Does Increasing Attentional Control Decrease Acute Fear Response

NCT04080115 | Completed

• 1 other identifier: 19-382
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

Despite decades of research, current psychological treatments designed to treat a variety of mental illnesses are not effective for all who receive them. Specifically, well-supported treatments for mental illnesses that involve fear (e.g., PTSD, panic) appear to be effective for the majority of individuals, but consistently leave a group of "treatment non-responders." One potential explanation for the observed discrepancy in treatment response may be the focus of modern psychotherapies on relieving symptoms specific to categorical diagnoses, rather than mechanisms underlying why the individual is experiencing the symptoms. Recently, fear-based psychological disorders (e.g., PTSD, specific phobia, panic disorder, social anxiety) have been identified as sharing a distinct set of biomarkers, including genetic biomarkers of acute fear (i.e., fear in the moment) and impairments in controlling attention. Neurobehavioral interventions are therefore a promising class of treatments designed to target the biological markers that may be maintaining the symptoms of various psychological disorders. The Attention Training Technique (ATT) is a neurobehavioral intervention that has garnered attention through its demonstrated effectiveness in reducing symptoms across a variety of psychological diagnoses. While grounded in well-established theory, the mechanisms of change in ATT are largely unknown. One proposed mechanism may be that ATT promotes functional connectivity between regions in the brain implicated in top-down executive control over attention (ventromedial prefrontal cortex \[vmPFC\] and dorsolateral prefrontal cortex \[dlPFC\]) and bottom-up attention networks (dorsal anterior cingulate cortex \[dACC\] and amygdala), resulting in increased top-down regulation of potentially problematic bottom-up attentional processes. The same brain regions implicated in both top-down and bottom-up attentional processes have also been associated with fear responding (i.e., startle response) and fear learning (i.e., how quickly one learns that a stimuli is safe or to be feared). Taken together, the research suggests that acute fear responding may be decreased through increased executive control over attention through engagement in ATT. The proposed randomized clinical trial will test whether a self-administered brief neurobehavioral intervention (ATT) to increase attentional control will decrease acute fear responding, and whether this change is associated with increased ability to handle attentional interference, an ability associated with normative dACC functioning and measured by behavioral proxy in this study via the Multi-Source Interference Task (MSIT). It is expected that those who engage in ATT will show greater attentional control efficiency, which will decrease their acute fear response. It is also expected that those who engage in ATT will also show lower sensitivity to attentional interference (measured through the MSIT) and will exhibit decreases in their reported fear as their attentional control increases over the course of the intervention. Additionally, it is expected that the intervention (ATT) will indirectly decrease symptoms of categorical fear-based psychological diagnoses through the identified biomarkers (i.e., attentional control, attentional interference sensitivity, acute fear response) to decrease reported symptoms.

Conditions

Fear; Attention

Outcome Measures

Primary Outcomes (5)

• Change in Attention Network Task(ANT)/Attentional Control Efficiency at Post-intervention

  The ANT is a behavioral reaction time (RT) measure of attentional alerting, orienting, and executive control (Fan et al., 2002). The test is a combination of the commonly used flanker task (see Eriksen \& Eriksen, 1974) and a simple cued reaction time task (see Posner, 1980). The ANT provides measures of both RT and error rates (ER). There are several test conditions of interest in the ANT that produce scores that are indications of efficiency in the three separate attention networks.

  Day 1 (Baseline/pre-intervention) and Day 7 (Post-intervention)

• Change in Acute Fear Response (i.e., Fear Load and Fear Inhibition) at Post-intervention

  The acoustic startle response (eyeblink component) will be measured via electromyography (EMG) of the right orbicularis oculi muscle and will be measured as the maximum amplitude of the eyeblink muscle contraction 20 to 200 ms after the startle probe is presented. FPS score will be calculated by subtracting startle magnitude to the noise alone trials (NA) from the startle magnitude to the CS in each conditioning block. For the purposes of the current study, acute fear is conceptualized as fear load and fear inhibition. Fear load will be operationalized as the FPS score to the CS+ during the first and second blocks of the extinction phase and fear inhibition is operationalized as the FPS to CS+ in the last two blocks of extinction. Fear load and fear inhibition are continuous scores when calculated in such a manner.

  Day 1 (Baseline/pre-intervention) and Day 7 (Post-intervention)

• Change in dACC functioning, as measured by a behavioral proxy (i.e., Multi-Source Interference Task)

  The Multi-Source Interference Task (MSIT; Bush, Shin, Holmes, Rosen \& Vogt, 2003) is a behavioral task designed to cognitively tax the cingulo-frontal parietal cognitive/attention network with two conditions (i.e., interference and control) and two performance scores (i.e., absolute and relative processing speed). Specifically, in an fMRI study, Bush and colleagues (2003) showed that the MSIT activates the dACC, specifically, to a greater degree than any previously utilized behavioral task.

  Day 1 (Baseline/pre-intervention) and Day 7 (Post-intervention)

• Change in Self-Reported Attentional Control:. Attentional Control Scale, Short form (ACS-S; Judah et al., 2014)

  The ACS-S form is a 12-item short form of the Attentional Control Scale (Derrybery \& Reed, 2002). Similar to the long form, the ACS-S measures perceived attentional control, consisting of attentional focusing (i.e., When I am reading or studying, I am easily distracted if there are people talking in the same room) and attention shifting (i.e., It is easy for me to alternate between two different tasks). Participants rate their agreement with each item on a 1 (Almost never) to 4 (Always) scale as each statement applies to them. Higher scores reflect greater perceived attentional regulation.

  Day 0 (Online baseline survey) through study completion, anticipated average 6 weeks

• Change in Self-reported Fear: NIH Toolbox for Assessment of Neurological and Behavioral Function- Fear (NIHTB- Fear; Salsman et al., 2013)

  The Fear-Affect survey is a 29-item measure of symptoms of anxiety that reflect the presence of autonomic arousal (e.g., I had a racing or pounding heart) and threat perception (e.g., I felt fearful). Participants rate their agreement with a 7-day timeframe for each item on a 5-point Likert scale from 1 (Never) to 5 (Always), with higher scores reflecting more fearful responding; a T score of 60 is recommended as the cut-off for high levels of fear responding (Slotkin et al., 2012), and as such will serve as the cut-off for inclusion criteria in the proposed study. The short form of the Fear Affect scale will also be utilized by the proposed study during the Ecological Momentary Assessment (EMA) intervention period (T3). The Fear-Affect short form is a 7-item measure assessing fearful emotions in the past 7 days on the same 5-point Likert scale. For T3, the time frame will be "since the last signal." For T5, the time frame will be modified to "in the past month."

  Day 0 (Online baseline survey) through study completion, anticipated average 6 weeks

Secondary Outcomes (4)

• Change in Panic Disorder Self-Report (PDSR; Newman, Holmes, Zuellig, Kachin & Behar, 2006)

  Day 0 (Online baseline survey), Day 7, and one month follow-up (week 5)

• Change in Social Interaction Anxiety Scale (SIAS; Mattick & Clarke, 1998)

  Day 0 (Online baseline survey), Day 7, and one month follow-up (week 5)

• Change in PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013)

  Day 0 (Online baseline survey), Day 7, and one month follow-up (week 5)

• Change in Circumscribed Fear Measure, Most Feared (CFM-MF; McCraw & Valentiner, 2015)

  Day 0 (Online baseline survey), Day 7, and one month follow-up (week 5)

Study Arms (2)

Attention Training Technique (ATT)

EXPERIMENTAL

Behavioral: Attention Training Technique

Sham intervention control condition

ACTIVE COMPARATOR

Behavioral: Sham intervention control condition

Interventions

Attention Training Technique BEHAVIORAL

ATT will be administered through a customized Expiwell smartphone application that will be downloaded onto participants' cell phones at the first laboratory session (T2). For the purposes of the proposed study, participants need to complete the intervention once a day, for the six days between their lab sessions; signals will begin the day after their T2 session and they will be notified up to a maximum of five times per day to complete their daily session. The ATT sessions are comprised of three phases. The first is a 5-minute phase during which the participant is instructed to attend to specific sounds in the recording and disregard other sounds. The subsequent 5-minute phase includes instructions to rapidly switch their attention between sounds in the recording. The final phase is a dual attention task lasting 2 minutes wherein the participant is instructed to pay attention to multiple sounds in the recording at once. In total, each session of ATT lasts 12 minutes.

Attention Training Technique (ATT)

Sham intervention control condition BEHAVIORAL

The sham control condition consists of the same 12 minutes of simultaneous sounds as the ATT technique, but will not include any verbal instruction, thus isolating the effects of intentional orientation of attention.

Sham intervention control condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled student at Northern Illinois University
• Age at least 18 years old
• fluent in English
• Elevated symptoms of a fear-based disorder (i.e., PTSD, social anxiety, panic, specific phobia; Gorka et al., 2017)
• Increased reaction times on flanker task
• Possession of an Android or IOS smartphone

You may not qualify if:

• auditory or visual impairment
• active psychotic symptoms
• self-reported diagnosis of ADHD including a prescription for stimulant medication for the treatment of ADHD

Sponsors & Collaborators

• Northern Illinois University: lead

Study Sites (1)

Northern Illinois University

DeKalb, Illinois, 60115, United States

Location

Related Publications (10)

• Barrett J, Armony JL. Influence of trait anxiety on brain activity during the acquisition and extinction of aversive conditioning. Psychol Med. 2009 Feb;39(2):255-65. doi: 10.1017/S0033291708003516. Epub 2008 May 9.

  PMID: 18466667 BACKGROUND

• Bar-Haim Y. Research review: Attention bias modification (ABM): a novel treatment for anxiety disorders. J Child Psychol Psychiatry. 2010 Aug;51(8):859-70. doi: 10.1111/j.1469-7610.2010.02251.x. Epub 2010 May 6.

  PMID: 20456540 BACKGROUND

• Block SR, Liberzon I. Attentional processes in posttraumatic stress disorder and the associated changes in neural functioning. Exp Neurol. 2016 Oct;284(Pt B):153-167. doi: 10.1016/j.expneurol.2016.05.009. Epub 2016 May 10.

  PMID: 27178007 BACKGROUND

• Davis M. Neural systems involved in fear and anxiety measured with fear-potentiated startle. Am Psychol. 2006 Nov;61(8):741-756. doi: 10.1037/0003-066X.61.8.741.

  PMID: 17115806 BACKGROUND

• Eysenck MW, Derakshan N, Santos R, Calvo MG. Anxiety and cognitive performance: attentional control theory. Emotion. 2007 May;7(2):336-53. doi: 10.1037/1528-3542.7.2.336.

  PMID: 17516812 BACKGROUND

• Lazarov A, Suarez-Jimenez B, Abend R, Naim R, Shvil E, Helpman L, Zhu X, Papini S, Duroski A, Rom R, Schneier FR, Pine DS, Bar-Haim Y, Neria Y. Bias-contingent attention bias modification and attention control training in treatment of PTSD: a randomized control trial. Psychol Med. 2019 Oct;49(14):2432-2440. doi: 10.1017/S0033291718003367. Epub 2018 Nov 12.

  PMID: 30415648 BACKGROUND

• Pacheco-Unguetti AP, Acosta A, Marques E, Lupianez J. Alterations of the attentional networks in patients with anxiety disorders. J Anxiety Disord. 2011 Oct;25(7):888-95. doi: 10.1016/j.janxdis.2011.04.010.

  PMID: 21641180 BACKGROUND

• Sehlmeyer C, Dannlowski U, Schoning S, Kugel H, Pyka M, Pfleiderer B, Zwitserlood P, Schiffbauer H, Heindel W, Arolt V, Konrad C. Neural correlates of trait anxiety in fear extinction. Psychol Med. 2011 Apr;41(4):789-98. doi: 10.1017/S0033291710001248. Epub 2010 Jun 16.

  PMID: 20550755 BACKGROUND

• Taylor CT, Cross K, Amir N. Attentional control moderates the relationship between social anxiety symptoms and attentional disengagement from threatening information. J Behav Ther Exp Psychiatry. 2016 Mar;50:68-76. doi: 10.1016/j.jbtep.2015.05.008. Epub 2015 May 23.

  PMID: 26072705 BACKGROUND

• Bush G, Shin LM, Holmes J, Rosen BR, Vogt BA. The Multi-Source Interference Task: validation study with fMRI in individual subjects. Mol Psychiatry. 2003 Jan;8(1):60-70. doi: 10.1038/sj.mp.4001217.

  PMID: 12556909 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: September 6, 2019
• Study Start: November 5, 2021
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)