Cognitive Control Training for Obsessive-Compulsive Disorder
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Columbia University
Must not be taking: Psychotropics
Disqualifiers: Major depression, PTSD, Bipolar, others
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This study aims to examine the effects of a game-like program called cognitive control training (CT) for children with obsessive compulsive disorder (OCD). Children enrolled in this study will receive 4 weeks of the at-home computerized cognitive training program (AKL-T01) delivered on iPad (25 minutes/day, 5 days/week). Styled as a child-friendly video game, AKL-T01 CT taps focused attention, response inhibition, and working memory using a series of games to engage cognitive control processes. Children will complete the NIH Toolbox prior to, mid (2-weeks), and post-CT (4-weeks). Participants will complete MRI scans pre- and post-CT and then be offered a 12-week course of gold-standard Cognitive behavioral therapy with exposure and response prevention (or community referrals) after CT. The long-term goal of this study is to test how this CT intervention may enhance cognitive control capacity to reduce symptoms and improve response to cognitive behavioral therapy with exposure and response prevention in children with OCD.
Will I have to stop taking my current medications?
Yes, participants must not be on psychotropic medication and should be free of such medication for at least three months before joining the trial.
What data supports the effectiveness of the treatment Cognitive Control Training (CT) for Obsessive-Compulsive Disorder?
Research suggests that combining self-directed exposure therapy with Cognitive Bias Modification (CBM) can significantly reduce OCD symptoms, indicating that similar cognitive training approaches may be effective. Additionally, cognitive-behavioral therapy (CBT) is a well-established treatment for OCD, and innovative computerized tools have been explored to enhance its efficacy.
12345How is Cognitive Control Training (CT) different from other treatments for OCD?
Cognitive Control Training (CT) is unique because it uses a computerized approach to enhance cognitive control, which may help manage obsessive-compulsive disorder (OCD) symptoms by targeting the brain's ability to regulate thoughts and behaviors. This differs from traditional treatments like cognitive-behavioral therapy (CBT) and exposure with response prevention (ERP), which focus more on behavioral changes and exposure to fears.
12567Eligibility Criteria
This trial is for children aged 8-12 with clinically significant OCD as their main issue, not on medication or psychotherapy for OCD. They must meet specific criteria and have a score of ≥16 on the C-YBOCS scale. Kids can't join if they're pregnant, nursing, use illicit drugs, have metal implants/braces, major depression or other serious mental disorders, suicidal thoughts, major medical issues or an IQ <80.Inclusion Criteria
I am between 8 and 12 years old.
I understand the trial details and agree to participate.
My main issue is severe OCD, confirmed by specific tests.
+2 more
Exclusion Criteria
I am not pregnant or nursing.
Positive urine screen for illicit drugs
Presence of metallic device or dental braces
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Cognitive Training
Participants receive 4 weeks of at-home computerized cognitive training program (AKL-T01) delivered on iPad
4 weeks
Baseline, 2-week follow-up (mid-training), and 4-week follow-up (post-training)
Cognitive Behavioral Therapy
Participants are offered a 12-week course of gold-standard Cognitive Behavioral Therapy with exposure and response prevention
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests a game-like cognitive control training program (CT) using iPad games to improve attention and memory in young children with OCD. Over four weeks at home followed by MRI scans and standard Cognitive Behavioral Therapy (CBT), it aims to see if CT helps reduce symptoms and enhance response to CBT.
1Treatment groups
Experimental Treatment
Group I: Cognitive Training for Obsessive-Compulsive DisorderExperimental Treatment1 Intervention
This is an open-label, one-arm study. Children who meet DSM-V diagnostic criteria for OCD and have clinically significant obsessive-compulsive symptoms (CY-BOCS score\>16) will complete 4-weeks of at-home cognitive training.
Cognitive Control Training (CT) is already approved in United States for the following indications:
🇺🇸 Approved in United States as AKL-T01 for:
- Attention Deficit Hyperactivity Disorder (ADHD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Columbia University Irving Medical CenterNew York, NY
New York State Psychiatric InstituteNew York, NY
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Who Is Running the Clinical Trial?
Columbia UniversityLead Sponsor
New York State Psychiatric InstituteCollaborator
National Institute of Mental Health (NIMH)Collaborator
References
[Can the efficacy of behavioral and cognitive therapy for obsessive compulsive disorder be augmented by innovative computerized adjuvant?] [2018]Cognitive behavioral therapy (CBT) is recognized as an effective treatment for obsessive-compulsive disorder (OCD). To maximize its effectiveness, we designed an "experimental" CBT defined by the addition of a computerized psychoeducative tool.
Using Family-Based Exposure With Response Prevention to Treat Obsessive-Compulsive Disorder in Young Children: A Case Study. [2018]Cognitive-behavioral therapy (CBT) using exposure with response prevention (ERP) is the treatment of choice for obsessive-compulsive disorder (OCD); however, developmental modifications should be considered when treating young children. This article presents a case study illustrating family-based CBT using ERP with a 7-year-old boy. The delivery of ERP for this case was guided by 3 main principles: (a) family involvement with a focus on reducing family accommodation, (b) understanding the functional relation between the client's obsessions and compulsions, and (c) creating conditions to facilitate habituation during exposure. Outcomes for this case indicate significant improvement in functioning and OCD symptoms. Results highlight the importance of family involvement and the applicability of using a function-based habituation framework when delivering ERP to this unique population.
An Exploratory Study of a Novel Combined Therapeutic Modality for Obsessive-Compulsive Disorder. [2022]To explore whether a systematic combined therapeutic modality (CTM) could quickly and effectively improve the severity of obsessive-compulsive disorder (OCD) and the insight of OCD patients.
Efficacy of Augmentation of Cognitive Behavior Therapy With Weight-Adjusted d-Cycloserine vs Placebo in Pediatric Obsessive-Compulsive Disorder: A Randomized Clinical Trial. [2018]Cognitive behavior therapy (CBT) among youth with obsessive-compulsive disorder (OCD) is effective, but many patients remain symptomatic after intervention. d-cycloserine, a partial agonist at the N-methyl-d-aspartate receptor in the amygdala, has been associated with enhanced CBT outcome for OCD among adults but requires evaluation among youth.
Preliminary Evidence for the Enhancement of Self-Conducted Exposures for OCD using Cognitive Bias Modification. [2019]Exposure and Response Prevention (ERP) is the most effective treatment for OCD but it is not accessible to most patients. Attempts to increase the accessibility of ERP via self-directed ERP (sERP) programs such as computerized delivery and bibliotherapy have met with noncompliance, presumably because patients find the exposure exercises unacceptable. Previous research suggests that Cognitive Bias Modification (CBM) interventions may help individuals approach feared situations. The goal of the current study was to test the efficacy of a treatment program for OCD that integrates sERP with CBM. Twenty-two individuals meeting diagnostic criteria for OCD enrolled in our 7-week treatment program. Results suggest that sERP with CBM led to significant reduction of OCD symptoms and functional impairment. Indeed, the magnitude of the effect of this novel treatment, that requires only an initial session with a clinician trained in ERP for OCD, was comparable to that of the gold standard clinician-administered ERP. Moreover, preliminary evidence suggests that CBM interventions targeting interpretation bias may be most effective, whereas those targeting attention and working memory bias may not be so.
Competitive Memory Training (COMET) for OCD: a self-treatment approach to obsessions. [2018]Competitive Memory Training (COMET) is a cognitive intervention that aims to change the maladaptive cognitive-emotional networks underlying obsessive-compulsive disorder (OCD). COMET has not been previously tried as a self-help intervention. The present study tested the preliminary feasibility, acceptability, and effectiveness of COMET for OCD implemented as a self-help intervention. Sixty-five participants with OCD recruited through online OCD self-help fora completed an online baseline assessment including measures of OCD symptoms, self-esteem, and depression. Participants were randomly assigned to either COMET or a wait-list control group. All participants were approached 4 weeks later to complete an online post-assessment. There was no evidence for a greater decline of OCD symptoms or depression under COMET. When analyses were limited to only those participants who reported reading the entire manual at least once, self-esteem was higher at post-assessment in the COMET group. Although 78.1% of patients in the COMET group rated it as appropriate for self-administration, only 56.5% performed COMET exercises regularly and 26.4% read the entire manual at least once. The feasibility and effectiveness of COMET as a self-help internet intervention for OCD was not supported in this study. Further work is needed to better understand if modifications to our implementation of COMET may yield improved outcomes.
A pilot study of computer-aided vicarious exposure for obsessive-compulsive disorder. [2019]This study reports the use of an interactive computer program to instruct vicarious exposure and ritual prevention for obsessive-compulsive disorder (OCD).