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

Primary Purpose

Posttraumatic Stress Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sensory Strategies Training
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring sensory, psychoeducation, Canadian Armed Forces, PTSD, virtual, veteran

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Program group

    Waitlist control group

    Arm 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.

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

    Outcomes

    Primary Outcome Measures

    Recruitment rate feasibility
    Rate of recruitment per month.
    Eligibility criteria feasibility
    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.
    Length of completion of procedures feasibility
    Time it takes to complete each study procedure.
    Location logistics
    Issues that arise as a result of the virtual nature of the study.
    Attrition rates
    Percentage of participants who drop out of SST.
    Attendance rates of program
    Percentage of SST sessions attended per participant.
    Staff size feasibility
    Facilitator feedback about how onerous their workload is.
    Communication feasibility
    Research team feedback on whether communication between research team members is adequate.

    Secondary Outcome Measures

    Sensory difficulties
    Changes in performance on the Adult/Adolescent Sensory Profile (semi-structured interview) at baseline, post-program, and 3-month follow-up. Scores can range between 60 and 300 with higher scores denoting greater sensory difficulties.
    Occupational performance
    Changes in performance on the Canadian Occupational Performance Measure (semi-structured interview) at baseline, post-program, and 3-month follow-up. Average performance and satisfaction scores are rated from 1 (poor performance/low satisfaction) to 10 (very good performance/high satisfaction). These scores are individually compared to prior scores at each time point (baseline, post-program and 3-month follow-up), with lower scores denoting greater sensory difficulties.
    PTSD symptomatology (structured interview)
    Changes in performance on Clinician Administered PTSD Scale (structured interview) at baseline, post-program, and 3-month follow-up. Scores can range between 0 and 120 with higher scores denoting more severe PTSD symptomatology.
    Mental health symptomatology
    Changes in performance on the Mini International Neuropsychiatric Interview (structured interview) at baseline, post-program, and 3-month follow-up. The Mini International Neuropsychiatric Interview will be used to indicate whether participants have PTSD or meet criteria for other psychiatric diagnoses. Diagnoses are made on a pass-or-fail basis, not reliant on minimum or maximum scores.
    Depression, anxiety, and stress symptomatology
    Changes in performance on Depression Anxiety Stress Scale 21-item version at baseline, post-program, and 3-month follow-up. Scores can range between 0 and 42 with higher scores denoting higher depression, anxiety, and/or stress symptomatology.
    Dissociation
    Changes in performance on the Multiscale Dissociation Inventory at baseline, post-program, and 3-month follow-up. Scores can range between 0 and 120 with higher scores denoting higher dissociative symptomatology.
    PTSD symptomatology (checklist)
    Changes in performance on the PTSD Checklist for DSM-5 at baseline, post-program, and 3-month follow-up. up. Scores can range between 0 and 80 with higher scores denoting higher PTSD symptomatology.
    Emotion regulation
    Changes in performance on the Difficulties in Emotion Regulation Scale at baseline, post-program, and 3-month follow-up. up. Scores can range between 36 and 180 with higher scores denoting poorer emotion regulation.
    Sleep quality
    Changes in performance on the Pittsburgh Sleep Quality Index at baseline, post-program, and 3-month follow-up. up. Scores can range between 0 and 21 with higher scores denoting poorer sleep quality.
    Moral injury
    Changes in performance on the Moral Injury Events Scale at baseline, post-program, and 3-month follow-up. up. Scores can range between 9 and 54 with lower scores denoting higher moral injury.
    Verbal short-term/working memory
    Changes in performance on the Digit Span neuropsychological assessments from the Wechsler Adult Intelligence Scales at baseline, post-program, and 3-month follow-up will be used to assess working memory. This task assesses working memory based on the average of digit sequences correctly remembered. Task difficulty dynamically varies based on the number of digits remembered, increasing or decreasing by 1 depending on whether the participants got the last trial correct. The test ends after 3 errors, with a maximum difficulty level of 25 and a minimum level of 2. The outcome measure is the maximum level achieved.
    Attention
    Changes in performance on the Feature Match neuropsychological assessment from the Wechsler Adult Intelligence Scales at baseline, post-program, and 3-month follow-up, will be used to assess attention. This task assesses attention based on one's ability to correctly identify similarities and differences between as many problems as possible within 90 seconds. The total score increases when participants respond correctly and decreases by the number of shapes in the current grid when participants respond incorrectly. The outcome measure is the total score.
    Response inhibition
    Changes in performance on the Double Trouble neuropsychological assessment from the Wechsler Adult Intelligence Scales at baseline, post-program, and 3-month follow-up, will be used to assess response inhibition. This task assesses response inhibition based on one's ability to make an appropriate response even when interference/distractors are present. To gain maximum points participants must solve as many problems as possible within 90 seconds, where the total score increases or decreases by 1 depending on if participants answer correctly or incorrectly. The outcome measure is the total score.
    Executive functioning
    Changes in performance on the Spatial Planning neuropsychological assessment from the Wechsler Adult Intelligence Scales at baseline, post-program, and 3-month follow-up, will be used to assess one's executive functioning. This task assesses executive functioning based on correctly solving specific problems in as few moves as possible within 3-minutes. After each trial, the total score is incremented by adding the minimum number of moves required multiplied by 2, minus the number of moves made. The outcome measure is the total score.

    Full Information

    First Posted
    September 28, 2022
    Last Updated
    October 19, 2023
    Sponsor
    McMaster University
    Collaborators
    Veterans Affairs Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05766241
    Brief Title
    Investigating a Novel Sensory-based Program for Veterans With PTSD
    Acronym
    SENSE-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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2025 (Anticipated)
    Study Completion Date
    August 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    McMaster University
    Collaborators
    Veterans Affairs Canada

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Posttraumatic Stress Disorder
    Keywords
    sensory, psychoeducation, Canadian Armed Forces, PTSD, virtual, veteran

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Program group
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Waitlist control group
    Arm Type
    No Intervention
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Sensory Strategies Training
    Other Intervention Name(s)
    SST
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Recruitment rate feasibility
    Description
    Rate of recruitment per month.
    Time Frame
    17 weeks
    Title
    Eligibility criteria feasibility
    Description
    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.
    Time Frame
    17 weeks
    Title
    Length of completion of procedures feasibility
    Description
    Time it takes to complete each study procedure.
    Time Frame
    17 weeks
    Title
    Location logistics
    Description
    Issues that arise as a result of the virtual nature of the study.
    Time Frame
    17 weeks
    Title
    Attrition rates
    Description
    Percentage of participants who drop out of SST.
    Time Frame
    17 weeks
    Title
    Attendance rates of program
    Description
    Percentage of SST sessions attended per participant.
    Time Frame
    17 weeks
    Title
    Staff size feasibility
    Description
    Facilitator feedback about how onerous their workload is.
    Time Frame
    17 weeks
    Title
    Communication feasibility
    Description
    Research team feedback on whether communication between research team members is adequate.
    Time Frame
    17 weeks
    Secondary Outcome Measure Information:
    Title
    Sensory difficulties
    Description
    Changes in performance on the Adult/Adolescent Sensory Profile (semi-structured interview) at baseline, post-program, and 3-month follow-up. Scores can range between 60 and 300 with higher scores denoting greater sensory difficulties.
    Time Frame
    17 weeks
    Title
    Occupational performance
    Description
    Changes in performance on the Canadian Occupational Performance Measure (semi-structured interview) at baseline, post-program, and 3-month follow-up. Average performance and satisfaction scores are rated from 1 (poor performance/low satisfaction) to 10 (very good performance/high satisfaction). These scores are individually compared to prior scores at each time point (baseline, post-program and 3-month follow-up), with lower scores denoting greater sensory difficulties.
    Time Frame
    17 weeks
    Title
    PTSD symptomatology (structured interview)
    Description
    Changes in performance on Clinician Administered PTSD Scale (structured interview) at baseline, post-program, and 3-month follow-up. Scores can range between 0 and 120 with higher scores denoting more severe PTSD symptomatology.
    Time Frame
    17 weeks
    Title
    Mental health symptomatology
    Description
    Changes in performance on the Mini International Neuropsychiatric Interview (structured interview) at baseline, post-program, and 3-month follow-up. The Mini International Neuropsychiatric Interview will be used to indicate whether participants have PTSD or meet criteria for other psychiatric diagnoses. Diagnoses are made on a pass-or-fail basis, not reliant on minimum or maximum scores.
    Time Frame
    17 weeks
    Title
    Depression, anxiety, and stress symptomatology
    Description
    Changes in performance on Depression Anxiety Stress Scale 21-item version at baseline, post-program, and 3-month follow-up. Scores can range between 0 and 42 with higher scores denoting higher depression, anxiety, and/or stress symptomatology.
    Time Frame
    17 weeks
    Title
    Dissociation
    Description
    Changes in performance on the Multiscale Dissociation Inventory at baseline, post-program, and 3-month follow-up. Scores can range between 0 and 120 with higher scores denoting higher dissociative symptomatology.
    Time Frame
    17 weeks
    Title
    PTSD symptomatology (checklist)
    Description
    Changes in performance on the PTSD Checklist for DSM-5 at baseline, post-program, and 3-month follow-up. up. Scores can range between 0 and 80 with higher scores denoting higher PTSD symptomatology.
    Time Frame
    17 weeks
    Title
    Emotion regulation
    Description
    Changes in performance on the Difficulties in Emotion Regulation Scale at baseline, post-program, and 3-month follow-up. up. Scores can range between 36 and 180 with higher scores denoting poorer emotion regulation.
    Time Frame
    17 weeks
    Title
    Sleep quality
    Description
    Changes in performance on the Pittsburgh Sleep Quality Index at baseline, post-program, and 3-month follow-up. up. Scores can range between 0 and 21 with higher scores denoting poorer sleep quality.
    Time Frame
    17 weeks
    Title
    Moral injury
    Description
    Changes in performance on the Moral Injury Events Scale at baseline, post-program, and 3-month follow-up. up. Scores can range between 9 and 54 with lower scores denoting higher moral injury.
    Time Frame
    17 weeks
    Title
    Verbal short-term/working memory
    Description
    Changes in performance on the Digit Span neuropsychological assessments from the Wechsler Adult Intelligence Scales at baseline, post-program, and 3-month follow-up will be used to assess working memory. This task assesses working memory based on the average of digit sequences correctly remembered. Task difficulty dynamically varies based on the number of digits remembered, increasing or decreasing by 1 depending on whether the participants got the last trial correct. The test ends after 3 errors, with a maximum difficulty level of 25 and a minimum level of 2. The outcome measure is the maximum level achieved.
    Time Frame
    17 weeks
    Title
    Attention
    Description
    Changes in performance on the Feature Match neuropsychological assessment from the Wechsler Adult Intelligence Scales at baseline, post-program, and 3-month follow-up, will be used to assess attention. This task assesses attention based on one's ability to correctly identify similarities and differences between as many problems as possible within 90 seconds. The total score increases when participants respond correctly and decreases by the number of shapes in the current grid when participants respond incorrectly. The outcome measure is the total score.
    Time Frame
    17 weeks
    Title
    Response inhibition
    Description
    Changes in performance on the Double Trouble neuropsychological assessment from the Wechsler Adult Intelligence Scales at baseline, post-program, and 3-month follow-up, will be used to assess response inhibition. This task assesses response inhibition based on one's ability to make an appropriate response even when interference/distractors are present. To gain maximum points participants must solve as many problems as possible within 90 seconds, where the total score increases or decreases by 1 depending on if participants answer correctly or incorrectly. The outcome measure is the total score.
    Time Frame
    17 weeks
    Title
    Executive functioning
    Description
    Changes in performance on the Spatial Planning neuropsychological assessment from the Wechsler Adult Intelligence Scales at baseline, post-program, and 3-month follow-up, will be used to assess one's executive functioning. This task assesses executive functioning based on correctly solving specific problems in as few moves as possible within 3-minutes. After each trial, the total score is incremented by adding the minimum number of moves required multiplied by 2, minus the number of moves made. The outcome measure is the total score.
    Time Frame
    17 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stephanie Penta, BSc
    Phone
    226-600-3597
    Email
    pentas@mcmaster.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christina Chrysler, BA
    Phone
    905-517-7852
    Email
    chrysl@mcmaster.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Margaret McKinnon, PhD
    Organizational Affiliation
    McMaster University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33650202
    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.
    Results Reference
    background
    PubMed Identifier
    30450043
    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.
    Results Reference
    background
    PubMed Identifier
    23737408
    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.
    Results Reference
    background
    Links:
    URL
    https://www.thetraumaandrecoverylab.com/
    Description
    McKinnon Trauma and Recovery Lab website

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    Investigating a Novel Sensory-based Program for Veterans With PTSD

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