PTSD Affect Labeling Study

NCT05924399 | Completed

• 1 other identifier: W911NF-14-C-0056
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• 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.

  Change from baseline to Post-AL Training (3 weeks from baseline)

• 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.

  Change from baseline to Post-AL Training (3 weeks from baseline)

• 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.

  Change from baseline to Post-AL Training (3 weeks from baseline)

• 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.

  Change from baseline to Post-AL Training (3 weeks from baseline)

• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

  Clinician-reported PTSD symptom severity

  Change from baseline to Post-AL Training (3 weeks from baseline)

• 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.

  Change from baseline to Post-AL Training (3 weeks from baseline)

• 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.

  Change from baseline to Post-AL Training (3 weeks from baseline)

Study Arms (1)

Affect Labeling Training

EXPERIMENTAL

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.

Behavioral: Affect Labeling Training

Interventions

Affect Labeling Training BEHAVIORAL

(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.

Affect Labeling Training

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Must be 18-45 years old
• Must be English-speaking
• Male or female participants are allowed

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Defense Group, Inc.: collaborator
• Defense Advanced Research Projects Agency: collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Burklund LJ, Davies CD, Niles A, Torre JB, Brown L, Vinograd M, Lieberman MD, Craske MG. Affect labeling: a promising new neuroscience-based approach to treating combat-related PTSD in veterans. Front Psychol. 2024 Jun 7;15:1270424. doi: 10.3389/fpsyg.2024.1270424. eCollection 2024.

  PMID: 38911954 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Lisa J Burklund, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 29, 2023
• Study Start: August 5, 2014
• Primary Completion: October 9, 2015
• Study Completion: October 9, 2015
• Last Updated: June 29, 2023

Record last verified: 2023-06

Locations

US (1)