Obsessive-compulsive DisorderNCT02014194
Attentional Bias Modification Treatment in OCD
A study testing attentional bias modification treatment in people with Obsessive-compulsive Disorder, run by Roseli Shavitt at 1 site in Brazil.
Trial summary
Obsessive-compulsive disorder is a chronic condition. Even with proper treatment, no significant improvement is reached in about 30% to 40% of patients. Thus, the development of new treatment strategies is necessary. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-compulsive Disorder
- What is being tested?
- attentional bias modification treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2013to Dec 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: - 30 patients with obsessive-compulsive diagnosis according to DSM-V (with cleaning and or symmetry dimensions)
- 30 health controls
Exclusion Criteria: - doing any kind of behavioral therapy in the moment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attentional Bias and Attentional Bias Modification Treatment in Obsessive-compulsive Disorder
Obsessive-compulsive disorder is a chronic condition. Even with proper treatment, no significant improvement is reached in about 30% to 40% of patients. Thus, the development of new treatment strategies is necessary. The attentional bias - ability to aversive stimuli in capturing the attention of an individual compared to a neutral stimulus - has been extensively studied. Already training attentional bias modification has been shown effective in reducing anxiety present in other anxiety disorders.This project aims to: 1 - generate knowledge on attentional bias in individuals with OCD through the use of a standardized protocol developed for OCD; 2 - available to the scientific community the first specific paradigm for the study of attentional bias in OCD patients, 3 - test the effectiveness of a training protocol for reversing attentional bias in individuals with OCD.
- Conditions
- Obsessive-compulsive Disorder
- Being tested
- attentional bias modification treatment
- Keywords
- Attentional Bias, Attentional Bias modification treatment
- 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.
attentional bias modification treatmentBehavioural
The attentional bias modification treatment is a behavioral computerized program (software e-prime)
| Study group | Role | What they receive |
|---|---|---|
| attentional bias modification, placebo | Placebo comparator | Measure of attentional bias modification treatment after 10 sessions of attentional bias modification (two arms). There are two arms with 15 OCD patients each one. Receives: Behavioral: attentional bias modification treatment |
| attentional bias modification, active group | Active comparator | Measure of attentional bias modification treatment after 10 sessions of attentional bias modification (two arms). Receives: Behavioral: attentional bias modification treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of reduction of attentional bias
Measured: Patients will be followed an expected average of 7 weeks (baseline, 2 sessions per week - totalizing 5 weeks, 10 sessions and a session after end of treatment). Measures of attentional bias will be assessed in baseline, session 5 and after session 10.
Secondary outcomes (1)
Reduction of anxiety symptoms
Measured: Baseline, session 5 and end of treatment (after session 10) (expected average of 7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roseli Shavitt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roseli Shavitt, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014194
- Sponsor's protocol ID
- 13674113.2.0000.0068
- Status last verified
- Jan 2018
- First submitted
- 25 Nov 2013
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attentional Bias and Attentional Bias Modification Treatment in Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT02014194
- Acronym / sponsor ID
- 13674113.2.0000.0068
- Conditions
- Obsessive-compulsive Disorder
- Keywords
- Attentional Bias, Attentional Bias modification treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Roseli ShavittUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obsessive-compulsive disorder is a chronic condition. Even with proper treatment, no significant improvement is reached in about 30% to 40% of patients. Thus, the development of new treatment strategies is necessary. The attentional bias - ability to aversive stimuli in capturing the attention of an individual compared to a neutral stimulus - has been extensively studied. Already training attentional bias modification has been shown effective in reducing anxiety present in other anxiety disorders.This project aims to: 1 - generate knowledge on attentional bias in individuals with OCD through the use of a standardized protocol developed for OCD; 2 - available to the scientific community the first specific paradigm for the study of attentional bias in OCD patients, 3 - test the effectiveness of a training protocol for reversing attentional bias in individuals with OCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| attentional bias modification, placebo | Placebo comparator | Behavioral: attentional bias modification treatmentMeasure of attentional bias modification treatment after 10 sessions of attentional bias modification (two arms). There are two arms with 15 OCD patients each one. |
| attentional bias modification, active group | Active comparator | Behavioral: attentional bias modification treatmentMeasure of attentional bias modification treatment after 10 sessions of attentional bias modification (two arms). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| attentional bias modification treatmentThe attentional bias modification treatment is a behavioral computerized program (software e-prime) | Behavioural | attentional bias modification, active group, attentional bias modification, placebo |
Primary outcome
Percentage of reduction of attentional bias
Time frame: Patients will be followed an expected average of 7 weeks (baseline, 2 sessions per week - totalizing 5 weeks, 10 sessions and a session after end of treatment). Measures of attentional bias will be assessed in baseline, session 5 and after session 10.
1 secondary outcome
Reduction of anxiety symptoms
Time frame: Baseline, session 5 and end of treatment (after session 10) (expected average of 7 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing attentional bias modification treatment in people with Obsessive-compulsive Disorder, run by Roseli Shavitt 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?
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 25 Jan 2018. 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. Some participants in this study may receive a placebo. 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?
Percentage of reduction of attentional bias (time frame: Patients will be followed an expected average of 7 weeks (baseline, 2 sessions per week - totalizing 5 weeks, 10 sessions and a session after end of treatment). Measures of attentional bias will be assessed in baseline, session 5 and after session 10.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2018.