Self-Distancing for Pediatric Anxiety and OCD

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06339463
• Other study ID #: AAAU7985
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Columbia University
• Contact: Sherry Chen
• Phone: 734-276-0443
• Email: yc4415[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Obsessive-Compulsive Disorder

Intervention

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").
• 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").

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (21)

Abramovitch A, Abramowitz JS, McKay D, Cham H, Anderson KS, Farrell LJ, Geller DA, Hanna GL, Mathieu S, McGuire JF, Rosenberg DR, Stewart SE, Storch EA, Wilhelm S. An ultra-brief screening scale for pediatric obsessive-compulsive disorder: The OCI-CV-5. J Affect Disord. 2022 Sep 1;312:208-216. doi: 10.1016/j.jad.2022.06.009. Epub 2022 Jun 11. — View Citation

Ale CM, McCarthy DM, Rothschild LM, Whiteside SP. Components of Cognitive Behavioral Therapy Related to Outcome in Childhood Anxiety Disorders. Clin Child Fam Psychol Rev. 2015 Sep;18(3):240-51. doi: 10.1007/s10567-015-0184-8. — View Citation

Bilek E, Tomlinson RC, Whiteman AS, Johnson TD, Benedict C, Phan KL, Monk CS, Fitzgerald KD. Exposure-Focused CBT Outperforms Relaxation-Based Control in an RCT of Treatment for Child and Adolescent Anxiety. J Clin Child Adolesc Psychol. 2022 Jul-Aug;51(4):410-418. doi: 10.1080/15374416.2021.1901230. Epub 2021 Apr 27. — View Citation

Birmaher B, Khetarpal S, Brent D, Cully M, Balach L, Kaufman J, Neer SM. The Screen for Child Anxiety Related Emotional Disorders (SCARED): scale construction and psychometric characteristics. J Am Acad Child Adolesc Psychiatry. 1997 Apr;36(4):545-53. doi: 10.1097/00004583-199704000-00018. — View Citation

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Chu BC, Colognori DB, Yang G, Xie MG, Lindsey Bergman R, Piacentini J. Mediators of exposure therapy for youth obsessive-compulsive disorder: specificity and temporal sequence of client and treatment factors. Behav Ther. 2015 May;46(3):395-408. doi: 10.1016/j.beth.2015.01.003. Epub 2015 Feb 8. — View Citation

Gibby BA, Casline EP, Ginsburg GS. Long-Term Outcomes of Youth Treated for an Anxiety Disorder: A Critical Review. Clin Child Fam Psychol Rev. 2017 Jun;20(2):201-225. doi: 10.1007/s10567-017-0222-9. — View Citation

Ginsburg GS, Kendall PC, Sakolsky D, Compton SN, Piacentini J, Albano AM, Walkup JT, Sherrill J, Coffey KA, Rynn MA, Keeton CP, McCracken JT, Bergman L, Iyengar S, Birmaher B, March J. Remission after acute treatment in children and adolescents with anxiety disorders: findings from the CAMS. J Consult Clin Psychol. 2011 Dec;79(6):806-13. doi: 10.1037/a0025933. — View Citation

Kross E, Bruehlman-Senecal E, Park J, Burson A, Dougherty A, Shablack H, Bremner R, Moser J, Ayduk O. Self-talk as a regulatory mechanism: how you do it matters. J Pers Soc Psychol. 2014 Feb;106(2):304-24. doi: 10.1037/a0035173. — View Citation

Levy HC, Stevens KT, Tolin DF. Research Review: A meta-analysis of relapse rates in cognitive behavioral therapy for anxiety and related disorders in youth. J Child Psychol Psychiatry. 2022 Mar;63(3):252-260. doi: 10.1111/jcpp.13486. Epub 2021 Jul 23. — View Citation

Morgan J, Caporino NE, De Nadai AS, et al. Preliminary predictors of within-session adherence to exposure and response prevention in pediatric obsessive-compulsive disorder. Child Youth Care Forum. 2013;42(3):181-191. doi:10.1007/s10566-013-9196-z

Park LS, Burton CL, Dupuis A, Shan J, Storch EA, Crosbie J, Schachar RJ, Arnold PD. The Toronto Obsessive-Compulsive Scale: Psychometrics of a Dimensional Measure of Obsessive-Compulsive Traits. J Am Acad Child Adolesc Psychiatry. 2016 Apr;55(4):310-318.e4. doi: 10.1016/j.jaac.2016.01.008. Epub 2016 Feb 4. — View Citation

Pediatric OCD Treatment Study (POTS) Team. Cognitive-behavior therapy, sertraline, and their combination for children and adolescents with obsessive-compulsive disorder: the Pediatric OCD Treatment Study (POTS) randomized controlled trial. JAMA. 2004 Oct 27;292(16):1969-76. doi: 10.1001/jama.292.16.1969. — View Citation

Practice parameter for the assessment and treatment of children and adolescents with obsessive-compulsive disorder. J Am Acad Child Adolesc Psychiatry. 2012 Jan;51(1):98-113. doi: 10.1016/j.jaac.2011.09.019. — View Citation

Reynolds S, Wilson C, Austin J, Hooper L. Effects of psychotherapy for anxiety in children and adolescents: a meta-analytic review. Clin Psychol Rev. 2012 Jun;32(4):251-62. doi: 10.1016/j.cpr.2012.01.005. Epub 2012 Feb 13. — View Citation

Rough HE, Hanna BS, Gillett CB, Rosenberg DR, Gehring WJ, Arnold PD, Hanna GL. Screening for Pediatric Obsessive-Compulsive Disorder Using the Obsessive-Compulsive Inventory-Child Version. Child Psychiatry Hum Dev. 2020 Dec;51(6):888-899. doi: 10.1007/s10578-020-00966-x. — View Citation

Storch EA, Murphy TK, Geffken GR, Soto O, Sajid M, Allen P, Roberti JW, Killiany EM, Goodman WK. Psychometric evaluation of the Children's Yale-Brown Obsessive-Compulsive Scale. Psychiatry Res. 2004 Nov 30;129(1):91-8. doi: 10.1016/j.psychres.2004.06.009. — View Citation

Walkup JT, Albano AM, Piacentini J, Birmaher B, Compton SN, Sherrill JT, Ginsburg GS, Rynn MA, McCracken J, Waslick B, Iyengar S, March JS, Kendall PC. Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety. N Engl J Med. 2008 Dec 25;359(26):2753-66. doi: 10.1056/NEJMoa0804633. Epub 2008 Oct 30. Erratum In: N Engl J Med. 2013 Jan 31;368(5):490. — View Citation

Walter HJ, Bukstein OG, Abright AR, Keable H, Ramtekkar U, Ripperger-Suhler J, Rockhill C. Clinical Practice Guideline for the Assessment and Treatment of Children and Adolescents With Anxiety Disorders. J Am Acad Child Adolesc Psychiatry. 2020 Oct;59(10):1107-1124. doi: 10.1016/j.jaac.2020.05.005. Epub 2020 May 18. — View Citation

White RE, Carlson SM. What would Batman do? Self-distancing improves executive function in young children. Dev Sci. 2016 May;19(3):419-26. doi: 10.1111/desc.12314. Epub 2015 May 21. — View Citation

Whiteside SPH, Sim LA, Morrow AS, Farah WH, Hilliker DR, Murad MH, Wang Z. A Meta-analysis to Guide the Enhancement of CBT for Childhood Anxiety: Exposure Over Anxiety Management. Clin Child Fam Psychol Rev. 2020 Mar;23(1):102-121. doi: 10.1007/s10567-019-00303-2. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)	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)
Other	Screen for Child Anxiety Related Disorders (SCARED)- Parent and Child	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)
Other	Obsessive-Compulsive Inventory - Child Version (OCI- CV)	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)
Other	Toronto Obsessive Compulsive Scale, Parent version (TOCS)	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)
Other	Clinical Global Impression of Severity (CGI-S) Scale	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
Other	Clinical Global Impression of Improvement (CGI-I) Scale	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
Primary	Treatment Engagement and Adherence Ratings (TEARS)	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	Anxiety Disorders Interview Schedule for DSM-5 (ADIS) Clinical Severity Rating (CSR)	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)