Posttraumatic Stress Disorder (PTSD)
Conditions
Keywords
PTSD, Attention Bias to threat, Attention Bias Modification Treatment
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAttention 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.
BEHAVIORALAttention control training (ACT)
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.
Sponsors
Research Foundation for Mental Hygiene, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Males or females between the ages of 18 and 60; * Current DSM-IV PTSD for the last 12 months or more; * Fluent in English and willing and able to give informed written consent and participate responsibly in the protocol; * Attention bias toward or away from threat assessed by Dot-probe attention bias task
Exclusion criteria
* Current DSM-IV Axis I disorder other than PTSD. * Patients with comorbid (i.e., secondary diagnosis of) major depressive disorder (MDD) will be allowed for enrollment if their HAM-D score doesn't exceed 25; * Prior or current diagnosis of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial, schizotypal, and schizoid personality disorders; * Suicidal ideation or behavior that poses a significant danger to the subject. Unstable clinical condition such that participation in a controlled trial would pose a significant danger; * Prior participation in attention bias modification treatment (ABMT); * Current or past history of seizure disorder (except febrile seizure in childhood); * Currently on psychotropic medication. (excluding the use of hypnotics); * Currently participating in formal psychotherapy. This includes: * psychodynamic, * cognitive behavioral and interpersonal therapies * Current unstable or untreated medical illness; * Vision loss.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome: Clinician Administered PTSD Scale (CAPS) | 4 weeks | Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome: PTSD Check List-Civilian (PCL-C) | 4 weeks | Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Comparison-Training-Program 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
Attention control training (ACT): 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. | 24 |
| Attention Biased Modification 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. 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.
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 contingent on the bias measure. | 26 |
| Total | 50 |
Baseline characteristics
| Characteristic | Comparison-Training-Program | Attention Biased Modification | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 26 Participants | 50 Participants |
| Age, Continuous | 37.21 years STANDARD_DEVIATION 10.29 | 34.27 years STANDARD_DEVIATION 10.15 | 35.68 years STANDARD_DEVIATION 10.22 |
| Beck Depression Inventory-II (BDI-II) | 25.87 units on a scale STANDARD_DEVIATION 11.34 | 24.58 units on a scale STANDARD_DEVIATION 12.36 | 25.20 units on a scale STANDARD_DEVIATION 11.78 |
| Clinician-Administered PTSD Scale (CAPS) | 65.00 units on a scale STANDARD_DEVIATION 12.08 | 62.23 units on a scale STANDARD_DEVIATION 10.39 | 63.56 units on a scale STANDARD_DEVIATION 11.21 |
| Hamilton Rating Scale for Depression (HRSD) | 13.00 units on a scale STANDARD_DEVIATION 4.82 | 11.77 units on a scale STANDARD_DEVIATION 5.18 | 12.36 units on a scale STANDARD_DEVIATION 5 |
| PTSD Checklist Civilian Version (PCL-C) | 62.12 units on a scale STANDARD_DEVIATION 11.16 | 57.31 units on a scale STANDARD_DEVIATION 9.66 | 59.62 units on a scale STANDARD_DEVIATION 10.58 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 24 participants | 26 participants | 50 participants |
| Sex: Female, Male Female | 14 Participants | 17 Participants | 31 Participants |
| Sex: Female, Male Male | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 26 |
| other Total, other adverse events | 0 / 24 | 0 / 26 |
| serious Total, serious adverse events | 0 / 24 | 0 / 26 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comparison-Training-Program | Primary Outcome: Clinician Administered PTSD Scale (CAPS) | 26.44 units on a scale | Standard Deviation 16.09 |
| Attention Biased Modification | Primary Outcome: Clinician Administered PTSD Scale (CAPS) | 15.96 units on a scale | Standard Deviation 15.75 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comparison-Training-Program | Secondary Outcome: PTSD Check List-Civilian (PCL-C) | 20.22 units on a scale | Standard Deviation 15.07 |
| Attention Biased Modification | Secondary Outcome: PTSD Check List-Civilian (PCL-C) | 7.84 units on a scale | Standard Deviation 10.24 |