AzTrials
AzTrials

OBSESSIVE COMPULSIVE DISORDER (OCD)NCT02656784

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

A study testing Cognitive Therapy and Behavioral Therapy in people with OBSESSIVE COMPULSIVE DISORDER (OCD), run by Universidade Estadual do PiauÍ at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
OBSESSIVE COMPULSIVE DISORDER (OCD)
What is being tested?
Cognitive Therapy and Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteBrazil
Study dates
Feb 2015to 3 May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • It is going to be excluded patients who had previously undergone treatment behavioral psychotherapy or cognitive-behavioral approach.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Piauí State University - UESPI

    Teresina, Piauí, 64002-150

Other trials in Brazil

About this study

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

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.

Read the 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.
Being tested
Cognitive Therapy, Behavioral Therapy
Medical subject headings
Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive TherapyBehavioural

    Also called Trial-based 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 TherapyBehavioural

    Also called Exposure and Response Prevention (ERP)

    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.

Study groups in NCT02656784
Study groupRoleWhat they receive
Trial-Based Cognitive Therapy (TBCT)ExperimentalTrial-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
Receives: Behavioral: Behavioral Therapy
Behavioral Therapy (ERP)ExperimentalThe 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
Receives: Behavioral: Cognitive Therapy
Control GroupNo interventionThe 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 .

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks (3 months)

Secondary outcomes (13)

  1. 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

    Measured: 12 weeks

  2. Quality of Life

    At follow-up, after three months, six months and one year. The scale used is SF-36

    Measured: 1 year

  3. Cognitive Distortions

    Data colected every week (during 12 weeks). The scale used is CD-Quest

    Measured: 12 weeks

  4. Cognitive Distortions

    At follow-up, after three months, six months and one year. The scale used is Cognitive Distortions Questionnaire.

    Measured: 1 year

  5. 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

    Measured: 12 weeks

  6. Severity of OCD

    At follow-up, after three months, six months and one year. The scale used is Y-BOCS.

    Measured: 1 year

  7. 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

    Measured: 12 weeks

  8. The Assessment of Depression

    At follow-up, after three months, six months and one year. The scale used is BDI

    Measured: 1 year

  9. 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

    Measured: 12 weeks

  10. The Assessment of Anxiety

    At follow-up, after three months, six months and one year. The scale used is BAI

    Measured: 1 year

  11. The Assessment of Magnetic Resonance (MRI)

    Data colected at zero week and 15th week. The scale used is MRI

    Measured: 15 weeks

  12. The Assessment of The Obssessive Beliefs

    Data colected at zero week and 15th week. The scale used is OBQ-87

    Measured: 15 weeks

  13. The level of Anxiety (Obssessive, Compulsive and Evitation Symptoms)

    Data colected every week (during 12 weeks). The scale used is SUDS

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2016 (estimated)
  2. Study startFeb 2015
  3. Primary completionDec 2016
  4. Study completion3 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02656784
Sponsor's protocol ID
UESPI
Status last verified
Jun 2017
First submitted
5 Dec 2015
Last updated
22 Jun 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Therapy and Behavioral Therapy in people with OBSESSIVE COMPULSIVE DISORDER (OCD), run by Universidade Estadual do PiauÍ at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The severity of OCD (Morphological and physiological changes in the brain) (time frame: 12 weeks (3 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02656784.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in