Ignite Creation Date:
2024-05-06 @ 12:40 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03827057
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2019-01-04
Brief Title:
RECONsolidation of Traumatic Memories to ResOLve Post Traumatic Stress Disorder RECONTROLPTSD
Sponsor:
Uniformed Services University of the Health Sciences
Organization:
Uniformed Services University of the Health Sciences
Study Overview
Official Title:
RECONsolidation of Traumatic Memories to ResOLve Post Traumatic Stress Disorder RECONTROLPTSD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECONTROLPTSD
Brief 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 eg 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
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 andor 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 CNRMs 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
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 CNRMs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None