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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT05874362 Recruiting - Clinical trials for Post Traumatic Stress Disorder

People Bereaved by Violent Death : Negative Event Biases and Temporal Perception

PrEVENT
Start date: September 19, 2023
Phase: N/A
Study type: Interventional

A violent death is defined by its brutality, unexpectedness and is secondary to an external cause (suicide, homicide, accident). Bereavement following a violent death constitutes a particular clinical situation, at risk of complications. Research on bereavement after a violent death shows higher risks of psychiatric and somatic complications than in bereavement by non-violent death. These complications, sometimes comorbid, take the form of depressive episodes, post-traumatic stress disorders, suicidal behavior and prolonged grief disorders after 12 months, precociously mediated by ruminations. Processes responsible for this increased risk of complications are poorly documented. Current literature relates mainly to socio-demographic and epidemiological factors which, alone, do not explain this difference in risks. Further research is needed exploring other kinds of data and processes. To our knowledge, there is no description of early neurocognitive functioning in people bereaved after violent death. This study aims at exploring early neurocognitive processes which can lead to complications in people bereaved by violent death.

NCT ID: NCT05865704 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Childbirth-related Post-traumatic Stress Disorder in Switzerland: The Swiss Cohort on Traumatic Childbirth and Health

SwiTCH
Start date: May 1, 2022
Phase:
Study type: Observational

The goal of this observational study is to investigate the prevalence of Childbirth post-traumatic stress disorder (CB-PTSD) and Childbirth post-traumatic stress symptom (CB-PTSS) in Switzerland, and to analyze the psychological, medical, and social factors linked with CB-PTSD and CB-PTSS, whether they are antecedent factors or further consequences. The main questions it aims to answer are : - The prevalence of CB-PTSS and CB-PTSD in Switzerland, for both mothers and partners (Primary outcome) - The risk and protective factors of CB-PTSD and CB-PTSS (Secondary outcome) - The impact of CB-PTSD and CB-PTSS on the marital and co-parental adjustment and the bonding with the infant (Secondary outcome) - The role of the childbirth experience on the triggering of CB-PTSD and CB-PTSS, including emotional and affective aspects (Secondary outcome) - The social and economic determinants of CB-PTSD and CB-PTSS, including, for example, social support and religion (Secondary outcome) Participants will fill up surveys at four time points: - T1, during the third trimester of pregnancy - T2, at 6 to 12 weeks post-partum - T3, at 6 months post-partum - T4, at 12 months post-partum

NCT ID: NCT05862467 Recruiting - Trauma Clinical Trials

A Pilot Participatory Program Evaluation of a Virtual Trauma Support Program for Autistic Adults

Start date: October 26, 2023
Phase: N/A
Study type: Interventional

The goal of this single-group clinical trial is to learn about the initial efficacy and feasibility of telehealth-delivered Written Exposure Therapy (WET) for autistic adults with traumatic stress symptoms. The main questions the investigators aim to answer are: - Do symptoms of posttraumatic stress disorder (PTSD) and co-occurring mental health concerns decrease after receiving WET? - Do biobehavioral health outcomes, including objective (Fitbit indicators of activity, sleep, and heart rate) and subjectively-reported health variables (e.g., sleep, pain, health-related quality of life), improve after receiving WET? - How do autistic adults experience WET, and how can this program be modified and enhance in the future in collaboration with autistic adults? Participants will complete the following as part of the study, which is completed entirely over telehealth. - Participants will first complete an initial assessment, involving brief measures of cognition and autistic traits, as well as interviews and questionnaires about PTSD, mental health, and physical health. If eligible, participants will proceed to the following steps: - Eligible participants will then start wearing a Fitbit, to be used for the duration of the study. - Participants will then participate in 5 weekly virtual visits involving the WET protocol, including weekly brief assessment of PTSD and mental and physical health. - Then, participants will complete a sixth virtual visit the following week where PTSD, mental and physical health, and treatment feedback are assessed. - Lastly, participants will complete virtual visits 1 and 6 months later involving re-assessment of PTSD and mental and physical health. Therefore, this is a pre-post single group design, where all participants will receive WET to establish initial efficacy and feasibility. Investigators will also consult with an autistic advisory board throughout the project, and make adaptations as recommended in consultation with autistic adults. The goal is to better understand the initial efficacy and feasibility of WET for supporting autistic adults who have experienced trauma.

NCT ID: NCT05855876 Recruiting - Clinical trials for Traumatic Brain Injury

Reversal of Battle-Related Aging (ROBRA) in a Special Operations Forces Cohort

Start date: July 5, 2023
Phase:
Study type: Observational

The purpose of this study is to examine measures of GrimAge clock in SOF members undergoing treatment for PTSD/TBI using CSB.

NCT ID: NCT05853627 Recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Mismatch vs. Standard Intervention During Memory Reconsolidation Blockade With Propranolol: Effect on Psychophysiological Reactivity During Traumatic Imagery

Start date: June 15, 2023
Phase: Phase 4
Study type: Interventional

The proposed R21 project will attempt to further develop a novel intervention for posttraumatic stress symptoms inspired by the science of memory reconsolidation. Work in normal humans has shown that when a stable, consolidated memory is reactivated (i.e., retrieved) under appropriate conditions, it reverts to an unstable state, a process referred to herein as deconsolidation. In such a state, the memory is susceptible to the action of various "amnestic" agents that may inhibit its reconsolidation, thereby weakening it. The β-adrenergic blocker propranolol (PPNL) possesses such amnestic properties. More recent research has found that in order to initiate deconsolidation, there must be a prediction error, or mismatch, between what is expected and what occurs when the memory is reactivated. Prior placebo-controlled, randomized clinical trials (PBO-RCT) from our laboratory have found that when propranolol is administered concomitant with the reactivation of a psychologically traumatic memory, the memory is weakened, as revealed by subsequent lower physiological (heart rate, skin conductance, facial electromyogram) responding during script-driven mental imagery. Clinical applicability was evaluated in a PBO-RCT, in which PTSD participants receiving propranolol underwent six weekly sessions of 10-20 min of "standard" (STD) traumatic memory reactivation stimulated by reading a narrative. At post-treatment, these participants showed a greater reduction of PTSD symptoms compared to participants who had taken PBO. The goal of the proposed study is to test whether intentionally incorporating innovative mismatch (MM) into traumatic memory reactivation can improve upon physiological responding during script-driven mental imagery. Participants will be randomized to one of 2 treatment arms: STD/PPNL and MM/PPNL. A baseline assessment will measure psychophysiological responsivity to script-driven mental imagery (target measure). PPNL will be administered 90-min prior to each of six weekly 10-20 min. traumatic memory reactivation sessions. In the MM condition, a different, unexpected mismatch (e.g., singing the narrative) will be incorporated into the reactivation. In the STD condition, the participant will read the narrative the same way each time. The focus of the R21 proposal will be to assess whether the MM/PPNL group shows lower subsequent physiological responses than the STD/PPNL group

NCT ID: NCT05843695 Recruiting - Anxiety Disorders Clinical Trials

Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety

Start date: September 22, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare two different intensive formats of delivering cognitive-behavioral treatment for people with PTSD and anxiety disorders. The main questions it aims to answer are: - Is iTCBT delivered in individual and group formats more effective than TAU in improving anxiety symptoms and quality of life? - For treatment non-responders, is iTCBT-Enhanced more effective than TAU improving anxiety symptoms and quality of life? - Does iTCBT-Individual produce a larger improvement in anxiety and quality of life compared with iTCBT-Group? Participants will undergo several assessments throughout the course of the study. Based on randomization, they will receive: (1) iTCBT in an individual format over a 2-week period, (2) iTCBT in a group format over a 2-day period, or (3) usual care. Those who do not show a response to treatment will receive 4 additional individual therapy sessions.

NCT ID: NCT05817344 Recruiting - Clinical trials for Stress Disorders, Post-Traumatic

New Beginnings Following Trauma

Start date: January 9, 2024
Phase: N/A
Study type: Interventional

Posttraumatic stress disorder (PTSD) is associated with increased rates of prescription opioid misuse, high-risk opioid use, illicit use of substances, and overdose (Meshberg-Cohen et al., 2021) Some research has demonstrated that among individuals with opioid use disorder (OUD), 92% report exposure to a traumatic event (Mills et al., 2005). Approximately 41% of those with OUD have a lifetime history of PTSD and 33.2% of individuals with OUD meet current diagnostic criteria for PTSD, indicating very high rates of PTSD among people with co-occurring OUD (Mills et al., 2006, 2007). PTSD also prospectively increases risk for OUD after exposure to opioids (Hassan et al., 2017). Medications for opioid use disorder (MOUD) are evidence-based pharmacological interventions for OUD (methadone, buprenorphine, naltrexone) to manage pain and withdrawal (Leshner & Mancher, 2019). Though effective, dropout from MOUD programs is high (Mokri et al., 2016; O'Connor et al., 2020). It is also common in substance use disorder (SUD) treatment settings not to treat PTSD (Norman & Hien, 2020), though concurrent PTSD and MOUD treatment is associated with higher continuation in MOUD programs compared to no PTSD treatment (Meshberg-Cohen et al., 2019; Schacht et al., 2017). Despite this, there is little data regarding efficacy or effectiveness of specific trauma-focused PTSD treatments among patients in MOUD programs. Combined with effective cognitive-behavioral techniques for substance use disorder (SUD), evaluation of brief, trauma-focused interventions for PTSD has substantial potential to improve care for individuals with PTSD receiving MOUD. The present study will begin to address this need by evaluating the feasibility, acceptability, and initial efficacy of Written Exposure Therapy (WET) for PTSD integrated with harm reduction skills for managing SUD symptoms among a sample of patients receiving MOUD [Written Exposure Therapy-Integrated (WET-I)]. WET is a five-session treatment for PTSD requiring limited therapist training and minimal patient burden (Sloan & Marx, 2019). WET has shown comparable outcomes to gold-standard interventions for PTSD, with improved retention rates (Sloan et al., 2018). WET has marked potential within this population, especially given that many clinicians in SUD programs do not have specialized training in PTSD treatments (Killeen et al., 2015). Using a multiple baseline single case experimental design (SCED), 6 participants with current PTSD and current or past OUD will be recruited from MOUD treatment programs to engage in 5 weekly sessions of WET-I. Participants will complete an intake assessment to establish PTSD and OUD diagnoses and will be randomized to a 3- or 5-week baseline assessment period. Weekly assessments of symptoms (i.e., PTSD, anxiety, depression), substance craving and use, quality of life, and compliance with MOUD treatment will be completed during the baseline, treatment, and one-month follow-up phase. During the treatment phase, participants will also complete weekly measures of therapeutic alliance and will provide feedback on treatment credibility and treatment satisfaction. Aim 1: To examine feasibility and acceptability of WET-I among participants in MOUD treatment with co-occurring PTSD/OUD. Feasibility of WET-I will be demonstrated via treatment retention and completion. Acceptability of engaging in WET-I in tandem with MOUD treatment will be demonstrated via high patient credibility ratings of WET-I and high treatment satisfaction ratings. Aim 2: To determine if WET-I can significantly reduce symptoms of PTSD, anxiety, and depression in participants with comorbid PTSD and OUD and to monitor changes in drug use behaviors and craving over the treatment period. Participants will report reliable clinical improvement in symptoms (PTSD, anxiety, depression) and quality of life during the treatment phase and post-assessment without corresponding increases in substance use behavior or craving, and these improvements will be maintained at follow-up.

NCT ID: NCT05811897 Recruiting - Clinical trials for Major Depressive Disorder

RESILIENT : A Self-Managed Online Platform for Victims of Sexual Assault

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

There are 636,000 self-reported cases of sexual assault annually in Canada, and nine out of ten persons who have experienced sexual assault are women. Cognitive and behavioural therapies (CBT) are the treatment of choice for many psychological problems arising from sexual assault. However, accessing CBT is a significant challenge, especially for women who have experienced sexual assault who may be ashamed and not disclose the sexual assault. Online CBT is an effective option to circumvent these barriers. In addition to being accessible and less resource-intensive, studies report that patients are less inhibited and that the online environment provides greater emotional safety. There is also a growing body of evidence that online CBT programs requiring little or no contact with a mental health professional are effective, this having been demonstrated primarily with individuals with anxiety and mood disorders. But when it comes to treating the psychological symptoms of sexual assault in potentially vulnerable individuals, can we really suggest a self-care approach? There is no direct empirical evidence to support such a recommendation, and it is this important question that this project wishes to address. To compare the effectiveness, acceptability and user engagement in a self-managed treatment platform with or without the support of a therapist to reduce post-traumatic symptoms, depression and insomnia in people who have suffered one or more sexual assaults, 204 victims of sexual assault experiencing significant distress will be recruited and randomly assigned to either the self-managed or the therapist-assisted online treatment condition. Participants will complete measures assessing post-traumatic stress disorder, insomnia, depression, anxiety, and maladaptive beliefs before, during, after and 3 months after treatment. Secondary outcome will be and appreciation of the online treatment measures by a self-report questionnaire and a semi-structured interview. If effective in reducing symptoms, this treatment would offer the potential to support a self-care approach to treating a wide range of psychological symptoms resulting from sexual assault. The self-managed online platform would fill a service gap deplored by this population.

NCT ID: NCT05791760 Recruiting - Clinical trials for Posttraumatic Stress Disorder

The Effectiveness of CFT for Reducing Self-criticism in Patients With Complex PTSD: a Single-case Experimental Study

Start date: March 19, 2023
Phase: N/A
Study type: Interventional

PTSD is a mental disorder including psychological symptoms related to severe traumatic event(s). PTSD can negatively affect people's functioning in several life domains. Several effective therapies for the treatment of PTSD have been developed in recent decades. However, these treatments are not effective for every patient. Several studies show that people suffering from PTSD also experience feelings of trauma-related guilt, shame, self-blame and negative self-evaluation. These emotions may contribute to the maintenance cycle of PTSD or even become worse over time. In particularly in patients with trauma who have been exposed to repeated traumatic experiences within the context of interpersonal relationships including childhood sexual/physical abuse and domestic violence. This type of trauma is known as complex PTSD. cPTSD is marked by severe difficulties in problems with self and emotion-regulation, relationship difficulties and shame. One key factor for reducing self-criticism in individuals might be self-compassion as the antidote to self-criticism and shame. Compassion focused therapy by Paul Gilbert focuses specifically on increasing self-compassion. Although some studies show promising results of CFT in patients with cPTSS, the effectiveness for this group has not yet been sufficiently examined. Therefore, this Single case experimental design study is conducted with the primary objective of examining the effectiveness of CFT in reducing the primary outcome self-criticism. Secondary outcomes that will be examined are CFT reduces PTSD symptoms and shame and increases self-compassion and well-being. This SCED study is a noncurrent multiple baseline across subjects study, consisting of three phases with twice-weekly repeated measurements of self-criticism. First the pre-intervention baseline phase, in which participants are randomly assigned to different baseline lengths (either 5, 6 or 7 weeks). The second phase is the subsequent CFT-intervention, consisting of 12 weeks of weekly CFT group sessions with two-weekly assessments of self-criticism. The third phase is follow up for 5 weeks from the end of the intervention, again including two-weekly assessments of self-criticism. By comparing the baseline phases with the intervention and follow-up phases for individual participants, the effectiveness of the CFT intervention on self-critical beliefs can be determined. Changes that occur within participants can be seen as evidence of intervention effectiveness.

NCT ID: NCT05789329 Recruiting - PTSD Clinical Trials

Non-Inferiority Trial of TrIGR for PTSD

TrIGR/CPT
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Trauma-related guilt is common and impairing among trauma survivors, particularly among Veterans with posttraumatic stress disorder (PTSD). The investigators' work shows that a brief treatment targeting trauma-related guilt, Trauma Informed Guilt Reduction Therapy (TrIGR), can reduce guilt and PTSD and depression symptoms. Whether TrIGR is no less effective than longer, more resource heavy PTSD treatments disseminated by by VA, like cognitive processing therapy (CPT), is the next critical question that this study will seek to answer. 158 Veterans across two VA sites will be randomized to TrIGR or CPT to evaluate changes in PTSD, depression, guilt and shame symptoms across the two treatments.