Clinical trial NCT05766241: Investigating a Novel Sensory-based Program for Veterans With PTSD
Official title: Investigating the Feasibility and Efficacy of a Novel Sensory-based Psychoeducation Program for Military Veterans With Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: sensory
psychoeducation
Canadian Armed Forces
PTSD
virtual
veteran
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Veterans Affairs Canada
First posted: 2023-03-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomized to a program group or a waitlist control group. Individuals in the waitlist control group will be offered the opportunity to participate in the program once they have completed the study.
Primary purpose: TREATMENT

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increased heart rate, anxiety/stress, faster breathing) or low levels of arousal (e.g., decreased heart rate, numb, withdrawn).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

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.

Primary outcomes:
measure: Recruitment rate feasibility
timeFrame: 17 weeks
measure: Eligibility criteria feasibility
timeFrame: 17 weeks
measure: Length of completion of procedures feasibility
timeFrame: 17 weeks
measure: Location logistics
timeFrame: 17 weeks
measure: Attrition rates
timeFrame: 17 weeks
measure: Attendance rates of program
timeFrame: 17 weeks
measure: Staff size feasibility
timeFrame: 17 weeks
measure: Communication feasibility
timeFrame: 17 weeks
Secondary outcomes:
measure: Sensory difficulties
timeFrame: 17 weeks
measure: Occupational performance
timeFrame: 17 weeks
measure: PTSD symptomatology (structured interview)
timeFrame: 17 weeks
measure: Mental health symptomatology
timeFrame: 17 weeks
measure: Depression, anxiety, and stress symptomatology
timeFrame: 17 weeks
measure: Dissociation
timeFrame: 17 weeks
measure: PTSD symptomatology (checklist)
timeFrame: 17 weeks
measure: Emotion regulation
timeFrame: 17 weeks
measure: Sleep quality
timeFrame: 17 weeks
measure: Moral injury
timeFrame: 17 weeks
measure: Verbal short-term/working memory
timeFrame: 17 weeks
measure: Attention
timeFrame: 17 weeks
measure: Response inhibition
timeFrame: 17 weeks
measure: Executive functioning
timeFrame: 17 weeks
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University
name: Margaret McKinnon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.