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| ID | Type | Description | Link |
|---|---|---|---|
| FDN148371 | Other Grant/Funding Number | Canadian Institutes of Health Research (CIHR) |
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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:
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:
Everyone will be asked to complete online surveys about their mental health and functioning 3 times during the study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Videos Delivered by Text Message | Behavioral | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Posttraumatic Stress as Assessed by the PTSD Checklist (PCL-5) at 3 Months After 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and Acceptability as Measured by Engagement and Video Ratings | 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick J McGrath, PhD | Contact | +13435588921 | patrick.mcgrath@iwk.nshealth.ca | |
| Research Coordinator | Contact | +19024707552 | text4ptsd@iwk.nshealth.ca |
| Name | Affiliation | Role |
|---|---|---|
| Patrick J McGrath, PhD | IWK Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IWK Health | Recruiting | Halifax | Nova Scotia | B3K 6R8 | Canada |
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.
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|
| 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 | The GAD-7 is a 7-item measure assessing generalized anxiety symptoms. Higher scores indicate greater anxiety severity. | 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 | The PHQ-9 is a 9-item measure assessing depression symptoms. Higher scores indicate greater depression severity. | 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. | The SDS will assess the severity of functional impairment. Higher scores indicate more impairment. | 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 | The PTGI-SF is a 10-item measure assessing positive psychological changes following trauma. | From enrolment to the end of treatment at 10 weeks and 3 months after treatment ends. |
| From enrolment to end of treatment (10 weeks) |
| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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