Self-Distancing for Pediatric Anxiety and OCD

March 25, 2024 updated by: Kate D. Fitzgerald, MD, Columbia University

Targeting Approach Behaviors in Exposures With Self-distancing to Improve Outcomes in Pediatric Anxiety and Obsessive Compulsive Disorders

Self-Distancing is a cognitive technique that involves shifting perspective away from first person to promote an adaptive, self-reflective stance in emotionally charged situations. This trial aims to help learn how self-distancing may increase approach during exposure and thereby improve treatment response. To find out if self-distancing works by helping children approach fear inducing stimuli, the study will look at behaviors related to approach as well as symptom severity, before, after and during treatment.

The study hypothesizes that Self-Distancing will produce greater increases in approach behaviors and greater decreases in anxiety severity than in the Classic Exposure.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pediatric anxiety and obsessive-compulsive disorders (OCD) affect 1 in 3 youth by adolescence and increase risk for depression, substance use, school dropout, and suicide. Therapy involving repeated exposure to feared stimuli is the gold-standard for affected youth, however, as many as 50% of those treated continue to struggle with illness. Theory suggests that to be effective, patients must fully engage with (i.e., approach) feared stimuli to learn that feared outcomes do not occur. Yet, approaching feared stimuli is difficult for anyone, and particularly aversive for clinically anxious youth who are highly motivated to avoid anxiety- inducing situations. Strategies to increase approach during exposure therapy could improve exposure therapy response in anxious and OCD- affected youth.

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • Columbia University Irving Medical Center
        • Principal Investigator:
          • Kate Fitzgerald, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 7-17.99 years at time of consent
  2. Written informed consent by a parent/legal guardian and assent by child
  3. Has a primary clinical diagnosis (diagnosis with the highest CSR) of one of the following Diagnostic and Statistical Manual-5 (DSM-5) Disorders: Separation Anxiety Disorder, Specific Phobia, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Generalized Anxiety Disorder, and/or Obsessive-Compulsive Disorder (OCD)
  4. Fluent in English (Participant may be bilingual, but must be able to speak and understand fluent English to participate in study)

Exclusion Criteria:

  1. Current or past manic/hypomanic episode
  2. Current or past psychotic symptoms
  3. Autism spectrum disorder diagnosis or elevated symptoms
  4. Active alcohol or substance dependence
  5. Co-primary clinical diagnosis (CSR ≥ 4) other than Separation Anxiety Disorder, Specific Phobia, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Generalized Anxiety Disorder, and/or Obsessive-Compulsive Disorder (OCD). Other clinical diagnoses are not exclusionary, provided that they are not co-primary or primary (i.e., equal or greater Clinical Severity Rating)
  6. Active suicidal ideation or suicidal behavior within the past 3 months prior to baseline assessment
  7. Engagement in non-suicidal self-injurious behavior within 6 months prior to baseline
  8. Any major medical or neurological problem (e.g., unstable hypertension, seizure disorder, head trauma)
  9. Intelligence Quotient < 81
  10. Change in psychotropic medication within 1 month of baseline visit
  11. Receiving concurrent psychotherapy
  12. History of exposure therapy within last 24 months
  13. Exposure not appropriate treatment recommendation (e.g., comorbid condition requires different or tailored treatment or higher level of care)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-Distancing
Youth will be randomized to 10 weekly exposure therapy sessions. In the Self-Distanced arm, participants will be instructed to describe exposure tasks from a self-distanced perspective (e.g., "Emily is going to touch the dirty floor").
Behavioral: Self-Distancing (EXSD)
In the EXSD condition, participants will be instructed to describe exposure tasks from a self- distanced perspective (e.g., "Emily is going to touch the dirty floor").
Active Comparator: Classic Exposure
Youth will be randomized to 10 weekly exposure therapy sessions. In the Classic Exposure arm, participants will be instructed to describe exposure tasks from a self-immersed perspective (e.g.,"I'm going to touch a dirty floor")
Behavioral: Classic Exposure (EXC)
In the classic condition (EXC), participants will be instructed to describe exposure tasks from a self-immersed perspective ("I'm going to touch a dirty floor").

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Engagement and Adherence Ratings (TEARS)
Time Frame: Week 3, 4, 5, 6, 7, 8, 9, 10
The TEARS is a brief questionnaire assessing youth and therapist reports of youth's adherence to their assigned exposure condition (EXC vs EXSD), and their approach toward the exposure. Adherence and engagement are rated on a Likert scale from 1-7, with higher scores indicating greater engagement and adherence.
Week 3, 4, 5, 6, 7, 8, 9, 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Disorders Interview Schedule for DSM-5 (ADIS) Clinical Severity Rating (CSR)
Time Frame: Pre-treatment (Baseline) and post-treatment assessments (approximately 12 weeks)
The Anxiety Disorders Interview Schedule for DSM-5 (ADIS) is a structured clinical interview that is adapted for DSM-5 and allows clinicians to ascertain the presence of DSM-5 anxiety disorders or OCD, as well as relevant rule-out diagnoses (e.g., PTSD, bipolar disorder). The ADIS includes clinical severity ratings (CSR) for each diagnosis to allow for easy tracking of the principal and secondary diagnoses, as well as change in severity and remittance status over time. The CSR score range is 0-8, 0= Absence of symptoms/No disturbance in functioning/No disability and 8= Very severe symptoms/Very severe disturbance in functioning/Very severely disabling. The ADIS will be administered to participants and caregivers by a clinician with prior ADIS training and experience.
Pre-treatment (Baseline) and post-treatment assessments (approximately 12 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
Time Frame: Baseline (Week 0), Week 1, Post-Treatment (Week 11)
The CY-BOCS is a clinician-rated measure administered to children and caregivers in a semi-structured manner to assess presence and severity of obsessive-compulsive disorder symptoms. The CY-BOCS includes a checklist of obsessions and compulsions, as well as a series of items to assess the severity of obsessions and compulsions. Items are rated 0-5, with higher scores indicating greater severity of symptoms.
Baseline (Week 0), Week 1, Post-Treatment (Week 11)
Screen for Child Anxiety Related Disorders (SCARED)- Parent and Child
Time Frame: Baseline (Week 0), Mid-Treatment (Week 5), Post-Treatment (Week 11)
The SCARED is 41-item measure with parallel forms for youth and caregivers that indexes five domains of anxiety. The SCARED is a robust measure with excellent support for its psychometric properties. Items are rated 0=Not true or hardly ever true to 2=Very true or often true, with higher scores indicating more severe symptoms.
Baseline (Week 0), Mid-Treatment (Week 5), Post-Treatment (Week 11)
Obsessive-Compulsive Inventory - Child Version (OCI- CV)
Time Frame: Baseline (Week 0), Mid-Treatment (Week 5), Post-Treatment (Week 11)
The OCI-CV is an 18-item measure that assesses youth report of obsessive-compulsive symptoms commonly seen in youth. Items are rated 0-4, 0=Not at all and 4=Extremely.
Baseline (Week 0), Mid-Treatment (Week 5), Post-Treatment (Week 11)
Toronto Obsessive Compulsive Scale, Parent version (TOCS)
Time Frame: Baseline (Week 0), Mid-Treatment (Week 5), Post-Treatment (Week 11)
The TOCS is a 21-item measure of OCD symptoms. The parent-report version provides report of obsessive-compulsive symptoms commonly seen in youth. Items are rated on a 7-point Likert scale from -3= far less often, to 3= far more often.
Baseline (Week 0), Mid-Treatment (Week 5), Post-Treatment (Week 11)
Clinical Global Impression of Severity (CGI-S) Scale
Time Frame: Baseline, up to Week 12
The CGI-S is a single item severity score clinicians assign about the global severity of anxiety symptoms a patient is experiencing. The CGI-S score range is 1-7, 1=Normal and 7=Among the extremely ill patients. This measure will be completed by independent evaluators at Baseline and Post-treatment, and by the treating clinicians at all therapy session time points.
Baseline, up to Week 12
Clinical Global Impression of Improvement (CGI-I) Scale
Time Frame: Baseline, up to Week 12
The CGI-I is a single item severity score clinicians assign about the global severity of anxiety symptoms a patient is experiencing. The CGI-I score range is 1-7, 1=Very much improved and 7=Very much worse. This measure will be completed by independent evaluators at Baseline and Post-treatment, and by the treating clinicians at all therapy session time points.
Baseline, up to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Kate D Fitzgerald, MD, Professor of Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAU7985

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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