Posttraumatic Stress Disorder (PTSD)NCT01888653
Attention-Bias Modification Treatment for PTSD
A study testing Attention Bias Modification (ABM) in people with Posttraumatic Stress Disorder (PTSD), run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Attention Bias Modification (ABM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 2 Apr 2018
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric INstitute
New York, New York, 10032
About this study
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- Attention Bias Modification (ABM), Attention control training (ACT)
- Keywords
- PTSD, Attention Bias to threat, Attention Bias Modification Treatment
- 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 Modification (ABM)Behavioural
Also called ABMT
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.
Attention control training (ACT)Behavioural
Also called ABMT Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| Comparison-Training-Program | Placebo comparator | 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 Receives: Behavioral: Attention control training (ACT) |
| Attention Biased Modification | Active comparator | 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. Receives: Behavioral: Attention Bias Modification (ABM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome: Clinician Administered PTSD Scale (CAPS)
Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).
Measured: 4 weeks
Secondary outcomes (1)
Secondary Outcome: PTSD Check List-Civilian (PCL-C)
Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startMay 2013
- Primary completion2 Apr 2018
- Study completion2 Apr 2018
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.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuval Y Neria, Research Foundation for Mental Hygiene, Inc.
- Investigators
- Yuval Neria, PhD, Principal investigator, Columbia University and the New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888653
- Sponsor's protocol ID
- IRB# 6688
- Status last verified
- Feb 2022
- First submitted
- 25 Jun 2013
- Last updated
- 13 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention-Bias Modification Treatment for PTSD
- ClinicalTrials.gov ID
- NCT01888653
- Acronym / sponsor ID
- IRB# 6688
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- PTSD, Attention Bias to threat, Attention Bias Modification Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Study start
- May 2013
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 2 Apr 2018 (actual)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Posted 13 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison-Training-Program | Placebo comparator | Behavioral: Attention control training (ACT)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 Biased Modification | Active comparator | Behavioral: Attention Bias Modification (ABM)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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);
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 Modification (ABM)Also: ABMTThe 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. | Behavioural | Attention Biased Modification |
| Attention control training (ACT)Also: ABMT PlaceboIn 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. | Behavioural | Comparison-Training-Program |
Primary outcome
Primary Outcome: Clinician Administered PTSD Scale (CAPS)
Time frame: 4 weeks
Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).
1 secondary outcome
Secondary Outcome: PTSD Check List-Civilian (PCL-C)
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- PTSD Program, New York State Psychiatric InstituteLink provided by the sponsor.
- 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.
Yuval Neria, PhD principal investigator
Columbia University and the New York State Psychiatric Institute
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 (ABM) in people with Posttraumatic Stress Disorder (PTSD), run by Research Foundation for Mental Hygiene, Inc. 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 4 inclusion and 12 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 13 Apr 2022. 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. Some participants in this study may receive a placebo. 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 13 Apr 2022). 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?
Primary Outcome: Clinician Administered PTSD Scale (CAPS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2022.