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Clinical Trials/NCT05766241
NCT05766241
Not yet recruiting
Not Applicable

Investigating the Feasibility and Efficacy of a Novel Sensory-based Psychoeducation Program for Military Veterans With Posttraumatic Stress Disorder

McMaster University0 sites90 target enrollmentApril 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Posttraumatic Stress Disorder
Sponsor
McMaster University
Enrollment
90
Primary Endpoint
Length of completion of procedures feasibility
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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 (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increased heart rate, anxiety/stress, faster breathing) or low levels of arousal (e.g., decreased heart rate, numb, withdrawn).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.

Registry
clinicaltrials.gov
Start Date
April 2024
End Date
August 31, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Margaret McKinnon

Professor

McMaster University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Length of completion of procedures feasibility

Time Frame: 17 weeks

Time it takes to complete each study procedure.

Recruitment rate feasibility

Time Frame: 17 weeks

Rate of recruitment per month.

Eligibility criteria feasibility

Time Frame: 17 weeks

Percentage of individuals who are deemed eligible to participate in the study out of the total number of individuals who complete the pre-screening survey.

Location logistics

Time Frame: 17 weeks

Issues that arise as a result of the virtual nature of the study.

Staff size feasibility

Time Frame: 17 weeks

Facilitator feedback about how onerous their workload is.

Communication feasibility

Time Frame: 17 weeks

Research team feedback on whether communication between research team members is adequate.

Attrition rates

Time Frame: 17 weeks

Percentage of participants who drop out of SST.

Attendance rates of program

Time Frame: 17 weeks

Percentage of SST sessions attended per participant.

Secondary Outcomes

  • Sleep quality(17 weeks)
  • Occupational performance(17 weeks)
  • Mental health symptomatology(17 weeks)
  • Depression, anxiety, and stress symptomatology(17 weeks)
  • Dissociation(17 weeks)
  • Emotion regulation(17 weeks)
  • Response inhibition(17 weeks)
  • Sensory difficulties(17 weeks)
  • PTSD symptomatology (structured interview)(17 weeks)
  • PTSD symptomatology (checklist)(17 weeks)
  • Moral injury(17 weeks)
  • Attention(17 weeks)
  • Executive functioning(17 weeks)
  • Verbal short-term/working memory(17 weeks)

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