Cognitive Behavioral Therapy for Pediatric OCD

Overseen By Eric A Storch, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must be taking: SRI medications

Must not be taking: Paroxetine

Disqualifiers: Bipolar, Psychotic disorder, Intellectual disability, others

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if children with OCD who improve with therapy can stop their medication without symptoms returning over 24 weeks. Participants will begin with Cognitive Behavioral Therapy (CBT) and, upon improvement, will be divided into two groups: one continuing their medication and another tapering off to a placebo (inactive substance). Children aged 7-17 with OCD symptoms for over six months and taking specific medications may qualify. Both the child and parent must speak English and reside in Texas.

As an unphased trial, this study offers a unique opportunity to enhance understanding of OCD treatment in children.

Do I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it requires that you are on a stable SRI medication for at least 12 weeks before joining. The study aims to see if you can stop the medication without relapsing, so you might need to continue your current medication initially.

What prior data suggests that Cognitive Behavioral Therapy is safe for pediatric OCD?

Research has shown that cognitive behavioral therapy (CBT) is a safe and effective treatment for children with obsessive-compulsive disorder (OCD). Studies indicate that CBT, whether conducted in person or online, can significantly help manage OCD symptoms in kids. No serious safety issues have been reported with CBT, making it a safe treatment option.

In this trial, all participants will receive CBT. Some will either continue their current medication (SRI) or switch to a placebo (a non-active treatment). Since the trial involves CBT and existing medication, no new experimental drugs are involved. This results in fewer safety concerns compared to trials with new drugs.

Overall, CBT is considered safe, with no major side effects reported in studies, making it a reliable choice for managing OCD in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy (CBT) for pediatric OCD because it offers a non-medication approach to treating the condition, which is traditionally managed with serotonin reuptake inhibitors (SRIs) like fluoxetine or sertraline. Unlike drugs, CBT empowers young patients by teaching them skills to manage their obsessions and compulsions, potentially reducing reliance on medication. Moreover, CBT can have lasting effects even after treatment ends, making it a powerful tool for long-term management of OCD symptoms.

What evidence suggests that CBT could be an effective treatment for pediatric OCD?

Research shows that cognitive-behavioral therapy (CBT) effectively treats obsessive-compulsive disorder (OCD) in children. Studies have found that CBT can greatly improve OCD symptoms in kids. Some research even suggests that CBT might work as well as certain medications, such as SSRIs, for this condition. In this trial, all participants will initially receive open-label CBT. CBT has proven effective both in-person and online, offering flexibility. Overall, CBT reliably helps children manage OCD symptoms. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for children aged 7-17 in Texas with a primary diagnosis of OCD lasting over 6 months, who are moderately symptomatic despite being on stable SRI medication for at least 12 weeks. Participants must speak English and not be taking certain excluded medications or have specific other mental health diagnoses.

Inclusion Criteria

Both the child and parent participating in the study are English speaking

Both the child and their parent participating in the study reside in Texas

My child has been on the same SRI medication for 12 weeks or more but still has symptoms.

Exclusion Criteria

My child currently has severe thoughts of harming themselves or others, needing medical help.

Child has a diagnosis of lifetime DSM-5 bipolar disorder, psychotic disorder, and/or intellectual disability

My child is currently getting therapy for OCD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I: CBT Treatment

All participants receive web-based CBT for 12 to 18 weeks

12-18 weeks

Web-based sessions

Phase II: Randomized Treatment

Participants are randomized to either continue SRI or undergo discontinuation titration to placebo, with CBT maintenance sessions

24 weeks

Medication visits and web-based CBT maintenance

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up assessment

What Are the Treatments Tested in This Trial?

Interventions

• CBT

Trial Overview The study tests if Cognitive Behavioral Therapy (CBT) can help kids with OCD stop taking their Selective Serotonin Reuptake Inhibitor (SRI) meds without their symptoms coming back. The test lasts for half a year to see if the benefits last.

How Is the Trial Designed?

Group I: Open label CBT Experimental Treatment 1 Intervention

During Phase I, all participants will receive open label cognitive-behavioral therapy. Only those who achieve significant benefit will be able to most on to the post-phase I assessment, and then to the random assignment to Continued SRI or Discontinuation titration to placebo arms.

Group II: Continued SRI Active Control 1 Intervention

After post-phase I assessment, participants who are eligible will be randomized to 1) Continued SRI. For these participants, the medication (SRI) will be provided at a consistent dosage.

Group III: Discontinuation titration to placebo Placebo Group 1 Intervention

After post-phase I assessment, participants who are eligible will be randomized to 2) Discontinuation titration to placebo. For these participants, the placebo substitution in an increasing proportion of capsules will be implemented until all drug is withdrawn.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

A study involving 28 children aged 8-17 with obsessive-compulsive disorder (OCD) showed that manual-guided cognitive-behavioral therapy (CBT) led to significant symptom reduction, with a mean decrease of 60.6% on the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) after treatment, increasing to 68.8% at the 6-month follow-up.

The study demonstrated that manual-guided CBT can be effectively implemented in regular outpatient child psychiatric clinics, achieving outcomes similar to those seen in specialized university clinics, with 86% of participants completing the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open clinical trial of cognitive-behaviour therapy in children and adolescents with obsessive-compulsive disorder administered in regular outpatient clinics. Valderhaug, R., Larsson, B., Götestam, KG., et al.[2018]

Cognitive-behavioral psychotherapy (CBT) is recognized as the most effective psychosocial treatment for pediatric obsessive-compulsive disorder (OCD), demonstrating a clear link between the disorder and treatment outcomes over the past 15 years.

Despite its effectiveness, many children and adolescents do not receive CBT due to issues with clinician training and patient compliance, highlighting the need for better implementation strategies and further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral psychotherapy for pediatric obsessive-compulsive disorder. March, JS., Franklin, M., Nelson, A., et al.[2018]

Booster sessions after a 12-week group family-based cognitive-behavioral therapy (GF-CBT) for pediatric OCD were attended by 23% of participants, indicating a need for continued support after initial treatment.

Participants who attended booster sessions reported finding them valuable for peer support and skills reinforcement, suggesting that these sessions could enhance the overall effectiveness of OCD treatment, especially for those with comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy booster treatment in pediatric obsessive-compulsive disorder: A utilization assessment pilot study. Negreiros, J., Selles, RR., Lin, S., et al.[2020]

Cognitive behavioral therapy (CBT) is an effective treatment for pediatric obsessive-compulsive disorder (OCD), helping to reduce symptoms and improve functioning in youth.

To be considered an expert in delivering CBT for pediatric OCD, clinicians must master specific knowledge areas and possess personal qualities that enhance their ability to engage with youth and families throughout the treatment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for pediatric obsessive-compulsive disorder: development of expert-level competence and implications for dissemination. Franklin, ME., Dingfelder, HE., Coogan, CG., et al.[2018]

This study will analyze adverse events in psychotherapy for youth with OCD by including at least 128 participants aged 8-17, comparing family-based cognitive behavioral therapy (FCBT) and family-based psychoeducation and relaxation training (FPRT).

The mixed methods approach will combine quantitative assessments of adverse events with qualitative interviews to better understand their nature and causes, aiming to improve the safety and effectiveness of psychotherapy for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder: A mixed methods study and analysis plan for the TECTO trial. Pretzmann, L., Christensen, SH., Bryde Christensen, A., et al.[2023]

Cognitive Behavioral Therapy (CBT) is the first-line treatment for pediatric OCD, but many clinicians lack training in effective techniques like exposure/response prevention, which may lead to reliance on less effective pharmacotherapy alone.

There is a need for improved access to trained CBT professionals and the exploration of intensive CBT programs to provide effective treatment for pediatric OCD, especially for those with co-occurring mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current directions in pediatric obsessive-compulsive disorder. Lewin, AB., Storch, EA., Adkins, J., et al.[2022]

In a study involving 269 children and adolescents aged 7-17 with OCD, 72.6% of participants who completed 14 weeks of manualized exposure-based CBT showed significant treatment response, as indicated by a CY-BOCS score of ≤15.

The treatment resulted in a mean symptom reduction of 52.9% and a high effect size of 1.58, demonstrating that this CBT approach is both effective and feasible for use in community mental health clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive behavior treatment for pediatric obsessive-compulsive disorder: acute outcomes from the Nordic Long-term OCD Treatment Study (NordLOTS). Torp, NC., Dahl, K., Skarphedinsson, G., et al.[2022]

Cognitive-behavioral therapy (CBT) has been shown to be effective for treating pediatric obsessive-compulsive disorder (OCD), based on a review of 14 methodologically sound studies that compared CBT to various control conditions.

Both strictly behavioral and cognitive-focused CBT protocols were found to be efficacious, indicating that CBT can be successfully implemented in community clinics, not just academic settings, which supports broader treatment availability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for pediatric obsessive-compulsive disorder: Empirical review and clinical recommendations. Franklin, ME., Kratz, HE., Freeman, JB., et al.[2018]

Cognitive Behavioral Therapy (CBT) using exposure plus response prevention (ERP) was effective for treating childhood obsessive-compulsive disorder (OCD), with a 79% response rate among 42 participants, showing a 45% reduction in symptoms.

The study found that treatment outcomes were not influenced by factors like age, gender, or medication status, but worse outcomes were linked to more severe obsessions and greater academic impairment, suggesting that these factors may need to be addressed in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open trial of cognitive behavior therapy for childhood obsessive-compulsive disorder. Piacentini, J., Bergman, RL., Jacobs, C., et al.[2022]

Cognitive-behavioral therapy (CBT) effectively reduces symptoms of obsessive-compulsive disorder (OCD) in children and adolescents, with strong effect sizes of 0.91 for parent ratings and 0.88 for self-ratings based on a study of 53 patients.

Approximately 46.3% of children and adolescents achieved clinically significant improvements in OCD symptoms post-treatment, demonstrating that routine CBT in a clinical setting is effective for managing juvenile OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of cognitive-behavioral therapy in children and adolescents with obsessive-compulsive disorders treated in an outpatient clinic]. Beig, I., Döpfner, M., Goletz, H., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4915322/

Efficacy of Cognitive-Behavioral Therapy in Pediatric ... Cognitive-behavioral therapy (CBT) is the only psychological therapy that has been demonstrated to be effective in treating pediatric OCD in many studies [1,8].

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00369642

A Controlled Trial of Daily Cognitive-Behavioral Therapy ... Results indicated marked improvements in clinician-rated OCD symptoms and self-reported depressive symptoms. Storch et al. (2004) provides data on five children ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0890856719320696

Cognitive-Behavioral Therapy for Obsessive-Compulsive ... Conclusion. CBT may be more effective than no intervention and comparable to SSRIs for pediatric OCD, but we are very uncertain about the effect estimates.

4. capmh.biomedcentral.com capmh.biomedcentral.com/articles/10.1186/s13034-024-00844-7

Cognitive behavioral therapy for pediatric obsessive ... The primary results of our study suggest that vCBT with a multimodal sensor system, used for the first time in the treatment of pediatric OCD, ...

5. publications.aap.org publications.aap.org/pediatrics/article/155/3/e2024068992/200215/Treatment-of-Obsessive-Compulsive-Disorder-in

Treatment of Obsessive-Compulsive Disorder in Children ... CBT with ERP, provided in-person or via telehealth, is an effective treatment for OCD. SSRIs and clomipramine (a TCA) are both more effective than pill placebo.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11619461/

Cognitive behavioral therapy for pediatric obsessive ... Predicting Treatment outcomes from internet-based cognitive behavior therapy for obsessive-compulsive disorder. Behav Ther. 2021;52(1):77–85 ...

7. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/1861509

The Pediatric Obsessive-Compulsive Disorder Treatment ... Results Family-based CBT was superior to FB-RT on both primary outcome measures. The percentages of children who were rated as 1 (very much ...

8. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2021.669494/full

Effects of Treatment Setting on Outcomes of Flexibly-Dosed ... Intensive CBT is an efficacious treatment for pediatric OCD. Families opted for differing doses based on their needs. Home-based treatment, while not ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11364205/

Advances in Pediatric Obsessive-Compulsive Disorder ... The aim of this study is to provide a comprehensive overview of current trends and emerging strategies in the treatment of pediatric obsessive-compulsive ...