Brief Videos Delivered by Text Messages as a Public Health Intervention for PTSD in Youth

Официальное название

Brief Videos Delivered by Text Messages as a Public Health Intervention for PTSD in Youth: A Feasibility and Acceptability Randomized Trial

Обзор

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)

Вмешательства

• Поведенческое Brief Videos Delivered by Text Message
  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 - Encourag

Первичные конечные точки

• Change in Posttraumatic Stress as Assessed by the PTSD Checklist (PCL-5) at 10 Weeks (End of Treatment) [Срок оценки: From enrolment to the end of treatment at 10 weeks]

Вторичные конечные точки (5)

• Change in Posttraumatic Stress as Assessed by the PTSD Checklist (PCL-5) at 3 Months After Treatment [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: From enrolment to the end of treatment at 10 weeks and 3 months after treatment ends.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• IWK Health — Halifax

Идентификаторы

NCT: NCT07165782 · 1031707 · FDN148371

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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