NCT07165782

Brief Summary

The goal of this clinical trial is to learn if informational videos (the intervention) sent by text messages can help young people (age 15 - 25) manage symptoms of post traumatic stress disorder (PTSD). This is a small-scale trial to evaluate whether the intervention has potential to be effective, whether it is feasible to carry out a bigger study, and whether youth find the intervention acceptable.The main questions it aims to answer are:

  • Beginning of the study
  • 10 weeks into the study
  • 3 months after the videos end (end of study)

Trial Health

77
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
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

Study Progress50%
Sep 2025Dec 2026

First Submitted

Initial submission to the registry

September 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 10, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 3, 2025

Last Update Submit

September 3, 2025

Conditions

Keywords

posttraumatic stress disorderpost-traumatic stress disordertraumapublic healthrcttext messagevideo intervention

Outcome Measures

Primary Outcomes (1)

  • Change in Posttraumatic Stress as Assessed by the PTSD Checklist (PCL-5) at 10 Weeks (End of Treatment)

    The PCL-5 is a 20-item self-report measure assessing PTSD symptom severity based on Diagnostic Statistical Manual of Mental Disorders (DSM-5) criteria. Participants rate how much symptoms have bothered them in the past month on a scale from 0 (not at all) to 4 (extremely). Symptom scores range from 0 to 80, with higher scores indicating more severe symptoms. A score of 31 or higher indicates a probable diagnosis of PTSD.

    From enrolment to the end of treatment at 10 weeks

Secondary Outcomes (5)

  • Change in Posttraumatic Stress as Assessed by the PTSD Checklist (PCL-5) at 3 Months After Treatment

    3 Months After Treatment (22 weeks after enrolment)

  • Change in Anxiety Score as Measured by the Generalized Anxiety Disorder-7 (GAD-7) at 10 Weeks After Enrolment (Post-Treatment) and 3 Months After Treatment

    From enrolment to the end of treatment at 10 weeks and 3 months after treatment ends.

  • Change in Depression Score as Measured by the Patient Health Questionnaire-9 (PHQ-9) at 10 Weeks After Enrolment (Post-Treatment) and 3 Months After Treatment

    From enrolment to the end of treatment at 10 weeks and 3 months after treatment ends.

  • Change in Functional Impairment Scores as Measured by the Sheehan Disability Scale (SDS) at 10 Weeks After Enrolment (Post-Treatment) and 3 Months After Treatment.

    From enrolment to the end of treatment at 10 weeks and 3 months after treatment ends.

  • Change in Posttraumatic Growth as Measured by The Posttraumatic Growth Inventory - Short Form (PTGI-SF) at 10 Weeks After Enrolment and 3 Months After Treatment

    From enrolment to the end of treatment at 10 weeks and 3 months after treatment ends.

Other Outcomes (1)

  • Feasibility and Acceptability as Measured by Engagement and Video Ratings

    From enrolment to end of treatment (10 weeks)

Study Arms (2)

Brief Video Intervention

ACTIVE COMPARATOR

Participants will receive three text messages per week for 10 weeks. Each message contains a link to a video providing information about PTSD and coping strategies.

Behavioral: Brief Videos Delivered by Text Message

Control Group

NO INTERVENTION

The control group will receive no intervention. They will have access to the intervention after they complete all study activities, however they will not be included in the data analysis.

Interventions

The intervention consists of brief videos delivered by text message, designed to deliver psychoeducation, coping strategies, and social support guidance for youth with PTSD. The focus is to reduce avoidance behaviors, increase exposure, change cognitions and enhance social support. The text messages will follow a six-module curriculum, covering key PTSD recovery topics: 1. Psychoeducation on PTSD - Understanding symptoms, trauma responses, and brain plasticity. 2. Reducing Avoidance - Encouraging gradual engagement with feared thoughts and situations. 3. Cognitive Coping Strategies - Introducing cognitive restructuring techniques. 4. Behavioral Coping Strategies - Teaching relaxation techniques (e.g., deep breathing, grounding). 5. Social Support - Highlighting the role of social support and strategies to strengthen connections. 6. Maintenance and Relapse Prevention - Preparing for setbacks and reinforcing progress.

Brief Video Intervention

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Likely diagnosis of PTSD as indicated by a minimum score of 31 on the Post Traumatic Stress Disorder Checklist
  • Direct exposure to actual or threatened death, serious injury, or sexual violence or through witnessing, learning it happened to a close relation as assessed by the Life Events Checklist
  • Between 15 and 25 years old at time of enrolment
  • Access to a mobile phone and a data plan that allows them to receive text messages and videos
  • Live in Canada

You may not qualify if:

  • Presence of active suicidality, determined by items from the Patient Safety Screener
  • Active symptoms of psychosis, indicated by a brief Psychosis Screener Questionnaire
  • An inability to read and/or understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IWK Health

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

MeSH Terms

Conditions

Combat DisordersStress Disorders, Post-TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Patrick J McGrath, PhD

    IWK Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick J McGrath, PhD

CONTACT

Research Coordinator

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 10, 2025

Study Start

September 10, 2025

Primary Completion (Estimated)

September 10, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

During the informed consent process, study participants are invited to provide consent for their de-identified study data to be shared with other researchers only with the consent of the study participants. Data from those who consent may be shared with researchers provided they have ethics board approval. All participant data except for identifying data may be shared.

Locations