An interventional study of Attention Bias Modification (ABM) and Attention control training (ACT) in Posttraumatic Stress Disorder (PTSD), sponsored by Research Foundation for Mental Hygiene, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-04-13.
Sponsored by Research Foundation for Mental Hygiene, Inc. · Not applicable, Interventional, and Treatment
Emerging research implicates biased attention to threat in the pathophysiology of anxiety disorders. Recent findings demonstrate significant associations between attention bias and stress vulnerability. This work has motivated the development of a novel therapy, attention-bias-modification (ABM) treatment . ABM is designed to implicitly modify patients' biased threat attendance via computerized training protocols. Emerging evidence indicates that ABM is effective in modifying threat-related attention biases and in ameliorating anxiety symptoms. However, it is unclear whether ABM is efficacious for posttraumatic stress disorder (PTSD). The present pilot study is a double blind trial that seeks to examine feasibility, acceptability, safety, efficacy, and risk/benefit ratio of ABM in individuals with PTSD. In addition this pilot study seeks to identify specific genes associated with anxiety disorders and to examine whether these can predict the success of the ABM.
ABM is designed to implicitly modify patients' biased threat attendance via computerized training protocols. Emerging evidence indicates that ABM is effective in modifying threat-related attention biases and in ameliorating anxiety symptoms.
2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.
This study's enrollment of 50 is below the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Research Foundation for Mental Hygiene, Inc. is the lead sponsor of 35 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Currently participating in formal psychotherapy. This includes:
Placebo-training program: attention control training (ACT), is identical to the ABM protocol except that during the presentation of the trials where a threat word is presented, the probe will appear with equal frequency in the position of the threat and neutral word. Thus, neither threat nor neutral words provide information regarding the position of the target probe, and there is no contingency between the position of either threat or neutral words, and the position of the probes
Behavioral: Attention control training (ACT)
Attention-bias-modification treatment (ABM) is designed to implicitly modify patients' biased threat attendance via computerized training protocols. During each session, 240 trials (80 neutral-neutral pairs, 160 threat-neutral pairs) will be presented. On trials where participants see one neutral word and one threat word, the probe will always follow the neutral word location. Thus, although there is no specific instruction to direct attention away from threat words, on 66% of all trials (and 100% of the threat-neutral trials) the position of the neutral word will indicate the position of the target probe.
Behavioral: Attention Bias Modification (ABM)
The training protocol consisted of 160 trials per session with 120 angry-neutral and 40 neutral-neutral trials. Each participant was trained with an alternative set of faces to the one used in the assessment task (i.e. if measured with set A then trained with set B and vice-versa). In the ABM condition, training was contin- gent on the bias measured at pre-treatment. Specifically, for those showing a bias toward the threat, the target appeared at the neutral-face location in 100% of the threat-neutral trials, while for those showing a bias away from the threat, the target appeared at the threat-face location in 100% of the threat-neutral trials.
Also known as: ABMT
In the ACT condition, threat- face location, probe location, and probe type were fully counter- balanced with no contingency between face valence and probe location, thus resembling the assessment task.
Also known as: ABMT Placebo
Primary Outcome: Clinician Administered PTSD Scale (CAPS)
Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).
Time frame: 4 weeks
Secondary Outcome: PTSD Check List-Civilian (PCL-C)
Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).
Time frame: 4 weeks
| Milestone | Comparison-Training-Program | Attention Biased Modification |
|---|---|---|
| Started | 24 | 26 |
| Completed | 24 | 26 |
| Not completed | 0 | 0 |
Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).
| units on a scale | Comparison-Training-Program | Attention Biased Modification |
|---|---|---|
| Primary Outcome: Clinician Administered PTSD Scale (CAPS) | 26.44 ± 16.09 | 15.96 ± 15.75 |
Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).
| units on a scale | Comparison-Training-Program | Attention Biased Modification |
|---|---|---|
| Secondary Outcome: PTSD Check List-Civilian (PCL-C) | 20.22 ± 15.07 | 7.84 ± 10.24 |
Collected over Through study completion (average 1 month).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Comparison-Training-Program | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Attention Biased Modification | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Age, Categorical(Participants) | Comparison-Training-Program | Attention Biased Modification | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 26 | 50 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Comparison-Training-Program | Attention Biased Modification | Total |
|---|---|---|---|
| Mean | 37.21 ± 10.29 | 34.27 ± 10.15 | 35.68 ± 10.22 |
| Sex: Female, Male(Participants) | Comparison-Training-Program | Attention Biased Modification | Total |
|---|---|---|---|
| Female | 14 | 17 | 31 |
| Male | 10 | 9 | 19 |
| Race and Ethnicity Not Collected(Participants) | Comparison-Training-Program | Attention Biased Modification | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Comparison-Training-Program | Attention Biased Modification | Total |
|---|---|---|---|
| United States | 24 | 26 | 50 |
| Clinician-Administered PTSD Scale (CAPS)(units on a scale) | Comparison-Training-Program | Attention Biased Modification | Total |
|---|---|---|---|
| Mean | 65.00 ± 12.08 | 62.23 ± 10.39 | 63.56 ± 11.21 |
| Hamilton Rating Scale for Depression (HRSD)(units on a scale) | Comparison-Training-Program | Attention Biased Modification | Total |
|---|---|---|---|
| Mean | 13.00 ± 4.82 | 11.77 ± 5.18 | 12.36 ± 5.00 |
| PTSD Checklist Civilian Version (PCL-C)(units on a scale) | Comparison-Training-Program | Attention Biased Modification | Total |
|---|---|---|---|
| Mean | 62.12 ± 11.16 | 57.31 ± 9.66 | 59.62 ± 10.58 |
1 further baseline measures are reported on the registry.
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Stress Disorders, Post-Traumatic→
Research Foundation for Mental Hygiene, Inc.