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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT05023252 Recruiting - Schizophrenia Clinical Trials

Mobile Self-Tracking

Start date: October 18, 2021
Phase: N/A
Study type: Interventional

Serious mental illnesses require years of monitoring and adjustments in treatment. Stress, substance abuse or reduced medication adherence cause rapid worsening of symptoms, with consequences that include job loss, homelessness, suicide, incarceration, and hospitalization. Treatment visits can be infrequent. Illness exacerbations usually occur with no clinician awareness, leaving little opportunity to make treatment adjustments. Tools are needed that quickly detect illness worsening. At least two thirds of Veterans with serious mental illness use a smart phone. These phones generate data that characterize sociability, activity and sleep. Changes in these are warning signs for relapse. Members of this project developed an app that monitors and transmits these mobile data. This project studies passive mobile sensing that allows Veterans to self-track their activities, sociability and sleep; and studies whether this can be used to track symptoms. The project intends to produce a mobile platform that monitors the clinical status of patients, identifies risk for relapse, and allows early intervention.

NCT ID: NCT05020587 Recruiting - Moral Injury Clinical Trials

Consulting After Combat: Interviewing Veterans to Develop a Therapy to Restore Functioning and Reintegration After Moral Injury Events

CAC
Start date: February 1, 2022
Phase: Early Phase 1
Study type: Interventional

Despite the VA's best efforts to treat the psychosocial impact of war, many combat Veterans report lingering difficulty reintegrating into meaningful post-deployment lives. War is among the most extreme forms of human experience but, for many, wartime trauma was treated using models transported from civilian single-incident trauma contexts. Veterans have unique needs and experiences that require culturally responsive and sensitive conceptualizations and treatments. Patient-centered care is improved by providing multiple effective treatment options and this project, if successful, could have a significant impact on VA care. This CDA-2 project has the potential to offer innovative treatment for traumatized combat Veterans who otherwise may not find full relief from PTSD. Clinical research practice will be advanced by employing state-of-the-art user-centered design methods combined with expert clinical feedback to develop an effective and usable group treatment manual that will meet VA needs.

NCT ID: NCT05020197 Recruiting - Clinical trials for Post-Traumatic Stress Disorder

Study of the Association Between the Type of Attachment and the Risk of Post-Traumatic Stress Disorder

TRAUMAFFECT
Start date: March 23, 2022
Phase:
Study type: Observational

Attachment theory models the emotional bonding that is activated in situations of danger, via mental representations of self and others. Four types of attachment (TA) exist in adults: 3 insecure (Preoccupied, Detached, Fearful) and 1 secure. Attachment type is a major factor in the development of Post-Traumatic Stress Disorder (PTSD), a frequent and disabling mental disorder that occurs after a traumatic event. A meta-analysis based on Anglo-Saxon studies including various populations (general, military or clinical) (n=9268 patients) suggested an association between Fearful BP and high level of PTSD symptoms (r=0.44). Nevertheless, these results did not allow the identification of variations related to the individual risk factors (RDFs) of the subject and his environment, especially in the French socio-cultural context. The investigators propose to study the association between LDs and the risk of PTSD in the days following exposure, their mutual influence in the months following, and their associated factors. Thus, a prospective cohort study among French adult victims of a traumatic event could objectify the link between BP - as close as possible to the event - and the risk of PTSD.

NCT ID: NCT05011825 Completed - Depression Clinical Trials

A Pilot Evaluation of the Pregnant Moms' Empowerment Program

Start date: March 15, 2017
Phase: N/A
Study type: Interventional

This project will use a longitudinal design with assessments at baseline (T1), post-treatment (T2), 3 month post-partum (T3), 1 year postpartum (T4) and 3.5-5 years postpartum to examine whether the PMEP improves participants': a) mental health (depression, PTSD) and resilience, b) parenting skills, c) birth, infant, and toddler developmental outcomes, and d) lowers re-victimization rates. We hypothesize significantly improved outcomes in the intervention group compared to the control group at post-treatment and at all follow-ups. The pilot will use a quasi-randomized design, with participants assigned to alternating treatment and control blocks. Analyses will be conducted using intent to treat and per protocol methods. Following group assignment, all women will be scheduled for a baseline interview at a time convenient for the participant. Participant interviews will take approximately 1.5 hours. Mothers will be compensated with a gift card in the amount of 40 USD for each interview. In addition to the core evaluation metrics, mothers' demographic information will be obtained (age, relationship status, employment, education, number of children, income). Following the baseline interview, the PMEP will be provided to the treatment group; participants will receive 2-hours of contact time per week for 5 weeks (2-hour sessions, held once weekly). Women will receive reminder calls the day of each session to identify and resolve any barriers to attendance (e.g., transportation). Taxi fare will be supported for women who are unable to obtain transportation if the bus is not feasible. Following the completion of the PMEP groups or - for the control group - after 5-6 weeks has passed, all participants will complete a second interview. This interview will include all of the core measures of hypothesized treatment change, thereby permitting a comparison between women in the treatment and control groups over time. All women will be invited in a third time when their infant is 3 months old and again when their infant is 1 year of age to evaluate parenting and infant outcomes. Women will participate in a brief phone assessment when their children are between 3.5 and 5 years of age that includes all primary study outcomes.

NCT ID: NCT05001542 Completed - Distress, Emotional Clinical Trials

Digital Interventions for Detection and Reduction of Moral Distress

VR
Start date: May 31, 2021
Phase: N/A
Study type: Interventional

Stress, anxiety, distress and depression are exceptionally high among healthcare workers at the frontline of the COVID-19 pandemic. Factors underlying distress and resilience are unknown and there are no evidence based interventions to impact the mental wellbeing of frontline healthcare workers. This study will evaluate a novel virtual reality platform to gather the "distress experience" of frontline healthcare workers at Unity Health Toronto in real time during the ongoing COVID pandemic by developing and showing feasibility of digital technology (Virtual Reality (VR) and mobile app) as a digital platform to understand the causes and ultimately reduce the moral distress of healthcare providers during the COVID-19 pandemic. The project will develop innovations which can be used for future pandemics and other contexts prone to producing moral distress and injury.

NCT ID: NCT05001399 Completed - Chronic Pain Clinical Trials

Feasibility of Using Holographic Memory Resolution® (HMR) in Patients/Clients With Pain

Start date: October 25, 2021
Phase: N/A
Study type: Interventional

Study Purpose: This study will explore the feasibility of administering Holographic Memory Resolution® (HMR) to adults who are experiencing chronic pain for 6 months or more.

NCT ID: NCT04999852 Completed - Anxiety Clinical Trials

The Effects of the Safe and Sound Protocol on PTSD Symptoms and Anxiety

Start date: July 12, 2021
Phase: N/A
Study type: Interventional

The Safe and Sound Protocol (SSP) is a passive acoustic intervention that is designed as a "neural exercise" to promote efficient regulation of autonomic state. Prior research has shown that the SSP can improve autonomic function, auditory hypersensitivities, and emotion regulation in individuals with Autism Spectrum Disorders. This observational pilot study is being conducted to establish methods for an upcoming randomized controlled trial to test the utility of the SSP for trauma treatment. This study will enroll clients at the Spencer Psychology clinic who are set to take part in SSP under the supervision of their therapist. Because the therapists have participated in the design of the protocol and will participate in data collection and analysis, SSP will be considered a research procedure. In addition to taking part in SSP, subjects complete a set of questionnaires and have their pulse measured before starting the SSP intervention, after having completed 2/5 hours of the SSP, one week after completing all 5 hours of the SSP, and one month after completing the SSP intervention. The investigators will also pull relevant information from Spencer Psychology's medical records to document diagnosis, track client progress during study, and augment self-reported demographics. Clients who are receiving psychotherapy but not the SSP will be recruited as a comparison group.

NCT ID: NCT04992767 Recruiting - Pregnancy Related Clinical Trials

Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy

Start date: October 21, 2022
Phase: N/A
Study type: Interventional

The investigators will design, construct, and pilot a prototype of a trauma-informed online intervention, which will be called "SunnysideFlex," that functionally integrates a web-based intervention targeting skills to decrease symptoms of PTSD and better manage mood during and after pregnancy. SunnysideFlex will build upon the previously IRB-approved "Sunnyside" intervention which targeted skills to manage mood through an interactive website with didactic material and tools. Women in weeks 16-28 of their pregnancy who self-report symptoms of PTSD will be randomized to one of three study groups: (1) SunnysideFlex, (2) the original Sunnyside intervention (active control), or (3) treatment as usual (TAU). The SunnysideFlex intervention will consist of 6 weeks of trauma-informed online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. Outcomes will be measured at baseline, post-intervention, 6 weeks postpartum, and 12 weeks postpartum. SunnysideFlex has the potential to provide a novel paradigm for improving maternal and child health outcomes in high-risk, trauma-exposed women.

NCT ID: NCT04985344 Recruiting - PTSD Clinical Trials

Treatment of Pediatric Post-traumatic Stress Disorder With Memory Reactivation Under the Influence of Propranolol

PPP
Start date: February 1, 2023
Phase: Phase 3
Study type: Interventional

By age 18, roughly 8% of traumatized youth have met criteria for a diagnosis of PTSD, with numbers rising up to 40% in cases of sexual abuse and assault. To date there is no empirical support for the use of psychopharmacological interventions as treatment of pediatric PTSD. Trauma-focused psychotherapeutic/TFP approaches should be favored in childhood PTSD. However, when compared to active control conditions, TFP produced a mean effect size on child and adolescents population (g=0.83). Moreover, in therapies with a substantial exposure component, the intense and lengthy reexperiencing of the traumatic event results in a substantial proportion of participants dropping out. The reactivation of a previously consolidated memory can make it labile, subsequently requiring a re-stabilization of it called reconsolidation of the memory. Acting on these reconsolidation processes makes possible to interfere with the subsequent storage of this memory.

NCT ID: NCT04982523 Completed - Clinical trials for Post Traumatic Stress Disorder

Online Mental Health Program for Female College Students

Start date: April 27, 2020
Phase: N/A
Study type: Interventional

Late adolescence and early adulthood are the most exposed to trauma. College students exposed to trauma may experience depression, anxiety, stress, and difficulties adapting to college life. Depression symptoms are the most common reactions that people experience after traumatic experiences. Depression also harms college students reactions that people experience after traumatic experiences. It is difficult for people who are depressed to meet their social function. Trauma also has adverse physical effects, including dysfunction of the hypothalamus and adrenal axis, lowering blood cortisol levels. As a result, the body's immune system is disturbed, leaving people more exposed to diseases and experiencing more pain and fatigue. In particular, women are more vulnerable to PTSD than men. Women with post-traumatic stress and depression are also more likely to be exposed to several diseases. Moreover, when traumatized female college students experience life stress, it worsens their mental health and interferes with their studies. Cognitive behavioral therapy is the most effective content composition method for trauma intervention. CBT should be improved by helping to reduce PTSS and depression and managing various aspects of life, such as nutrition, activity, and rest. One major advantage of online programs is that they do not face any time or space constraints, and they are also less expensive than face-to-face programs. More importantly, online programs can reduce psychological barriers to participation. This is especially important for women who are more likely to feel shame and stigma about interpersonal traumas, such as those arising from relationships and sexual trauma, which are obstacles to their access to face-to-face programs. College students can easily access online programs because of their familiarity with the Internet, so the programs can be immediately available in response to crises without requiring them to expose personal information to unfamiliar therapists. In this study, the interventions program was based on the Roy Adaptation Model to address post-traumatic physical and mental health problems among female college students in Korea. Hypothesis - The post-traumatic stress scores, depressive symptom scores of participants who access the program will decrease more than those who do not. - The functional health scores, college adaptation scores of participants who access the program will increase more than those who do not.