do PiauÍ
Collaborators
Federal University of Bahia
1. Study Identification
Unique Protocol Identification Number
NCT02656784
Brief Title
The Efficacy of TBCT Compared to ERP in the Treatment of OCD Patients, by the Assessment of Magnetic Resonance.
Official Title
The Resonance Assessment in Magnetic Measurement of the Effect of Psychotherapy in Obsessive-compulsive Disorder in a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
May 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual do PiauÍ
Collaborators
Federal University of Bahia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Describe the neuroanatomical profile of the sample participants before and after the psychotherapeutic intervention by MRI;
Compare the profile neuroanatomical between the experimental group and the control group by MRI;
Identify possible neuroanatomical differences in the participating sample of pre and post-treatment, both among individuals and among psychotherapeutic intervention groups;
To investigate associations between the results of MRI scans and indexes the scales currently used to assess severity of OCD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OBSESSIVE COMPULSIVE DISORDER (OCD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trial-Based Cognitive Therapy (TBCT)
Arm Type
Experimental
Arm Description
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
Arm Title
Behavioral Therapy (ERP)
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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 .
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Therapy
Other Intervention Name(s)
Trial-based cognitive therapy
Intervention Description
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
Intervention Name(s)
Behavioral Therapy
Other Intervention Name(s)
Exposure and Response Prevention (ERP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The severity of OCD (Morphological and physiological changes in the brain)
Description
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.
Time Frame
12 weeks (3 months)
Secondary Outcome Measure Information:
Title
Quality of Life
Description
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
Time Frame
12 weeks
Title
Quality of Life
Description
At follow-up, after three months, six months and one year. The scale used is SF-36
Time Frame
1 year
Title
Cognitive Distortions
Description
Data colected every week (during 12 weeks). The scale used is CD-Quest
Time Frame
12 weeks
Title
Cognitive Distortions
Description
At follow-up, after three months, six months and one year. The scale used is Cognitive Distortions Questionnaire.
Time Frame
1 year
Title
Severity of OCD
Description
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
Time Frame
12 weeks
Title
Severity of OCD
Description
At follow-up, after three months, six months and one year. The scale used is Y-BOCS.
Time Frame
1 year
Title
The Assessment of Depression
Description
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
Time Frame
12 weeks
Title
The Assessment of Depression
Description
At follow-up, after three months, six months and one year. The scale used is BDI
Time Frame
1 year
Title
The Assessment of Anxiety
Description
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
Time Frame
12 weeks
Title
The Assessment of Anxiety
Description
At follow-up, after three months, six months and one year. The scale used is BAI
Time Frame
1 year
Title
The Assessment of Magnetic Resonance (MRI)
Description
Data colected at zero week and 15th week. The scale used is MRI
Time Frame
15 weeks
Title
The Assessment of The Obssessive Beliefs
Description
Data colected at zero week and 15th week. The scale used is OBQ-87
Time Frame
15 weeks
Title
The level of Anxiety (Obssessive, Compulsive and Evitation Symptoms)
Description
Data colected every week (during 12 weeks). The scale used is SUDS
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleonardo P Rodrigues, Psy MSc
Organizational Affiliation
Piaui State University - Brazil - UESPI - Recruiting
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Irismar R De Oliveira, PhD
Organizational Affiliation
Bahia Federal University - Brazil - UFBA
Official's Role
Study Director
Facility Information:
Facility Name
Piauí State University - UESPI
City
Teresina
State/Province
Piauí
ZIP/Postal Code
64002-150
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of TBCT Compared to ERP in the Treatment of OCD Patients, by the Assessment of Magnetic Resonance.
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