Attention Training for Childhood Obsessive Compulsive Disorder (AMP-OCD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of California, Los Angeles
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Susanna Chang, PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02114918
First received: April 11, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

Voluntary and involuntary attention processes are thought to play an important role in the development and maintenance of anxiety disorders including OCD. Individuals with OCD pay greater attention to threat information related to their illness and have difficulty shifting their attention from such triggers. Studies suggest that a change in attention bias may lead to a change in anxiety vulnerability. However, few studies have directly examined the causal role of attention bias in the maintenance of anxiety underlying OCD and whether modification of such biases may reduce pathological anxiety symptoms particularly in children. In this proposal, we aim to translate basic findings from research on cognitive biases in anxiety into a novel computerized intervention for child Obsessive Compulsive Disorder (OCD). The treatment is designed to target a basic cognitive vulnerability in OCD, namely the selective processing of threatening OCD-related information. 52 children with OCD will be randomly assigned to either a 12-session attention modification program (AMP) or an attention control condition (ACC). Clinical assessment of symptom severity along with a brief neurocognitive battery will be conducted before and after treatment. We hypothesize that children in the AMP group at end of treatment will show (1) decreased attention bias to OCD-related triggers using an independent measure of attention bias to assess change and (b) reduced OCD severity. This study is an initial step towards demonstrating the feasibility and efficacy of a novel computerized attention training program for OCD that ultimately may prove to be a highly transportable and accessible intervention for this childhood psychiatric disorder. Furthermore, the project will also examine neurocognitive performance before and after attention training to elucidate possible predictors and mechanisms of treatment response.


Condition Intervention
Obsessive Compulsive Disorder
Behavioral: Attention Modification Program
Behavioral: Attention Control Condition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Attention Training for Childhood Obsessive Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I) Scales Change From Pre-Treatment to Post-Treatment [ Time Frame: pre-treatment (week 0) and post-treatment (week 5) ] [ Designated as safety issue: No ]
    Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I) Scales. The CGI-S and CGI-I are clinician-rated scales used in clinical trials for over 25 years. Participants receiving a post-treatment CGI-I score of 1 (very much improved) or 2 (much improved) on this one-item, 7-point rating will be considered treatment responders.


Secondary Outcome Measures:
  • Children's Yale-Brown Obsessive Compulsive Scale Change From Pre-Treatment to Post-Treatment [ Time Frame: pre-treatment (week 0) and post-treatment (week 5) ] [ Designated as safety issue: No ]
    Children's Yale Brown Obsessive Compulsive Scale (CYBOCS) is a psychometrically sound, semi-structured clinical interview assessing OCD severity. The measure includes a comprehensive symptom checklist and will be used as one measure of treatment response.

  • Attention Bias Assessment Change from Pre-Treatment to Post-Treatment [ Time Frame: pre-treatment (week 0) and post-treatment (week 5) ] [ Designated as safety issue: No ]
    Computerized assessment of attention bias. The classic dot-probe paradigm used in the majority of studies examining attention bias will be adapted for this project. AMP will occur with one set of words (e.g., Set A) and the other word set (Set B) will be used for pre and post-training assessment of attention bias. We plan to use a modified version of the Posner spatial cueing paradigm using 8 OCD-related threat and eight neutral word cues word pairs.


Estimated Enrollment: 52
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Attention Modification Program
Active computer-based attention training treatment designed to directly but implicitly modify biased attention patterns in anxious patients in service of symptom relief. AMP is a modified version of the dot-probe paradigm similar to the original task used by MacLeod, Mathews, and Tata. This paradigm has been modified to facilitate an attention bias away from threatening material. In this case, the probe always replaces the neutral word.
Behavioral: Attention Modification Program
Each trial begins with a fixation cross presented in the center of the computer screen for 500 ms. The cross is then replaced by a word pair presented in the center of the screen for 500 ms. The word pair disappears and a probe (i.e., the letter "E" or "F") appears immediately in the location of one of the two words. Participants will be instructed to decide whether the letter is an E or an F and press the corresponding mouse button. This paradigm has been modified to facilitate an attention bias away from threatening material. In this case, the probe always replaces the neutral word. Thus, although there will be no specific instruction to direct attention away from the threat word, on all trials, the position of the neutral word will indicate the position of the probe.
Other Name: AMP, attention bias modification, attention training
Placebo Comparator: Attention Control Condition
Control computer-based attention training task, which is not designed to modify biased attention patterns in anxious patients. ACC is a modified version of the dot-probe paradigm similar to the original task used by MacLeod, Mathews, and Tata. In this case, the probe randomly replaces the neutral word or the threat word.
Behavioral: Attention Control Condition
Each trial begins with a fixation cross presented in the center of the computer screen for 500 ms. The cross is then replaced by a word pair presented in the center of the screen for 500 ms. The word pair disappears and a probe (i.e., the letter "E" or "F") appears immediately in the location of one of the two words. Participants will be instructed to decide whether the letter is an E or an F and press the corresponding mouse button. This paradigm is not intended to facilitate an attention bias away from threatening material. In this case, the probe randomly replaces the threat or neutral word.
Other Name: ACC

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 8-17 (inclusive) at the time of initial evaluation
  • Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnostic criteria for OCD.
  • Unmedicated or on stable medication treatment for anxiety, OCD, attention deficit hyperactivity disorder, tics, and/or depressive disorder for at least 6 weeks prior to study entry, with no planned changes for duration of study participation.
  • Child is fluent English speaker.
  • Parental informed consent and child informed assent must be completed. Parents must agree to their child's participation in this protocol.

Exclusion Criteria:

  • Intelligence Quotient < 80 on Wechsler Abbreviated Scale of Intelligence (WASI).
  • Excessive or problematic substance use as reported per initial telephone screening, or DSM-IV Conduct Disorder within the past 3 months.
  • Subject has a lifetime DSM-IV diagnosis of pervasive developmental disorder, Mania, or Psychotic Disorder.
  • Subject has any serious psychiatric, psychosocial, or neurological condition (i.e., attention deficit hyperactivity disorder, major depressive disorder, anxiety, anxiety, severe aggression, family discord) requiring immediate treatment other than that provided in the current study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02114918

Contacts
Contact: Olivia E Johnson, BA 310-825-2064 OJohnson@mednet.ucla.edu

Locations
United States, California
UCLA Semel Institute for Neuroscience and Human Behavior Recruiting
Los Angeles, California, United States, 90024
Contact: Olivia E Johnson, BA       OJohnson@mednet.ucla.edu   
Principal Investigator: Susanna Chang, PhD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Susanna Chang, PhD University of California, Los Angeles
Principal Investigator: John Piacentini, PhD University of California, Los Angeles
  More Information

Additional Information:
No publications provided

Responsible Party: Susanna Chang, PhD, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02114918     History of Changes
Other Study ID Numbers: IRB#11-000195, 1R34MH095885-01A1
Study First Received: April 11, 2014
Last Updated: April 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
obsessive compulsive disorder
children
adolescents
attention bias modification

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

ClinicalTrials.gov processed this record on July 22, 2014