Cognitive Control Training for Obsessive-Compulsive Disorder

Recruiting at 1 trial location

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: Psychotropics

Disqualifiers: Major depression, PTSD, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

60 Participants Needed

What You Need to Know Before You Apply

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.

How 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. ^{1 2 3 4 5}

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. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I am not pregnant or nursing.

Positive urine screen for illicit drugs

Presence of metallic device or dental braces

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Control Training (CT)

Trial Overview 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.

How Is the Trial Designed?

Group I: Cognitive Training for Obsessive-Compulsive Disorder Experimental Treatment 1 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)

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

New York State Psychiatric Institute

Collaborator

Trials

481

Recruited

154,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A randomized trial with 35 patients showed that both standard cognitive behavioral therapy (CBT) and an experimental CBT with a computerized psychoeducative tool led to significant improvements in obsessive-compulsive disorder (OCD) symptoms, with similar reductions in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores (48% vs 45%).

While the computerized tool was well-received by patients and therapists, it did not enhance the overall effectiveness of CBT, indicating that while it may be a useful addition, it does not replace the core therapeutic benefits of standard CBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Can the efficacy of behavioral and cognitive therapy for obsessive compulsive disorder be augmented by innovative computerized adjuvant?] Morgiève, M., N'Diaye, K., Clair, AH., et al.[2018]

A case study of a 7-year-old boy with obsessive-compulsive disorder (OCD) demonstrated significant improvement in symptoms and functioning through family-based cognitive-behavioral therapy (CBT) using exposure with response prevention (ERP).

The treatment emphasized family involvement, understanding the relationship between obsessions and compulsions, and creating conditions for habituation, highlighting the effectiveness of these strategies in adapting ERP for young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Family-Based Exposure With Response Prevention to Treat Obsessive-Compulsive Disorder in Young Children: A Case Study. Herren, J., Freeman, J., Garcia, A.[2018]

A combined therapeutic modality (CTM) that includes drug treatment, cognitive behavioral therapy (CBT), and repetitive transcranial magnetic stimulation (rTMS) significantly improved OCD severity and patient insight compared to drug treatment alone in a study of 100 patients over 2 weeks.

The CTM group showed a higher success rate and greater reductions in obsessive-compulsive symptoms, depression, and anxiety scores, with 57.14% of patients with poor insight experiencing improvement, indicating that CTM is a promising approach for treating OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Exploratory Study of a Novel Combined Therapeutic Modality for Obsessive-Compulsive Disorder. Huang, Y., Yang, H., Zhu, C., et al.[2022]

In a study involving 142 youths aged 7-17 with obsessive-compulsive disorder (OCD), d-cycloserine did not provide any additional benefit when added to cognitive behavior therapy (CBT) compared to a placebo, indicating that it may not be an effective augmentation strategy for this age group.

Both treatment groups (d-cycloserine plus CBT and placebo plus CBT) showed similar improvements in OCD symptoms, as measured by the Children's Yale-Brown Obsessive Compulsive Scale, suggesting that CBT alone is effective and that d-cycloserine does not enhance its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Augmentation of Cognitive Behavior Therapy With Weight-Adjusted d-Cycloserine vs Placebo in Pediatric Obsessive-Compulsive Disorder: A Randomized Clinical Trial. Storch, EA., Wilhelm, S., Sprich, S., et al.[2018]

A 7-week treatment program combining self-directed Exposure and Response Prevention (sERP) with Cognitive Bias Modification (CBM) significantly reduced OCD symptoms in 22 participants, showing promise as an accessible alternative to traditional ERP.

The effectiveness of this integrated approach was comparable to standard clinician-administered ERP, suggesting that initial clinician guidance may be sufficient for patients to benefit from self-directed treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Evidence for the Enhancement of Self-Conducted Exposures for OCD using Cognitive Bias Modification. Amir, N., Kuckertz, JM., Najmi, S., et al.[2019]

The study involving 65 participants with OCD found that the Competitive Memory Training (COMET) self-help intervention did not significantly reduce OCD symptoms or depression compared to a wait-list control group.

While many participants rated COMET as appropriate for self-administration, only a small percentage engaged fully with the material, suggesting that the current implementation may need modifications to improve its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Competitive Memory Training (COMET) for OCD: a self-treatment approach to obsessions. Schneider, BC., Wittekind, CE., Talhof, A., et al.[2018]

The study involved 13 volunteers with OCD and 10 non-OCD volunteers, who participated in three 45-minute sessions using an interactive computer program for vicarious exposure and ritual prevention.

Results showed that OCD participants experienced significant reductions in anxiety and depression symptoms, as measured by the Padua Inventory and Beck Depression Inventory, suggesting that this computer program could be a helpful addition to traditional behavior therapy for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of computer-aided vicarious exposure for obsessive-compulsive disorder. Clark, A., Kirkby, KC., Daniels, BA., et al.[2019]

Citations

1. France pubmed.ncbi.nlm.nih.gov

[Can the efficacy of behavioral and cognitive therapy for obsessive compulsive disorder be augmented by innovative computerized adjuvant?] [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Using Family-Based Exposure With Response Prevention to Treat Obsessive-Compulsive Disorder in Young Children: A Case Study. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

An Exploratory Study of a Novel Combined Therapeutic Modality for Obsessive-Compulsive Disorder. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Augmentation of Cognitive Behavior Therapy With Weight-Adjusted d-Cycloserine vs Placebo in Pediatric Obsessive-Compulsive Disorder: A Randomized Clinical Trial. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Preliminary Evidence for the Enhancement of Self-Conducted Exposures for OCD using Cognitive Bias Modification. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Competitive Memory Training (COMET) for OCD: a self-treatment approach to obsessions. [2018]

7. England pubmed.ncbi.nlm.nih.gov

A pilot study of computer-aided vicarious exposure for obsessive-compulsive disorder. [2019]