200 Participants Needed

Cognitive Behavioral Therapy for Pediatric OCD

EA
Overseen ByEric A Storch, Ph.D.
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Baylor College of Medicine
Must be taking: SRI medications

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine whether youth with OCD who benefit from CBT augmentation to SRI can discontinue their medication without relapse over 24 weeks.

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 data supports the idea that Cognitive Behavioral Therapy for Pediatric OCD is an effective treatment?

The available research shows that Cognitive Behavioral Therapy (CBT) is effective for treating pediatric OCD. Studies have compared CBT to other treatments like medication and found it to be beneficial. For example, CBT has been shown to work better than just waiting for symptoms to improve on their own. It also works well when combined with medication. Research conducted in regular clinics, not just academic settings, confirms that CBT can significantly help children and teens with OCD. This means that CBT is a reliable option for treating OCD in young people.12345

What safety data exists for CBT in treating pediatric OCD?

The safety data for CBT in treating pediatric OCD is limited, as there is sparse knowledge on adverse events in psychotherapy for youth with OCD. The TECTO trial aims to expand this knowledge. While CBT is considered effective, there are no official guidelines for defining or monitoring adverse events in psychotherapy. More qualitative and quantitative assessments are recommended to better understand potential adverse events.12678

Is CBT a promising treatment for kids with OCD?

Yes, CBT is a promising treatment for kids with OCD. It has been shown to be effective in many studies and is considered the best choice for treating OCD in children and teens. It helps them manage their symptoms and improve their daily lives.135910

Eligibility Criteria

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.
See 1 more

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.
See 1 more

Timeline

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

Treatment Details

Interventions

  • CBT
Trial OverviewThe 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.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Open label CBTExperimental Treatment1 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 SRIActive Control1 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 placeboPlacebo Group1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials
1,044
Recruited
6,031,000+

Findings from Research

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.
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.
Open trial of cognitive behavior therapy for childhood obsessive-compulsive disorder.Piacentini, J., Bergman, RL., Jacobs, C., et al.[2022]
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.
Cognitive-behavioral psychotherapy for pediatric obsessive-compulsive disorder.March, JS., Franklin, M., Nelson, A., et al.[2018]

References

Cognitive-behavioral therapy for pediatric obsessive-compulsive disorder: Empirical review and clinical recommendations. [2018]
Open trial of cognitive behavior therapy for childhood obsessive-compulsive disorder. [2022]
Cognitive-behavioral psychotherapy for pediatric obsessive-compulsive disorder. [2018]
An open clinical trial of cognitive-behaviour therapy in children and adolescents with obsessive-compulsive disorder administered in regular outpatient clinics. [2018]
Cognitive behavioral therapy for pediatric obsessive-compulsive disorder: development of expert-level competence and implications for dissemination. [2018]
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. [2023]
Current directions in pediatric obsessive-compulsive disorder. [2022]
Effectiveness of cognitive behavior treatment for pediatric obsessive-compulsive disorder: acute outcomes from the Nordic Long-term OCD Treatment Study (NordLOTS). [2022]
Cognitive-behavioral therapy booster treatment in pediatric obsessive-compulsive disorder: A utilization assessment pilot study. [2020]
[Effectiveness of cognitive-behavioral therapy in children and adolescents with obsessive-compulsive disorders treated in an outpatient clinic]. [2019]