Posttraumatic Stress DisorderNCT02615717
Using Attentional Bias Modification to Address Trauma Symptoms
A study testing Attention Bias Modification in people with Posttraumatic Stress Disorder, run by University of Nebraska Lincoln at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Attention Bias Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female, 19+, have experienced at least one adult sexual trauma, and must currently be experiencing PTSD symptoms as a result of the sexual assault
Who cannot join
- male
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska-Lincoln
Lincoln, Nebraska, 68588
About this study
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Attention Bias Modification
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Bias ModificationBehavioural
comparison of treatment versus control
| Study group | Role | What they receive |
|---|---|---|
| Attentional Bias Modification | Experimental | In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word). Receives: Behavioral: Attention Bias Modification |
| Attentional Control Condition | Active comparator | Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc. Receives: Behavioral: Attention Bias Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale (CAPS-5)
Assesses symptoms and severity of Posttraumatic Stress Disorder Range: 0-80; total score utilized. Higher values indicate higher severity Subscales are summed to create a total score; subscales made up of different facets of PTSD.
Measured: within three days
Secondary outcomes (3)
PTSD Checklist (PCL-5)
Self-report of PTSD symptom severity Scale range: 0-80 Total score utilized, all items summed. Higher score indicates higher severity.
Measured: within three days
Patient Health Questionnaire (PHQ-9)
Self-report measure of 9 symptoms related to depression Range: 0-27, all items summed Higher score indicates higher severity
Measured: within three days
Beck Anxiety Inventory (BAI)
Self-report measure of 20 symptoms of anxiety Range: 0-60 all items summed Higher score indicates higher severity
Measured: within three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska Lincoln
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Hein, University of Nebraska Lincoln
- Investigators
- Christina L Hein, B.A., Principal investigator, University of Nebraska Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615717
- Sponsor's protocol ID
- UNebraskaLincoln
- Status last verified
- Dec 2016
- First submitted
- 23 Nov 2015
- Last updated
- 3 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Aupperle RL, Melrose AJ, Stein MB, Paulus MP. Executive function and PTSD: disengaging from trauma. Neuropharmacology. 2012 Feb;62(2):686-94. doi: 10.1016/j.neuropharm.2011.02.008. Epub 2011 Feb 22.
PubMed 21349277Bar-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.
PubMed 20456540Bar-Haim Y, Holoshitz Y, Eldar S, Frenkel TI, Muller D, Charney DS, Pine DS, Fox NA, Wald I. Life-threatening danger and suppression of attention bias to threat. Am J Psychiatry. 2010 Jun;167(6):694-8. doi: 10.1176/appi.ajp.2009.09070956. Epub 2010 Apr 15.
PubMed 20395400Carlbring P, Apelstrand M, Sehlin H, Amir N, Rousseau A, Hofmann SG, Andersson G. Internet-delivered attention bias modification training in individuals with social anxiety disorder--a double blind randomized controlled trial. BMC Psychiatry. 2012 Jun 25;12:66. doi: 10.1186/1471-244X-12-66.
PubMed 22731889Echiverri AM, Jaeger JJ, Chen JA, Moore SA, Zoellner LA. "Dwelling in the Past": The Role of Rumination in the Treatment of Posttraumatic Stress Disorder. Cogn Behav Pract. 2011 Aug;18(3):338-349. doi: 10.1016/j.cbpra.2010.05.008.
PubMed 22190846Eldar S, Apter A, Lotan D, Edgar KP, Naim R, Fox NA, Pine DS, Bar-Haim Y. Attention bias modification treatment for pediatric anxiety disorders: a randomized controlled trial. Am J Psychiatry. 2012 Feb;169(2):213-20. doi: 10.1176/appi.ajp.2011.11060886.
PubMed 22423353Hakamata Y, Lissek S, Bar-Haim Y, Britton JC, Fox NA, Leibenluft E, Ernst M, Pine DS. Attention bias modification treatment: a meta-analysis toward the establishment of novel treatment for anxiety. Biol Psychiatry. 2010 Dec 1;68(11):982-90. doi: 10.1016/j.biopsych.2010.07.021.
PubMed 20887977Iacoviello, B. M., Amir, N., Bar-Haim, Y., Beard, C., Montana, R., Kuckertz, J. W., … & De Raedt, R. (2014). Maximizing the effects of attention bias modification for anxiety: How and for whom. Symposium presented that the 48th annual congress presented at Associaion for Behavioral and Cognitive Therapies, 21 November 2014.
Kuckertz JM, Amir N, Boffa JW, Warren CK, Rindt SE, Norman S, Ram V, Ziajko L, Webb-Murphy J, McLay R. The effectiveness of an attention bias modification program as an adjunctive treatment for Post-Traumatic Stress Disorder. Behav Res Ther. 2014 Dec;63:25-35. doi: 10.1016/j.brat.2014.09.002. Epub 2014 Sep 16.
PubMed 25277496Moser JS, Cahill SP, Foa EB. Evidence for poorer outcome in patients with severe negative trauma-related cognitions receiving prolonged exposure plus cognitive restructuring: implications for treatment matching in posttraumatic stress disorder. J Nerv Ment Dis. 2010 Jan;198(1):72-5. doi: 10.1097/NMD.0b013e3181c81fac.
PubMed 20061873Najmi S, Amir N. The effect of attention training on a behavioral test of contamination fears in individuals with subclinical obsessive-compulsive symptoms. J Abnorm Psychol. 2010 Feb;119(1):136-42. doi: 10.1037/a0017549.
PubMed 20141250Schoorl M, Putman P, Van Der Does W. Attentional bias modification in posttraumatic stress disorder: a randomized controlled trial. Psychother Psychosom. 2013;82(2):99-105. doi: 10.1159/000341920. Epub 2012 Dec 22.
PubMed 23295710Sharpe L, Ianiello M, Dear BF, Perry KN, Refshauge K, Nicholas MK. Is there a potential role for attention bias modification in pain patients? Results of 2 randomised, controlled trials. Pain. 2012 Mar;153(3):722-731. doi: 10.1016/j.pain.2011.12.014. Epub 2012 Jan 26.
PubMed 22281100Weathers, F. W., Blake, D. D., Schnurr, P. P., Marx, B. P., & Keane, T. M. (2013). The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Interview available from the National Center for PTSD at www.ptsd.va.gov.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Attentional Bias Modification to Address Trauma Symptoms
- ClinicalTrials.gov ID
- NCT02615717
- Acronym / sponsor ID
- UNebraskaLincoln
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Nebraska LincolnUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Posted 3 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attentional Bias Modification | Experimental | Behavioral: Attention Bias ModificationIn the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word). |
| Attentional Control Condition | Active comparator | Behavioral: Attention Bias ModificationParticipants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female, 19+, have experienced at least one adult sexual trauma, and must currently be experiencing PTSD symptoms as a result of the sexual assault
Key exclusion criteria (1 listed)
- male
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attention Bias Modificationcomparison of treatment versus control | Behavioural | Attentional Bias Modification, Attentional Control Condition |
Primary outcome
Clinician-Administered PTSD Scale (CAPS-5)
Time frame: within three days
Assesses symptoms and severity of Posttraumatic Stress Disorder Range: 0-80; total score utilized. Higher values indicate higher severity Subscales are summed to create a total score; subscales made up of different facets of PTSD.
3 secondary outcomes
PTSD Checklist (PCL-5)
Time frame: within three days
Patient Health Questionnaire (PHQ-9)
Time frame: within three days
Beck Anxiety Inventory (BAI)
Time frame: within three days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21349277Aupperle RL, Melrose AJ, Stein MB, Paulus MP. Executive function and PTSD: disengaging from trauma. Neuropharmacology. 2012 Feb;62(2):686-94. doi: 10.1016/j.neuropharm.2011.02.008. Epub 2011 Feb 22.
- Background: PubMed 20456540Bar-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.
- Background: PubMed 20395400Bar-Haim Y, Holoshitz Y, Eldar S, Frenkel TI, Muller D, Charney DS, Pine DS, Fox NA, Wald I. Life-threatening danger and suppression of attention bias to threat. Am J Psychiatry. 2010 Jun;167(6):694-8. doi: 10.1176/appi.ajp.2009.09070956. Epub 2010 Apr 15.
- Background: PubMed 22731889Carlbring P, Apelstrand M, Sehlin H, Amir N, Rousseau A, Hofmann SG, Andersson G. Internet-delivered attention bias modification training in individuals with social anxiety disorder--a double blind randomized controlled trial. BMC Psychiatry. 2012 Jun 25;12:66. doi: 10.1186/1471-244X-12-66.
- Background: PubMed 22190846Echiverri AM, Jaeger JJ, Chen JA, Moore SA, Zoellner LA. "Dwelling in the Past": The Role of Rumination in the Treatment of Posttraumatic Stress Disorder. Cogn Behav Pract. 2011 Aug;18(3):338-349. doi: 10.1016/j.cbpra.2010.05.008.
- Background: PubMed 22423353Eldar S, Apter A, Lotan D, Edgar KP, Naim R, Fox NA, Pine DS, Bar-Haim Y. Attention bias modification treatment for pediatric anxiety disorders: a randomized controlled trial. Am J Psychiatry. 2012 Feb;169(2):213-20. doi: 10.1176/appi.ajp.2011.11060886.
- Background: PubMed 20887977Hakamata Y, Lissek S, Bar-Haim Y, Britton JC, Fox NA, Leibenluft E, Ernst M, Pine DS. Attention bias modification treatment: a meta-analysis toward the establishment of novel treatment for anxiety. Biol Psychiatry. 2010 Dec 1;68(11):982-90. doi: 10.1016/j.biopsych.2010.07.021.
- BackgroundIacoviello, B. M., Amir, N., Bar-Haim, Y., Beard, C., Montana, R., Kuckertz, J. W., … & De Raedt, R. (2014). Maximizing the effects of attention bias modification for anxiety: How and for whom. Symposium presented that the 48th annual congress presented at Associaion for Behavioral and Cognitive Therapies, 21 November 2014.
- Background: PubMed 25277496Kuckertz JM, Amir N, Boffa JW, Warren CK, Rindt SE, Norman S, Ram V, Ziajko L, Webb-Murphy J, McLay R. The effectiveness of an attention bias modification program as an adjunctive treatment for Post-Traumatic Stress Disorder. Behav Res Ther. 2014 Dec;63:25-35. doi: 10.1016/j.brat.2014.09.002. Epub 2014 Sep 16.
- Background: PubMed 20061873Moser JS, Cahill SP, Foa EB. Evidence for poorer outcome in patients with severe negative trauma-related cognitions receiving prolonged exposure plus cognitive restructuring: implications for treatment matching in posttraumatic stress disorder. J Nerv Ment Dis. 2010 Jan;198(1):72-5. doi: 10.1097/NMD.0b013e3181c81fac.
- Background: PubMed 20141250Najmi S, Amir N. The effect of attention training on a behavioral test of contamination fears in individuals with subclinical obsessive-compulsive symptoms. J Abnorm Psychol. 2010 Feb;119(1):136-42. doi: 10.1037/a0017549.
- Background: PubMed 23295710Schoorl M, Putman P, Van Der Does W. Attentional bias modification in posttraumatic stress disorder: a randomized controlled trial. Psychother Psychosom. 2013;82(2):99-105. doi: 10.1159/000341920. Epub 2012 Dec 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina L Hein, B.A. principal investigator
University of Nebraska Lincoln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention Bias Modification in people with Posttraumatic Stress Disorder, run by University of Nebraska Lincoln at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale (CAPS-5) (time frame: within three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02615717, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017; AzTrials last refreshed its copy on 31 Oct 2026.