Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05924399
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2023-06-06
Brief Title:
PTSD Affect Labeling Study
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Affect Labeling A Promising New Approach for Mitigating PTSD
Status:
COMPLETED
Status Verified Date:
2023-06
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:
The overall goal of this study is to use fMRI and psychophysiological measures to investigate a novel strategy involving Affect Labeling for improving emotion regulation in PTSD that could lead to a new treatment regimen for PTSD
Our project has two specific aims First the investigators aim to identify a novel neural target for possible PTSD intervention by verifying that RVLPFC-based inhibitory processing is impaired in PTSD Second the investigators will examine whether repeated practice with a simple cognitive-emotional task that requires inhibitory processing namely affect labeling can strengthen the RVLPFCs ability to down-regulate emotional responses and physiological reactivity in PTSD and thereby form the basis of a novel treatment strategy to be developed in future studies Secondary objectives are to examine the extent to which RVLPFC-based inhibitory impairments in PTSD are specific to trauma-relevant emotional processing ie trauma-related distress or extend to other types of inhibitory regulation in general which would have implications for the future study of inhibitory-enhancement-based interventions for PTSD
Our project has two specific aims First the investigators aim to identify a novel neural target for possible PTSD intervention by verifying that RVLPFC-based inhibitory processing is impaired in PTSD Second the investigators will examine whether repeated practice with a simple cognitive-emotional task that requires inhibitory processing namely affect labeling can strengthen the RVLPFCs ability to down-regulate emotional responses and physiological reactivity in PTSD and thereby form the basis of a novel treatment strategy to be developed in future studies Secondary objectives are to examine the extent to which RVLPFC-based inhibitory impairments in PTSD are specific to trauma-relevant emotional processing ie trauma-related distress or extend to other types of inhibitory regulation in general which would have implications for the future study of inhibitory-enhancement-based interventions for PTSD
Detailed Description:
Previous research suggests that individuals with PTSD have impaired RVLPFC- based inhibitory regulation Such deficits would appear to contribute to poor inhibitory regulation of emotional responses when faced with trauma-reminders which represents a core pathological mechanism of PTSD
However no previous studies have directly examined RVLPFC-based inhibitory deficits of emotional responses in PTSD Affect labeling is a simple process that involves linguistic processing of emotional responses for example verbally labeling current feelings as anxious or angry and is an established form of affective inhibitory regulation involving RVLPFC down-regulation of amygdala-based affective responses Therefore the investigators will test whether PTSD is associated with impaired RVLPFC-based emotional inhibitory processing compared to healthy control participants by performing fMRI scan while they use affect labeling to label their own emotional responses to emotionally-evocative images relevant to their trauma The investigators will then test whether repeated practice with affect labeling will repair the impaired RVLPFC inhibitory control in PTSD by strengthening the capacity of the RVLPFC to down-regulate amygdala responses In support of this idea the investigators have previously demonstrated that exposure therapy augmented with affect labeling was more effective in reducing fear responses than exposure alone in specific phobia Kircanski et al 2013 In the present study following the initial baseline fMRI scan mentioned above participants with PTSD will complete three weeks of affect labeling training and then undergo a second fMRI scan to again assess inhibitory regulation capacity
The investigators hypothesize that compared to healthy without PTSD subjects participants with PTSD will exhibit less RVLPFC activity more amygdala activity ie less amygdala deactivation as well as less inverse correlation between the RVLPFC and the amygdala at baseline reflecting impaired inhibitory regulation In addition the investigators hypothesize that participants will exhibit increased physiological reactivity compared to healthy control subjects
The investigators also hypothesize that affect labeling training will lead to increased inhibitory regulation success which will be reflected by increased RVLPFC activity decreased amygdala activity increased inverse connectivity between RVLPFC and amygdala from pre to post training The results from this initial effort will form the foundation for future studies examining affect labeling training as a bona fide treatment strategy for PTSD
However no previous studies have directly examined RVLPFC-based inhibitory deficits of emotional responses in PTSD Affect labeling is a simple process that involves linguistic processing of emotional responses for example verbally labeling current feelings as anxious or angry and is an established form of affective inhibitory regulation involving RVLPFC down-regulation of amygdala-based affective responses Therefore the investigators will test whether PTSD is associated with impaired RVLPFC-based emotional inhibitory processing compared to healthy control participants by performing fMRI scan while they use affect labeling to label their own emotional responses to emotionally-evocative images relevant to their trauma The investigators will then test whether repeated practice with affect labeling will repair the impaired RVLPFC inhibitory control in PTSD by strengthening the capacity of the RVLPFC to down-regulate amygdala responses In support of this idea the investigators have previously demonstrated that exposure therapy augmented with affect labeling was more effective in reducing fear responses than exposure alone in specific phobia Kircanski et al 2013 In the present study following the initial baseline fMRI scan mentioned above participants with PTSD will complete three weeks of affect labeling training and then undergo a second fMRI scan to again assess inhibitory regulation capacity
The investigators hypothesize that compared to healthy without PTSD subjects participants with PTSD will exhibit less RVLPFC activity more amygdala activity ie less amygdala deactivation as well as less inverse correlation between the RVLPFC and the amygdala at baseline reflecting impaired inhibitory regulation In addition the investigators hypothesize that participants will exhibit increased physiological reactivity compared to healthy control subjects
The investigators also hypothesize that affect labeling training will lead to increased inhibitory regulation success which will be reflected by increased RVLPFC activity decreased amygdala activity increased inverse connectivity between RVLPFC and amygdala from pre to post training The results from this initial effort will form the foundation for future studies examining affect labeling training as a bona fide treatment strategy for PTSD
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