Obsessive Compulsive DisorderCCT-OCNCT01414023
Assessing the Effects of a Neurobehavioral Intervention on Symptoms of Obsessive Compulsive Disorder
A study testing Peripheral Vision Task in people with Obsessive Compulsive Disorder, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
This experiment will examine if the use of computerized tasks that train individuals to control their attention more effectively will predict individual differences in obsessive-compulsive symptoms, rumination and BDNF change. 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?
- Peripheral Vision Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jul 2012
- 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
Who may be able to join
- Adults ages 18-65 years
- OCI-R total score ≥ 16
- Ability to read and provide informed consent.
- Familiarity with a computer keyboard and mouse.
Who cannot join
- BDI-II suicidality score of > 1
Trial locations and contacts
1 site in 1 country.
About this study
This experiment will examine if the use of computerized tasks that train individuals to control their attention more effectively will predict individual differences in obsessive-compulsive symptoms, rumination and BDNF change. After giving consent, filling out self-report forms, and giving blood for the BDNF test, 80 participants will be randomized to Cognitive Control Training (CCT) or Peripheral Vision Task (PVT) (described below) which will be administered three times over a two week period. At the third visit, participants will also complete an anagram task and repeat the blood draw for BDNF testing. The investigators hypothesize that computerized tasks that train individuals to control their attention more effectively will reduce Obsessive Compulsive (OC) symptoms. Additionally, individuals training in CCT will show increased ability to disengage from unattainable goals as assessed by responses to an unsolvable anagram task. Finally, individuals training in CCT will show a greater increase in BDNF levels as compared to individuals training in PVT.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Cognitive Control Training, Peripheral Vision Task
- Keywords
- High OCI-R scores
- 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 Control TrainingBehavioural
Pace Auditory Serial Addition Task (PASAT;(Gronwall, 1977): A computer version of the PASAT will be used to measure sustained attention and working memory. Participants are asked to add serially presented numbers. Attention Control Intervention (Wells, 2000): This task involves training individuals to attend differentially to multiple auditory sources (e.g., by counting tones, discriminating the location of tones, and moving their attention between auditory sources for a prolonged period).
Peripheral Vision TaskBehavioural
Peripheral Vision Task (PVT; C. Moore, personal communication): This task serves as a non-active control condition which does not target the brain regions influenced by the Wells and PASAT tasks. Participants focus on the placement of dots on a computer screen in this task while listening to a tone.
| Study group | Role | What they receive |
|---|---|---|
| CCT | Experimental | Cognitive Control Training - Pace Auditory Serial Addition Task (PASAT;(Gronwall, 1977): A computer version of the PASAT will be used to measure sustained attention and working memory. Participants are asked to add serially presented numbers. Attention Control Intervention (Wells, 2000): This task involves training individuals to attend differentially to multiple auditory sources (e.g., by counting tones, discriminating the location of tones, and moving their attention between auditory sources for a prolonged period). Receives: Behavioral: Cognitive Control Training |
| PVT | Placebo comparator | Peripheral Vision Task (PVT; C. Moore, personal communication): This task serves as a non-active control condition which does not target the brain regions influenced by the Wells and PASAT tasks. Participants focus on the placement of dots on a computer screen in this task while listening to a tone. Receives: Behavioral: Peripheral Vision Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCI-R scores
3 times over a two week period
Measured: up to two weeks
Secondary outcomes (1)
BDNF serum levels
Two times over a two week period
Measured: up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionJul 2012
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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414023
- Sponsor's protocol ID
- BU-2487
- Other IDs
- NCT01414023
- Acronym
- CCT-OC
- Status last verified
- May 2020
- First submitted
- 9 Aug 2011
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of a Neurobehavioral Intervention on Symptoms of Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT01414023
- Acronym / sponsor ID
- CCT-OC / BU-2487
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- High OCI-R scores
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Aug 2011 (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.
This experiment will examine if the use of computerized tasks that train individuals to control their attention more effectively will predict individual differences in obsessive-compulsive symptoms, rumination and BDNF change. After giving consent, filling out self-report forms, and giving blood for the BDNF test, 80 participants will be randomized to Cognitive Control Training (CCT) or Peripheral Vision Task (PVT) (described below) which will be administered three times over a two week period. At the third visit, participants will also complete an anagram task and repeat the blood draw for BDNF testing. The investigators hypothesize that computerized tasks that train individuals to control their attention more effectively will reduce Obsessive Compulsive (OC) symptoms. Additionally, individuals training in CCT will show increased ability to disengage from unattainable goals as assessed by responses to an unsolvable anagram task. Finally, individuals training in CCT will show a greater increase in BDNF levels as compared to individuals training in PVT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCT | Experimental | Behavioral: Cognitive Control TrainingCognitive Control Training - Pace Auditory Serial Addition Task (PASAT;(Gronwall, 1977): A computer version of the PASAT will be used to measure sustained attention and working memory. Participants are asked to add serially presented numbers. Attention Control Intervention (Wells, 2000): This task involves training individuals to attend differentially to multiple auditory sources (e.g., by counting tones, discriminating the location of tones, and moving their attention between auditory sources for a prolonged period). |
| PVT | Placebo comparator | Behavioral: Peripheral Vision TaskPeripheral Vision Task (PVT; C. Moore, personal communication): This task serves as a non-active control condition which does not target the brain regions influenced by the Wells and PASAT tasks. Participants focus on the placement of dots on a computer screen in this task while listening to a tone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ages 18-65 years
- OCI-R total score ≥ 16
- Ability to read and provide informed consent.
- Familiarity with a computer keyboard and mouse.
Key exclusion criteria (1 listed)
- BDI-II suicidality score of > 1
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 |
|---|---|---|
| Cognitive Control TrainingPace Auditory Serial Addition Task (PASAT;(Gronwall, 1977): A computer version of the PASAT will be used to measure sustained attention and working memory. Participants are asked to add serially presented numbers. Attention Control Intervention (Wells, 2000): This task involves training individuals to attend differentially to multiple auditory sources (e.g., by counting tones, discriminating the location of tones, and moving their attention between auditory sources for a prolonged period). | Behavioural | CCT |
| Peripheral Vision TaskPeripheral Vision Task (PVT; C. Moore, personal communication): This task serves as a non-active control condition which does not target the brain regions influenced by the Wells and PASAT tasks. Participants focus on the placement of dots on a computer screen in this task while listening to a tone. | Behavioural | PVT |
Primary outcome
OCI-R scores
Time frame: up to two weeks
3 times over a two week period
1 secondary outcome
BDNF serum levels
Time frame: up to two 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 18 May 2020.
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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 Peripheral Vision Task in people with Obsessive Compulsive Disorder, run by Boston University Charles River Campus at 1 site in United States.
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 4 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 18 May 2020. 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 United States. 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?
OCI-R scores (time frame: up to two weeks). 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 18 May 2020.