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Assessing the Effects of a Neurobehavioral Intervention on Symptoms of Obsessive Compulsive Disorder (CCT-OC)

This study is currently recruiting participants.
Verified November 2012 by Boston University
Sponsor:
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT01414023
First received: August 9, 2011
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Obsessive Compulsive Disorder
 Behavioral: Cognitive Control Training
Behavioral: Peripheral Vision Task

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston University:

Primary Outcome Measures:
  • OCI-R scores [ Time Frame: up to two weeks ] [ Designated as safety issue: No ]
    3 times over a two week period


Secondary Outcome Measures:
  • BDNF serum levels [ Time Frame: up to two weeks ] [ Designated as safety issue: No ]
    Two times over a two week period


Estimated Enrollment: 48
Study Start Date: July 2011
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
 Behavioral: 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).
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.
 Behavioral: Peripheral Vision Task
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414023

Locations
United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States, 02215
Contact: Amanda Calkins, M.A.     617-353-9610     calkins@bu.edu    
Sponsors and Collaborators
Boston University
  More Information

No publications provided

Responsible Party: Amanda Calkins, Boston University
ClinicalTrials.gov Identifier: NCT01414023     History of Changes
Other Study ID Numbers: BU-2487
Study First Received: August 9, 2011
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
High OCI-R scores

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013