The Resonance Assessment in Magnetic Measurement of the Effect of Psychotherapy in Obsessive-compulsive Disorder in a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- The severity of OCD (Morphological and physiological changes in the brain)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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
Intervention: Behavioral Therapy (Behavioral)
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
Intervention: Cognitive Therapy (Behavioral)
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 .
Outcomes
Primary Outcomes
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 Outcomes
- Quality of Life(1 year)
- Cognitive Distortions(1 year)
- The Assessment of The Obssessive Beliefs(15 weeks)
- Severity of OCD(1 year)
- The level of Anxiety (Obssessive, Compulsive and Evitation Symptoms)(12 weeks)
- The Assessment of Depression(1 year)
- The Assessment of Anxiety(1 year)
- The Assessment of Magnetic Resonance (MRI)(15 weeks)
- Quality of Life(12 weeks)
- Cognitive Distortions(12 weeks)
- Severity of OCD(12 weeks)
- The Assessment of Depression(12 weeks)
- The Assessment of Anxiety(12 weeks)
Investigators
Eleonardo Pereira Rodrigues
Effective Professor of Psychology Course. Coordinator of the Cognitive Neuroscience Laboratory.
Universidade Estadual do PiauÍ