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Investigating a Novel Sensory-based Program for Veterans With PTSD (SENSE-PTSD)

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McMaster University

Status

Not yet enrolling

Conditions

Posttraumatic Stress Disorder

Treatments

Behavioral: Sensory Strategies Training

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Full 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 (i.e., 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 (e.g., increased heart rate, anxiety/stress, faster breathing) or low levels of arousal (e.g., decreased heart rate, numb, withdrawn). PTSD can hinder someone's 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 someone's risk for experiencing traumatic events. Examples of traumatic events commonly experienced by military personnel include severe injury, loss of life, and sexual misconduct (e.g., 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 (e.g., gaps in memory, persistent negative thinking, difficulty with concentration and making plans), and can neglect physical or sensory regulation-based symptoms (e.g., 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 graduate/post-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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • English-speaking adults between the ages of 18 and 65
  • Veterans of the Canadian Armed Forces (active service and/or reservist);
  • Meet diagnostic criteria for PTSD on the Clinician Administered PTSD Scale (CAPS-5);
  • Able to provide written informed consent;
  • Have access to a smart phone, tablet, or computer with a working microphone and camera;
  • Have access to consistent and reliable Internet.

Exclusion criteria

  • Use benzodiazepines daily or almost daily;
  • Use narcotics daily or almost daily;
  • Diagnosis of substance use disorder in the past 3 months;
  • History of severe head trauma with loss of consciousness or history of traumatic brain injury;
  • History of neurological disorder;
  • Diagnosis of a psychotic disorder or bipolar disorder;
  • Diagnosis of a neurodevelopmental disorder;
  • Have not had stable psychiatric medication for 6 months prior to study participation;
  • Currently receiving counselling which targets trauma or sensory processing.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Program group
Experimental group
Description:
Participants in this group will receive five weekly sessions of Sensory Strategies Training (SST), facilitated by a trained clinician or graduate/post-graduate student in a health-related field.
Treatment:
Behavioral: Sensory Strategies Training
Waitlist control group
No Intervention group
Description:
Participants in the waitlist control group will not receive SST or any other PTSD or sensory-processing treatments for the duration of the study.

Trial contacts and locations

0

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Central trial contact

Stephanie Penta, BSc; Christina Chrysler, BA

Data sourced from clinicaltrials.gov

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