Posttraumatic Stress DisorderNCT01564667
Attention Bias Modification Treatment for Warzone-Related Posttraumatic Stress Disorder (PTSD)
A study testing Attention Bias Modification Training Protocol in people with Posttraumatic Stress Disorder, run by Creighton University at 1 site in United States.
Trial summary
Veterans with Posttraumatic Stress Disorder (PTSD) will be randomly assigned to either Attention Bias Modification Treatment (ABMT) designed to reduce bias toward threat or a placebo control condition not designed to change attention patterns. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Attention Bias Modification Training Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2014
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veterans with Posttraumatic Stress Disorder (PTSD) serving in United States Military after March 20, 2003.
Who cannot join
- Schizophrenia
- Bipolar Disorder
- Obsessive Compulsive Disorder
- Head Injury with Loss of Consciousness for more than 30 minutes
- Active Alcohol/Substance Dependence in past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attention Bias Modification Treatment for Warzone-Related PTSD: A Randomized Clinical Trial Magnetoencephalography Study
Veterans with Posttraumatic Stress Disorder (PTSD) will be randomly assigned to either Attention Bias Modification Treatment (ABMT) designed to reduce bias toward threat or a placebo control condition not designed to change attention patterns. Outcome measures will be PTSD, anxiety, depression, and alexithymia symptoms as measured by standard psychological interviews and questionnaires. Participants will also be invited to participate in physiological testing before and after receiving AMBT or placebo to serve as additional outcome measures and assess brain functioning, heart rate, and muscle tension.
The investigators expect to see significant PTSD symptom reduction in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group in which no symptomatic relief is expected. At the end of the study, if ABMT is shown to be effective, we will offer active ABMT to those participants randomly assigned to the placebo arm if they would like to receive the treatment.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Attention Bias Modification Training Protocol
- Keywords
- PTSD, Posttraumatic Stress, Post Traumatic Stress, Attention Bias, Threat Bias, Combat, Warzone
- 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 Training ProtocolBehavioural
Attention Bias Modification computerized training sessions administered 2 times per week for 4 weeks making a total of 8 training sessions.
| Study group | Role | What they receive |
|---|---|---|
| Attention Bias Modification Treatment | Experimental | Attention bias modification training using a computerized spatial attention task (dot-probe) designed to alter threat-bias attention patterns away from threat. Receives: Behavioral: Attention Bias Modification Training Protocol |
| Attentional Control Training | Active comparator | Attention control training using a computerized spatial attention taks (dot-probe) counter balances training toward and away from threat. Receives: Behavioral: Attention Bias Modification Training Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Will Posttraumatic Stress Disorder and Symptom decrease with intervention
Using Clinician-Administered PTSD Scale (CAPS): The clinician-Administered PTSD Scale (CAPS) is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD (Blake, Weathers, Nagy, Kaloupek, Charney, \& Keane, 1995) to assess symptoms of PTSD outcome.
Measured: 8 weeks
Secondary outcomes (1)
Other psychiatics symptoms (ie Depression, Anger, Anxiety)
To assess potential decrease in psychiatric symptoms associated with PTSD, by comparing pre intervention and post intervention scores on psychological measures of deprssion, anger and anxiety.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- At Ease USA
- Responsible party
- Sponsor
- Investigators
- Amy S Badura Brack, PhD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564667
- Sponsor's protocol ID
- 11-16311
- Status last verified
- Jan 2016
- First submitted
- 26 Mar 2012
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hakamata 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 20887977Badura-Brack AS, Naim R, Ryan TJ, Levy O, Abend R, Khanna MM, McDermott TJ, Pine DS, Bar-Haim Y. Effect of Attention Training on Attention Bias Variability and PTSD Symptoms: Randomized Controlled Trials in Israeli and U.S. Combat Veterans. Am J Psychiatry. 2015 Dec;172(12):1233-41. doi: 10.1176/appi.ajp.2015.14121578. Epub 2015 Jul 24.
PubMed 26206075
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Bias Modification Treatment for Warzone-Related PTSD: A Randomized Clinical Trial Magnetoencephalography Study
- ClinicalTrials.gov ID
- NCT01564667
- Acronym / sponsor ID
- 11-16311
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, Posttraumatic Stress, Post Traumatic Stress, Attention Bias, Threat Bias, Combat, Warzone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- At Ease USA
- Study start
- Apr 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Mar 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.
Veterans with Posttraumatic Stress Disorder (PTSD) will be randomly assigned to either Attention Bias Modification Treatment (ABMT) designed to reduce bias toward threat or a placebo control condition not designed to change attention patterns. Outcome measures will be PTSD, anxiety, depression, and alexithymia symptoms as measured by standard psychological interviews and questionnaires. Participants will also be invited to participate in physiological testing before and after receiving AMBT or placebo to serve as additional outcome measures and assess brain functioning, heart rate, and muscle tension.
The investigators expect to see significant PTSD symptom reduction in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group in which no symptomatic relief is expected. At the end of the study, if ABMT is shown to be effective, we will offer active ABMT to those participants randomly assigned to the placebo arm if they would like to receive the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Bias Modification Treatment | Experimental | Behavioral: Attention Bias Modification Training ProtocolAttention bias modification training using a computerized spatial attention task (dot-probe) designed to alter threat-bias attention patterns away from threat. |
| Attentional Control Training | Active comparator | Behavioral: Attention Bias Modification Training ProtocolAttention control training using a computerized spatial attention taks (dot-probe) counter balances training toward and away from threat. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Veterans with Posttraumatic Stress Disorder (PTSD) serving in United States Military after March 20, 2003.
Key exclusion criteria (5 listed)
- Schizophrenia
- Bipolar Disorder
- Obsessive Compulsive Disorder
- Head Injury with Loss of Consciousness for more than 30 minutes
- Active Alcohol/Substance Dependence in past 6 months
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 Training ProtocolAttention Bias Modification computerized training sessions administered 2 times per week for 4 weeks making a total of 8 training sessions. | Behavioural | Attention Bias Modification Treatment, Attentional Control Training |
Primary outcome
Will Posttraumatic Stress Disorder and Symptom decrease with intervention
Time frame: 8 weeks
Using Clinician-Administered PTSD Scale (CAPS): The clinician-Administered PTSD Scale (CAPS) is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD (Blake, Weathers, Nagy, Kaloupek, Charney, \& Keane, 1995) to assess symptoms of PTSD outcome.
1 secondary outcome
Other psychiatics symptoms (ie Depression, Anger, Anxiety)
Time frame: 8 weeks
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 14 Jan 2016.
- 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.
- Derived from this study: PubMed 26206075Badura-Brack AS, Naim R, Ryan TJ, Levy O, Abend R, Khanna MM, McDermott TJ, Pine DS, Bar-Haim Y. Effect of Attention Training on Attention Bias Variability and PTSD Symptoms: Randomized Controlled Trials in Israeli and U.S. Combat Veterans. Am J Psychiatry. 2015 Dec;172(12):1233-41. doi: 10.1176/appi.ajp.2015.14121578. Epub 2015 Jul 24.
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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.
Amy S Badura Brack, PhD principal investigator
Creighton University
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 Training Protocol in people with Posttraumatic Stress Disorder, run by Creighton University 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 5 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 14 Jan 2016. 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?
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?
Will Posttraumatic Stress Disorder and Symptom decrease with intervention (time frame: 8 weeks). 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 NCT01564667, which also lists 2 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 14 Jan 2016.