Investigating a Novel Sensory-based Program for Veterans With PTSD

NCT ID: NCT05766241

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2025-08-31

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increased heart rate, anxiety/stress, faster breathing) or low levels of arousal (e.g., decreased heart rate, numb, withdrawn).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

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Program group

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.

Group Type: EXPERIMENTAL

Sensory Strategies Training

Intervention Type: BEHAVIORAL

In SST, participants will be introduced to the concept of sensory processing in the context of PTSD and will learn about the ways in which difficulties in this area can impact their affective, cognitive, and functional outcomes. Participants will learn about the effects of PTSD symptoms on their ability to regulate stressful situations and engage in social interactions, as well as the benefits of physical activity and proper sleep hygiene. Participants will also identify functional goals (e.g., reduce sensation-avoiding, better regulate physical and emotional reactions to trauma reminders, increase sensory sensitivity, etc.) which they will aim to achieve with the knowledge and resources gained from SST. Throughout the program, participants will learn various strategies to help with movement, sleep, and interacting with others, and will have opportunities to practice the strategies identified as being relevant to their specific needs during their baseline sensory assessment.

Waitlist control group

Participants in the waitlist control group will not receive SST or any other PTSD or sensory-processing treatments for the duration of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sensory Strategies Training

In SST, participants will be introduced to the concept of sensory processing in the context of PTSD and will learn about the ways in which difficulties in this area can impact their affective, cognitive, and functional outcomes. Participants will learn about the effects of PTSD symptoms on their ability to regulate stressful situations and engage in social interactions, as well as the benefits of physical activity and proper sleep hygiene. Participants will also identify functional goals (e.g., reduce sensation-avoiding, better regulate physical and emotional reactions to trauma reminders, increase sensory sensitivity, etc.) which they will aim to achieve with the knowledge and resources gained from SST. Throughout the program, participants will learn various strategies to help with movement, sleep, and interacting with others, and will have opportunities to practice the strategies identified as being relevant to their specific needs during their baseline sensory assessment.

Intervention Type: BEHAVIORAL

Other Intervention Names

SST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Veterans Affairs Canada

UNKNOWN

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Margaret McKinnon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margaret McKinnon, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Central Contacts

Stephanie Penta, BSc

Role: CONTACT

pentas@mcmaster.ca

226-600-3597

Christina Chrysler, BA

Role: CONTACT

chrysl@mcmaster.ca

905-517-7852

References

Jackson CE, Ciarleglio MM, Aslan M, Marx BP, Ko J, Concato J, Proctor SP, Vasterling JJ. Associations Among Increases in Posttraumatic Stress Symptoms, Neurocognitive Performance, and Long-Term Functional Outcomes in U.S. Iraq War Veterans. J Trauma Stress. 2021 Jun;34(3):628-640. doi: 10.1002/jts.22663. Epub 2021 Mar 2.

Reference Type: BACKGROUND

PMID: 33650202 (View on PubMed)

Watkins LE, Sprang KR, Rothbaum BO. Treating PTSD: A Review of Evidence-Based Psychotherapy Interventions. Front Behav Neurosci. 2018 Nov 2;12:258. doi: 10.3389/fnbeh.2018.00258. eCollection 2018.

Reference Type: BACKGROUND

PMID: 30450043 (View on PubMed)

Regier DA, Kuhl EA, Kupfer DJ. The DSM-5: Classification and criteria changes. World Psychiatry. 2013 Jun;12(2):92-8. doi: 10.1002/wps.20050.

Reference Type: BACKGROUND

PMID: 23737408 (View on PubMed)

Related Links

https://www.thetraumaandrecoverylab.com/

McKinnon Trauma and Recovery Lab website

Other Identifiers

13743

Identifier Type: -

Identifier Source: org_study_id