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Clinical Trials/NCT02114918
NCT02114918CompletedNot Applicable

Attention Training for Childhood Obsessive Compulsive Disorder

University of California, Los Angeles2 sites in 1 country47 target enrollmentStarted: April 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
47
Locations
2
Primary Endpoint
Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I) Scales Change From Pre-Treatment to Post-Treatment

Study Overview

Brief Summary

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.

Detailed Description

In this proposal, we aim to translate basic findings from research on cognitive biases in anxiety into a novel computerized intervention for child OCD. The treatment is designed to target a basic cognitive vulnerability in OCD, namely the selective processing of threatening OCD-related information. Briefly, the computerized procedure involves repeatedly redirecting participants' attention away from OCD-relevant threat cues in order to induce selective processing of neutral (non-threat) stimuli. This study is an initial step towards demonstrating the efficacy of a potentially highly transportable and accessible intervention for OCD. Furthermore, the project will also examine neurocognitive performance before and after attention modification to elucidate possible predictors and mechanisms of treatment response.

Aim 1: To examine the preliminary efficacy of a 12-session computerized attention modification program (AMP) on attention bias and symptom severity in children with OCD.

Hypothesis 1a: AMP treatment compared to the attention control condition (ACC) will be associated with a decrease in attention bias towards threat-cues in youth with OCD.

Hypothesis 1b: AMP treatment will be associated with a decrease in OCD symptom severity among OCD youth as measured by clinician-administered diagnostic interview and symptom rating scales.

Aim 2: To examine the changes in neurocognitive status over the course of treatment with AMP in children and adolescents with OCD.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
8 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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)

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 Outcomes

  • Attention Bias Assessment Change from Pre-Treatment to Post-Treatment(pre-treatment (week 0) and post-treatment (week 5))
  • Children's Yale-Brown Obsessive Compulsive Scale Change From Pre-Treatment to Post-Treatment(pre-treatment (week 0) and post-treatment (week 5))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Susanna Chang, PhD

Assistant Professor

University of California, Los Angeles

Study Sites (2)

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