Clinical trial NCT02615717: Using Attentional Bias Modification to Address Trauma Symptoms
Official title: Using Attentional Bias Modification to Address Trauma Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Lead sponsor: University of Nebraska Lincoln
Sponsor class: OTHER
First posted: 2015-11-26
Enrollment: 6
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Threat-related attentional biases have been identified as a possible precursor to the onset and maintenance of posttraumatic stress disorder (PTSD). As a result, protocols such as Attention Bias Modification (ABM) have been developed and utilized to treat these attentional biases in adults diagnosed with PTSD. However, to-date, ABM protocols have not been examined for use specifically among victims of sexual assaults. Participants are 20 undergraduate women enrolled in a Midwest university. The efficacy of ABM in this population will be assessed, as will the relationship between ABM and PTSD symptom clusters and outcome variables such as anxiety and depression scores.

Detailed description: A relatively new intervention designed to reduce attention toward (or minimize disengagement from) threat-related information is attention bias modification (ABM). ABM is a novel treatment that may address several limitations posed by the use of CPT and PE. ABM is typically administered via computer, involving brief 20-minute sessions in which participants are trained to disengage from the threat cues to which they are naturally attuned. ABM addresses attentional biases in a similar, though more direct, manner as does CBT through the use of uninterrupted, repetitive exposure to feared threat cues or words in order to allow the patient to interpret that feared objects and situations are safe. In particular, ABM's effectiveness arises through the intent to normalize both attentional biases towards and away from threats such that the intended outcome is the non-existence of any bias surrounding threat cues. ABM addresses the specific bias in attention through targeting implicit, sub-cortical processes that focus on perturbed neural circuitry function. It trains individuals to remove any attention to or avoidance of threat cues by training brains to focus equally on threat and non-threat cues. Therefore, ABM further extends work implicating threat-related attention bias in anxiety disorders.

ABM has successfully improved or alleviated symptoms of many disorders, including anxiety disorders, depression, obsessive-compulsive disorder, and chronic pain. In addition, ABM has been successfully implemented in many populations such as inpatient active duty U.S. military members, Israeli Defense Force soldiers, pediatrics, and outpatients with chronic PTSD. Despite these findings, ABM has never been applied to individuals with current, lifetime, or chronic PTSD resulting from sexual assaults. Furthermore, studies assessing the use of ABM have found consistent benefits from ABM control groups, although this effect has been smaller than those in the ABM treatment groups. Authors contend that the reason that ABM control groups may have experienced a decrease in symptoms may be that the use of training (regardless of treatment or control status) improves the relationship between emotional stimuli and the response required by participants in order to learn to exert attentional control.

If ABM proves to be effective in addressing attentional biases associated with PTSD and its associated symptom clusters, it is a unique treatment that has the potential to address many of the limitations or concerns faced by those who rely exclusively on CPT or PE; benefits of ABM include that the treatment (1) is a relatively simple and brief intervention, (2) may be administered electronically and remotely at a patient's home or at locations beyond a typical clinical office, and (3) has the potential to be mass-administered. As ABM is a relatively new treatment with many implications for utilization, its full potential has not yet been explored; in particular, there are several ways with which ABM may interact with empirically supported treatments (ESTs) as CPT and PE.

Firstly, it is important to recognize that CPT and PE have both been criticized for their role in requiring participants to immediately "dwell in the past", frequently resulting in clients reporting distress. This is particularly true in individuals who may have potentially been coping with or managing their trauma reaction through the use of intense avoidance. Thus, as a prelude to integrating individuals into CPT or PE, ABM has the potential to be a useful transition prior to ESTs to increase tolerance and prepare individuals to transition and integrate into these more provocative types of treatments. Starting with a treatment such as ABM, which introduces individuals to non-specific trauma content, might serve to help people to be more amenable to other ESTs such as CPT or PE, ultimately increasing willingness to start and stay in therapy, decreasing attrition, and improving retention.

Secondly, ABM interventions have been shown in several populations to result in at least a mild reduction of symptoms. Even mild reductions of symptoms may open the door to allowing an individual to make larger improvements through more other evidence-based interventions. Studies show that individuals with more severe pretreatment trauma-related cognitions have slightly worse PE outcomes than do individuals beginning treatment with more moderate symptoms. In applying ABM prior to CPT or PE, it is likely that the mild reduction of symptoms beforehand may ultimately increase the effectiveness and efficiency of ESTs.

Current Study Despite recent focus on attention training in PTSD, researchers have not yet examined whether training procedures such as ABM are capable of modifying attentional biases in individuals whose most disturbing and impactful trauma is a sexual assault. Thus, in this current study, the investigators aimed to examine the effect of ABM in a sample of women who have previously experienced an adult sexual assault. The aims of this study are three-fold: first and foremost, as this is the first study of its kind to assess the efficacy of ABM treatment in a sample of sexual assault victims, the investigators will be examining the effect of ABM in reducing PTSD symptoms within this trauma type. Secondly, investigators are exploring what PTSD symptoms or symptom clusters predict treatment outcomes and attentional variability. Finally, investigators expect to quantify and document attention variability in this population, and will explore whether variability is predictive of treatment outcomes.

Regarding this study's aims, investigators hypothesize that (1) both the ABM treatment and control groups will experience decreased PTSD, depressive, and anxiety symptoms, but with a greater decrease from baseline in the treatment condition. Secondly, investigators hypothesize that (2) there will be a relationship between heightened symptom clusters as expressed by the individuals and their attentional biases, such that individuals high in avoidance symptoms (Criterion C on the Clinician-Administered PTSD Scale, CAPS-5) will demonstrate decreased response times to threat cues on measures of executive functioning with low variability, while those high in hyperarousal symptoms (Criterion E on the CAPS-5) will demonstrate increased response times and low variability. In contrast, investigators expect those high in both symptom clusters (hyperarousal and avoidance) will demonstrate high variability in reaction times, and those low in both symptom clusters will demonstrate low variability. Finally, investigators hypothesize that (3) increased attention variability will be associated with higher PTSD, depressive, and anxiety symptoms, but greater changes in attention variability across the study will be associated with greater improvements on PTSD, depressive, and anxiety symptoms. More specifically, investigators hypothesize that as a result of treatment, those participants who have the greatest decreases in variability over the course of treatment will be higher in hyperarousal and/or avoidance over those who are low in both symptom clusters.

Eligibility criteria: Inclusion Criteria:

* Female, 19+, have experienced at least one adult sexual trauma, and must currently be experiencing PTSD symptoms as a result of the sexual assault

Exclusion Criteria:

* male

Primary outcomes:
measure: Clinician-Administered PTSD Scale (CAPS-5)
timeFrame: within three days
Secondary outcomes:
measure: PTSD Checklist (PCL-5)
timeFrame: within three days
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: within three days
measure: Beck Anxiety Inventory (BAI)
timeFrame: within three days
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: University of Nebraska-Lincoln
state: Nebraska
Study officials:
affiliation: University of Nebraska Lincoln
name: Christina L Hein, B.A.
role: PRINCIPAL_INVESTIGATOR
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