Stress Disorders, Post-traumaticNCT00601952
Information Processing Modification in PTSD (Oct. 18)
A study testing Attention Bias Modification (ABM) in people with Stress Disorders, Post-traumatic, run by San Diego State University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a computerized intervention designed to change the nature of attention biases will be effective in reducing the symptoms of post traumatic stress disorder (PTSD) in American combat veterans returning from the wars in Afghanistan and Iraq. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stress Disorders, Post-traumatic
- What is being tested?
- Attention Bias Modification (ABM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary DSM-IV-TR Axis I diagnosis of post-traumatic stress disorder
- Combat veteran from Iraq and/or Afghanistan
Who cannot join
- No change in medication type or dose during the twelve weeks prior to treatment
- No current psychotherapy
- No evidence of suicidal intent
- No evidence of current substance dependence in the past 6 months
- No evidence of current or past schizophrenia, bipolar disorder, or organic mental disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Understanding and Treating Anxiety
San Diego, California, 92120
About this study
Official title: Information Processing Modification in PTSD
The purpose of this study is to determine whether a computerized intervention designed to change the nature of attention biases will be effective in reducing the symptoms of post traumatic stress disorder (PTSD) in American combat veterans returning from the wars in Afghanistan and Iraq.
Read the detailed description
Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) in Afghanistan are the largest sustained ground operations since the Vietnam War, and the psychological effects of combat on military personnel can be devastating. Approximately thirty percent of returning veterans present with mental health problems. Posttraumatic stress disorder (PTSD) is the most common problem in this group (52% of overall diagnoses). This translates into PTSD prevalence rates of 12% in Afghani veterans and 19% for Iraqi veterans, rates that are two to three times higher than the overall lifetime prevalence rate in the general population (8%). Of those veterans screened positive for mental health problems 70% have not received any mental health services. Therefore, even for individuals identified as having psychological problems the majority are not receiving any help. Prevention and treatment of this disorder represents one of the greatest challenges facing government officials and health care professionals working with combat veteran populations.
PTSD often manifests after the experience of a trauma in which individuals undergo threat of injury or death to themselves or others. The experience includes intense feelings of fear, helplessness, and/or horror. Symptoms of this disorder are often chronic lasting for years. Those with PTSD are likely to experience problems across several life domains including higher rates of divorce, problems raising children, and engaging in domestic violence. They are also more likely to suffer from other mental health problems including depression, substance abuse, and generalized anxiety disorder. Moreover, they tend to report less life satisfaction, experience poorer physical health, earn less money, and change jobs frequently.
Although effective treatments do exist for PTSD, as many as 44% of individuals do not respond to psychosocial and pharmacological treatments. Thus, there is a clear need to develop highly effective and efficient treatments for PTSD. Researchers have established a relationship between PTSD and difficulty disengaging attention from threat relevant inforamtion. This knowledge; however, has not been translated into more effective treatments for this disorder. This three-year proposal aims to test a computerized treatment for PTSD in a double-blind, placebo-controlled study that would bridge research on attention bias and treatment development. Those in the active condition will receive a computer-delivered attention modification program (AMP) designed to enhance attention disengagement from threatening stimuli. The AMP protocol includes six weeks of biweekly sessions in which participants see 240 trials consisting of the various combinations of probe type (E or F), probe position (top or bottom), and word type (Neutral or Trauma). Of the 240 trials, 48 include only neutral words: 2 (probe type) X 2 (probe position) X 12 (word pairs). The remaining 192 trials include one neutral word and one trauma word: 2 (probe type) X 2 (probe position) X 2 (repetitions) X 24 (word pairs). On trials where participants see one neutral word and one trauma word (i.e., 80% of the trials), the probe always follows the neutral word. Thus, although there is no specific instruction to direct attention away from threat word, on 80% of the trials the position of the threat word indicates the position of the probe (i.e., in the location opposite the threat word). The placebo condition (PC) will be identical to the AMP condition except that during the presentation of threat-neutral word pairs, the probe will appear with equal frequency in the position of threat and neutral words. Thus, neither threat nor neutral words have signal value. We have used a very similar training procedure to successfully establish a pattern of enhanced attention disengagement to threat words in our pilot studies.
We present the results from 2 clinical trials demonstrating the efficacy of attention modification programs (AMP) in ameliorating symptoms of anxiety. Specifically, we report results from studies of individuals with generalized social phobia (GSP; n=32) and generalized anxiety disorder (GAD; n=24) demonstrating the effectiveness of the procedures described in this proposal. In brief, our intervention was effective in: a) changing biased attention, b) reducing clinical symptoms of anxiety, c) maintaining its effects in up to one year follow-up. This efficient and efficacious technique for changing attention bias in anxiety can provide a low-cost, easy to administer treatment that is grounded in basic cognitive science that may help reduce suffering in individuals with anxiety. The goal of the current proposal is to extend these findings to the highly related disorder of PTSD, and to examine the generalizability of the results to individuals with comorbid conditions. In the current proposal we will test two hypotheses: 1) Individuals with PTSD completing the AMP will show a larger reduction in their attention bias to threat compared to the placebo group, 2) Individuals with PTSD completing AMP will show a larger reduction in anxiety symptoms compared to the placebo group.
- Conditions
- Stress Disorders, Post-traumatic
- Being tested
- Attention Bias Modification (ABM), Attention Control Condition (ACC)
- Keywords
- post traumatic stress disorder, cognitive bias, attention, combat
- 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 (ABM)Behavioural
The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
Attention Control Condition (ACC)Behavioural
The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
| Study group | Role | What they receive |
|---|---|---|
| 1 Attention Bias Modification (ABM) | Experimental | The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe. Receives: Behavioral: Attention Bias Modification (ABM) |
| 2 Attention Control Condition (ACC) | Placebo comparator | The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat. Receives: Behavioral: Attention Control Condition (ACC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M)
The PCL-M is a 17-item questionnaire that assesses the severity of PTSD symptoms using a 5-point Likert scale ranging from "not at all" to "extremely," with a minimum score of 17 and a maximum score of 85 (Weathers, Litz, Herman, Huska, \& Keane, 1993). Participants are asked to rate to what extent they experienced PTSD symptoms over the previous month due to prior combat experiences. The military version of the PCL (PCL-M) refers specifically to a traumatic military related event (Weathers, Litz, Huska, \& Keane, 1994). Research suggests that the PCL-M has good test-retest reliability (r = .70) and internal consistency (alpha = .97; Weathers et al., 1993).
Measured: Pre, Post, Followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startJul 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress Disorders, Post-traumaticStudies 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, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nader Amir, San Diego State University
- Investigators
- Nader Amir, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601952
- Sponsor's protocol ID
- PT074970
- Other IDs
- PT074970
- Status last verified
- Jul 2009
- First submitted
- 15 Jan 2008
- Last updated
- 4 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Information Processing Modification in PTSD
- ClinicalTrials.gov ID
- NCT00601952
- Acronym / sponsor ID
- PT074970
- Conditions
- Stress Disorders, Post-traumatic
- Keywords
- post traumatic stress disorder, cognitive bias, attention, combat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Posted 4 Feb 2014
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 determine whether a computerized intervention designed to change the nature of attention biases will be effective in reducing the symptoms of post traumatic stress disorder (PTSD) in American combat veterans returning from the wars in Afghanistan and Iraq.
Detailed description
Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) in Afghanistan are the largest sustained ground operations since the Vietnam War, and the psychological effects of combat on military personnel can be devastating. Approximately thirty percent of returning veterans present with mental health problems. Posttraumatic stress disorder (PTSD) is the most common problem in this group (52% of overall diagnoses). This translates into PTSD prevalence rates of 12% in Afghani veterans and 19% for Iraqi veterans, rates that are two to three times higher than the overall lifetime prevalence rate in the general population (8%). Of those veterans screened positive for mental health problems 70% have not received any mental health services. Therefore, even for individuals identified as having psychological problems the majority are not receiving any help. Prevention and treatment of this disorder represents one of the greatest challenges facing government officials and health care professionals working with combat veteran populations.
PTSD often manifests after the experience of a trauma in which individuals undergo threat of injury or death to themselves or others. The experience includes intense feelings of fear, helplessness, and/or horror. Symptoms of this disorder are often chronic lasting for years. Those with PTSD are likely to experience problems across several life domains including higher rates of divorce, problems raising children, and engaging in domestic violence. They are also more likely to suffer from other mental health problems including depression, substance abuse, and generalized anxiety disorder. Moreover, they tend to report less life satisfaction, experience poorer physical health, earn less money, and change jobs frequently.
Although effective treatments do exist for PTSD, as many as 44% of individuals do not respond to psychosocial and pharmacological treatments. Thus, there is a clear need to develop highly effective and efficient treatments for PTSD. Researchers have established a relationship between PTSD and difficulty disengaging attention from threat relevant inforamtion. This knowledge; however, has not been translated into more effective treatments for this disorder. This three-year proposal aims to test a computerized treatment for PTSD in a double-blind, placebo-controlled study that would bridge research on attention bias and treatment development. Those in the active condition will receive a computer-delivered attention modification program (AMP) designed to enhance attention disengagement from threatening stimuli. The AMP protocol includes six weeks of biweekly sessions in which participants see 240 trials consisting of the various combinations of probe type (E or F), probe position (top or bottom), and word type (Neutral or Trauma). Of the 240 trials, 48 include only neutral words: 2 (probe type) X 2 (probe position) X 12 (word pairs). The remaining 192 trials include one neutral word and one trauma word: 2 (probe type) X 2 (probe position) X 2 (repetitions) X 24 (word pairs). On trials where participants see one neutral word and one trauma word (i.e., 80% of the trials), the probe always follows the neutral word. Thus, although there is no specific instruction to direct attention away from threat word, on 80% of the trials the position of the threat word indicates the position of the probe (i.e., in the location opposite the threat word). The placebo condition (PC) will be identical to the AMP condition except that during the presentation of threat-neutral word pairs, the probe will appear with equal frequency in the position of threat and neutral words. Thus, neither threat nor neutral words have signal value. We have used a very similar training procedure to successfully establish a pattern of enhanced attention disengagement to threat words in our pilot studies.
We present the results from 2 clinical trials demonstrating the efficacy of attention modification programs (AMP) in ameliorating symptoms of anxiety. Specifically, we report results from studies of individuals with generalized social phobia (GSP; n=32) and generalized anxiety disorder (GAD; n=24) demonstrating the effectiveness of the procedures described in this proposal. In brief, our intervention was effective in: a) changing biased attention, b) reducing clinical symptoms of anxiety, c) maintaining its effects in up to one year follow-up. This efficient and efficacious technique for changing attention bias in anxiety can provide a low-cost, easy to administer treatment that is grounded in basic cognitive science that may help reduce suffering in individuals with anxiety. The goal of the current proposal is to extend these findings to the highly related disorder of PTSD, and to examine the generalizability of the results to individuals with comorbid conditions. In the current proposal we will test two hypotheses: 1) Individuals with PTSD completing the AMP will show a larger reduction in their attention bias to threat compared to the placebo group, 2) Individuals with PTSD completing AMP will show a larger reduction in anxiety symptoms compared to the placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Attention Bias Modification (ABM) | Experimental | Behavioral: Attention Bias Modification (ABM)The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe. |
| 2 Attention Control Condition (ACC) | Placebo comparator | Behavioral: Attention Control Condition (ACC)The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary DSM-IV-TR Axis I diagnosis of post-traumatic stress disorder
- Combat veteran from Iraq and/or Afghanistan
Key exclusion criteria (5 listed)
- No change in medication type or dose during the twelve weeks prior to treatment
- No current psychotherapy
- No evidence of suicidal intent
- No evidence of current substance dependence in the past 6 months
- No evidence of current or past schizophrenia, bipolar disorder, or organic mental disorder
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 (ABM)The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe. | Behavioural | 1 Attention Bias Modification (ABM) |
| Attention Control Condition (ACC)The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat. | Behavioural | 2 Attention Control Condition (ACC) |
Primary outcome
Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M)
Time frame: Pre, Post, Followup
The PCL-M is a 17-item questionnaire that assesses the severity of PTSD symptoms using a 5-point Likert scale ranging from "not at all" to "extremely," with a minimum score of 17 and a maximum score of 85 (Weathers, Litz, Herman, Huska, \& Keane, 1993). Participants are asked to rate to what extent they experienced PTSD symptoms over the previous month due to prior combat experiences. The military version of the PCL (PCL-M) refers specifically to a traumatic military related event (Weathers, Litz, Huska, \& Keane, 1994). Research suggests that the PCL-M has good test-retest reliability (r = .70) and internal consistency (alpha = .97; Weathers et al., 1993).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Stress Disorders, Post-traumatic
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Recruiting
Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico
Post-Traumatic Stress Disorder
RecruitingPhase 3
Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression
Major Depression
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
Not yet recruiting
Enhancing Operational Readiness With Digital Self-Managed Cognitive Behavioral Therapy for Insomnia (CBTI)
Insomnia, Depression - Major Depressive Disorder
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.
Nader Amir, PhD principal investigator
San Diego State 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 (ABM) in people with Stress Disorders, Post-traumatic, run by San Diego State 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 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 4 Feb 2014. 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?
Yes. Results are posted in the registry (first posted 4 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Stress Disorder Checklist-Military Version (PCL-M) (time frame: Pre, Post, Followup). 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 4 Feb 2014.