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PTSD Affect Labeling Study

Primary Purpose

Post-traumatic Stress Disorder, Post-Traumatic Stress Disorder, Chronic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Affect Labeling Training
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Post-traumatic Stress Disorder

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA Inclusion Criteria for All Veteran Participants (Ps): All Ps must be veterans with deployment experience. Ps must meet DSM-IV criterion "A" for PTSD, which requires exposure to a traumatic event involving actual or threatened physical injury or death. This trauma must have occurred during military service, but may take a variety of forms (e.g., injury to self, witnessing death of another, etc.). Ps must be 18-45 years old (18-60 for non-fMRI Ps) since normal age-related structural and functional variations in participants above and below this age range could prevent accurate comparison of neural activity across participants. Ps must be English-speaking as translation of all study materials into other languages would be cost-prohibitive. Both male and female participants are allowed. Ps who will complete the fMRI must be right-handed in order to allow comparison of neural activity across participants. Additional Inclusion Criterion for PTSD Participants (PTSDs): PTSDs must meet full DSM- IV criteria for PTSD with a trauma related to their military service, as assessed by the CAPS. Additional Inclusion Criterion for Healthy Control Participants (HCs): HCs must not meet DSM-IV criteria for current/lifetime PTSD or any other current Axis I disorders. Inclusion Criteria for Non-Veteran Healthy Controls: Must be 18-45 years old Must be English-speaking Male or female participants are allowed EXCLUSION CRITERIA Exclusion Criteria for All fMRI Participants: Ps must not have any metallic implants or other non-removable metal in the body (e.g., shrapnel, surgical staples or screws, etc.) as this would preclude them from undergoing any MRI scanning. Ps must not be claustrophobic in order to be able to complete all fMRI procedures. Ps must not be pregnant (as assessed by verbal report) as the research question is not pregnancy-related. Ps must not have any serious unstable medical illnesses. Ps must not have intellectual impairment, bipolar disorder, psychosis, delusional disorder, or suicidality. Ps must not have any organic brain damage, including a history of moderate to severe traumatic brain injury (TBI), as this would confound analyses comparing activations across subjects. A history of mild TBI is allowed. Ps must not meet DSM-IV criteria for Substance Dependence within the last six months due to both the possibility of neural changes associated with the substance use, and issues of participant safety. Ps must not have made any recent modifications to psychotropic medication status (i.e., within the last 1 month for benzodiazepines and within the last 3 months for SSRI and SSNIs). Ps must not have recently initiated or made changes to any psychotherapy (within the last 3 months). Ps must not have had any chronic or repeated neglect/maltreatment, sexual abuse, physical abuse, emotional abuse, or domestic violence prior to the age of 7 (as assessed with the Early Trauma Inventory and CAPS), given evidence for adverse brain development and structural abnormalities in this subgroup of individuals. Exclusion Criteria for All Non-fMRI Participants: Ps must not be pregnant (as assessed by verbal report) as the research question is not pregnancy-related. Ps must not have any serious unstable medical illnesses. Ps must not have intellectual impairment, bipolar disorder, psychosis, delusional disorder, or suicidality. Ps must not meet DSM-IV criteria for Substance Dependence within the last six months due to issues of participant safety. Ps must not have made any recent modifications to psychotropic medication status (i.e., within the last 1 month for benzodiazepines and within the last 3 months for SSRI and SSNIs). Ps must not have recently initiated or made changes to any psychotherapy (within the last 3 months). Additional Exclusion Criterion for PTSD Participants (PTSDs): The investigators will exclude highly-dissociative individuals, defined as those who score 15 or higher on the Clinician Administered Dissociative States Scale (Bremner et al., 1998). While the majority (i.e., 70%) of individuals with PTSD are characterized by prefrontal under-regulation and limbic over-responding to trauma cues, research has also identified a subgroup of PTSD individuals, up to 30%, who are characterized as highly 'dissociative' and exhibit the opposite neural pattern to trauma cues, i.e., abnormally low and over-regulated amygdala responses (Lanius et al., 2010). The current proposal focuses on the former, larger group of less-dissociation-prone PTSD individuals with inhibitory deficits, as this appears to be the group for whom inhibitory enhancement may be particularly helpful. Accordingly, the investigators will exclude those with high levels of baseline dissociative symptomology in this first proof-of-concept study. Exclusion Criteria for Non-Veteran Healthy Controls: Ps must not have been exposed to a DSM-IV defined traumatic event. Ps must not meet criteria for any current DSM-IV Axis I disorder and must not have intellectual impairment or current suicidality. Ps must not be pregnant (as assessed by verbal report) as the research question is not pregnancy-related. Ps must not have any serious unstable medical illnesses. Ps must not be currently receiving treatment for a psychiatric problem (including psychotherapy and psychotropic medication).

Sites / Locations

  • University of California, Los Angeles

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Affect Labeling Training

Arm Description

Participants complete a total of six training sessions, twice a week for three consecutive weeks. In each session, they spend 40 minutes completing computer-based inhibitory regulation training utilizing four strategies.

Outcomes

Primary Outcome Measures

Positive and Negative Affective Schedules - State & Trait Versions (PANAS)
The PANAS is a widely used measure comprising 20-items assessing activated forms of Positive Affect and Negative Affect using 5-point scales (1 = very slightly/not at all, 5 = extremely). Higher scores on each subscale (positive affect and negative affect) reflect higher levels of positive and negative affect, respectively.
Mood and Anxiety Symptom Questionnaire - Mini Version
The Mini-MASQ is a 26-item measure of mood and anxiety symptoms developed to evaluate predictions of the tripartite model of anxiety and depression. The MASQ has three subscales: (1) General Distress (GD: 8 items), (2) Anxious Arousal (AA: 10 items), and (3) Anhedonic Depression (AD: 8 items). Respondents indicate the extent to which they experienced each symptom during the past week from 1=not at all to 5=extremely.
Emotion Regulation Questionnaires (ERQ)
The ERQ is a 10-item measure designed to assess individual differences in the habitual use of two emotion regulation strategies: cognitive reappraisal and expressive suppression.
fMRI Inhibitory regulation of trauma-relevant emotion
The primary outcome variables for our key objectives will be neural activity obtained during the baseline fMRI scans for participants with PTSD (PTSDs) vs. healthy controls (HCs) as well as changes in neural activity from pre to post training for PTSDs.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Clinician-reported PTSD symptom severity
Mindful Attention Awareness Scale (MAAS)
The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place.
PTSD Checklist for DSM-5 (PCL-5)
Self-reported PTSD symptom severity. The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD using a 5-point Likert scale of how much they were bothered by each symptom (0 = "not at all" to 4 = "extremely"). Scores are summed and higher scores represent greater self-reported PTSD symptoms. Scores range from 0-80.

Secondary Outcome Measures

Full Information

First Posted
June 6, 2023
Last Updated
June 20, 2023
Sponsor
University of California, Los Angeles
Collaborators
Defense Group, Inc., Defense Advanced Research Projects Agency
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1. Study Identification

Unique Protocol Identification Number
NCT05924399
Brief Title
PTSD Affect Labeling Study
Official Title
Affect Labeling: A Promising New Approach for Mitigating PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 5, 2014 (Actual)
Primary Completion Date
October 9, 2015 (Actual)
Study Completion Date
October 9, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Defense Group, Inc., Defense Advanced Research Projects Agency

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 RVLPFC's 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 (i.e., 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 (i.e., 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder, Post-Traumatic Stress Disorder, Chronic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Affect Labeling Training
Arm Type
Experimental
Arm Description
Participants complete a total of six training sessions, twice a week for three consecutive weeks. In each session, they spend 40 minutes completing computer-based inhibitory regulation training utilizing four strategies.
Intervention Type
Behavioral
Intervention Name(s)
Affect Labeling Training
Intervention Description
(1) Participants will view combat-relevant images and then label the image or how they feel while viewing the image. (2) Participants will view facial expressions and then label the image. (3) Participants will view negative combat- irrelevant images (such as snakes or spiders) and then label the image or how they feel while viewing the image. (4) Participants will complete Go-NoGo trials similar to the fMRI Go-NoGo task described above. Participants will receive all four types of inhibitory training.
Primary Outcome Measure Information:
Title
Positive and Negative Affective Schedules - State & Trait Versions (PANAS)
Description
The PANAS is a widely used measure comprising 20-items assessing activated forms of Positive Affect and Negative Affect using 5-point scales (1 = very slightly/not at all, 5 = extremely). Higher scores on each subscale (positive affect and negative affect) reflect higher levels of positive and negative affect, respectively.
Time Frame
Change from baseline to Post-AL Training (3 weeks from baseline)
Title
Mood and Anxiety Symptom Questionnaire - Mini Version
Description
The Mini-MASQ is a 26-item measure of mood and anxiety symptoms developed to evaluate predictions of the tripartite model of anxiety and depression. The MASQ has three subscales: (1) General Distress (GD: 8 items), (2) Anxious Arousal (AA: 10 items), and (3) Anhedonic Depression (AD: 8 items). Respondents indicate the extent to which they experienced each symptom during the past week from 1=not at all to 5=extremely.
Time Frame
Change from baseline to Post-AL Training (3 weeks from baseline)
Title
Emotion Regulation Questionnaires (ERQ)
Description
The ERQ is a 10-item measure designed to assess individual differences in the habitual use of two emotion regulation strategies: cognitive reappraisal and expressive suppression.
Time Frame
Change from baseline to Post-AL Training (3 weeks from baseline)
Title
fMRI Inhibitory regulation of trauma-relevant emotion
Description
The primary outcome variables for our key objectives will be neural activity obtained during the baseline fMRI scans for participants with PTSD (PTSDs) vs. healthy controls (HCs) as well as changes in neural activity from pre to post training for PTSDs.
Time Frame
Change from baseline to Post-AL Training (3 weeks from baseline)
Title
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Description
Clinician-reported PTSD symptom severity
Time Frame
Change from baseline to Post-AL Training (3 weeks from baseline)
Title
Mindful Attention Awareness Scale (MAAS)
Description
The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place.
Time Frame
Change from baseline to Post-AL Training (3 weeks from baseline)
Title
PTSD Checklist for DSM-5 (PCL-5)
Description
Self-reported PTSD symptom severity. The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD using a 5-point Likert scale of how much they were bothered by each symptom (0 = "not at all" to 4 = "extremely"). Scores are summed and higher scores represent greater self-reported PTSD symptoms. Scores range from 0-80.
Time Frame
Change from baseline to Post-AL Training (3 weeks from baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA Inclusion Criteria for All Veteran Participants (Ps): All Ps must be veterans with deployment experience. Ps must meet DSM-IV criterion "A" for PTSD, which requires exposure to a traumatic event involving actual or threatened physical injury or death. This trauma must have occurred during military service, but may take a variety of forms (e.g., injury to self, witnessing death of another, etc.). Ps must be 18-45 years old (18-60 for non-fMRI Ps) since normal age-related structural and functional variations in participants above and below this age range could prevent accurate comparison of neural activity across participants. Ps must be English-speaking as translation of all study materials into other languages would be cost-prohibitive. Both male and female participants are allowed. Ps who will complete the fMRI must be right-handed in order to allow comparison of neural activity across participants. Additional Inclusion Criterion for PTSD Participants (PTSDs): PTSDs must meet full DSM- IV criteria for PTSD with a trauma related to their military service, as assessed by the CAPS. Additional Inclusion Criterion for Healthy Control Participants (HCs): HCs must not meet DSM-IV criteria for current/lifetime PTSD or any other current Axis I disorders. Inclusion Criteria for Non-Veteran Healthy Controls: Must be 18-45 years old Must be English-speaking Male or female participants are allowed EXCLUSION CRITERIA Exclusion Criteria for All fMRI Participants: Ps must not have any metallic implants or other non-removable metal in the body (e.g., shrapnel, surgical staples or screws, etc.) as this would preclude them from undergoing any MRI scanning. Ps must not be claustrophobic in order to be able to complete all fMRI procedures. Ps must not be pregnant (as assessed by verbal report) as the research question is not pregnancy-related. Ps must not have any serious unstable medical illnesses. Ps must not have intellectual impairment, bipolar disorder, psychosis, delusional disorder, or suicidality. Ps must not have any organic brain damage, including a history of moderate to severe traumatic brain injury (TBI), as this would confound analyses comparing activations across subjects. A history of mild TBI is allowed. Ps must not meet DSM-IV criteria for Substance Dependence within the last six months due to both the possibility of neural changes associated with the substance use, and issues of participant safety. Ps must not have made any recent modifications to psychotropic medication status (i.e., within the last 1 month for benzodiazepines and within the last 3 months for SSRI and SSNIs). Ps must not have recently initiated or made changes to any psychotherapy (within the last 3 months). Ps must not have had any chronic or repeated neglect/maltreatment, sexual abuse, physical abuse, emotional abuse, or domestic violence prior to the age of 7 (as assessed with the Early Trauma Inventory and CAPS), given evidence for adverse brain development and structural abnormalities in this subgroup of individuals. Exclusion Criteria for All Non-fMRI Participants: Ps must not be pregnant (as assessed by verbal report) as the research question is not pregnancy-related. Ps must not have any serious unstable medical illnesses. Ps must not have intellectual impairment, bipolar disorder, psychosis, delusional disorder, or suicidality. Ps must not meet DSM-IV criteria for Substance Dependence within the last six months due to issues of participant safety. Ps must not have made any recent modifications to psychotropic medication status (i.e., within the last 1 month for benzodiazepines and within the last 3 months for SSRI and SSNIs). Ps must not have recently initiated or made changes to any psychotherapy (within the last 3 months). Additional Exclusion Criterion for PTSD Participants (PTSDs): The investigators will exclude highly-dissociative individuals, defined as those who score 15 or higher on the Clinician Administered Dissociative States Scale (Bremner et al., 1998). While the majority (i.e., 70%) of individuals with PTSD are characterized by prefrontal under-regulation and limbic over-responding to trauma cues, research has also identified a subgroup of PTSD individuals, up to 30%, who are characterized as highly 'dissociative' and exhibit the opposite neural pattern to trauma cues, i.e., abnormally low and over-regulated amygdala responses (Lanius et al., 2010). The current proposal focuses on the former, larger group of less-dissociation-prone PTSD individuals with inhibitory deficits, as this appears to be the group for whom inhibitory enhancement may be particularly helpful. Accordingly, the investigators will exclude those with high levels of baseline dissociative symptomology in this first proof-of-concept study. Exclusion Criteria for Non-Veteran Healthy Controls: Ps must not have been exposed to a DSM-IV defined traumatic event. Ps must not meet criteria for any current DSM-IV Axis I disorder and must not have intellectual impairment or current suicidality. Ps must not be pregnant (as assessed by verbal report) as the research question is not pregnancy-related. Ps must not have any serious unstable medical illnesses. Ps must not be currently receiving treatment for a psychiatric problem (including psychotherapy and psychotropic medication).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa J Burklund, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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PTSD Affect Labeling Study

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