Posttraumatic Stress DisorderPhase 2/3RECONTROLPTSDNCT03827057
RECONsolidation of Traumatic Memories to ResOLve Post Traumatic Stress Disorder (RECONTROLPTSD)
A Phase 2/3 study testing Reconsolidation of Traumatic Memories (RTM) and Prolonged Exposure (PE) in people with Posttraumatic Stress Disorder and Traumatic Brain Injury, run by Uniformed Services University of the Health Sciences at 1 site in United States.
Trial summary
Posttraumatic Stress Disorder (PTSD) is a common cause of morbidity in combat veterans, but current treatments are often inadequate. Reconsolidation of Traumatic Memories (RTM) is a novel treatment that seeks to alter key aspects of the target memory (e.g., color, clarity, speed, distance, perspective) to make it less… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Traumatic Brain Injury
- What is being tested?
- Reconsolidation of Traumatic Memories (RTM) and Prolonged Exposure (PE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2019to 6 May 2025
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets criteria for PTSD on the CAPS5, with past month nightmares or flashbacks.
- Willing to be randomly assigned to one of the two interventions and to complete all study measures.
- Able to exhibit capacity to understand the informed consent process, by completion of a corresponding series of questions
Who cannot join
- 1. history of psychosis, bipolar disorder, or active suicidal or homicidal ideation
Trial locations and contacts
1 site in 1 country.
United States1 site
Uniformed Services University of Health Sciences (USUHS)
Bethesda, Maryland, 20814
About this study
Posttraumatic Stress Disorder (PTSD) is a common cause of morbidity in combat veterans, but current treatments are often inadequate. Reconsolidation of Traumatic Memories (RTM) is a novel treatment that seeks to alter key aspects of the target memory (e.g., color, clarity, speed, distance, perspective) to make it less impactful, and reduce nightmares, flashbacks, and other features of PTSD. The memory is reviewed in the context of an imaginal movie theater, presenting a fast (~45 sec) black and white movie of the trauma memory, with further adjustment as needed so the patient can comfortably watch it. Open and waitlist studies of RTM have reported high response rates and rapid remission, setting the stage for this randomized, controlled, single-blind trial comparing RTM versus prolonged exposure (PE), the PTSD therapy with the strongest current evidence base.
The investigators hypothesize that RTM will be non-inferior to PE in reducing PTSD symptom severity post-treatment and at 1-year follow up; will achieve faster remission, with fewer dropouts; will improve cognitive function; and that epigenetic markers will correlate with treatment response. The investigators will randomize 108 active or retired service members (SMs) with PTSD to ≤10 sessions of RTM or PE, affording power to test our hypotheses while allowing for ≤ 25% dropouts. The investigators will use an intent to treat analysis, and the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, or DSM5 (CAPS-5), conducted by blinded assessors, will be the primary outcome measure. Secondary measures of depression (PHQ-9), anxiety (GAD-7), sleep (PSQI), and functional status (WHOQOL-100), will be assessed pre- and post-treatment, and at 2, 6, and 12 months. ANOVA will compare symptom severity over time within and between groups. The investigators will track comorbid TBI, anticipating it will not adversely impact response. More effective therapies for PTSD, with and without TBI, must be developed and evaluated. RTM is safe and promising, but requires testing against evidence-based interventions in well-designed randomized clinical trials (RCTs). The full study can be conducted either in person or via secure video conferencing.
Read the detailed description
Primary Objective: The primary intent of this study is to determine whether Reconsolidation of Traumatic Memories (RTM) achieves a greater and/or more rapid response than prolonged exposure (PE) in the treatment of military service members with PTSD. This is an interventional randomized controlled trial in which all participants will receive active psychotherapy for PTSD, either what is currently considered the best-evidenced treatment, prolonged exposure, or a novel approach, reconsolidation of traumatic memories, that the investigators believe can achieve a higher response rate that will also prove more rapid and more durable. Participants will be active duty, reserve or National Guard service members, or former service members who were retired either medically or for length of service, who are eligible for care in the Department of Defense Healthcare System. Our findings should be generalizable to current and former military service members with PTSD.
Approach This is a randomized controlled trial, enrolling 108 SMs with active PTSD, to RTM and PE, with up to 10 treatment sessions in each arm. The anticipated average enrollment rate will be 2 new participants per week. Participants may be male and female adult (ages 18+) participants who are active, reserve component, National Guard, or retired SMs; those with active suicidal or homicidal ideation, or a history of a psychotic disorder, will be excluded. Participants may have a history of lifetime mild or moderate traumatic brain injury (TBI), or no TBI history, but no lifetime history of severe TBI. Given that most participants are expected to be referred from the Center for Neuroscience and Regenerative Medicine (CNRM)'s Military Recruitment Protocol, it is anticipated that the great majority will have comorbid mild TBI (mTBI). All participants will also complete a total of 5 assessment visits: at baseline, immediately after the course of treatment, and at 2, 6 and 12 months. The baseline visit will begin with the completion of informed consent, followed by the administration of a series of questionnaires, a detailed neurocognitive assessment, and a blood draw; serial assessment will occur throughout the intervention period and for 12 months of follow-up. Participants will be randomly assigned to PE or RTM using a random number generator in MS Excel or other program to generate a random sequence of 108 zeroes and ones as a list. Subjects will be assigned to the treatment arms from that list: all zeros will be assigned to RTM and ones to PE.
Hypotheses: Military service members with PTSD who are randomized to Reconsolidation of Traumatic Memories (RTM) therapy will be significantly more likely to achieve PTSD resolution than those randomized to Prolonged Exposure (PE) therapy, measured by the Clinician-Administered PTSD Scale for DSM5 (CAPS-5, by expert assessors blinded to treatment group assignment). The investigators also anticipate that RTM will achieve a response more rapidly, and will prove more durable. Among the secondary measures that will correlate with response to therapy are measures of depression, anxiety, sleep quality, and overall functional status. Primary Aim: Compare response rates of PTSD to RTM vs. PE, defined by remission of diagnosis on the CAPS-5, using a 2-tailed t-test, from baseline to post-intervention. The investigators will also utilize repeated measures ANOVA to compare CAPS-5 scores at baseline, post-intervention, and at 2-, 6-, and 12-month follow up within groups. In addition to this primary measure, the investigators will also use independent sample t-tests to document the efficacy of randomization by comparing the two groups' baseline CAPS-5 total scores, along with PCL5, PHQ-9, NSI, GAD-7, PSQI, WHOQOL-10, number of TBIs, and all other demographic variables.
Secondary Aim 1: Corroborate impact on PTSD symptom severity by measuring changes in CAPS-5 and PCL5, respectively, from baseline to post-treatment for RTM and PE, using a 2-tailed t-test. The investigators will then use repeated measures ANOVA to compare within and between group changes in the CAPS-5 at baseline, post-treatment, 2-, 6-, and 12-month follow-up for the CAPS-5, and these as well as scores obtained prior to treatment sessions 2, 4, 6, 8 and 10 for the PCL5.
Secondary Aim 2: Compare rapidity of improvement in PTSD symptom severity between RTM and PE, measured by PCL5 scores at baseline, prior to treatment sessions 2, 4, 6, 8 and 10, and post-treatment, using a log-rank test to compare Kaplan-Meier curves for two groups.
Secondary Aim 3: Compare the durability of response to treatment, with the primary measure being the percentage meeting criteria for PTSD on the CAPS-5, at post-treatment, and at 2-, 6-, and 12-month follow-ups, using repeated measures ANOVA between the two groups. The investigators will also determine whether this is corroborated by symptom severity reduction by comparing the CAPS-5 and PCL5 scores at these time points, again using repeated measures ANOVA.
Secondary Aim 4: Compare the impact of RTM and PE upon comorbid conditions by using ANOVA with Bonferroni adjustment for multiple comparisons, to compare scores at baseline, post-treatment, and each of the follow-up time-points, on postconcussive symptoms (NSl), depression (PHQ-9), anxiety (GAD-7), sleep (PSQI), and functional status (WHOQOL-100).
- Being tested
- Reconsolidation of Traumatic Memories (RTM), Prolonged Exposure (PE)
- Keywords
- posttraumatic stress disorder, traumatic brain injury, cognitive behavioral therapy, exposure therapy, reconsolidation
- Medical subject headings
- Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconsolidation of Traumatic Memories (RTM)Behavioural
RTM is a trauma-focused, but not cognitive behavioral, therapy: it involves brief exposure to the trauma memory, but does rely on conscious responses to correct the symptoms of PTSD. RTM was first used to treat phobias in the 1970s, and has more recently been refined to focus on reconsolidation to update long-term memories, reconfiguring the salience structure of the original memory, and incorporating those changes into the overall memory structure. Reconsolidation is a neural mechanism for updating long-term memory, inserting new information that contradicts an essential element of the memory, which makes it possible to change the emotional tone and salience of the memory. It is hypothesized that RTM can thereby achieve quicker, greater, and more durable responses than with "traditional" exposure therapies.
Prolonged Exposure (PE)Behavioural
PE is a trauma-focused cognitive behavioral therapy (TFCBT) that depends on exposure to the feared stimulus as a central effector of change, utilizing extinction, which theorizes that if a trigger that previously elicited a fear response is presented enough times without reinforcement, the response fades. Previous researchers have shown that extinction involves the creation of a new blocking memory which prevents expression of the original fear memory. While PE has more evidence to support its efficacy in PTSD than other approaches, and a majority achieve a clinical response (e.g., decrease in CAPS score of 10 or more), many do not achieve complete remission of symptoms, and the blocking memory may be fragile, so subsequent triggers may result in relapse.
| Study group | Role | What they receive |
|---|---|---|
| Reconsolidation of Traumatic Memories (RTM) | Experimental | Participants in each arm of the study will receive up to 10 90-minute manualized treatment sessions. RTM will follow a manual developed by the Research and Recognition Project, who will also train and supervise the therapists. It is anticipated that these treatments will most often be administered once per week for 10 weeks. To best meet participant needs, we will allow therapy in either arm to be "massed" in the pattern recently reported by Foa et al. for PE, with sessions separated by at least 24 hours over two weeks. This schedule has been used with both RTM and PE without hurting response rates, and may reduce drop-out rates. Participants who achieve remission of their PTSD before 10 sessions, measured by a PCL5 <34, can decide with their therapist whether early cessation of therapy is appropriate. Receives: Behavioral: Reconsolidation of Traumatic Memories (RTM) |
| Prolonged Exposure (PE) | Active comparator | Participants in each arm of the study will receive up to 10 90-minute manualized treatment sessions. PE will follow a manual written by the Foa and colleagues, and the therapists will be trained by expert trainers from the Center for Deployment Psychology. It is anticipated that these treatments will most often be administered once per week for 10 weeks. To best meet participant needs, we will allow therapy in either arm to be "massed" in the pattern recently reported by Foa et al. for PE, with sessions separated by at least 24 hours over two weeks. This schedule has been used with both RTM and PE without hurting response rates, and may reduce drop-out rates. Participants who achieve remission of their PTSD before 10 sessions, measured by a PCL5 <34, can decide with their therapist whether early cessation of therapy is appropriate. Receives: Behavioral: Prolonged Exposure (PE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Symptom Scale for DSM5 (CAPS-5)
the gold standard for PTSD diagnosis, a trained expert administrator scores PTSD symptom severity; range 0-80, higher score represents greater severity
Measured: week 10
Secondary outcomes (5)
Change in Patient Health Questionnaire (PHQ-9) Score
well-validated and widely used 9-item self-report measure of depression symptom severity, range 0-27, higher score represents greater severity
Measured: week 10, and 2, 6 and 12 months later, compared to baseline
Change in PTSD Checklist for DSM5 (PCL5) Score
a reliable 20-item screen for PTSD, in which each item is rated on a 5-point Likert scale, range 0-80, higher score represents greater severity
Measured: week 10, and 2, 6 and 12 months later, compared to baseline
Change in Pittsburgh Sleep Quality Index (PSQI) Score
a clinically validated 9-item assessment of sleep quality and sleep disturbances; range 0 to 21, higher score represents greater severity
Measured: week 10, and 2, 6 and 12 months later, compared to baseline
Change in Neurobehavioral Symptom Inventory (NSI) Score
a reliable 22-item self-report measure assessing functional status and post concussive symptoms, range 0-88, higher score represents greater severity
Measured: week 10, and 2, 6 and 12 months later, compared to baseline
Change in World Health Organization Quality of Life Inventory (WHOQOL-100) Score
a reliable 100 item self-report inventory measuring overall quality of life in 8 dimensions; range 100 to 500, higher score represents greater severity
Measured: week 10, and 2, 6 and 12 months later, compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start12 Jun 2019
- Primary completion30 Apr 2024
- Study completion6 May 2025
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an interventional randomized controlled trial in which participants have an equal chance of receiving either the current best-evidenced PTSD treatment, prolonged exposure, or a novel approach, reconsolidation of traumatic memories, that has the potential to achieve a more rapid, durable and greater overall response rate.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Collaborators
- Research and Recognition Project
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827057
- Sponsor's protocol ID
- CNRM-83-9763
- Acronym
- RECONTROLPTSD
- Status last verified
- Jul 2025
- First submitted
- 4 Jan 2019
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be entered into the Federal Interagency TBI Research Informatics System (FITBIR) through the CNRM after completion of the study and after all codes or links to personal identifying information have been destroyed.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECONsolidation of Traumatic Memories to ResOLve Post Traumatic Stress Disorder (RECONTROLPTSD)
- ClinicalTrials.gov ID
- NCT03827057
- Acronym / sponsor ID
- RECONTROLPTSD / CNRM-83-9763
- Keywords
- posttraumatic stress disorder, traumatic brain injury, cognitive behavioral therapy, exposure therapy, reconsolidation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Collaborators
- Research and Recognition Project
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 1 Feb 2019 (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.
Posttraumatic Stress Disorder (PTSD) is a common cause of morbidity in combat veterans, but current treatments are often inadequate. Reconsolidation of Traumatic Memories (RTM) is a novel treatment that seeks to alter key aspects of the target memory (e.g., color, clarity, speed, distance, perspective) to make it less impactful, and reduce nightmares, flashbacks, and other features of PTSD. The memory is reviewed in the context of an imaginal movie theater, presenting a fast (~45 sec) black and white movie of the trauma memory, with further adjustment as needed so the patient can comfortably watch it. Open and waitlist studies of RTM have reported high response rates and rapid remission, setting the stage for this randomized, controlled, single-blind trial comparing RTM versus prolonged exposure (PE), the PTSD therapy with the strongest current evidence base.
The investigators hypothesize that RTM will be non-inferior to PE in reducing PTSD symptom severity post-treatment and at 1-year follow up; will achieve faster remission, with fewer dropouts; will improve cognitive function; and that epigenetic markers will correlate with treatment response. The investigators will randomize 108 active or retired service members (SMs) with PTSD to ≤10 sessions of RTM or PE, affording power to test our hypotheses while allowing for ≤ 25% dropouts. The investigators will use an intent to treat analysis, and the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, or DSM5 (CAPS-5), conducted by blinded assessors, will be the primary outcome measure. Secondary measures of depression (PHQ-9), anxiety (GAD-7), sleep (PSQI), and functional status (WHOQOL-100), will be assessed pre- and post-treatment, and at 2, 6, and 12 months. ANOVA will compare symptom severity over time within and between groups. The investigators will track comorbid TBI, anticipating it will not adversely impact response. More effective therapies for PTSD, with and without TBI, must be developed and evaluated. RTM is safe and promising, but requires testing against evidence-based interventions in well-designed randomized clinical trials (RCTs). The full study can be conducted either in person or via secure video conferencing.
Detailed description
Primary Objective: The primary intent of this study is to determine whether Reconsolidation of Traumatic Memories (RTM) achieves a greater and/or more rapid response than prolonged exposure (PE) in the treatment of military service members with PTSD. This is an interventional randomized controlled trial in which all participants will receive active psychotherapy for PTSD, either what is currently considered the best-evidenced treatment, prolonged exposure, or a novel approach, reconsolidation of traumatic memories, that the investigators believe can achieve a higher response rate that will also prove more rapid and more durable. Participants will be active duty, reserve or National Guard service members, or former service members who were retired either medically or for length of service, who are eligible for care in the Department of Defense Healthcare System. Our findings should be generalizable to current and former military service members with PTSD.
Approach This is a randomized controlled trial, enrolling 108 SMs with active PTSD, to RTM and PE, with up to 10 treatment sessions in each arm. The anticipated average enrollment rate will be 2 new participants per week. Participants may be male and female adult (ages 18+) participants who are active, reserve component, National Guard, or retired SMs; those with active suicidal or homicidal ideation, or a history of a psychotic disorder, will be excluded. Participants may have a history of lifetime mild or moderate traumatic brain injury (TBI), or no TBI history, but no lifetime history of severe TBI. Given that most participants are expected to be referred from the Center for Neuroscience and Regenerative Medicine (CNRM)'s Military Recruitment Protocol, it is anticipated that the great majority will have comorbid mild TBI (mTBI). All participants will also complete a total of 5 assessment visits: at baseline, immediately after the course of treatment, and at 2, 6 and 12 months. The baseline visit will begin with the completion of informed consent, followed by the administration of a series of questionnaires, a detailed neurocognitive assessment, and a blood draw; serial assessment will occur throughout the intervention period and for 12 months of follow-up. Participants will be randomly assigned to PE or RTM using a random number generator in MS Excel or other program to generate a random sequence of 108 zeroes and ones as a list. Subjects will be assigned to the treatment arms from that list: all zeros will be assigned to RTM and ones to PE.
Hypotheses: Military service members with PTSD who are randomized to Reconsolidation of Traumatic Memories (RTM) therapy will be significantly more likely to achieve PTSD resolution than those randomized to Prolonged Exposure (PE) therapy, measured by the Clinician-Administered PTSD Scale for DSM5 (CAPS-5, by expert assessors blinded to treatment group assignment). The investigators also anticipate that RTM will achieve a response more rapidly, and will prove more durable. Among the secondary measures that will correlate with response to therapy are measures of depression, anxiety, sleep quality, and overall functional status. Primary Aim: Compare response rates of PTSD to RTM vs. PE, defined by remission of diagnosis on the CAPS-5, using a 2-tailed t-test, from baseline to post-intervention. The investigators will also utilize repeated measures ANOVA to compare CAPS-5 scores at baseline, post-intervention, and at 2-, 6-, and 12-month follow up within groups. In addition to this primary measure, the investigators will also use independent sample t-tests to document the efficacy of randomization by comparing the two groups' baseline CAPS-5 total scores, along with PCL5, PHQ-9, NSI, GAD-7, PSQI, WHOQOL-10, number of TBIs, and all other demographic variables.
Secondary Aim 1: Corroborate impact on PTSD symptom severity by measuring changes in CAPS-5 and PCL5, respectively, from baseline to post-treatment for RTM and PE, using a 2-tailed t-test. The investigators will then use repeated measures ANOVA to compare within and between group changes in the CAPS-5 at baseline, post-treatment, 2-, 6-, and 12-month follow-up for the CAPS-5, and these as well as scores obtained prior to treatment sessions 2, 4, 6, 8 and 10 for the PCL5.
Secondary Aim 2: Compare rapidity of improvement in PTSD symptom severity between RTM and PE, measured by PCL5 scores at baseline, prior to treatment sessions 2, 4, 6, 8 and 10, and post-treatment, using a log-rank test to compare Kaplan-Meier curves for two groups.
Secondary Aim 3: Compare the durability of response to treatment, with the primary measure being the percentage meeting criteria for PTSD on the CAPS-5, at post-treatment, and at 2-, 6-, and 12-month follow-ups, using repeated measures ANOVA between the two groups. The investigators will also determine whether this is corroborated by symptom severity reduction by comparing the CAPS-5 and PCL5 scores at these time points, again using repeated measures ANOVA.
Secondary Aim 4: Compare the impact of RTM and PE upon comorbid conditions by using ANOVA with Bonferroni adjustment for multiple comparisons, to compare scores at baseline, post-treatment, and each of the follow-up time-points, on postconcussive symptoms (NSl), depression (PHQ-9), anxiety (GAD-7), sleep (PSQI), and functional status (WHOQOL-100).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is an interventional randomized controlled trial in which participants have an equal chance of receiving either the current best-evidenced PTSD treatment, prolonged exposure, or a novel approach, reconsolidation of traumatic memories, that has the potential to achieve a more rapid, durable and greater overall response rate.
| Arm | Type | Receives |
|---|---|---|
| Reconsolidation of Traumatic Memories (RTM) | Experimental | Behavioral: Reconsolidation of Traumatic Memories (RTM)Participants in each arm of the study will receive up to 10 90-minute manualized treatment sessions. RTM will follow a manual developed by the Research and Recognition Project, who will also train and supervise the therapists. It is anticipated that these treatments will most often be administered once per week for 10 weeks. To best meet participant needs, we will allow therapy in either arm to be "massed" in the pattern recently reported by Foa et al. for PE, with sessions separated by at least 24 hours over two weeks. This schedule has been used with both RTM and PE without hurting response rates, and may reduce drop-out rates. Participants who achieve remission of their PTSD before 10 sessions, measured by a PCL5 <34, can decide with their therapist whether early cessation of therapy is appropriate. |
| Prolonged Exposure (PE) | Active comparator | Behavioral: Prolonged Exposure (PE)Participants in each arm of the study will receive up to 10 90-minute manualized treatment sessions. PE will follow a manual written by the Foa and colleagues, and the therapists will be trained by expert trainers from the Center for Deployment Psychology. It is anticipated that these treatments will most often be administered once per week for 10 weeks. To best meet participant needs, we will allow therapy in either arm to be "massed" in the pattern recently reported by Foa et al. for PE, with sessions separated by at least 24 hours over two weeks. This schedule has been used with both RTM and PE without hurting response rates, and may reduce drop-out rates. Participants who achieve remission of their PTSD before 10 sessions, measured by a PCL5 <34, can decide with their therapist whether early cessation of therapy is appropriate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets criteria for PTSD on the CAPS5, with past month nightmares or flashbacks.
- Willing to be randomly assigned to one of the two interventions and to complete all study measures.
- Able to exhibit capacity to understand the informed consent process, by completion of a corresponding series of questions
Key exclusion criteria (1 listed)
- 1. history of psychosis, bipolar disorder, or 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 |
|---|---|---|
| Reconsolidation of Traumatic Memories (RTM)RTM is a trauma-focused, but not cognitive behavioral, therapy: it involves brief exposure to the trauma memory, but does rely on conscious responses to correct the symptoms of PTSD. RTM was first used to treat phobias in the 1970s, and has more recently been refined to focus on reconsolidation to update long-term memories, reconfiguring the salience structure of the original memory, and incorporating those changes into the overall memory structure. Reconsolidation is a neural mechanism for updating long-term memory, inserting new information that contradicts an essential element of the memory, which makes it possible to change the emotional tone and salience of the memory. It is hypothesized that RTM can thereby achieve quicker, greater, and more durable responses than with "traditional" exposure therapies. | Behavioural | Reconsolidation of Traumatic Memories (RTM) |
| Prolonged Exposure (PE)PE is a trauma-focused cognitive behavioral therapy (TFCBT) that depends on exposure to the feared stimulus as a central effector of change, utilizing extinction, which theorizes that if a trigger that previously elicited a fear response is presented enough times without reinforcement, the response fades. Previous researchers have shown that extinction involves the creation of a new blocking memory which prevents expression of the original fear memory. While PE has more evidence to support its efficacy in PTSD than other approaches, and a majority achieve a clinical response (e.g., decrease in CAPS score of 10 or more), many do not achieve complete remission of symptoms, and the blocking memory may be fragile, so subsequent triggers may result in relapse. | Behavioural | Prolonged Exposure (PE) |
Primary outcome
Clinician Administered PTSD Symptom Scale for DSM5 (CAPS-5)
Time frame: week 10
the gold standard for PTSD diagnosis, a trained expert administrator scores PTSD symptom severity; range 0-80, higher score represents greater severity
5 secondary outcomes
Change in Patient Health Questionnaire (PHQ-9) Score
Time frame: week 10, and 2, 6 and 12 months later, compared to baseline
Change in PTSD Checklist for DSM5 (PCL5) Score
Time frame: week 10, and 2, 6 and 12 months later, compared to baseline
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: week 10, and 2, 6 and 12 months later, compared to baseline
Change in Neurobehavioral Symptom Inventory (NSI) Score
Time frame: week 10, and 2, 6 and 12 months later, compared to baseline
Change in World Health Organization Quality of Life Inventory (WHOQOL-100) Score
Time frame: week 10, and 2, 6 and 12 months later, compared to baseline
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 15 Jul 2025.
- Individual participant dataSharing planned: Yes. Deidentified data will be entered into the Federal Interagency TBI Research Informatics System (FITBIR) through the CNRM after completion of the study and after all codes or links to personal identifying information have been destroyed.
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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 Phase 2/3 study testing Reconsolidation of Traumatic Memories (RTM) and Prolonged Exposure (PE) in people with Posttraumatic Stress Disorder and Traumatic Brain Injury, run by Uniformed Services University of the Health Sciences 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 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 15 Jul 2025. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinician Administered PTSD Symptom Scale for DSM5 (CAPS-5) (time frame: week 10). 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 15 Jul 2025.