- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01414023
Assessing the Effects of a Neurobehavioral Intervention on Symptoms of Obsessive Compulsive Disorder (CCT-OC)
May 14, 2020 updated by: Boston University Charles River Campus
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Boston University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults ages 18-65 years
- OCI-R total score ≥ 16
- Ability to read and provide informed consent.
- Familiarity with a computer keyboard and mouse.
Exclusion Criteria:
- BDI-II suicidality score of > 1
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CCT
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).
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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).
|
Placebo Comparator: PVT
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OCI-R scores
Time Frame: up to two weeks
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3 times over a two week period
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up to two weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BDNF serum levels
Time Frame: up to two weeks
|
Two times over a two week period
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up to two weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
August 9, 2011
First Submitted That Met QC Criteria
August 10, 2011
First Posted (Estimate)
August 11, 2011
Study Record Updates
Last Update Posted (Actual)
May 18, 2020
Last Update Submitted That Met QC Criteria
May 14, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BU-2487
- NCT01414023 (Registry Identifier: Clinical Trials)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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