IWK Health
Halifax, Nova Scotia, B3K 6R8, Canada
Location status: Recruiting
NCT Number: NCT07165782
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:
1. Does the intervention help youth reduce their symptoms of PTSD, anxiety, and depression, improve how well they function day-to-day, and lead to post-traumatic growth. 2. Will it be possible to conduct a larger study on the intervention (e.g., are we able to attract participants to take part in the study; do participants follow through with the intervention and the study) and is the intervention acceptable to youth (e.g., do they watch the videos, and rate the videos as useful, interesting, understandable, and relevant)?
Researchers will compare those who receive the intervention right away to those who wait to receive the intervention to see if there are differences between groups.
Videos will teach youth about PTSD and provide the opportunity to practice strategies that have been shown to help with reduce symptoms of PTSD, such as exposure, reducing avoidance, social support, and coping strategies (e.g., changing your thoughts, deep breathing, and muscle relaxation).
The study is fully online. Participants will be randomly placed in one of two groups:
1. Intervention Group: Gets three PTSD-related text messages per week for 10 weeks. They will also be asked to rate each of the videos on how helpful you found them. 2. Waitlist Group: Does not receive text messages until AFTER the final surveys for the study are completed (i.e., 5 months), then will receive the intervention.
Everyone will be asked to complete online surveys about their mental health and functioning 3 times during the study:
* Beginning of the study * 10 weeks into the study * 3 months after the videos end (end of study)
Interested in participating?
Request Info15 year–25 year
All sexes
Interventional
Not applicable
Halifax, Nova Scotia, B3K 6R8, Canada
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
Time frame: From enrolment to the end of treatment at 10 weeks
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.
Time frame: 3 Months After Treatment (22 weeks after enrolment)
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.
Time frame: From enrolment to the end of treatment at 10 weeks and 3 months after treatment ends.
The GAD-7 is a 7-item measure assessing generalized anxiety symptoms. Higher scores indicate greater anxiety severity.
Time frame: From enrolment to the end of treatment at 10 weeks and 3 months after treatment ends.
The PHQ-9 is a 9-item measure assessing depression symptoms. Higher scores indicate greater depression severity.
Time frame: From enrolment to the end of treatment at 10 weeks and 3 months after treatment ends.
The SDS will assess the severity of functional impairment. Higher scores indicate more impairment.
Time frame: From enrolment to the end of treatment at 10 weeks and 3 months after treatment ends.
The PTGI-SF is a 10-item measure assessing positive psychological changes following trauma.
Time frame: From enrolment to end of treatment (10 weeks)
The feasibility and acceptability of the text message-based intervention will be assessed throughout the study using recruitment and retention rates (i.e., number of participants enrolled and completing follow-ups), message engagement (i.e., number of messages rated by participants), and participant satisfaction (i.e., ratings of message helpfulness, relevance, and supportiveness). After each text, participants will be asked to rate how useful, relevant, interesting, and understandable they found the messages on a scale of 0 (not at all) to 4 (extremely).
Contact information is provided by the study sponsor or research team.
Patrick J McGrath, PhD
CONTACT
Research Coordinator
CONTACT
IWK Health Centre
Other
Brief Videos Delivered by Text Messages as a Public Health Intervention for PTSD in Youth: A Feasibility and Acceptability Randomized Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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