Clinical trial NCT06339463: Self-Distancing for Specific Phobia in Youth
Official title: Targeting Approach Behaviors in Exposures With Self-distancing to Improve Outcomes in Youth Specific Phobia
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Specific Phobias
Keywords: Self-distancing
Specific phobia
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 35
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Youth (7-12.99 years) with DSM-5 specific phobia (e.g. spider phobia) will be randomized to SD or a control condition (first-person perspective). Self-distancing or control condition will be delivered over the course of one visit. These conditions will run in parallel.
Primary purpose: TREATMENT

Brief summary: 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).

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. Specific phobia is the earliest occurring and most common anxiety disorder and increases risk for later onset of other anxiety disorders (e.g., separation, social, generalized anxiety disorders), OCD, depression, and substance abuse problems. Exposure therapy is the standard treatment for specific phobia, 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 second or third-person language to enhance a person's psychological distance from self, helping them to "take a step back" from emotional situations and adopt a more objective perspective. In community samples, SD has been found to boost determination and persistence during difficult tasks, including those that induce anxiety (e.g., giving a speech). However, SD has yet to be tested as a strategy for helping clinically anxious youth engage with exposures. 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 a behavioral approach test (BAT). 20 youth (7-12.99 years) with specific phobia of spiders will be randomized to either a SD or a control condition. In the SD condition, participants will engage with the exposure task (BAT) from a self-distanced view (e.g., "Emily will touch a spider"), while in the control condition the subject will use first-person perspective (e.g., "I will touch a spider") Before and after the exposure therapy session, a BAT will be applied. This study will assess: 1) Approach -indexed using both behavioral (ability to get physically closer to spider, and video-derived motion analysis) and neuro-physiological (i.e., electroencephalogram \[EEG\], heart rate \[HR\], heart rate variability \[HRV\] and electrodermal activity \[EDA\]) metrics, collected during a BAT and 2) severity of specific phobia using validated self-report scales. During SD or control intervention, continuous audio and video data will be collected to derive behavioral metrics of engagement with the intervention (i.e., video-derived motion analysis and audio-derived linguistic metrics) and participants will be asked to subjectively rate their distress and engagement with the activity. Data will be analyzed to determine whether SD improves behavioral, neural, and physiological markers of approach to feared stimuli in youth with specific phobia and reduces symptom severity, and to explore the degree to which changes in video and audio-derived objective metrics of behavioral engagement with the intervention associate with changes in subjective ratings of fear/distress, subjective self-report of engagement and symptom severity.

Eligibility criteria: Inclusion Criteria

* Age 7-12.99 years at the time of consent
* Written informed consent by a parent/legal guardian and assent by the child
* Clinically significant symptoms of specific phobia (i.e., spider phobia)
* Fluent in English (Participant may be bilingual but must be able to speak and understand fluent English to participate in the study)

Exclusion Criteria

* Prior diagnosis of bipolar disorder
* Prior diagnosis of psychotic disorders
* Prior diagnosis of autism spectrum disorder
* Active alcohol or substance dependence
* Active suicidal ideation or suicidal behavior within the past 3 months prior to baseline assessment
* Any major medical or neurological problem (e.g., unstable hypertension, seizure disorder, head trauma)
* Any history of cognitive impairment or developmental delay

Primary outcomes:
measure: Behavioral Approach Test (BAT)
timeFrame: Immediately before and after intervention.
measure: Spider Phobia Questionnaire (SPQ-C)
timeFrame: At baseline (~1 week before the intervention) and immediately after the intervention.
measure: Treatment Engagement and Adherence Ratings (TEARS)
timeFrame: Immediately after the intervention.
measure: Subjective Units of Distress Scale (SUDS)
timeFrame: Immediately before and after the intervention.
Secondary outcomes:
measure: Heart Rate Variability
timeFrame: Immediately before and after the intervention.
measure: Electrodermal activity
timeFrame: Immediately before and after the intervention.
measure: Electroencephalogram (EEG)
timeFrame: Immediately before and after the intervention.
Other outcomes:
measure: Screen for Child Anxiety Related Disorders (SCARED)- Parent and Child
timeFrame: At baseline (~1 week before intervention) and immediately after intervention.
measure: Child Behavior Checklist (CBCL)
timeFrame: This measure is completed by the child's caregiver at baseline (~1 week before the intervention).
measure: Clinical Expectancy Questionnaire (CEQ)
timeFrame: It will be applied immediately before the intervention.
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Professor of Psychiatry
name: Kate D Fitzgerald, MD
role: PRINCIPAL_INVESTIGATOR
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