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39 Post-Traumatic Stress Disorder Trials near Albuquerque, NM
Power is an online platform that helps thousands of Post-Traumatic Stress Disorder patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerMDMA Assisted Therapy for PTSD and Opioid Use Disorder
Albuquerque, New Mexico
This is an open-label study of the use of MDMA Assisted Therapy for postpartum people with co-occurring Post Traumatic Stress Disorder (PTSD) and Opioid Use Disorder (OUD). The study protocol has been adapted from the Phase 3 studies sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) for PTSD. Due to the high rate of concurrence of PTSD and OUD, people with OUD may experience great benefit from the treatment of their PTSD with MDMA-assisted therapy based on the phase 2 and 3 studies for PTSD. Use of MDMA-assisted therapy in this population has the potential to be of benefit for their OUD and maternal- infant attachment.
This study will serve to explore the feasibility and safety of offering MDMA-assisted therapy for treatment of PTSD in postpartum people with opioid use disorder. The CAPs 5 (PTSD) is the primary outcome, the Timeline Follow-Back (TLFB) for opioid use is the secondary outcome and other assessments of opioid use disorder, effects on maternal-infant attachment, social connectedness and other mental health outcomes are exploratory. The study will be conducted at the University of New Mexico Health Sciences Center located in Albuquerque New Mexico. In addition to northern New Mexico being an epicenter of the current opioid use disorder epidemic in the United States there is a long-standing history of multigenerational use of illicit opioids in many communities of northern New Mexico. There are high rates of opioid use disorder on pregnancy and accompanying Neonatal Opioid Use Withdrawal Syndrome (NOWS) in Albuquerque, Santa Fe, and surrounding communities.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Sex:Female
Key Eligibility Criteria
Disqualifiers:Psychotic Disorder, Bipolar, Arrhythmia, Others
Must Be Taking:Methadone, Buprenorphine
15 Participants Needed
Brain Stimulation for PTSD
Albuquerque, New Mexico
MAGNETS is a prospective, randomized, parallel-design, sham-controlled clinical trial of accelerated, functional magnetic resonance imaging (fMRI)-guided intermittent theta burst stimulation (iTBS) to the right dorsolateral prefrontal cortex (dlPFC) for chronic symptoms of posttraumatic stress disorder (PTSD) in a comorbid Veteran population.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Neurological Disease, Seizures, Psychotic Disorder, Substance Dependence, Others
Must Be Taking:Psychotropic Medications
64 Participants Needed
Quetiapine for Post-Concussion Syndrome
Albuquerque, New Mexico
A two site, 2-arm, Phase III randomized pragmatic clinical trial evaluating the effectiveness of quetiapine monotherapy in comparison to Treatment As Usual (TAU) medication management for symptoms experienced by veterans receiving rehabilitation therapy for mild traumatic brain injury (mTBI) and comorbid symptoms of posttraumatic stress disorder (PTSD).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Moderate TBI, Schizophrenia, Bipolar, Others
Must Be Taking:CNS Active Psychotropics
146 Participants Needed
Parenting-STAIR Therapy for Parent-Child Relationship
El Paso, Texas
The goal of this study is to assess Parenting STAIR Modular (PSTAIR-M), a promising and innovative intervention for military-connected mothers (MCM) who have experienced trauma and their young children (ages 2-10). PSTAIR-M aims to help mothers manage the strong feelings that sometimes happen after experiencing something scary or stressful, as well as to better connect with their children and manage their behavior effectively.
The main questions the study aims to answer are: 1) Does PSTAIR-M reduce maternal PTSD and/or depression symptoms?, and 2) Does PSTAIR-M improve parental functioning?
Researchers will compare PSTAIR-M to treatment as usual (TAU) - other EBTs offered at participating study sites - to determine if PSTAIR-M is more effective in improving mental health and parenting.
Participants will: 1) attend 12-16 weekly, 1-hour online treatment sessions with their assigned clinicians, 2) complete three 1-hour online assessments administered by research staff, 3) engage with their child in three 15-30-minute online, observed play sessions, and 4) have assessments audio and video recorded.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Suicide Risk, Psychotic Symptoms, Communication Disability, Others
120 Participants Needed
Ketamine for Orthopedic Surgery Patients
Lubbock, Texas
The goal of this clinical trial is to learn if ketamine, given during surgery, can help improve recovery for adults with serious orthopedic trauma. The study will test whether ketamine reduces pain, lowers the need for opioids, and improves mental health outcomes like depression and post-traumatic stress disorder (PTSD).
The main questions it aims to answer are:
Does ketamine reduce pain after surgery compared to standard anesthesia?
Does ketamine reduce the amount of opioids patients need for pain control?
Does ketamine improve symptoms of depression and PTSD after orthopedic trauma?
Researchers will compare patients who receive ketamine during surgery with those who receive standard anesthesia without ketamine to see if ketamine helps improve both physical and psychological recovery.
Participants will:
Be randomly assigned to receive either a single dose of ketamine or standard anesthesia during surgery.
Report their pain using a simple pain scale (Visual Analog Scale, VAS).
Complete short surveys about mood and mental health (PHQ-9 for depression and PCL-5 for PTSD) at several time points after surgery.
Allow the research team to review their electronic medical records to measure opioid prescriptions during recovery.
Attend follow-up visits in clinic or by secure telehealth (e.g., Zoom) at 1-7 days, 2-3 weeks, 6 weeks, 3 months, and 6 months after surgery
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Severe Psychiatric, Dementia, Glaucoma, Others
Must Not Be Taking:Ketamine
90 Participants Needed
Inhaled Cannabis for PTSD
Cave Creek, Arizona
The rationale for the use of inhalational cannabis to potentially treat PTSD symptoms is based on the many reports of cannabis attenuating PTSD symptom expression among individuals with PTSD, including veterans. Study MJP2 is intended to build off MJP-1 through use of a larger sample size, a parallel study design, and subjective bias mitigation methods to re-examine the use of inhaled high THC-containing cannabis versus placebo for management of PTSD symptoms in a U.S. Veteran sample. Together these studies are intended to provide valuable insights on the already widespread use of cannabis in individuals with PTSD, for which there is currently a lack of controlled evidence available reflective of this real-world use.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Major Depressive Disorder, Others
Must Not Be Taking:Antiarrhythmics, Opiates, Methamphetamine, Others
320 Participants Needed
Service Dogs + Prolonged Exposure Therapy for PTSD
Tucson, Arizona
This study investigates the impact of Service Dog partnership on the effectiveness of Prolonged Exposure Therapy. We will learn whether Service Dog partnership in combination with Prolonged Exposure Therapy treatment can help Veterans with PTSD.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Current Service Dog, Current Therapy
216 Participants Needed
Service Dogs for PTSD
Tucson, Arizona
Posttraumatic stress disorder (PTSD) among military Veterans is a critical public health concern. Veteran suicide rates exceed those of the general population, with the disorder creating a mental health challenge that is costly and debilitating. The majority of Veterans with PTSD also have comorbid mental health diagnoses, such as generalized anxiety disorder, substance abuse disorder, and major depression. The treatment of Veteran PTSD and comorbid disorders represents an important therapeutic and rehabilitation problem. The disorder is complex and difficult to treat, with high treatment dropout and nonresponse rates spurring some Veterans to seek complementary integrative health strategies. One promising complementary strategy is the provision of a trained service dog. Initial evidence across multiple research groups highlights service dogs as a promising complement to evidence-based practices that can offer short-term improvements. However, the long-term effectiveness, mechanisms of action, and moderators of efficacy remain largely unknown. Thus, the overarching objective of this proposal is to understand how, why, and for whom PTSD service dogs are most effective.
To address this objective, the present project will assess the longitudinal efficacy and dose-response curve of service dogs for Veteran PTSD symptomology and psychosocial functioning. The research design will consist of a two-arm, randomized clinical trial (RCT) with longitudinal assessments over a period of 15 months. Results are expected to elucidate the clinical impact of service dogs for military Veterans with PTSD, as well as the biobehavioral mechanisms of action and characteristics that moderate efficacy. These outcomes will support the long-term goal of accelerating complementary and integrative health interventions, through optimized and evidence-based service dog interventions. As such, this project will further advance the scientific understanding of human-animal interactions for psychosocial health.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Generalized Anxiety, Substance Abuse, Major Depression, Others
150 Participants Needed
MPACT Intervention for Methadone Treatment
Tucson, Arizona
Examine the preliminary effect of the MPACT intervention on methadone treatment retention, in treatment overdose and patient trauma symptoms. The study will also explore the relationship between staff trauma symptoms and MPACT implementation.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Must Be Taking:Methadone
102 Participants Needed
Psilocybin Mushrooms for PTSD
Scottsdale, Arizona
This study will examine the safety and preliminary efficacy of psilocybin mushrooms to treat adults with PTSD. Up to 24 participants will take part in this study. Each participant will ingest psilocybin from dried mushrooms in a chocolate formulation.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Not Listed
24 Participants Needed
Online Parenting Program for Forcibly Displaced Families
Tempe, Arizona
This Randomized Controlled Trial will test the effectiveness of the Parenting in the Moment (PIM) online parenting program for parents with experiences of forced displacement.
The primary objective of this study is to conduct a summative (impact) evaluation of the PIM online parenting program as an in-home parent, skill-based program for parents of school-aged children, using a randomized controlled trial research design with community partnerships that inform the research throughout. The longer-term objectives are to build the evidence-base for in-home parent skill-based programs with strong empirical support (i.e., eligible for listing on the Families First Clearinghouse) and increase access to parenting programs for forcibly displaced families thereby improving child safety and wellbeing and strengthening their public health support.
720 families will be recruited with forced migration backgrounds and within 10 years of arrival in the USA; 360 families will be assigned to the PIMonline program and 360 to a family resource list only, wait-list control group. Families will be recruited using stratified random sampling within the four PIM language groups: English, Spanish, Arabic, French. Within each language, half the families will be assigned to the PIMonline intervention program and the other half will be assigned to receiving a Family Resource List with access to the PIMonline program once the study ends.
One parent and one child per eligible family may participate. Data collection with participating families will take place at baseline (T1), 4-months after baseline (T2) and finally, 16 months after baseline (T3). Data collection includes caregiver online surveys, caregiver and child Zoom recorded Family Interaction Task conversations and interviewer administered child surveys for children aged 8-12 at each time point. Standardized, reliable and valid measures in the four languages will be used to assess change in outcomes through the surveys. Longitudinal growth curve analysis will be used to test PIM intervention effects. Our extensive dissemination plan involves nationwide community partners in child welfare and services to forcibly displaced families.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Prisoners, Impaired Decision-making, Active Psychosis, Others
720 Participants Needed
Cognitive Processing Therapy for PTSD
Phoenix, Arizona
Recent estimates suggest that over 610,000 US Veterans treated by the Veterans Health Administration (VHA) suffer from PTSD, a disorder that can be chronic and debilitating. The heterogeneity of the 20 symptoms of PTSD; comorbidity with disorders such as depression, panic, and substance use; high rates of lingering effects of physical injury; and suicidality all contribute to complex clinical presentations and can exact a significant toll on functioning, quality of life, and well-being even decades after exposure to the traumatic event. Perhaps spurred by the President's New Freedom Commission on Mental Health, psychosocial rehabilitation has shifted from the periphery in mental health recovery models to a more primary focus in clinical settings, including recommendations for use of psychosocial rehabilitation techniques in trauma-focused mental health care. Support for the efficacy of psychosocial rehabilitation techniques in PTSD recovery programs has burgeoned in recent years and data supporting psychological treatments for PTSD has increased exponentially, yet the two approaches to recovery have largely remained independent.
Cognitive Processing Therapy (CPT), the evidence-based psychotherapy (EBP) for PTSD most frequently delivered within VHA, yields large magnitude reductions in primary PTSD outcomes. Corresponding gains in occupational, social, leisure, and sexual functioning, and in health-related concerns have also been demonstrated. Despite CPT's effectiveness, there is room for improvement in overall outcomes and patient engagement. Further, improvements in functioning and quality of life are more modest than those observed in PTSD and associated mental health symptoms. Prior work suggests that unaddressed difficulties in functioning contribute to premature dropout from EBPs for PTSD among Veterans. Directly targeting impairments associated with psychosocial functioning has the potential to substantially increase the scope of recovery beyond the core symptoms of PTSD and facilitate greater patient engagement, resulting in more Veterans benefitting from CPT. Modifying the CPT protocol to personalize the intervention for the individual patient has resulted in better overall response rates for a wider variety of patient populations suffering from complicated clinical presentations.
Case formulation (CF) is a well-established approach to cognitive-behavioral treatment that facilitates a collaborative process between providers and patients to guide the tailoring of treatment to meet idiosyncratic patient needs. Integrating CF strategies into the existing CPT protocol will enable providers to personalize CPT to directly address impairment in functioning as well as provide the latitude to directly intervene with the complex challenges that threaten optimal outcomes within the context of trauma-focused therapy. CF-integrated CPT (CF-CPT) expands and enhances the CPT protocol to facilitate a personalized and flexible approach to treating PTSD that prioritizes the administration of the full dose of CPT while expanding the protocol to directly target important domains of functioning and result in more holistic outcomes.
This controlled treatment outcome trial will randomize a national sample of CPT providers (Veteran n = 200; provider n = 50) to either deliver CF-CPT or CPT to compare the relative effectiveness of CF-CPT to CPT in improving primary outcomes, including Veterans' psychosocial functioning, quality of life and well-being over the course of treatment and 3-month follow-up as compared to Veterans who receive standard CPT. Further, Veterans who receive CF-CPT will demonstrate greater reductions in PTSD and depression over the course of treatment and 3-month follow-up than those who receive CPT.
This study also seeks to determine the effectiveness of CF-CPT as compared to CPT in improving Veterans' treatment engagement (CF-CPT will demonstrate higher rates of Veteran treatment completion than CPT).
This study will valuate CF-CPT's indirect impact on Veterans' psychosocial functioning and PTSD/depression symptomology Change in functioning, quality of life, and well-being \& PTSD and depression will be associated with improvement in the idiosyncratic clinical challenges targeted by the CF.
This study will also examine between-group differences across secondary outcomes (e.g. anger, anxiety, health concerns, sleep, numbing/reactivity) and describe the frequency and type of the clinical and rehabilitative needs of the Veterans and the type and duration of divergences (e.g. rehabilitative techniques) made by providers.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Suicidal Ideation, Homicidality, Mania, Psychosis, Serious Substance Abuse, Others
179 Participants Needed
RRFT for Substance Use and PTSD in Teens
Denver, Colorado
This trial tests a new treatment called Risk Reduction through Family Therapy (RRFT) for teens aged 13-18 who have both substance use problems and PTSD due to past trauma. RRFT combines different therapy methods to treat both issues at the same time, involving the family in the process. The goal is to see if this approach works better and if it can be effectively used in regular outpatient settings. Risk Reduction through Family Therapy (RRFT) is an integrative and exposure-based treatment approach for adolescents with substance use problems and PTSD, developed to address the gap in effective treatments for this population.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:13 - 75
Key Eligibility Criteria
Disqualifiers:Pervasive Developmental Disability, Active Psychosis, Others
212 Participants Needed
SLS-002 for PTSD
Phoenix, Arizona
This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for Post Traumatic Stress Disorder (PTSD) utilizing an adaptive platform trial (APT) design.
Intervention D - SLS-002 will assess the safety and efficacy of SLS-002 in participants with PTSD.
Please see NCT05422612 for information on the S-21-02 Master Protocol.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Seizures, Hypertension, Cardiovascular Disease, Others
Must Not Be Taking:MAOIs, Opioids, Antipsychotics, Others
200 Participants Needed
Fluoxetine for PTSD
Phoenix, Arizona
This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design.
Intervention A - Fluoxetine will assess the safety and efficacy of fluoxetine in participants with PTSD.
Please see NCT05422612 for information on the S-21-02 Master Protocol.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Must Not Be Taking:Fluoxetine
200 Participants Needed
Daridorexant for PTSD
Phoenix, Arizona
This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design.
Intervention C - Daridorexant will assess the safety and efficacy of daridorexant in participants with PTSD.
Please see NCT05422612 for information on the S-21-02 Master Protocol.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Narcolepsy, Others
Must Not Be Taking:Daridorexant
200 Participants Needed
New Treatments for PTSD
Phoenix, Arizona
This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design. Participants are randomized among the multiple cohorts in the study and the resulting randomization enables sharing/pooling of control participants, where all interventions may be compared to a common control (placebo). This master protocol describes the default procedures and analyses for all cohorts; treatment-specific procedures will be described in the Master Protocol cohort-specific appendices. Individual cohorts may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in corresponding intervention-specific clinicaltrials.gov records.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Pregnancy, Suicide Risk, Substance Use, Others
Must Not Be Taking:Psychiatric Medications
800 Participants Needed
Methylone for PTSD
Denver, Colorado
This is an extension study of participants who previously completed a Transcend-sponsored clinical trial evaluating TSND-201 as a treatment for PTSD.
Participants will be followed for up to 52 weeks. During the 52 week period, PTSD symptoms and safety will be assessed monthly.
Participants' PTSD symptoms will be assessed at each observational visit and if criteria for Relapse has been met, participants may be eligible to receive a course of TSND-201 treatment.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Non-compliance, Physical Or Psychological Findings
150 Participants Needed
Integrated Health Care for Post-Traumatic Stress Disorder
Phoenix, Arizona
The goal of this clinical trial is to determine whether which types of integrative care, meaning a combination of psychotherapy and mind-body interventions, lead to the most changes in functioning among Veterans with posttraumatic stress disorder (PTSD). The main aims are:
1. To evaluate the impact of integrative care approaches on functional outcomes among Veterans with PTSD.
2. To examine factors relevant to the implementation of integrated treatments for PTSD from the perspective of patients, providers and administrators in the VA Healthcare System.
Participants will:
1. Complete assessments at the beginning of the study and 12- and 24-weeks later.
2. Engage in 12 weeks of integrated care, with the type being randomly assigned.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Active Engagement In Included Approaches, Contraindicating Medical Conditions
300 Participants Needed
Therapy Methods for Post-Traumatic Stress Disorder
Phoenix, Arizona
Investigators' overall objective is to compare methods of identifying individuals who may be experiencing challenges in Cognitive Processing Therapy (CPT) and compare methods of intervening to optimize treatment retention and outcomes. Investigators' specific aims are:
1. to determine whether the use of CPT skills versus collaboratively considering switching to Present Centered Therapy (PCT) is more effective in improving outcomes for individuals experiencing challenges with CPT. Outcomes include post-traumatic stress disorder (PTSD) severity \[primary\], depression, functioning, and treatment retention;
2. to compare two approaches to identifying individuals in CPT in need of additional support during treatment;
3. to study the barriers and facilitators of implementing these intervention strategies.
Finally, exploratory aims will examine the stability of differences between treatment conditions, compare combinations of interventions tested, and examine moderators of intervention effects.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Severe Cognitive Impairment, Suicidal Intent, Psychotic Symptoms, Others
280 Participants Needed
Why Other Patients Applied
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
Partner-Assisted Therapy for PTSD
Phoenix, Arizona
PTSD occurs in up to 17% of post-9/11 US Service Members and is associated with long-term functional impairment, family problems, unemployment, and suicidality. Trauma-focused therapies (TFTs), such as Prolonged Exposure (PE), result in significant relief for many. Yet, TFTs are not equally effective for everyone. An important minority (\~40%) will retain their PTSD diagnoses after treatment, and many discontinue treatment prematurely, especially post-9/11 Service Members. TFTs are also more effective in addressing symptoms than psychosocial functioning. More work is needed to improve the consistency and potency of TFTs. Partnering with significant others may provide a powerful method for helping individuals get more out of their PTSD treatment. Observational research shows that relationship factors can help patients initiate, stay in, and experience greater benefit from PTSD treatment. Veterans that were surveyed experienced greater treatment gains when they shared more about their treatment with loved ones and when loved ones accommodated less for PTSD symptoms. Despite the promise of partner-involved interventions, there is no couples approach to PTSD treatment that has demonstrated superior outcomes to individual-only treatment models (i.e., TFTs). To address this gap, the investigators have completed a series of partner-assisted PTSD treatment studies, leading up the current proposal (Partnered PE, PPE). The investigators found that treatment completion rates were better than routine clinical care, and the treatment led to large improvements in participants' functioning, PTSD symptoms, and romantic functioning. For this proposed study, the primary objective is to conduct a randomized controlled trial (Research Level 3; larger-scale clinical trial) to test the superiority of PPE to standard PE among post 9/11 Veterans. The investigator's primary hypothesis is that PPE will lead to greater improvements in psychosocial functioning than standard PE. Secondary and tertiary aims examine posttreatment clinical outcomes (PTSD, depression) and intimate partner outcomes (relationship functioning, distress, caregiver burden, and psychosocial functioning), as well as examine strategies for PPE implementation. In exploratory aims, the investigators will examine the stability of group differences, treatment completion rates, the role military sexual trauma history, and treatment mechanisms.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Imminent Suicidality, Mania, Psychosis, Others
420 Participants Needed
NightWare for Post-Traumatic Stress Disorder
Denver, Colorado
The purpose of this study is to determine whether NightWare therapeutic intervention improves biomarkers of vascular and renal function in premenopausal women with PTSD-related nightmares, and examine whether these improvements restore them to levels observed in age-matched women without PTSD.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:22 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Hypertension, Cancer, Others
Must Not Be Taking:Antihypertensives, Lipid-lowering, Insulin, Others
36 Participants Needed
Mindfulness Training for PTSD
Phoenix, Arizona
This trial compares mindfulness meditation and problem-solving skills classes for Veterans with anxiety, depression, or PTSD. It aims to see which method better reduces symptoms and improves overall functioning in 300 Veterans across various locations. Mindfulness-based stress reduction (MBSR) has been studied extensively and shown to improve PTSD symptoms, depression, and overall well-being in veterans.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Recent Suicide Attempt, Others
300 Participants Needed
Antidepressants + Therapy for PTSD
Aurora, Colorado
Individuals with PTSD are more likely to engage in unhealthy behaviors such as tobacco use, drug use, alcohol misuse, and have high rates of morbidity/mortality. PTSD negatively impacts marriages, educational attainment, and occupational functioning. Some patients with PTSD can be successfully referred to specialty mental health clinics, but most patients with PTSD cannot engage in specialty care because of geographical, financial and cultural barriers and must be treated in primary care. However, policy makers do not know the best way to treat PTSD in primary care clinics, especially for patients who do not respond to the initial treatment choice. There are effective treatments for PTSD that are feasible to deliver in primary care. These treatments include commonly prescribed antidepressants and brief exposure-based therapies. However, because there are no head-to-head comparisons between pharmacotherapy and psychotherapy in primary care settings, primary care providers do not know which treatments to recommend to their patients. In addition, despite high treatment non-response rates, very few studies have examined which treatment should be recommend next when patients do not respond well to the first, and no such studies have been conducted in primary care settings.
This trial will be conducted in Federally Qualified Health Centers and VA Medical Centers, where the prevalence of both past trauma exposure and PTSD are particularly high. The investigators will enroll 700 primary care patients. The investigators propose to 1) compare outcomes among patients randomized to initially receive pharmacotherapy or brief psychotherapy, 2) compare outcomes among patients randomized to treatment sequences (i.e., switching and augmenting) for patients not responding to the initial treatment and 3) examine variation in treatment outcomes among different subgroups of patients. Telephone and web surveys will be used to assessed outcomes important to patients, like self-reported symptom burden, side-effects, health related quality of life, and recovery outcomes, at baseline, 4 and 8 months. Results will help patients and primary care providers choose which treatment to try first and which treatment to try second if the first is not effective.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Not Listed
700 Participants Needed
Probiotics for PTSD
Denver, Colorado
This trial investigates using a beneficial bacteria called Lactobacillus rhamnosus GG (LGG) to help U.S. military Veterans with PTSD who do not respond well to traditional treatments. The probiotic aims to reduce inflammation in the body and brain, which is a common issue in PTSD. By balancing gut bacteria, it may improve PTSD symptoms and overall stress response. Lactobacillus rhamnosus GG (LGG) has shown several beneficial effects, including improved insulin sensitivity and anti-inflammatory properties.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Alcohol, Substance Abuse, Bipolar, Others
Must Not Be Taking:Antifungals, Antivirals, Antiparasitics, Others
150 Participants Needed
Whole Health Intervention for PTSD
Aurora, Colorado
This trial tests Omnis Salutis, a program for recent veterans of the Afghanistan and Iraq conflicts. The program helps veterans set and share their health goals with doctors and support systems to improve their well-being.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Affective Psychoses, Others
238 Participants Needed
Project Safe Guard-Trauma for PTSD
Aurora, Colorado
The goal of this randomized controlled trial is to determine if a counseling intervention, Project Safe Guard-Trauma (PSG-T), increases secure firearm storage practices in adults who screen positive for posttraumatic stress disorder (PTSD). The main questions this study aims to answer are:
* Does PSG-T lead to more secure firearm storage practices?
* Does PSG-T increase knowledge about the link between firearm storage practices and suicide risk?
* Does PSG-T increase intentions to store firearms securely?
Researchers will compare PSG-T to a control, Project Safe Guard (PSG), which is a counseling intervention that does not focus on the potential influence of PTSD symptoms on firearm storage practices. This will help to determine if PSG-T works better than PSG to increase secure firearm storage in adults with elevated PTSD symptoms.
Participants will:
* Complete a baseline survey
* Receive the counseling intervention
* Complete a survey immediately after the intervention and at 1-, 3-, and 6-months following the intervention
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Active Psychosis, Acute Mania, Others
168 Participants Needed
NightWare for PTSD
Aurora, Colorado
The purpose of this study is to learn more about the effectiveness of a prescription wrist-wearable device called NightWare (NW) on improving sleep in Veterans with nightmares related to posttraumatic stress disorder (PTSD). The investigators also want to learn whether it improves cardiovascular health among this population.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:22 - 88
Key Eligibility Criteria
Disqualifiers:Unstable Medical Condition, Pregnancy, Substance Abuse, Others
Must Not Be Taking:Insulin, Sulfonylureas
125 Participants Needed
PATH Program for NICU Parent Mental Health
Aurora, Colorado
The objective of this study is to develop and pilot test a telehealth-based mental health screening and engagement program that supports parents as their infants transition home from the NICU. The program will use a stepped-care approach to screen parents for depression, anxiety, and PTSD; provide a brief behavioral intervention to those who screen as having at least a low risk of these conditions; and provide a warm hand-off to community mental health services for those at medium to high risk.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Non-English/Spanish Speakers, Others
72 Participants Needed
MDMA-Assisted Therapy for Post-Traumatic Stress Disorder
Boulder, Colorado
The purpose of this study is to assess the safety and efficacy of MDMA-Assisted Therapy on Health Care Workers suffering from symptoms of Post-Traumatic Stress due to their work on the frontline of the COVID Pandemic.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Psychotic Disorder, Bipolar I, Others
Must Not Be Taking:QT Prolonging Drugs
30 Participants Needed
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