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

OBSESSIVE COMPULSIVE DISORDER (OCD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656784
• Other study ID #: UESPI
• Status: Completed
• Phase: N/A
• First received: December 5, 2015
• Last updated: June 21, 2017
• Start date: February 2015
• Est. completion date: May 3, 2017

Study information

• Verified date: June 2017
• Source: Universidade Estadual do PiauÍ
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 3, 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Compulsive Behavior
• OBSESSIVE COMPULSIVE DISORDER (OCD)
• Obsessive-Compulsive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Piauí State University - UESPI	Teresina	Piauí

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Estadual do PiauÍ	Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

Outcome

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