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Completed

NCT Number: NCT02656784

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

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.

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Key information

Conditions

Obsessive Compulsive Disorder (OCD) Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Piauí State University - UESPI

Teresina, Piauí, 64002-150, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cognitive therapy

Behavioral

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 names: Trial-based cognitive therapy

Behavioral therapy

Behavioral

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 names: Exposure and Response Prevention (ERP)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidade Estadual do PiauÍ

Other

Collaborators

  • Federal University of Bahia

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jan 15, 2016
Registry last updated
Jun 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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