Self-Distancing for Pediatric Anxiety and OCD

Overseen By Kate D Fitzgerald, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Bipolar, Psychotic disorders, Autism, others

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

Compensation: Varies

Number of Visits: 3

35 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Self-Distancing for pediatric anxiety and OCD?

Research on child-focused OCD treatments shows that they can improve family dynamics and reduce symptoms, suggesting that similar approaches like Self-Distancing might also be effective. Additionally, targeting family accommodation in OCD treatment has shown moderate improvement in symptoms, indicating that addressing family dynamics can be beneficial. ^{1 2 3 4 5}

Is self-distancing therapy safe for children with anxiety and OCD?

There is limited information on the safety of self-distancing therapy specifically, but cognitive behavioral therapy (CBT), a similar non-drug treatment, is generally considered safe for children with anxiety and OCD. More research is needed to fully understand any potential adverse effects. ^{6 7 8 9 10}

How is the treatment Self-Distancing unique for pediatric anxiety and OCD?

Self-Distancing is a unique treatment approach that involves helping children view their thoughts and feelings from a third-person perspective, which can reduce the intensity of their anxiety and obsessive-compulsive symptoms. This method differs from traditional treatments like cognitive-behavioral therapy, which focuses more on changing thought patterns and behaviors directly. ^{10 11 12 13 14}

What is the purpose of this trial?

Self-Distancing is a cognitive technique that involves a shift in self-talk characterized by replacing first-person (e.g., "I") with second- or third-person pronouns (i.e., "you", one's own name) to promote an adaptive, self-reflective stance in emotionally charged situations. This trial aims to help learn how self-distancing may increase behavioral approach during exposures. To find out if self-distancing works by helping children approach fear-inducing stimuli, the study will look at behaviors and physiological responses related to approach, as well as symptom severity, before and after this cognitive technique. The study hypothesizes that Self-Distancing will lead to greater increases in approach behaviors and a larger decrease in symptom severity compared to a control condition (first-person self-talk).

Research Team

Kate D Fitzgerald, MD

Principal Investigator

Professor of Psychiatry

Eligibility Criteria

This trial is for children with anxiety disorders, OCD, or compulsive personality disorder. It's designed to see if a new way of thinking called self-distancing can help them better handle situations that scare them compared to classic exposure therapy.

Inclusion Criteria

I am between 7 and 17 years old.

Written informed consent by a parent/legal guardian and assent by child

I have been diagnosed with an anxiety disorder or OCD.

Exclusion Criteria

Any major medical or neurological problem

Current or past psychotic symptoms

Active alcohol or substance dependence

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Baseline Assessment

Baseline assessments including the Spider Phobia Questionnaire (SPQ-C) and Child Behavior Checklist (CBCL) are conducted

1 week

1 visit (in-person)

Intervention

Participants undergo the Behavioral Approach Test (BAT) with either Self-Distancing or first-person self-talk intervention

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in approach behaviors and symptom severity using various assessments

1 week

1 visit (in-person)

Treatment Details

Interventions

• Self-Distancing

Trial Overview The study compares two methods: Self-Distancing (EXSD), where kids learn to shift their perspective in scary situations, and Classic Exposure (EXC), the usual way of facing fears directly. Researchers will measure how these techniques affect the children's willingness to face fears and their anxiety levels.

Participant Groups

Group I: Self-Distancing Experimental Treatment 1 Intervention

Youth will be randomized to a BAT with Self-Distancing Intervention. In this arm, participants will be instructed to describe the exposure task from a self-distanced perspective (e.g., "Emily is going to touch the spider").

Group II: First-person self-talk Active Control 1 Intervention

Youth will be randomized to a BAT with a control condition. In this arm, participants will be instructed to describe the exposure task from a self-immersed perspective (e.g.,"I'm going to touch the spider")

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Findings from Research

Child-focused treatment for pediatric OCD, involving either Group Cognitive-Behavioral Therapy or fluoxetine over 14 weeks, significantly reduced family accommodation levels and improved family cohesion among 43 parents of 33 children.

Improvements in family dynamics, such as decreased distress and increased cohesion, were correlated with the children's clinical improvement, indicating that treating pediatric OCD can positively affect the entire family environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child-focused treatment of pediatric OCD affects parental behavior and family environment. Gorenstein, G., Gorenstein, C., de Oliveira, MC., et al.[2018]

Family accommodation in youth with OCD can worsen symptoms and treatment outcomes, but parent-focused treatments can effectively reduce this accommodation even when the child refuses direct treatment.

In a case study, parents reported moderate improvements in their child's OCD symptoms and reduced conflict after implementing treatment strategies without the child's involvement, demonstrating that effective interventions can still occur in challenging situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing Family Accommodation of OCD in the Context of Adolescent Treatment Refusal: A Case Example. Johnco, C.[2018]

In a study of 112 youth with OCD, those with lower severity of symptoms, less functional impairment, and greater insight showed better improvement in treatment outcomes, regardless of whether they received sertraline, CBT, or a combination of both.

Youth with a family history of OCD had significantly reduced benefits from CBT alone, suggesting that they may require combined treatment with an SSRI like sertraline for effective management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors and moderators of treatment outcome in the Pediatric Obsessive Compulsive Treatment Study (POTS I). Garcia, AM., Sapyta, JJ., Moore, PS., et al.[2022]

In a study of 215 youth aged 7-17 with OCD, specific fears such as separation anxiety and somatic concerns were found to predict different OCD symptom clusters, indicating a link between fear dimensions and OCD symptoms.

The findings suggest that understanding these associations can help tailor treatments for pediatric OCD by addressing both OCD symptoms and underlying fear constructs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distinguishing Fear Versus Distress Symptomatology in Pediatric OCD. Rozenman, M., Peris, T., Bergman, RL., et al.[2018]

Youths with obsessive-compulsive disorder (OCD) showed better treatment outcomes with family-focused cognitive behavioral therapy (FCBT) when their families had lower levels of parental blame and conflict, and higher levels of family cohesion, based on a study of 49 participants aged around 12 years.

Improvements in family cohesion during treatment were linked to better responses to FCBT, suggesting that addressing family dynamics could enhance the effectiveness of OCD treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family factors predict treatment outcome for pediatric obsessive-compulsive disorder. Peris, TS., Sugar, CA., Bergman, RL., et al.[2022]

The POWER study is a rigorous trial designed to evaluate whether children with OCD can safely discontinue serotonin reuptake inhibitors (SRIs) after successful cognitive behavioral therapy (CBT) augmentation, focusing on maintaining wellness for 24 weeks.

This research addresses a significant gap in existing data regarding the discontinuation of SRIs in pediatric OCD, as current practices often rely on SRIs as first-line treatments despite recommendations for CBT as initial therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting OCD WEllness and resilience (POWER) study: Rationale, design, and methods. Leuchter, JD., Kook, M., Geller, DA., et al.[2023]

Selective serotonin reuptake inhibitors (SSRIs) are considered the preferred pharmacological treatment for pediatric non-OCD anxiety disorders, showing significant effectiveness in reducing symptoms and improving functioning in children.

While there is a small increased risk of suicidality associated with SSRIs in the pediatric population, the overall benefit/risk ratio for treating anxiety disorders is more favorable compared to their use in treating depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective serotonin reuptake inhibitor use in the treatment of the pediatric non-obsessive-compulsive disorder anxiety disorders. Seidel, L., Walkup, JT.[2022]

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]

Recent research has expanded the understanding of pharmacologic treatments for pediatric anxiety disorders, with four new double-blind, placebo-controlled studies published in the last year, indicating a growing body of evidence.

While most studies still focus on obsessive-compulsive disorder (OCD), there is increasing data on the effectiveness of medications for other anxiety disorders in children, such as generalized anxiety disorder and social anxiety disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of childhood anxiety disorders. Kratochvil, CJ., Harrington, MJ., Burke, WJ., et al.[2019]

Separation Anxiety Disorder (SAD) affects 4-5% of children and adolescents, often leading to significant issues like school refusal, particularly in those from low socioeconomic backgrounds, with 75% of SAD cases linked to school refusal.

Cognitive-behavioral therapy (CBT) is the most effective nonpharmacological treatment for SAD, while selective serotonin reuptake inhibitors (SSRIs) are recommended as first-line pharmacotherapy for severe cases, showing a good safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Separation anxiety disorder in children and adolescents: epidemiology, diagnosis and management. Masi, G., Mucci, M., Millepiedi, S.[2022]

Separation anxiety disorder is characterized by intense and persistent anxiety that negatively affects children's functioning, and it is often linked to other anxiety and mood disorders, potentially leading to issues like school refusal.

Cognitive behavioral therapies are the most effective treatment for separation anxiety disorder in children and adolescents, and it is crucial for healthcare providers to recognize the disorder and promote positive parental involvement to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Separation anxiety in children]. Purper-Ouakil, D., Franc, N.[2010]

Youth with obsessive-compulsive disorder (OCD) showed poorer emotion regulation skills and greater cognitive problems compared to those with generalized anxiety disorder (GAD), social phobia (SoP), or separation anxiety disorder (SAD), based on a study involving 57 participants aged 7-12 years.

The study highlights unique characteristics of OCD that differentiate it from other anxiety disorders in youth, suggesting the need for tailored clinical approaches and further research into these distinctions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotional, behavioral, and cognitive factors that differentiate obsessive-compulsive disorder and other anxiety disorders in youth. Jacob, ML., Morelen, D., Suveg, C., et al.[2012]

Obsessive-compulsive disorder (OCD) is a common and chronic condition in children and adolescents that can cause significant distress and disability, yet it is often under-diagnosed and under-treated.

Effective treatments for OCD in this age group include cognitive-behavioral therapy and selective serotonin reuptake inhibitors, highlighting the importance of early detection through simple screening questions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Obsessive-compulsive disorder in children and adolescents]. Rotberg, B., Zalsman, G., Weizman, A.[2014]

Childhood OCD is a serious condition that significantly impacts children's lives and is not just a normal part of growing up, with a higher diagnosis rate in males.

Treatment typically includes individual therapy and family counseling, with options for behavioral therapy and medication like clomipramine to help manage symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Childhood obsessive-compulsive disorder. King, NJ., Tonge, BJ.[2019]

References

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Child-focused treatment of pediatric OCD affects parental behavior and family environment. [2018]

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Managing Family Accommodation of OCD in the Context of Adolescent Treatment Refusal: A Case Example. [2018]

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Predictors and moderators of treatment outcome in the Pediatric Obsessive Compulsive Treatment Study (POTS I). [2022]

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Distinguishing Fear Versus Distress Symptomatology in Pediatric OCD. [2018]

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Family factors predict treatment outcome for pediatric obsessive-compulsive disorder. [2022]

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Promoting OCD WEllness and resilience (POWER) study: Rationale, design, and methods. [2023]

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Selective serotonin reuptake inhibitor use in the treatment of the pediatric non-obsessive-compulsive disorder anxiety disorders. [2022]

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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]

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Pharmacotherapy of childhood anxiety disorders. [2019]

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