An Open-label Study of ALTO-100 in Adults With Major Depressive Disorder and/or Post-traumatic Stress Disorder
The goal of this study is to collect biologically based data for defining predictors and correlates of the effects of ALTO-100.
NCT05117632 — Major Depressive Disorder
Status: Completed
http://inclinicaltrials.com/major-depressive-disorder/NCT05117632/
Stellate Ganglion Block to Augment Trauma-focused Therapy Among Veterans With PTSD
Our long-term goal is to improve clinical outcomes among patients receiving psychological treatment for posttraumatic stress disorder (PTSD). The primary objective of this project is to examine if stellate ganglion block (SGB) improves outcomes among military personnel and veterans receiving cognitive processing therapy (CPT), an empirically-supported psychological treatment for PTSD. To accomplish this objective, we will enroll adult military personnel and veterans with a current diagnosis of PTSD and/or subthreshold PTSD, provide CPT sessions over two weeks, administer SGB during or after CPT, and repeatedly assess key outcomes during follow-up.
NCT05107752 — PTSD
Status: Recruiting
http://inclinicaltrials.com/ptsd/NCT05107752/
Adolescent BREATHE Primary Care Intervention for PTSD (PCIP) Randomized Feasibility Trial
There are three research questions: (1) whether the Primary Care Intervention for PTSD (PCIP) improves health outcomes; (2) whether and how the PCIP can be sustainably delivered via telehealth; and (3) how PCIP compares to treatment as usual (TAU) participants. The mixed methods randomized feasibility trial of the protocol will be measured by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) (n=44 patients and their care givers). We will collect data on patient, caregiver, and clinic staff participation, retention, and satisfaction (Reach and Adoption), change in hypothesized treatment mechanisms and symptoms (Effectiveness), and facilitators and barriers to intervention delivery and fidelity (Implementation). We will, 1. Assess the reach and adoption of the protocol by analyzing quantitative data on patient and clinic staff participation, retention, and satisfaction; 2. Explore the effectiveness of the protocol through medical record review, quantitative assessments at baseline and post-treatment, and semi-structured qualitative interviews at baseline and post-treatment to: 3. Evaluate the implementation of the screening and intervention protocol with post-intervention semi-structured qualitative interviews to assess facilitators and barriers to intervention delivery, quantitative fidelity scales, observation of screening, and review of intervention audio recordings to assess fidelity to the protocol and intervention process.
NCT05088915 — Post Traumatic Stress Disorder
Status: Recruiting
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT05088915/
Long-Term Safety and Persistence of Effectiveness of Manualized MDMA-Assisted Therapy for the Treatment of Posttraumatic Stress Disorder
Data from a series of Phase 2 and 3 studies of MDMA-assisted therapy conducted by the sponsor provide preliminary evidence that chronic Posttraumatic Stress Disorder (PTSD), independent of cause, is treatable with up to three sessions of MDMA-assisted therapy. This non-interventional study will serve as the long-term follow-up (LTFU) protocol for MDMA-assisted therapy clinical trials and will measure persistence of effectiveness using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) as a measure of PTSD symptom severity. Additionally, this study will gather data to support health economics and cost effectiveness analyses of this treatment. Participants who have received at least one dose of Investigational Medicinal Product (IMP) in the main study will be eligible to participate in this study.
NCT05066282 — PTSD
Status: Enrolling by invitation
http://inclinicaltrials.com/ptsd/NCT05066282/
Virtual Mantram Repetition Program for Patients With Posttraumatic Stress Disorder and Substance Use Disorders
The purpose of this study is to evaluate a virtual Mantram repetition program for adults with PTSD and substance use disorders. The program involves repetition of a personalized Mantram, which is a word or short phrase with spiritual meaning that is frequently repeated throughout the day. The program also involves slowing down thoughts and have one-pointed attention that help with stress.
NCT05058963 — Post Traumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT05058963/
Gaze-Contingent Music Reward Treatment (GC-MRT) for PTSD
The present study is a double-blind trial that seeks to examine the feasibility, acceptability, and efficacy of a recently developed eye-tracking-based, gaze-contingent music reward therapy (GC-MRT) in individuals with posttraumatic stress disorder (PTSD). The specific aims of this study are to: (1) examine the efficacy of GC-MRT in PTSD; and (2) elucidate its underpinnings (i.e. attention control, reward processes, and exposure via counter-conditioning). The investigators hypothesize that: 1. GC-MRT will produce greater reductions in symptoms compared to PC at post-treatment and follow-up (diverting attention away from threat). 2. GC-MRT-exp will produce greater reductions in symptoms compared to PC at post-treatment follow-up (exposure via counter-conditioning by rewarding threat stimuli). 3. Exploratory analysis will compare the reductions in symptoms of GC-MRT compared to GC-MRT-exp at post-treatment follow-up.
NCT05057624 — Posttraumatic Stress Disorder
Status: Not yet recruiting
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT05057624/
A Multimethod Psych-physiological Randomized Controlled Trial of a Couples' Intervention for PTSD
Posttraumatic stress disorder (PTSD) is a multifaceted disorder resulting from intense and/or life-threatening trauma. PTSD sequelae often have a ripple effect on close others, including spouses and children. Studies report high levels of relationship distress for both those with PTSD and their partners as well as emotional distress. Despite the extensive knowledge on the effects of PTSD on couple relations and vice versa, and the limitations of individual therapies in addressing these issues, there has been a major lag in the development and study of couples' interventions in the context of PTSD. the current study will examine the efficacy of Cognitive Behavioral Conjoint Therapy (CBCT) for PTSD. It will employ an RCT to examine both outcomes and processes of change via multiple methods of assessment, including self-report questionnaires, qualitative interviews and physiological co-regulation measures. Moreover, it will employ a modified procedure via video conference due to COVID-19 in addition to in-person treatment option. The study will therefore contribute to theoretical understandings of the effects of PTSD on couples, to the development of therapies specifically intended for such couples.
NCT05045859 — Psychological Trauma
Status: Recruiting
http://inclinicaltrials.com/psychological-trauma/NCT05045859/
Telehealth 2.0: Evaluating Effectiveness and Engagement Strategies for Asynchronous Texting Based Trauma Focused Therapy for PTSD
There is a pressing need to increase capacity to treat PTSD related to or exacerbated by the COVID-19 pandemic. Texting-based therapy holds promise to increase capacity and reduce barriers to delivering evidence-based treatments (EBTs), but ongoing engagement in digital mental health interventions is low. This study will compare a texting-based EBT for PTSD to culturally-informed texting-based treatment for PTSD as usual, and it will also compare a unique incentive strategy to typical platform reminders aimed to prevent early discontinuation in therapy. This online study is open to individuals who live in 13 different states.
NCT05037175 — Posttraumatic Stress Disorder
Status: Recruiting
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT05037175/
Low-Voltage, Direct Current Pulsed ElectroMagnetic Field (PEMF) Therapy in Treating Patients With Post-Traumatic Stress Disorder (PTSD and cPTSD) and Trauma
Use of low-voltage, direct current pulsed electromagnetic fields (PEMF) in treating Post Traumatic Stress Disorder (PTSD), complex PTSD (cPTSD) and trauma-related injuries manifesting in physical and/or mental symptoms.
NCT05033600 — Unspecified Trauma- and Stressor-Related Disorder
Status: Completed
http://inclinicaltrials.com/unspecified-trauma-and-stressor-related-disorder/NCT05033600/
Cognitive Processing Therapy for the Treatment of Post-Traumatic Stress Disorder in Syrian Patients
Background: Studies among Syrian refugees showed high prevalence rates of PTSD. The objective of the present study was to investigate the effectiveness of Cognitive Processing Therapy (CPT) in treating patients with posttraumatic stress disorder (PTSD) using a clinical trial. Methods: Data will be obtained through interviewing patients seeking for PTSD treatment. Patients will be interviewed by a clinician and asked to complete the Clinician-Administered PTSD Scale (CAPS-5), Beck Depression Inventory (BDI-II), Beck Anxiety Inventory (BAI). Assessments will be conducted at baseline, 3-, and 12-months posttreatment. The primary outcomes will be the scores of CAPS, BDI-II, and BAI. Results: we predict that CPT will result in greater reductions in CAPS scores.
NCT05031728 — Posttraumatic Stress Disorder (PTSD)
Status: Completed
http://inclinicaltrials.com/posttraumatic-stress-disorder-ptsd/NCT05031728/