Posttraumatic Stress DisorderABRNCT02041572
Attentional Bias Retraining in Veterans
A study testing Attentional bias retraining in people with Posttraumatic Stress Disorder, run by VA Pacific Islands Health Care System at 1 site in United States.
Trial summary
The study has two goals. First to develop a computer-based intervention meant to alter cognitive biases that contribute to ongoing PTSD symptoms. Second, we sought to pilot test the intervention in a small sample of veterans for feasibility and acceptability. Read more about this study
- Who is it for?
- Ages 18 to 89 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Attentional bias retraining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jun 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 89 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participated in ground combat operations in Vietnam
- Scored 40 - 80 on PTSD Checklist - Military version
- Availability and willingness to attend 2x weekly computer sessions for 6 weeks
Who cannot join
- Active substance dependence
- Significant cognitive impairment
- Current and active suicidal or homicidal ideation
Trial locations and contacts
1 site in 1 country.
About this study
The study has two goals. First to develop a computer-based intervention meant to alter cognitive biases that contribute to ongoing PTSD symptoms. Second, we sought to pilot test the intervention in a small sample of veterans for feasibility and acceptability.
Read the detailed description
Aim 1: Develop Attentional Bias Retraining protocol (Phase 1)
- 1.1 Computerized assessment \& retraining programs
- 1.2 Procedures and measures
Aim 2: Implement in pilot sample (Phase 2)
- 2.1: Assess feasibility and tolerability
- 2.2: Collect pilot data to plan future studies
- 2.3: Efficacy estimates based on changes in response time to dot probe task
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Attentional bias retraining
- 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.
Attentional bias retrainingBehavioural
Participants complete a computer-based intervention, which is designed to correct cognitive biases associated with PTSD by training to attend to neutral information rather than the trauma-related cue words.
| Study group | Role | What they receive |
|---|---|---|
| Attentional Bias Retraining | Other | Each participant receives 12 sessions. The first three sessions are baseline (assessment only) sessions. The last four sessions must be treatment sessions. The attentional bias intervention starts randomly on sessions 4 - 8, and continues until the end of the 12 sessions. Receives: Behavioral: Attentional bias retraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-traumatic Checklist - Military version (PCL-M)
PCL-M assess the 17-cardinal symptoms of PTSD.
Measured: Change from Baseline and Post-treatment (1 month after last training session)
Secondary outcomes (1)
Attentional bias scores
Attentional bias scores represent participants cognitive bias to orient towards trauma-relevant information more quickly than neutral information.
Measured: Change from Baseline and Post-treatment (1 month after last training session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startMay 2012
- Primary completionDec 2012
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Pacific Islands Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Margaret-Anne Mackintosh, PhD, Principal investigator, National Center for PTSD/PHREI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041572
- Sponsor's protocol ID
- 2012-05/MM/PROMISE 0001
- Acronym
- ABR
- Status last verified
- Jan 2014
- First submitted
- 15 Jan 2014
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attentional Bias Retraining in Veterans
- ClinicalTrials.gov ID
- NCT02041572
- Acronym / sponsor ID
- ABR / 2012-05/MM/PROMISE 0001
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- VA Pacific Islands Health Care SystemUS federal agency
- Study start
- May 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 22 Jan 2014 (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.
The study has two goals. First to develop a computer-based intervention meant to alter cognitive biases that contribute to ongoing PTSD symptoms. Second, we sought to pilot test the intervention in a small sample of veterans for feasibility and acceptability.
Detailed description
Aim 1: Develop Attentional Bias Retraining protocol (Phase 1)
- 1.1 Computerized assessment \& retraining programs
- 1.2 Procedures and measures
Aim 2: Implement in pilot sample (Phase 2)
- 2.1: Assess feasibility and tolerability
- 2.2: Collect pilot data to plan future studies
- 2.3: Efficacy estimates based on changes in response time to dot probe task
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Attentional Bias Retraining | Other | Behavioral: Attentional bias retrainingEach participant receives 12 sessions. The first three sessions are baseline (assessment only) sessions. The last four sessions must be treatment sessions. The attentional bias intervention starts randomly on sessions 4 - 8, and continues until the end of the 12 sessions. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participated in ground combat operations in Vietnam
- Scored 40 - 80 on PTSD Checklist - Military version
- Availability and willingness to attend 2x weekly computer sessions for 6 weeks
Key exclusion criteria (3 listed)
- Active substance dependence
- Significant cognitive impairment
- Current and active suicidal or homicidal ideation
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 |
|---|---|---|
| Attentional bias retrainingParticipants complete a computer-based intervention, which is designed to correct cognitive biases associated with PTSD by training to attend to neutral information rather than the trauma-related cue words. | Behavioural | Attentional Bias Retraining |
Primary outcome
Post-traumatic Checklist - Military version (PCL-M)
Time frame: Change from Baseline and Post-treatment (1 month after last training session)
PCL-M assess the 17-cardinal symptoms of PTSD.
1 secondary outcome
Attentional bias scores
Time frame: Change from Baseline and Post-treatment (1 month after last training session)
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 6 Nov 2017.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data
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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.
Margaret-Anne Mackintosh, PhD principal investigator
National Center for PTSD/PHREI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attentional bias retraining in people with Posttraumatic Stress Disorder, run by VA Pacific Islands Health Care System 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 3 inclusion and 3 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 6 Nov 2017. 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?
Post-traumatic Checklist - Military version (PCL-M) (time frame: Change from Baseline and Post-treatment (1 month after last training session)). 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 6 Nov 2017.