PTSDNCT03350360
Attention Control Training for PTSD Related to Combat or Interpersonal Violence
A study testing Comparison Task in people with PTSD, run by Creighton University at 1 site in United States.
Trial summary
Participants will complete a pre and post training psychological assessment. Participants will be assigned to attention control training or the comparison stimuli computer task in a double-blind randomized control trial design. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- PTSD
- What is being tested?
- Comparison Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2017to 17 Nov 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- military veteran or woman exposed to interpersonal violence (e.g. domestic or sexual violence).
- significant symptoms of PTSD
Who cannot join
- bipolar disorder, schizophrenia, OCD, unable to attend sessions sober.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trials of Attention Control Training for PTSD Related to Combat or Interpersonal Violence
Participants will complete a pre and post training psychological assessment. Participants will be assigned to attention control training or the comparison stimuli computer task in a double-blind randomized control trial design. Both computerized dot probe tasks display two stimuli on a computer screen, one above the other, followed by a small right or left arrow appearing in the location vacated by one of the stimuli. Participants are required to respond as quickly as they can by pressing the indicated right or left arrow on their computer keyboard without compromising accuracy. Participants complete 6 training sessions.
- Conditions
- PTSD
- Being tested
- Attention Control Training, Comparison Task
- 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 Control TrainingBehavioural
Attention control training teaches participants that the emotional salience of cues (i.e., threatening or neutral) is not related to successful completion of the computerized response task, and thus, teaches participants to ignore irrelevant threat-related contingencies (Badura-Brack et al., 2015).
Comparison TaskBehavioural
Neutral- neutral stimuli prior to response task
| Study group | Role | What they receive |
|---|---|---|
| Attention Control Training Clinic | Experimental | Attention Control Training Clinic will consist of:
* 6 sessions in the clinic lasting approximately 10 minutes each.
* Each session will consist of 128 presentations of pairs of neutral and threatening stimuli, followed by the presentation of a response cue (right or left arrow to be clicked on a computer keyboard). Receives: Behavioral: Attention Control Training |
| Attention Control Training Web-delivery | Experimental | Attention Control Training Web-delivery will consist of:
* 6 sessions lasting approximately 10 minutes each logged into via the internet from the participants' home.
* Each session will consist of 128 presentations of pairs of neutral and threatening stimuli, followed by the presentation of a response cue (right or left arrow to be clicked on a computer keyboard).
* Ideally participants will complete 2 sessions per week, allowing them to complete the trial in less than one month's time Receives: Behavioral: Attention Control Training |
| Comparison Task Clinic | Placebo comparator | * 6 sessions in the clinic of a presumably inactive neutral-neutral stimuli intervention lasting approximately 10 minutes each.
* Each session will consist of 128 presentations of pairs of faces, followed by the presentation of a response cue (right or left arrow to be clicked on a computer keyboard).
(Note that those receiving this arm, are invited to repeat the attention control training web-delivery arm at the end of their participation). Receives: Behavioral: Attention Control Training; Behavioral: Comparison Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in posttraumatic stress disorder (PTSD) symptoms from pre to post test
Structured diagnostic interview for PTSD
Measured: 30 minute long administration at both pre and post training to measure change. (repeat assessments are conducted 1 month apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start17 Nov 2017
- Primary completion17 Nov 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Badura Brack, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350360
- Sponsor's protocol ID
- 1123259
- Status last verified
- Jul 2022
- First submitted
- 16 Nov 2017
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Badura-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 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trials of Attention Control Training for PTSD Related to Combat or Interpersonal Violence
- ClinicalTrials.gov ID
- NCT03350360
- Acronym / sponsor ID
- 1123259
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 22 Nov 2017 (actual)
- 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.
Participants will complete a pre and post training psychological assessment. Participants will be assigned to attention control training or the comparison stimuli computer task in a double-blind randomized control trial design. Both computerized dot probe tasks display two stimuli on a computer screen, one above the other, followed by a small right or left arrow appearing in the location vacated by one of the stimuli. Participants are required to respond as quickly as they can by pressing the indicated right or left arrow on their computer keyboard without compromising accuracy. Participants complete 6 training sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Attention Control Training Clinic | Experimental | Behavioral: Attention Control TrainingAttention Control Training Clinic will consist of: * 6 sessions in the clinic lasting approximately 10 minutes each. * Each session will consist of 128 presentations of pairs of neutral and threatening stimuli, followed by the presentation of a response cue (right or left arrow to be clicked on a computer keyboard). |
| Attention Control Training Web-delivery | Experimental | Behavioral: Attention Control TrainingAttention Control Training Web-delivery will consist of: * 6 sessions lasting approximately 10 minutes each logged into via the internet from the participants' home. * Each session will consist of 128 presentations of pairs of neutral and threatening stimuli, followed by the presentation of a response cue (right or left arrow to be clicked on a computer keyboard). * Ideally participants will complete 2 sessions per week, allowing them to complete the trial in less than one month's time |
| Comparison Task Clinic | Placebo comparator | Behavioral: Attention Control Training, Behavioral: Comparison Task* 6 sessions in the clinic of a presumably inactive neutral-neutral stimuli intervention lasting approximately 10 minutes each. * Each session will consist of 128 presentations of pairs of faces, followed by the presentation of a response cue (right or left arrow to be clicked on a computer keyboard). (Note that those receiving this arm, are invited to repeat the attention control training web-delivery arm at the end of their participation). |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- military veteran or woman exposed to interpersonal violence (e.g. domestic or sexual violence).
- significant symptoms of PTSD
Key exclusion criteria (1 listed)
- bipolar disorder, schizophrenia, OCD, unable to attend sessions sober.
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 Control TrainingAttention control training teaches participants that the emotional salience of cues (i.e., threatening or neutral) is not related to successful completion of the computerized response task, and thus, teaches participants to ignore irrelevant threat-related contingencies (Badura-Brack et al., 2015). | Behavioural | Attention Control Training Clinic, Attention Control Training Web-delivery, Comparison Task Clinic |
| Comparison TaskNeutral- neutral stimuli prior to response task | Behavioural | Comparison Task Clinic |
Primary outcome
Change in posttraumatic stress disorder (PTSD) symptoms from pre to post test
Time frame: 30 minute long administration at both pre and post training to measure change. (repeat assessments are conducted 1 month apart)
Structured diagnostic interview for PTSD
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 Jul 2022.
- Background: 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison Task in people with PTSD, 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 2 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 Jul 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?
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?
Change in posttraumatic stress disorder (PTSD) symptoms from pre to post test (time frame: 30 minute long administration at both pre and post training to measure change. (repeat assessments are conducted 1 month apart)). 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 NCT03350360, which also lists 1 linked publication.
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 Jul 2022.