Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05766241
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2022-09-28
Brief Title:
Investigating a Novel Sensory-based Program for Veterans With PTSD
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Investigating the Feasibility and Efficacy of a Novel Sensory-based Psychoeducation Program for Military Veterans With Posttraumatic Stress Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SENSE-PTSD
Brief Summary:
SENSE-PTSD is an randomized controlled trial RCT which will evaluate the feasibility and efficacy of a novel sensory-based psychoeducational program for improving psychological functional sensory and cognitive outcomes in Canadian military veterans with posttraumatic stress disorder PTSD
Detailed Description:
Posttraumatic stress disorder PTSD is a disorder that can happen after a person experiences an event that makes them feel extremely frightened or helpless ie a traumatic event Some examples of traumatic events include physical sexual or emotional abuse automobile accidents and military combat Symptoms of PTSD typically include feeling overwhelmed by memories of the traumatic event trying to avoid reminders of the traumatic event feeling overly alert to danger and experiencing difficulty regulating emotions They can also include fluctuations in arousal in the body where one may feel high levels of arousal eg increased heart rate anxietystress faster breathing or low levels of arousal eg decreased heart rate numb withdrawn PTSD can hinder someones ability to meet the demands of everyday life including interacting with family friends and coworkers which can in turn have negative consequences on their employment status financial wellbeing and bonds with others
Engaging in military service can increase someones risk for experiencing traumatic events Examples of traumatic events commonly experienced by military personnel include severe injury loss of life and sexual misconduct eg sexual harassment gender discrimination among others While some treatments already exist for military personnel and veterans with PTSD they tend to focus on the cognitive - or thought-based - symptoms of PTSD eg gaps in memory persistent negative thinking difficulty with concentration and making plans and can neglect physical or sensory regulation-based symptoms eg muscle tension shaking crying feeling restless trouble sleeping
This pilot study will examine a novel virtual psychoeducational program called Sensory Strategies Training SST The main goal of this program is to provide military veterans with information and tools that they can use in their daily lives to reduce some of the PTSD symptoms mentioned above and expand the range of sensations they are able to tolerate in effect increasing their overall ability to function in daily life SST includes 5 one-on-one sessions with a trained clinician or graduatepost-graduate student in a mental health-related field in which participants will learn about how PTSD symptoms may be affecting their lives and how to use sensory-based strategies to help reduce some of these symptoms The main purpose of the current study is to inform our decision-making for a larger study that the investigators intend to conduct in the future This larger study will explore how helpful SST is for improving PTSD symptoms in military veterans The current pilot study will also explore this topic but on a smaller scale
Participants of the current study will be veterans of the Canadian Armed Forces CAF both active service and reservist with PTSD They will be randomized to either a psychoeducation program group in which they will receive SST for 5 weeks or a waitlist control group in which they will receive no PTSD treatment for the same amount of time Participants in the waitlist control group will be offered SST once they are finished participating in this study The investigators will compare changes in self-reported PTSD symptoms and sensory processing before and after participants take part in SST or spend the equivalent amount of time on a waitlist to determine whether the program is effective The investigators will also compare results 3 months later to determine if the effects of the program are sustained over time The study will be conducted entirely virtually via Zoom an online video conferencing platform
Ultimately SST may be helpful for regulating the physiological and emotional functioning of military veterans with PTSD to help them tolerate a range of sensations feelings thoughts and memories in the present moment It is expected that the knowledge and skills gained from the sensory-based strategies will help participants identify and communicate their needs effectively and organize their behaviours in order to improve daily functioning family relationships and their engagement with the community
Engaging in military service can increase someones risk for experiencing traumatic events Examples of traumatic events commonly experienced by military personnel include severe injury loss of life and sexual misconduct eg sexual harassment gender discrimination among others While some treatments already exist for military personnel and veterans with PTSD they tend to focus on the cognitive - or thought-based - symptoms of PTSD eg gaps in memory persistent negative thinking difficulty with concentration and making plans and can neglect physical or sensory regulation-based symptoms eg muscle tension shaking crying feeling restless trouble sleeping
This pilot study will examine a novel virtual psychoeducational program called Sensory Strategies Training SST The main goal of this program is to provide military veterans with information and tools that they can use in their daily lives to reduce some of the PTSD symptoms mentioned above and expand the range of sensations they are able to tolerate in effect increasing their overall ability to function in daily life SST includes 5 one-on-one sessions with a trained clinician or graduatepost-graduate student in a mental health-related field in which participants will learn about how PTSD symptoms may be affecting their lives and how to use sensory-based strategies to help reduce some of these symptoms The main purpose of the current study is to inform our decision-making for a larger study that the investigators intend to conduct in the future This larger study will explore how helpful SST is for improving PTSD symptoms in military veterans The current pilot study will also explore this topic but on a smaller scale
Participants of the current study will be veterans of the Canadian Armed Forces CAF both active service and reservist with PTSD They will be randomized to either a psychoeducation program group in which they will receive SST for 5 weeks or a waitlist control group in which they will receive no PTSD treatment for the same amount of time Participants in the waitlist control group will be offered SST once they are finished participating in this study The investigators will compare changes in self-reported PTSD symptoms and sensory processing before and after participants take part in SST or spend the equivalent amount of time on a waitlist to determine whether the program is effective The investigators will also compare results 3 months later to determine if the effects of the program are sustained over time The study will be conducted entirely virtually via Zoom an online video conferencing platform
Ultimately SST may be helpful for regulating the physiological and emotional functioning of military veterans with PTSD to help them tolerate a range of sensations feelings thoughts and memories in the present moment It is expected that the knowledge and skills gained from the sensory-based strategies will help participants identify and communicate their needs effectively and organize their behaviours in order to improve daily functioning family relationships and their engagement with the community
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None