NCT05766241

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

September 28, 2022

Last Update Submit

March 11, 2024

Conditions

Posttraumatic Stress Disorder

Keywords

sensorypsychoeducationCanadian Armed ForcesPTSDvirtualveteran

Outcome Measures

Primary Outcomes (8)

  • Recruitment rate feasibility

    Rate of recruitment per month.

    17 weeks

  • 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.

    17 weeks

  • Length of completion of procedures feasibility

    Time it takes to complete each study procedure.

    17 weeks

  • Location logistics

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

    17 weeks

  • Attrition rates

    Percentage of participants who drop out of SST.

    17 weeks

  • Attendance rates of program

    Percentage of SST sessions attended per participant.

    17 weeks

  • Staff size feasibility

    Facilitator feedback about how onerous their workload is.

    17 weeks

  • Communication feasibility

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

    17 weeks

Secondary Outcomes (14)

  • Sensory difficulties

    17 weeks

  • Occupational performance

    17 weeks

  • PTSD symptomatology (structured interview)

    17 weeks

  • Mental health symptomatology

    17 weeks

  • Depression, anxiety, and stress symptomatology

    17 weeks

  • +9 more secondary outcomes

Study Arms (2)

Program group

EXPERIMENTAL

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.

Behavioral: Sensory Strategies Training

Waitlist control group

NO INTERVENTION

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

Interventions

Sensory Strategies TrainingBEHAVIORAL

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.

Also known as: SST
Program group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 33650202BACKGROUND

  • 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.

    PMID: 30450043BACKGROUND

  • 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.

    PMID: 23737408BACKGROUND

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Margaret McKinnon, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Penta, BSc

CONTACT

226-600-3597pentas@mcmaster.ca

Christina Chrysler, BA

CONTACT

905-517-7852chrysl@mcmaster.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 28, 2022

First Posted

March 13, 2023

Study Start

April 1, 2024

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share