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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a simple mental trick called self-distancing can help children with anxiety or OCD. Self-distancing involves using second- or third-person language to talk about oneself, such as saying "Emily is going to touch the spider" instead of "I'm going to touch the spider." Researchers aim to determine if this technique helps kids face their fears more effectively and reduces anxiety symptoms. Children aged 7 to 12 with a specific phobia, like a fear of spiders, who speak English might be a good match for this study. As an unphased trial, this study offers a unique opportunity for children to try a novel approach to managing anxiety.

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 prior data suggests that this self-distancing technique is safe for children?

Research has shown that self-distancing is a safe method for children to manage anxiety. In a small study, nine young people aged 11 to 17 with anxiety disorders tried self-distancing. They completed the treatment without any serious side effects, indicating it is well-tolerated.

Self-distancing involves changing self-talk. Instead of saying "I am going to do something," individuals use their name or "you" (such as "Emily is going to do something"). This approach helps people think about their feelings more calmly. The goal is to help children face their fears more easily and reduce anxiety symptoms.

So far, studies have not reported any harmful effects from self-distancing. This is promising for its safety in helping children with anxiety and OCD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Self-Distancing technique for pediatric anxiety and OCD because it offers a fresh approach to managing these conditions. Unlike traditional treatments like cognitive-behavioral therapy (CBT) or medication, which focus on changing thought patterns or brain chemistry, Self-Distancing encourages kids to step back and view their anxiety-inducing tasks as if they are an observer. This method helps reduce emotional intensity and allows for better coping. By teaching children to describe situations from a third-person perspective, there's potential for a unique, non-invasive tool that empowers them to handle anxiety more effectively.

What evidence suggests that self-distancing is effective for pediatric anxiety and OCD?

Research has shown that self-distancing can help children with anxiety and OCD. In this trial, participants will be randomized to either a self-distancing intervention or a first-person self-talk control condition. A small study with children aged 11 to 17 found that using self-distancing during therapy improved their participation in activities designed to face their fears. This method may ease the process of dealing with difficult situations by altering their thought patterns. Self-distancing is associated with reduced emotional intensity, which may help children remain calmer in stressful situations. These early results suggest that self-distancing could reduce anxiety symptoms and boost children's confidence over time. ^{1 2 3 6 7}

Who Is on the Research Team?

Kate D Fitzgerald, MD

Principal Investigator

Professor of Psychiatry

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10212740/

Pilot Study of Self-Distancing Augmentation to Exposure ... This pilot examines a self-distancing augmentation to exposure. Nine youth with anxiety (ages 11–17; 67% female) completed treatment.

2. withpower.com withpower.com/trial/phase-anxiety-disorders-4-2024-d6982

Self-Distancing for Pediatric Anxiety and OCD 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4607548/

Spontaneous Self-Distancing and Adaptive Self-Reflection ... As expected, spontaneous self-distancing during reflection predicted lower levels of emotional reactivity by leading adolescents to reconstrue (rather than ...

4. adaa.org adaa.org/sites/default/files/2024-07/Sperling%20et%20al..--Sustained%20Treatment%20Gains%20in%20Intensive%20Virtual%20and%20In-Person%20CBT%20for%20Pediatric%20Anxiety%20Disorders%20and%20OCD.pdf

Sustained Treatment Gains in Intensive Virtual and In- ... Taken together, data strongly suggest that CBT for pediatric anxiety and OCD confers short and long-term clinical improvements when delivered through both ...

5. researchgate.net researchgate.net/publication/371071443_Pilot_Study_of_Self-Distancing_Augmentation_to_Exposure_Therapy_for_Youth_Anxiety

Pilot Study of Self-Distancing Augmentation to Exposure ... Self-distancing may be associated with increased exposure engagement and willingness to complete more difficult exposures, which has been linked ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0065260116300338

Self-Distancing: Theory, Research, and Current Directions In this article, we describe an integrative program of research that has addressed this issue by focusing on the role that self-distancing plays in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4857227/

Minimizing pediatric healthcare-induced anxiety and trauma This article introduces a new way to choice, agenda, resilience and emotion (CARE) for pediatric patients in the healthcare setting.