PTSDNCT02945709
Attention Control Treatment for Post Traumatic Stress Disorder ׂ(PTSD)
A study of PTSD, run by Tel Aviv University at 1 site in Israel.
Trial summary
The purpose of this study is to explore the efficacy of Attention Control Training for Post Traumatic Stress Disorder (PTSD). ACT was found to be effective in decreasing attention bias variability and PTSD symptoms in combat veterans (Badura-Brack, et al., 2015). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PTSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2016to Dec 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meeting a current diagnosis of Post-Traumatic Stress Disorder (PTSD) according to DSM-V (American Psychiatric Association, 2013);
Who cannot join
- A diagnosis of psychotic or bipolar disorders.
- A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
- Suicidal ideation.
- Drugs or alcohol abuse.
- Non-fluent Hebrew.
- A pharmacological treatment that is not stabilized in the past 3 months (a stable treatment will not be a reason for exclusion from the study).
- Pregnancy. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attention Control Treatment for Post Traumatic Stress Disorder
The purpose of this study is to explore the efficacy of Attention Control Training for Post Traumatic Stress Disorder (PTSD).
ACT was found to be effective in decreasing attention bias variability and PTSD symptoms in combat veterans (Badura-Brack, et al., 2015). It is now important to continue the examination of ACT's efficacy in additional populations of patients with PTSD. Such extension of treatment to other traumatic experiences raises the question of whether the threatening content of the training material could be personalized for each patient.
Read the detailed description
The aim of this study is to explore the efficacy of Attention Control Training for Post Traumatic Stress Disorder (PTSD).
ACT was found to be effective in decreasing attention bias variability and PTSD symptoms in combat veterans (Badura-Brack, et al., 2015). It is now important to continue the examination of ACT's efficacy in additional populations of patients with PTSD. Such extension of treatment to other traumatic experiences raises the question of whether the threatening content of the training material could be personalized for each patient.
For this purpose, we will recruit participants that are diagnosed with PTSD and will be randomly assigned to one of three conditions: personalized ACT, non-personalized ACT, or control training We expect that personalized ACT will produce greater reduction in PTSD symptoms relative to a non-personalized ACT, and that both these conditions will be more effective in symptoms reduction than a control condition not designed to affect attention or expose patients to threat stimuli. We also expect the ACT conditions to reduce attention bias variability relative to the control condition.
- Conditions
- PTSD
- Being tested
- Personalized Attention control training (ACT), Non-personalized Attention control training (ACT), Control training.
- Keywords
- PTSD, attention training, cognitive bias modification
- 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.
Personalized Attention control training (ACT)Behavioural
In this intervention, participants will be trained with a personalized Dot-Probe task. Each participant will perform the task with the set of words that he or she ranked as the most threatening according to a Word Ranking Task.
Non-personalized Attention control training (ACT)Behavioural
In this intervention, participants will be trained with the same Dot-Probe task as in the personalized condition, except that the word stimuli will be randomly fit for each participant. It should be noted that 25% out of the words in this condition will be high ranked words according to each patient's word ranking. The aim of this is to enhance similarity to a generic ACT intervention (see Badura-Brack et al., 2015), where there is some degree of exposure to what one may consider "personalized" stimuli (i.e., threat words that were randomly included by the researchers), although it is not deliberately set to idiosyncratic preferences.
Control training.Behavioural
In this intervention, participants will perform a computerized task, similar to the Dot-Probe task. In each trial, one neutral word will be presented at the center of the screen and participants will respond to a probe ('E' or 'f') presented following the removal of the words display. This version does not include the essential ingredients thought to reduce PTSD symptoms in the other dot-probe tasks: exposure to threat content and competition on attentional resources. Thus, this control version provides a control condition for the ACT interventions.
| Study group | Role | What they receive |
|---|---|---|
| Personalized ACT | Experimental | The personalized attention control training (ACT), comprised of six computerized sessions, in purpose of modulate biases in attention for personalized threat stimuli. Receives: Behavioral: Personalized Attention control training (ACT) |
| Non personalized ACT | Active comparator | The Non-personalized attention control training (ACT), comprised of six sessions, in purpose of modulate biases in attention for non-personalized threat stimuli. Receives: Behavioral: Non-personalized Attention control training (ACT) |
| Control training | Placebo comparator | Computerized control training, comprised of six sessions with a variation of the dot-probe task with neutral stimuli Receives: Behavioral: Control training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A diagnosis of PTSD and a total score of severity symptoms, as driven from the CAPS-5 interview
The Clinician Administered PTSD Scale (CAPS-5), is a structured interview that will be used to make a diagnosis of PTSD according to the DSM-V criteria. This interview is consists of 30 items regarding the frequency and intensity of PTSD symptoms and a total score of severity is been rated (Weathers, Blake, Schnurr, Kaloupek, Marx, \& Keane, 2013).
Measured: 40 minutes
Secondary outcomes (1)
Total score of the PTSD Checklist (PCL-5).
The PCL-5, is a 20-item National Center for PTSD Checklist of the Department of Veterans Affairs. Scores can range from 0 to 80, with higher scores reflecting more symptoms of PTSD (Weathers, Litz, Keane, Palmieri, Marx, \& Schnurr, 2013).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yair Bar-Haim, Tel Aviv University
- Investigators
- Yair Bar-Haim, Prof., Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945709
- Sponsor's protocol ID
- TAUPTSD
- Status last verified
- Jun 2020
- First submitted
- 25 Oct 2016
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Weathers, F., Blake, D., Schnurr, P., Kaloupek, D., Marx, B., & Keane, T., The clinician-administered PTSD scale for DSM-5 (CAPS-5). Interview available from the National Center for PTSD at www. ptsd. va. gov, 2013.
American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-5). American Psychiatric Pub, 2013
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 26206075Weathers, F., B. Litz, T. Keane, P. Palmieri, B. Marx, & P. Schnurr, The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www. ptsd. va. gov, 2013.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Control Treatment for Post Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT02945709
- Acronym / sponsor ID
- TAUPTSD
- Conditions
- PTSD
- Keywords
- PTSD, attention training, cognitive bias modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 26 Oct 2016 (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 purpose of this study is to explore the efficacy of Attention Control Training for Post Traumatic Stress Disorder (PTSD).
ACT was found to be effective in decreasing attention bias variability and PTSD symptoms in combat veterans (Badura-Brack, et al., 2015). It is now important to continue the examination of ACT's efficacy in additional populations of patients with PTSD. Such extension of treatment to other traumatic experiences raises the question of whether the threatening content of the training material could be personalized for each patient.
Detailed description
The aim of this study is to explore the efficacy of Attention Control Training for Post Traumatic Stress Disorder (PTSD).
ACT was found to be effective in decreasing attention bias variability and PTSD symptoms in combat veterans (Badura-Brack, et al., 2015). It is now important to continue the examination of ACT's efficacy in additional populations of patients with PTSD. Such extension of treatment to other traumatic experiences raises the question of whether the threatening content of the training material could be personalized for each patient.
For this purpose, we will recruit participants that are diagnosed with PTSD and will be randomly assigned to one of three conditions: personalized ACT, non-personalized ACT, or control training We expect that personalized ACT will produce greater reduction in PTSD symptoms relative to a non-personalized ACT, and that both these conditions will be more effective in symptoms reduction than a control condition not designed to affect attention or expose patients to threat stimuli. We also expect the ACT conditions to reduce attention bias variability relative to the control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Personalized ACT | Experimental | Behavioral: Personalized Attention control training (ACT)The personalized attention control training (ACT), comprised of six computerized sessions, in purpose of modulate biases in attention for personalized threat stimuli. |
| Non personalized ACT | Active comparator | Behavioral: Non-personalized Attention control training (ACT)The Non-personalized attention control training (ACT), comprised of six sessions, in purpose of modulate biases in attention for non-personalized threat stimuli. |
| Control training | Placebo comparator | Behavioral: Control training.Computerized control training, comprised of six sessions with a variation of the dot-probe task with neutral stimuli |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meeting a current diagnosis of Post-Traumatic Stress Disorder (PTSD) according to DSM-V (American Psychiatric Association, 2013);
Key exclusion criteria (7 listed)
- A diagnosis of psychotic or bipolar disorders.
- A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
- Suicidal ideation.
- Drugs or alcohol abuse.
- Non-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 |
|---|---|---|
| Personalized Attention control training (ACT)In this intervention, participants will be trained with a personalized Dot-Probe task. Each participant will perform the task with the set of words that he or she ranked as the most threatening according to a Word Ranking Task. | Behavioural | Personalized ACT |
| Non-personalized Attention control training (ACT)In this intervention, participants will be trained with the same Dot-Probe task as in the personalized condition, except that the word stimuli will be randomly fit for each participant. It should be noted that 25% out of the words in this condition will be high ranked words according to each patient's word ranking. The aim of this is to enhance similarity to a generic ACT intervention (see Badura-Brack et al., 2015), where there is some degree of exposure to what one may consider "personalized" stimuli (i.e., threat words that were randomly included by the researchers), although it is not deliberately set to idiosyncratic preferences. | Behavioural | Non personalized ACT |
| Control training.In this intervention, participants will perform a computerized task, similar to the Dot-Probe task. In each trial, one neutral word will be presented at the center of the screen and participants will respond to a probe ('E' or 'f') presented following the removal of the words display. This version does not include the essential ingredients thought to reduce PTSD symptoms in the other dot-probe tasks: exposure to threat content and competition on attentional resources. Thus, this control version provides a control condition for the ACT interventions. | Behavioural | Control training |
Primary outcome
A diagnosis of PTSD and a total score of severity symptoms, as driven from the CAPS-5 interview
Time frame: 40 minutes
The Clinician Administered PTSD Scale (CAPS-5), is a structured interview that will be used to make a diagnosis of PTSD according to the DSM-V criteria. This interview is consists of 30 items regarding the frequency and intensity of PTSD symptoms and a total score of severity is been rated (Weathers, Blake, Schnurr, Kaloupek, Marx, \& Keane, 2013).
1 secondary outcome
Total score of the PTSD Checklist (PCL-5).
Time frame: 10 minutes
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 22 Jun 2020.
- BackgroundWeathers, F., Blake, D., Schnurr, P., Kaloupek, D., Marx, B., & Keane, T., The clinician-administered PTSD scale for DSM-5 (CAPS-5). Interview available from the National Center for PTSD at www. ptsd. va. gov, 2013.
- BackgroundAmerican Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-5). American Psychiatric Pub, 2013
- 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.
- BackgroundWeathers, F., B. Litz, T. Keane, P. Palmieri, B. Marx, & P. Schnurr, The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www. ptsd. va. gov, 2013.
- 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.
Yair Bar-Haim, Prof. principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of 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 7 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 22 Jun 2020. 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?
A diagnosis of PTSD and a total score of severity symptoms, as driven from the CAPS-5 interview (time frame: 40 minutes). 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 NCT02945709, which also lists 4 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 22 Jun 2020.