Prolonged Exposure Therapy for Post Traumatic Stress Disorder Following Sexual Assault
Effectiveness of Treatment for PTSD in Community Agencies
Обзор исследования
Статус
Подробное описание
PE is a brief cognitive behavioral therapy that can ameliorate symptoms of PTSD, depression, and anxiety in survivors of various types of trauma. PE has been successfully implemented by counselors at a community rape crisis clinic (Women Organized Against Rape [WOAR]) who received extensive training and weekly supervision from PE experts. Such extensive expert involvement is not a practical model for long-term clinical practice in a community-based clinic. Therefore, Part 1 of this study will examine whether counselors at WOAR can maintain their PE implementation success with reduced expert involvement. In Part 2 of this study, PE will be implemented by counselors at another community clinic (Joseph J. Peters Institute [JJPI]) to examine its effectiveness in treating PTSD and to determine the generalizability of training procedures.
Participants in this study are randomly assigned to either PE or to individual and group therapy. Treatment sessions are conducted weekly for 10 to 20 weeks, based on participants' rates of improvement. Participants are assessed before treatment, after 10 weeks, and again in the follow-up phase at 3, 6, 12, and 24 months post-treatment.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
- Фаза 3
Контакты и местонахождение
Места учебы
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Соединенные Штаты, 19104
- Center for the Treatment and Study of Anxiety, University of Pennsylvania
-
Philadelphia, Pennsylvania, Соединенные Штаты, 19107
- Women Organized Against Rape (WOAR)
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- DSM-IV criteria for PTSD at least 12 weeks after sexual assault
- PTSD symptoms that result from sexual assault and not from another traumatic experience
Exclusion Criteria:
- DSM-IV criteria for schizophrenia or delusional disorder
- Unstable bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment. Clients who are medicated and still meet current criteria for these disorders will be excluded.
- Substance dependence
- Continued intimate relationship with the assailant
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 |
|---|---|
|
Активный компаратор: 1 Prolonged Exposure
Prolonged Exposure (PE) consists of 10 weekly 90-minute treatment sessions, which may be extended up to 20 sessions, depending on client response.
Treatment procedures include education about common reactions to trauma, breathing retraining, prolonged (repeated) exposure to trauma memories, repeated in vivo exposure to situations the client is avoiding due to trauma-related fear, and discussion of thoughts and feelings related to exposure exercises as well as beliefs about self and the world.
|
Prolonged Exposure (PE) consists of 10 weekly 90-minute treatment sessions, which may be extended up to 20 sessions, depending on client response.
Treatment procedures include education about common reactions to trauma, breathing retraining, prolonged (repeated) exposure to trauma memories, repeated in vivo exposure to situations the client is avoiding due to trauma-related fear, and discussion of thoughts and feelings related to exposure exercises as well as beliefs about self and the world.
|
|
Активный компаратор: 2 Individual and group therapy
TUGT (Treatment as usual group therapy - used in Study 1), delivered in ten weekly sessions, with 5 to 7 members and two counselors per group. There is no formal, structured format for these groups; counselors are sensitive to the participants' needs and follow their lead re content covered in discussions and exercises. Supportive counseling (SC - study 2): individual therapy delivered in 10 weekly, 90 minute sessions. Therapist helps patient identify daily stresses that may or may not be related to traumatic events and discusses them in a supportive non-directive mode with a problem-solving orientation. The goal of this present-focused treatment is to provide support and to help the client to identify problems and stresses of daily living and to help her cope with these. |
TUGT is delivered in ten weekly sessions, with 5 to 7 members and two counselors per group.
There is not a formal, structured format for these groups; the counselors are sensitive to the participants' needs and follow their lead in terms of content covered in discussions and exercises.
TUGT is conceptualized as supportive counseling and is based on the idea that members gain social support and information from one another.
Supportive counseling is an individual therapy delivered in 10 weekly, 90 minute sessions.
During this treatment, the therapist helps the patient identify daily stresses that may or may not be related to traumatic events and discusses them in a supportive non-directive mode with a problem-solving orientation.
The therapist uses active listening, encouragement of expression of feelings, praise, and encouragement.
The goal of this present-focused treatment is to provide support and to help the client to identify problems and stresses of daily living and to help her cope with these.
No instructions for exposure are given.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Severity of PTSD, depression, anxiety and general function
Временное ограничение: Measured pre- and post-treatment
|
Measured pre- and post-treatment
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Elizabeth A Hembree, PhD, University of Pennsylvania Faculty
Даты записи исследования
Изучение основных дат
Начало исследования
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 (Оценивать)
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
- R01MH042178 (Грант/контракт NIH США)
- DSIR AT-AS
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Prolonged Exposure (PE)
-
University Health Network, TorontoYork UniversityЗавершенныйЭпилепсия | Тревожные расстройства и симптомыКанада
-
Oslo University HospitalЗавершенный
-
Sunnybrook Health Sciences CentreNorth York General HospitalРекрутинг
-
Research Foundation for Mental Hygiene, Inc.University of Colorado, Boulder; Harvard UniversityЗавершенныйПосттравматическое стрессовое расстройство (ПТСР)Соединенные Штаты
-
University of VirginiaUniversity of North CarolinaАктивный, не рекрутирующийДиетическая привычка | Сахаросодержащие напиткиСоединенные Штаты
-
Sheba Medical CenterЗавершенный
-
Magneto Thrombectomy SolutionsЕще не набирают
-
Laval UniversityPraxis Spinal Cord InstituteЗапись по приглашениюНеполная травма спинного мозгаКанада
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityЕще не набираютХроническое лучевое поражение
-
University of VirginiaUniversity of North CarolinaРекрутингДиетическая привычка | Сахаросодержащие напиткиСоединенные Штаты