Enhancing Memory and Learning in Cognitive Processing Therapy for Post Traumatic Stress Disorder (PTSD)
The efficacy of psychological interventions for posttraumatic stress disorder (PTSD) is likely limited by the difficulty participants have learning and remembering important therapy content. Accordingly, the present study will examine the utility of integrating a Memory Support (MS) intervention into Cognitive Processing Therapy (CPT), an empirically supported and widely disseminated treatment for PTSD. MS was designed to integrate techniques aimed at facilitating encoding, consolidation, and retrieval of new learning into existing treatments, and has been shown to improve outcomes when integrated into cognitive therapy for depression. A pilot randomized controlled trial (n=52) comparing CPT with Memory Support (CPT+MS) to CPT-alone will be conducted. Study participants will be adults diagnosed with PTSD. The primary aim of the trial will be to determine if CPT+MS will lead to greater memory and learning of therapy content relative to CPT-alone, and to establish the acceptability and feasibility of integrating MS into CPT. Secondary aims include a preliminary examination of treatment efficacy, as indicated by the magnitude of changes in PTSD symptoms between conditions, and target validation, as indicated by associations between memory and learning of therapy content and treatment response. Exploratory analyses will examine several indicators of baseline memory-related cognitive functioning as predictors of memory and learning of therapy content, providing preliminary data to inform future research on personalized application of MS. Results of the trial will advance scientific knowledge about methods for optimizing memory and learning as a mechanism for improving PTSD treatment outcomes.
NCT05310097 — PTSD
Status: Recruiting
http://inclinicaltrials.com/ptsd/NCT05310097/
An Immersion Intervention for Symptoms of PTSD in Student Veterans
This study will explore the physical and psychological effects of warm water immersion to the chest on student Veterans who experience symptoms of Post-Traumatic Stress Disorder (PTSD) and may also have depression, anxiety and pain.
NCT05309031 — Stress Disorders, Post-Traumatic
Status: Completed
http://inclinicaltrials.com/stress-disorders-post-traumatic/NCT05309031/
Pilot Study Examining Adaptation of EAT-PTSD (the MOW Protocol) for Anxious Youth
The purpose of this research protocol is to adapt the Equine Assisted Therapy (EAT) protocol, which the investigators had developed to help treat PTSD (EAT-PTSD; the Man O' War (MOW) protocol), for use with adolescents who have an anxiety disorder. The MOW protocol is an eight session, group therapy EAT protocol, which the investigators developed, piloted, revised, and tested. EAT is an alternative treatment practiced across the United States and around the world for mental health disorders, in which the horse(s) play an essential role in an experientially oriented therapeutic approach. The MOW protocol is for group EAT, with groups led by a licensed mental health provider and an "equine specialist," working with two horses and assisted by a wrangler (horse handler) to assure safety. In the open trial, the MOW protocol showed promising results in reducing the level of PTSD and Depressive symptoms in veterans with moderate to severe PTSD, was found to be safe (no adverse events), and well accepted (very few dropouts (Fisher et al., 2021)) and found evidence of neural changes (Zhu et al, 2021). As part of the MOW project, the investigators prepared a well specified treatment manual (Fisher et al, 2021) - the first of its kind in the field of EAT - and have trained others in its use.
NCT05298397 — Anxiety Disorder of Childhood or Adolescence
Status: Suspended
http://inclinicaltrials.com/anxiety-disorder-of-childhood-or-adolescence/NCT05298397/
Psychological Interventions for Complex PTSD And Schizophrenia-Spectrum Disorder: PICASSO Trial
Psychosis is a highly distressing mental health condition, affecting up to 3% of the population. Conceptually, it has much in common with complex post-traumatic stress disorder (CPTSD), a recently introduced condition in ICD-11. Both involve negative self-esteem, impaired emotion regulation ability, interpersonal difficulties and intrusive trauma- related experiences (i.e. intrusive thoughts, flashbacks, nightmares). Both have been causally related to childhood trauma, such as abuse, neglect and loss. The current project will examine the feasibility of conducting an 'Umbrella trial' to test whether CPTSD is causally related to psychosis, and develop more effective trauma-focused psychological interventions for psychotic symptoms by treating underlying experiences of/reactions to trauma. An Umbrella trial involves running several individual randomised controlled trials concurrently. In this study, each trial will test whether psychological interventions designed to reduce different CPTSD symptoms cause improvements in psychotic symptoms. If the investigators can establish feasibility of this Umbrella trial, and if a definitive version shows that interventions for CPTSD also reduce psychosis, then this would be a breakthrough in both the conceptualisation and treatment of psychosis which will help transform the care of people with psychosis. Demonstrating the feasibility of our proposed methodology would also help to accelerate the development of interventions for other mental health problems.
NCT05281640 — Schizophrenia
Status: Completed
http://inclinicaltrials.com/schizophrenia/NCT05281640/
An Experiential, One-to-one Interview Process Examining the Perception of Research Assessments and Equipment From Individuals With Post-traumatic Stress Disorder (PTSD)
To gain insight and perspective unique to individuals with a diagnosis of PTSD, this study will utilize an experiential one-to-one interview format. During the interview, an investigator will walk the participants through several aspects of an ANS battery of tests, provide a tour and information about other equipment in the research lab and discuss tools and procedures associated with the application of chiropractic care. The aim of this research is to provide insight for future study designs that assess or provide care to individuals with PTSD.
NCT05276115 — Ptsd
Status: Suspended
http://inclinicaltrials.com/ptsd/NCT05276115/
Development and Feasibility Testing of an Integrated PTSD and Adherence Intervention Cognitive Processing Therapy-Lifesteps (CPT-L) to Improve HIV Outcomes
This study plans to adapt and examine the acceptability and feasibility of an evidence-based PTSD treatment that has reduced other HIV transmission behavior (e.g., sexual risk), Cognitive Processing Therapy (CPT), at an HIV clinic as a strategy to improve HIV outcomes in this population.
NCT05275842 — Hiv
Status: Recruiting
http://inclinicaltrials.com/hiv/NCT05275842/
Sustaining Remission From Posttraumatic Stress Disorder (PTSD) Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy
The purpose of this research is to examine a wearable device called Apollo that emits gentle vibrations found to benefit mood, energy, and focus. We want to understand how it affects outcomes related to MDMA-assisted psychotherapy for PTSD including depression, anxiety and emotion regulation. This study will test whether regular use of the Apollo wearable improves rates of sustained symptom remission in PTSD following MDMA-assisted psychotherapy over the course of two years
NCT05274230 — Stress Disorders, Post-Traumatic
Status: Recruiting
http://inclinicaltrials.com/stress-disorders-post-traumatic/NCT05274230/
Safety and Efficacy of Cannabidiol (CBD) for Symptoms of Post-Traumatic Stress Disorder (PTSD) in Adults Using Liquid StructureTM Formulation (NantheiaTM ATL5).
Double-blind placebo controlled study of Cannabidiol (CBD) for symptoms of PTSD in adults using liquid structure(TM) Formulation (Nantheia ATL5(TM)). Subjects complete 3 weeks of baseline data collection including assessments of activity and sleep. Intervention is Nantheia ATL5 or placebo. Dose is initiated at 400mg BID and maintained over 8 weeks. Standardized symptom profile measurements, clinician assessments, laboratory testing, collection of inflammatory biomarkers, and suicide screening is completed throughout. Age- and gender-matched healthy population subjects are enrolled and complete baseline data collection only. All subjects may complete optional procedures of driving assessments and functional MRI (fMRI).
NCT05269459 — PTSD
Status: Recruiting
http://inclinicaltrials.com/ptsd/NCT05269459/
Family Involvement in Treatment for PTSD (FIT-PTSD): A Brief, Feasible Method for Enhancing Outcomes, Retention, and Engagement
Although effective treatments for PTSD exist, high rates of treatment dropout and sub-optimal response rates remain common. Incorporating family members in treatment represents one avenue for improving outcomes and providing Veteran-centered care, and surveys of Veterans in outpatient VA PTSD care indicate that 80% desire family involvement. The VA has invested many years and millions of dollars on the dissemination of Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) for PTSD. A family-based intervention that complements these two first-line treatments would capitalize on existing treatment infrastructure while also potentially boosting outcomes and retention. Preliminary testing of the proposed Brief Family Intervention (BFI) resulted in 50% less dropout from CPT/PE among Veterans whose family members received the BFI. There was also a large impact on PTSD symptoms at 16 weeks (d = 1.12) in favor of the BFI group. The goal of this study is to test the effectiveness of the BFI among a fully-powered sample. One hundred Veteran-family member dyads (n = 200) will be recruited. Veterans will be beginning a course of usual-care CPT or PE at one of two VA sites. Family members will be randomized to receive or not receive the BFI, a two-session psychoeducational and skills-based protocol. PTSD symptom severity and treatment retention will be the primary outcomes. Assessments will be conducted by independent evaluators at baseline, 6-, 12-, 18-, and 26-weeks. Veterans whose family members receive the BFI are expected to have lower dropout and a greater rate of change in their PTSD symptoms compared to Veterans whose family members do not receive the BFI. If the BFI is found to increase the effectiveness of and retention in CPT/PE, it will be a highly appealing option for incorporating families into Veterans' PTSD care.
NCT05267665 — Posttraumatic Stress Disorder
Status: Recruiting
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT05267665/
Modular Patient Centred CBT for Danish Veterans With Complex PTSD: A Randomised Controlled Pilot Study
Modular Patient Centred CBT (MPC) for Complex PTSD (CPTSD) is a manualized psychotherapy programme that consists of five treatment modules addressing 1) Affect dysregulation, 2) Disturbed relationships, 3) Negative self-concept, 4) PTSD symptoms and 5) Insomnia and trauma-related nightmares. This aim of this first pilot randomised controlled trial (RCT) is to increase chances of a future successful efficacy RCT (Phase III trial) comparing the efficacy (on symptoms of CPTSD and co-morbid disorders) of a flexible, patient-centred version of the MPC treatment programme (where the client actively participates in treatment decisions) with a control treatment, where the five treatment modules are delivered in a predefined order. The primary objective of the pilot study is to: 1. Assess the implementation of the trial process in terms of inclusion, implementation and data collection 2. Assess necessary resources, including the use of tablets for data collection, time spent on the project by participating therapists, assessing psychologists and secretaries The secondary objective is to: 1. Assess changes in symptoms of CPTSD between the intervention and control group as well as within each group 2. Examine changes in levels of comorbidity associated with CPTSD, such as anxiety, depression, insomnia, somatic complaints, drugs and alcohol intake between the intervention and control group as well as within each group 3. Examine changes in well-being, functioning and attachment style between the intervention and control group as well as within each group 4. Examine developments in client motivation and working alliance between the intervention and control group as well as within each group. 60 veterans with CPTSD are randomised to receive either the flexible, patient-centred version of the MPC treatment programme or the control treatment. The investigators will consider the study as complete if the following success criteria are met: 1. > 70% of potential participants accept and be included in the study 2. Completion rate of 70%, that is, the investigators expect to have complete end-of-treatment data of at least 70% of all participants included 3. Complete three-month follow-up of at least 50% of all participants included. The project neither collects new biological material nor biological material from existing biobanks. The project is based on questionnaire data.
NCT05259592 — Complex Post-Traumatic Stress Disorder
Status: Recruiting
http://inclinicaltrials.com/complex-post-traumatic-stress-disorder/NCT05259592/