PTSDNCT01723215
Prevention of Combat-related PTSD Using Attention Bias Modification (ABM): A Randomized Controlled Trial
A study testing Active ABMT8 and Active ABMT4 in people with PTSD, run by Tel Aviv University at 1 site in Israel.
Trial summary
Military deployment to combat zones involves exposure to trauma at a higher than average rate and therefore presents a unique opportunity to study predisposing factors to posttraumatic stress reactions and test strategies designed to prevent and ameliorate posttraumatic symptoms. Read more about this study
- Who is it for?
- Ages 18 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- Active ABMT8 and Active ABMT4
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 862 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2012to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 28 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- combat soldiers
Who cannot join
- Fluent Hebrew
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Posttraumatic Symptoms in IDF Soldiers Using Attention Bias Modification (ABM): A Randomized Controlled Trial
Military deployment to combat zones involves exposure to trauma at a higher than average rate and therefore presents a unique opportunity to study predisposing factors to posttraumatic stress reactions and test strategies designed to prevent and ameliorate posttraumatic symptoms. Decades of scientific research on the origins of resilience and vulnerability to combat-related posttraumatic stress symptoms revealed various predisposing and protective factors. All these factors however, offer limited opportunity for systematic pre-deployment prevention efforts. Considering the magnitude of psychological adjustment difficulties encountered by combat personnel in deployment and the limited access to existing evidence-based therapies for PTSD, the development and testing of a novel evidence-based and theory-driven prevention protocol for these problems is of considerable significance. The current study translates cognitive-neuroscience knowledge and attention bias modification research into a novel computerized training tool that could be easily delivered to soldiers during different stages of the deployment cycle. If proved efficacious in reducing risk for posttraumatic symptoms ABMT could be integrated into the Army's resilience training program. Thus, we propose a longitudinal double-blind randomized controlled study of ABMT in soldiers. We will assess attention bias and symptoms before deployment, will randomly assign soldiers to either 8 ABMT sessions, 4 ABMT sessions, 8 Placebo training sessions, or no training. Following 6 months of deployment to combat zone symptoms will be assessed again.
- Conditions
- PTSD
- Being tested
- Active ABMT8, Active ABMT4, Placebo
- Keywords
- Attention bias modification, resilience, combat, PTSD, Depression, Anxiety
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ABMT8Behavioural
Active ABMT8 8 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance
Active ABMT4Behavioural
Active ABMT4 4 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance
PlaceboBehavioural
Placebo: will receive 4 training sessions(10 min. each, over 7-8 weeks) using the same task and stimuli as in the active arms, but not designed to change attention patterns
| Study group | Role | What they receive |
|---|---|---|
| Active ABMT8 | Active comparator | Active ABMT8 8 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance Receives: Behavioral: Active ABMT8 |
| Active ABMT4 | Active comparator | Active ABMT4 4 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance Receives: Behavioral: Active ABMT4 |
| Control | No intervention | Control: will not receive any intervention |
| Placebo | Placebo comparator | Placebo: will receive 4 training sessions(10 min. each, over 7-8 weeks) using the same task and stimuli as in the active arms, but not designed to change attention patterns Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in PTSD symptoms(PCL)
- pre-treatment 2.after first deployment 3.10 days after combat 4. 4 months after combat
Measured: Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat
Probable PTSD diagnosis(CAPS)
Four months after combat
Measured: Four months after combat
Secondary outcomes (1)
Changes in Depression(PHQ-9)) and Anxiety(STAI)
- Pre-treatment(baseline) 2.after first deployment 3.10 days after combat 4. 4 months after combat
Measured: Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 862 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Corps, Israel Defense Force, Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Principal investigator, Yair Bar-Haim, Tel Aviv University
- Investigators
- Yair Bar-Haim, PhD, Principal investigator, Tel Aviv UniversityEyal Fruchter, Principal investigator, Mental Health Department IDF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723215
- Sponsor's protocol ID
- TelAvivU
- Status last verified
- Mar 2015
- First submitted
- 5 Nov 2012
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bar-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 20395400Wald I, Fruchter E, Ginat K, Stolin E, Dagan D, Bliese PD, Quartana PJ, Sipos ML, Pine DS, Bar-Haim Y. Selective prevention of combat-related post-traumatic stress disorder using attention bias modification training: a randomized controlled trial. Psychol Med. 2016 Sep;46(12):2627-36. doi: 10.1017/S0033291716000945. Epub 2016 Jul 5.
PubMed 27377418
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Posttraumatic Symptoms in IDF Soldiers Using Attention Bias Modification (ABM): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01723215
- Acronym / sponsor ID
- TelAvivU
- Conditions
- PTSD
- Keywords
- Attention bias modification, resilience, combat, PTSD, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 862 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Medical Corps, Israel Defense Force, Walter Reed Army Institute of Research (WRAIR)
- Study start
- Dec 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 7 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Military deployment to combat zones involves exposure to trauma at a higher than average rate and therefore presents a unique opportunity to study predisposing factors to posttraumatic stress reactions and test strategies designed to prevent and ameliorate posttraumatic symptoms. Decades of scientific research on the origins of resilience and vulnerability to combat-related posttraumatic stress symptoms revealed various predisposing and protective factors. All these factors however, offer limited opportunity for systematic pre-deployment prevention efforts. Considering the magnitude of psychological adjustment difficulties encountered by combat personnel in deployment and the limited access to existing evidence-based therapies for PTSD, the development and testing of a novel evidence-based and theory-driven prevention protocol for these problems is of considerable significance. The current study translates cognitive-neuroscience knowledge and attention bias modification research into a novel computerized training tool that could be easily delivered to soldiers during different stages of the deployment cycle. If proved efficacious in reducing risk for posttraumatic symptoms ABMT could be integrated into the Army's resilience training program. Thus, we propose a longitudinal double-blind randomized controlled study of ABMT in soldiers. We will assess attention bias and symptoms before deployment, will randomly assign soldiers to either 8 ABMT sessions, 4 ABMT sessions, 8 Placebo training sessions, or no training. Following 6 months of deployment to combat zone symptoms will be assessed again.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active ABMT8 | Active comparator | Behavioral: Active ABMT8Active ABMT8 8 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance |
| Active ABMT4 | Active comparator | Behavioral: Active ABMT4Active ABMT4 4 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance |
| Control | No intervention | –Control: will not receive any intervention |
| Placebo | Placebo comparator | Behavioral: PlaceboPlacebo: will receive 4 training sessions(10 min. each, over 7-8 weeks) using the same task and stimuli as in the active arms, but not designed to change attention patterns |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- combat soldiers
Key exclusion criteria (1 listed)
- Fluent Hebrew
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 |
|---|---|---|
| Active ABMT8Active ABMT8 8 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance | Behavioural | Active ABMT8 |
| Active ABMT4Active ABMT4 4 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance | Behavioural | Active ABMT4 |
| PlaceboPlacebo: will receive 4 training sessions(10 min. each, over 7-8 weeks) using the same task and stimuli as in the active arms, but not designed to change attention patterns | Behavioural | Placebo |
Primary outcome
Changes in PTSD symptoms(PCL)
Time frame: Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat
1. pre-treatment 2.after first deployment 3.10 days after combat 4. 4 months after combat
Probable PTSD diagnosis(CAPS)
Time frame: Four months after combat
Four months after combat
1 secondary outcome
Changes in Depression(PHQ-9)) and Anxiety(STAI)
Time frame: Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- 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.
- Derived from this study: PubMed 27377418Wald I, Fruchter E, Ginat K, Stolin E, Dagan D, Bliese PD, Quartana PJ, Sipos ML, Pine DS, Bar-Haim Y. Selective prevention of combat-related post-traumatic stress disorder using attention bias modification training: a randomized controlled trial. Psychol Med. 2016 Sep;46(12):2627-36. doi: 10.1017/S0033291716000945. Epub 2016 Jul 5.
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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.
Yair Bar-Haim, PhD principal investigator
Tel Aviv University
Eyal Fruchter principal investigator
Mental Health Department IDF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active ABMT8 and Active ABMT4 in people with PTSD, run by Tel Aviv University at 1 site in Israel.
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 19 Mar 2015. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in PTSD symptoms(PCL) (time frame: Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat). The study lists 2 primary outcomes in all. 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 NCT01723215, which also lists 3 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 19 Mar 2015.