- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00862498
Examining Written Disclosure as a Treatment for Post-Traumatic Stress Disorder
Examining Written Disclosure as an Intervention for Posttraumatic Stress Disorder
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Post-traumatic stress disorder (PTSD) is a chronic and debilitating disorder caused by experiencing a stressful or traumatic event. Although there is evidence that treatments for PTSD are effective, many people do not seek treatment or seek treatment only after their PTSD has become severe. This study will test a low-cost, brief, and easily implemented treatment that may encourage people to seek treatment for PTSD. The treatment, called written disclosure (WD), involves writing about the traumatic event that caused a person's PTSD. In this study, people who have PTSD as the result of a motor vehicle accident will test two versions of WD, one administered in a clinic and the other administered over the phone.
Participation in this study will last 5 weeks, with follow-up assessments continuing until 6 months after treatment. After screening, participants will be assigned to one of three conditions: WD treatment delivered in the clinic, WD treatment delivered via phone, and waitlist. The WD treatment involves five weekly writing sessions. During the first session, trauma reactions and the rationale for WD will be explained to all participants, and then participants will write for 30 minutes about their motor vehicle accident. The next four sessions will involve only writing for 30 minutes. For those receiving treatment in the clinic, a therapist will communicate directions and explanations to participants, and participants will have their heart rate activity recorded continuously for 5 minutes prior to writing and during the 30 minutes of writing. For those receiving treatment over the phone, explanations of the study will be provided in writing, and a study staff member will call participants before and after each writing session to ensure that participants understand the directions and are not experiencing any unexpected negative reactions after writing. Participants in the waitlist condition will not receive treatment for the first 4 months. After that period, they will be offered the WD treatment.
Assessments of all participants will occur at baseline, after treatment, and 3 months after treatment. Participants assigned to receive WD treatment, either in a clinic or via phone, will also be assessed 6 months after treatment. Assessments administered at these points will involve semi-structured clinical interviews, self-report questionnaires, and measures of mood-related symptoms. Participants receiving treatment will also complete self-report measurements of emotional response after each writing session and the Daily Experiences Questionnaire every day during the 5 weeks of treatment. Participants on the waitlist will also undergo assessments of suicidal thoughts and PTSD symptoms every 2 weeks.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02130
- VA Boston Healthcare System, National Center for PTSD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Primary diagnosis of post-traumatic stress disorder
- Involved in motor vehicle accident that occurred at least 3 months ago
Exclusion Criteria:
- Current diagnosis of mania, hypomania, bipolar depression, psychotic disorder, substance abuse disorder, or severe depression
- History of psychosis
- Active suicidality or history of two or more suicide gestures or attempts in the past year
- Significant cognitive impairment
- Current participation in a psychosocial treatment, such as individual or group therapy led by a clinician
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Group 1 Treatment in Clinic
Participants will complete the written disclosure treatment in a clinic setting.
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Five sessions, each spaced 1 week apart, during which participants are asked to write about their motor vehicle accident for 30 minutes.
The first session of the intervention also involves a description of common reactions to a motor vehicle accident and the rationale for this treatment.
Другие имена:
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Экспериментальный: Group 2 Treatment via telephone
Participants will complete the written disclosure treatment in their homes via telephone.
|
Five sessions, each spaced 1 week apart, during which participants are asked to write about their motor vehicle accident for 30 minutes.
The first session of the intervention also involves a description of common reactions to a motor vehicle accident and the rationale for this treatment.
Другие имена:
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Без вмешательства: Group 3 Waitlist
Individuals will be placed on a waitlist for a period of 4 months, during which they will receive a phone call every other week to assess their suicidal ideation and post-traumatic stress disorder symptom severity.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
Clinician-Administered Posttraumatic Stress Disorder Scale
Временное ограничение: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
Beck Depression Inventory - Second Edition
Временное ограничение: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Posttraumatic Cognitions Inventory
Временное ограничение: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
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Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Anxious Driving Questionnaire
Временное ограничение: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
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Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
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Client Satisfaction Questionnaire
Временное ограничение: Measured at the end of the last treatment session
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Measured at the end of the last treatment session
|
Daily Experiences Questionnaire
Временное ограничение: Measured every day during the 5-week treatment period
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Measured every day during the 5-week treatment period
|
Oswestry Disability Index
Временное ограничение: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Quality of Life Inventory
Временное ограничение: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
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Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Self-Assessment Manikin
Временное ограничение: Measured after each writing session
|
Measured after each writing session
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Last Day of Writing Questionnaire
Временное ограничение: Measured after the last writing session
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Measured after the last writing session
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Follow-Up Writing Questionnaire
Временное ограничение: Measured after the 3-month follow-up assessment
|
Measured after the 3-month follow-up assessment
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Alcohol Use Disorders Identification Test
Временное ограничение: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
|
Posttraumatic Stress Disorder Checklist - Civilian Version
Временное ограничение: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
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Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Denise M. Sloan, PhD, VA Boston Healthcare System, National Center for PTSD; Boston University School of Medicine
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- H-27236
- R34MH077658 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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