Clinical trial NCT02656784: 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
Overall status: COMPLETED
Phase: NA
Conditions: OBSESSIVE COMPULSIVE DISORDER (OCD)
Lead sponsor: Universidade Estadual do PiauÍ
Sponsor class: OTHER
Collaborators: name: Federal University of Bahia
First posted: 2016-01-15
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: The severity of OCD (Morphological and physiological changes in the brain)
timeFrame: 12 weeks (3 months)
Secondary outcomes:
measure: Quality of Life
timeFrame: 12 weeks
measure: Quality of Life
timeFrame: 1 year
measure: Cognitive Distortions
timeFrame: 12 weeks
measure: Cognitive Distortions
timeFrame: 1 year
measure: Severity of OCD
timeFrame: 12 weeks
measure: Severity of OCD
timeFrame: 1 year
measure: The Assessment of Depression
timeFrame: 12 weeks
measure: The Assessment of Depression
timeFrame: 1 year
measure: The Assessment of Anxiety
timeFrame: 12 weeks
measure: The Assessment of Anxiety
timeFrame: 1 year
measure: The Assessment of Magnetic Resonance (MRI)
timeFrame: 15 weeks
measure: The Assessment of The Obssessive Beliefs
timeFrame: 15 weeks
measure: The level of Anxiety (Obssessive, Compulsive and Evitation Symptoms)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Teresina
country: Brazil
facility: Piauí State University - UESPI
state: Piauí
Study officials:
affiliation: Piaui State University - Brazil - UESPI - Recruiting
name: Eleonardo P Rodrigues, Psy MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Bahia Federal University - Brazil - UFBA
name: Irismar R De Oliveira, PhD
role: STUDY_DIRECTOR
References: