Attention Training for Childhood Obsessive Compulsive Disorder

NCT02114918 | Completed DMC

• 2 other identifiers: IRB#11-0001951R34MH095885-01A1
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive Compulsive Disorder

Keywords

obsessive compulsive disorder; children; adolescents; attention bias modification

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I) Scales Change From Pre-Treatment to Post-Treatment

  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.

  pre-treatment (week 0) and post-treatment (week 5)

Secondary Outcomes (2)

• Children's Yale-Brown Obsessive Compulsive Scale Change From Pre-Treatment to Post-Treatment

  pre-treatment (week 0) and post-treatment (week 5)

• Attention Bias Assessment Change from Pre-Treatment to Post-Treatment

  pre-treatment (week 0) and post-treatment (week 5)

Study Arms (2)

Attention Modification Program

EXPERIMENTAL

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

Attention Control Condition

PLACEBO COMPARATOR

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

Interventions

Attention Modification Program BEHAVIORAL

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.

Also known as: AMP, attention bias modification, attention training

Attention Modification Program

Attention Control Condition BEHAVIORAL

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.

Also known as: ACC

Attention Control Condition

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UCLA Semel Institute for Neuroscience and Human Behavior

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Adenosine Monophosphate

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Susanna Chang, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• John Piacentini, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 15, 2014
• Study Start: April 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: May 1, 2016
• Last Updated: January 16, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)