Viewing Study NCT06339463



Ignite Creation Date: 2024-05-06 @ 8:18 PM
Last Modification Date: 2024-10-26 @ 3:25 PM
Study NCT ID: NCT06339463
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-04-01
First Post: 2024-03-25

Brief Title: Self-Distancing for Specific Phobia in Youth
Sponsor: Columbia University
Organization: Columbia University

Study Overview

Official Title: Targeting Approach Behaviors in Exposures with Self-distancing to Improve Outcomes in Youth Specific Phobia
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 and physiological responses related to approach as well as symptom severity before after and during treatment

The study hypothesizes that Self-Distancing will lead to greater increases in approach behaviors and a larger decrease in symptom severity compared to Classic Exposure
Detailed Description: Anxiety disorders impact 1 in 3 youths by the time of adolescence and can lead to depression substance use school issues and suicide risk Ahlen and Ghaderi 2020 Merikangas et al 2010 Specific phobia is the earliest occurring and most common anxiety disorder and increases risk for later onset of other anxiety disorders eg separation social generalized anxiety disorders OCD depression and substance abuse problems Barzilay et al 2020 Bushnell et al 2019 Wetzer et al 2021 Exposure therapy is the standard treatment for specific phobia Ollendick and King 2004 Wolitzky-Taylor et al 2008 but many still struggle with symptoms even after treatment For exposure therapy to be effective youth with specific phobia must actively approach feared situations to learn that feared outcomes do not occur Therefore strategies to facilitate approach behaviors during exposure therapy may improve treatment outcomes

Self-distancing SD is a technique that may help youths approach their fears in exposure therapy SD utilizes third-person language to enhance a persons psychological distance from self helping them to take a step back from emotional situations to take a more objective perspective In community samples SD has been found to boost determination and persistence during difficult tasks including those that induce anxiety eg giving a speech However SD has yet to be tested as a strategy for helping clinically anxious youth engage with exposures in the context of therapy Additionally objective measures of approach are needed for measuring and modifying novel exposure therapy augmentation strategies such as SD to improve treatment outcomes

This study will examine if SD increases the ability to approach feared stimuli during exposure therapy to improve response to treatment Investigators will test SD in 20 youths 12-1799 years with specific phobia of spiders randomized to exposure therapy with or without SD Exposure therapy will be delivered using a one-session treatment ie OST which includes 7 increasingly challenging exposure tasks ie from observing to touching a spider adapted from prior work Ollendick and Davis III 2013 In the SD condition patients will engage with exposure tasks from a self-distanced view eg Emily will touch a spider while the standard exposure will use a first-person perspective eg I will touch a spider Before and after the exposure therapy session this study will assess 1 Approach -indexed using both behavioral ability to get physically closer to live spider and video-derived motion analysis and physiological ie heart rate HR heart rate variability HRV and electrodermal activity EDA metrics collected during a validated behavioral approach test BAT Bernstein and Nietzel 1973 Borkovec et al 1997 Ollendick et al 2011 and 2 severity of specific phobia using validated self-report scales During each of the 7 steps of exposure therapy investigators will measure physical distance from fear stimuli used in exposure tasks and collect continuous data to derive physiological ie HR and HRV and behavioral metrics of approach ie video-derived motion analysis and audio-derived linguistic metrics and ask participants to subjectively rate their distress Data will be analyzed to assess whether SD augmentation of exposure therapy improves treatment outcomes in youth with specific phobia as well as to establish objective measurable metrics for assessing engagement with exposure tasks

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None