Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Baylor College of Medicine
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.
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.12457
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.15789
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 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.236710
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.Treatment Details
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.
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
Research locations nearbySelect from list below to view details:
Baylor College of MedicineHouston, TX
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Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
References
Cognitive-behavioral psychotherapy for pediatric obsessive-compulsive disorder. [2018]Discusses the cognitive-behavioral psychotherapy for pediatric obsessive-compulsive disorder (OCD). Over the past 15 years, cognitive-behavioral psychotherapy has emerged as the psychosocial treatment of choice for OCD across lifespan. Unlike other psychotherapies that have been applied usually unsuccessfully to OCD, cognitive-behavioral treatment (CBT) presents a logically consistent and compelling relationship between the disorder, the treatment, and the specified outcome. Nevertheless, despite a consensus that CBT is usually helpful, clinicians routinely complain that patients will not comply with behavioral treatments and parents routinely complain that clinicians are poorly trained in CBT, with the result that many if not most children and adolescents are denied access to effective psychosocial treatment. This unfortunate situation may be avoidable, given an increased understanding regarding the implementation of CBT in children and adolescents with OCD. To this end, we review the principles and the practical aspects of the cognitive-behavioral treatment of OCD in youth, move on to discuss empirical studies supporting the use of CBT in the pediatric age group, and conclude by discussing directions for future research.
Open trial of cognitive behavior therapy for childhood obsessive-compulsive disorder. [2022]Examined the utility of CBT for childhood obsessive-compulsive disorder (OCD) including a preliminary exploration of predictors of response to this form of treatment. A total of 42 youngsters (mean age 11.8 years, 60% female, 52% on medication at baseline) with DSM-IV OCD were treated openly using a developmentally sensitive treatment protocol based on exposure plus response prevention (ERP). The treatment response rate (CGI
Current directions in pediatric obsessive-compulsive disorder. [2022]Pediatric OCD, a chronic and impairing condition, is not uncommon. Diagnosis is often difficult given the secrecy of many patients and co-occurring psychopathology. CBT alone or CBT with concurrent SSRI therapy are considered the first-line treatment. Nevertheless, relatively few mental health professionals are adequately trained in CBT for OCD. For example, in a national survey of 79 clinicians treating pediatric OCD in Norway, less than 33% of clinicians reported using exposure/response prevention (or similar techniques) despite rating CBT as a favorable approach to treatment. Limited access to professionals proficient in CBT may result in the prescription of pharmacotherapy alone or pharmacotherapy with other concurrent psychotherapies (that are not demonstrated as efficacious). Clearly, improving the referral network to experts trained in CBT for OCD is necessary to provide efficacious treatment, associated with reduced rates of relapse. Intensive CBT may extend resources to families without access to trained professionals in their area, given the potential for effective therapy in a succinct time period. Accordingly, in addition to the controlled trial evaluating CBT, pharmacotherapy, and combined treatment, initial investigations of intensive CBT for pediatric patients appear necessary. Additionally, intervention studies for children with significant comorbid psychopathology should be pursued.
An open clinical trial of cognitive-behaviour therapy in children and adolescents with obsessive-compulsive disorder administered in regular outpatient clinics. [2018]The aim of the present study was to examine the effectiveness of manual-guided cognitive-behaviour therapy (CBT) for childhood obsessive-compulsive disorder (OCD) administered within three regular, i.e., non-academic, Norwegian outpatient child psychiatric clinics.
Cognitive behavioral therapy for pediatric obsessive-compulsive disorder: development of expert-level competence and implications for dissemination. [2018]Pediatric obsessive-compulsive disorder (OCD) is associated with substantial morbidity, comorbidity, family difficulties, and functional impairment. Fortunately, OCD in youth has also been found responsive to cognitive behavioral therapy (CBT) both alone and in combination with medication. This paper highlights key areas a treatment provider must be highly knowledgeable in to be considered an expert in cognitive behavioral therapy (CBT) for pediatric obsessive-compulsive disorder (OCD). We describe the areas of knowledge that must be mastered to gain expertise, as well as the more difficult to quantify personal qualities that may allow a clinician to convey this knowledge in an expert manner. We provide detailed discussions of CBT theory, assessment strategies, implications of the treatment outcome literature for clinical decision-making, and how best to navigate CBT. We also discuss what the expert needs to accomplish by engaging youth and families throughout the evaluation and treatment process.
Effectiveness of cognitive behavior treatment for pediatric obsessive-compulsive disorder: acute outcomes from the Nordic Long-term OCD Treatment Study (NordLOTS). [2022]The purpose of this study was to examine the acute effectiveness of manualized exposure-based CBT with a family-based treatment, as an initial treatment for pediatric OCD delivered in regular community child and adolescents outpatient clinics. The report summarizes outcome of the first treatment step in the NordLOTS, which was conducted in Denmark, Sweden and Norway.
Cognitive-behavioral therapy for pediatric obsessive-compulsive disorder: Empirical review and clinical recommendations. [2018]The efficacy of cognitive-behavioral therapy (CBT) for pediatric obsessive-compulsive disorder (OCD) has been the subject of much study over the past fifteen years. Building on a foundation of case studies and open clinical trials, the literature now contains many methodologically sound studies that have compared full CBT protocols to waitlist controls, pill placebo, psychosocial comparison conditions, active medication, combined treatments, and brief CBT. This review is part of a series commissioned by The Canadian Institute for Obsessive Compulsive Disorders (CIOCD) in an effort to publish in one place what is known about the efficacy of treatments for OCD. A total of fourteen studies were identified; collectively their findings support the efficacy of CBT for youth with OCD. CBT protocols that emphasized either strictly behavioral or cognitive conceptualizations have each been found efficacious relative to waitlist controls. Efforts to enhance CBT׳s efficacy and reach have been undertaken. These trials provide guidance regarding next steps to be taken to maximize efficacy and treatment availability. Findings from studies in community clinics suggest that significant treatment benefits can be realized and are not reported only from within academic contexts. These findings bode well for broader dissemination efforts. Recommendations for future research directions are provided.
[Effectiveness of cognitive-behavioral therapy in children and adolescents with obsessive-compulsive disorders treated in an outpatient clinic]. [2019]Cognitive-behavioral therapy (CBT) is considered as treatment of first choice for children and adolescents with obsessive-compulsive disorders (OCD). However, its effectiveness has so far mostly been examined in randomized controlled trials with strictly manualized interventions. Only few studies have examined whether the effectiveness of CBT for juvenile OCD generalizes to clinical practice.
Cognitive-behavioral therapy booster treatment in pediatric obsessive-compulsive disorder: A utilization assessment pilot study. [2020]Cognitive-behavioral therapy (CBT) for pediatric obsessivecompulsive disorder (OCD) is effective, although many individuals report they need continued support after completing treatment.
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]Knowledge on adverse events in psychotherapy for youth with OCD is sparse. No official guidelines exist for defining or monitoring adverse events in psychotherapy. Recent recommendations call for more qualitative and quantitative assessment of adverse events in psychotherapy trials. This mixed methods study aims to expand knowledge on adverse events in psychotherapy for youth with OCD.