Body Therapy for War Veterans With Post Traumatic Stress Disorder (PTSD): A Combined Randomized Controlled Trial (RCT) and Qualitative Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Self-reported PTSD symptoms by the PTSD checklist - military version (PCL-M)
研究概览
简要总结
The present study is a randomized, controlled trial that compares a certain type of body therapy, called ManuVision, to treatment as usual (TAU) in war veterans with posttraumatic stress disorder (PTSD). The purpose of the study is to determine whether participation in the body therapy treatment by war veterans who have PTSD, will reduce symptoms of PTSD and depression, and improve quality of life, function level and body awareness.
Study hypotheses state that the ManuVision approach, compared to the treatment as usual, will be more effective at reducing the PTSD symptoms experienced by veterans because it will help the veterans learning to become aware of, accept the PTSD symptoms, reading their own emotional state and gain body awareness and subsequently have emotional control and improved coping mechanism when PTSD symptoms arise. The awareness, accept and improved coping mechanisms means that the nervous system is not under the same pressure and that PTSD symptoms therefore may be reduced.
详细描述
Background: A sizable proportion of soldiers involved in military missions are experiencing mental health and adjustment problems on their return, including PTSD. PTSD is both a psychological and a physical condition, which occurs as a post-reaction to one or more traumatic experiences. The symptoms include aggressive behaviour, difficulty sleeping, tiredness, anxiety, and social isolation, and many sufferers develop depression, and the war veterans are at a higher risk of suicide. Physiologically, people with PTSD experience an activation of their sympathetic nervous system, whereby the stress hormones adrenalin and cortisol are released, the heart rate increases, the blood pressure rises, and the body is geared toward a 'fight or flight' response. A major challenge for veterans with PTSD is emotional control and problems with reading their own and others' emotional state.
This study will provide a certain type of body therapy, called ManuVision, to war veterans with PTSD. ManuVision is a Danish developed body therapy working with direct physical treatment of the body and through this approach with the client's psychosocial resources. There are conversations during and before treatment, as appropriate, and trust is intentionally built from the first meeting through eye contact and open breathing on behalf of the ManuVision therapist. The treatment is based on the understanding that chock, trauma and stress are stored in the body blocking the muscles and breathing and affecting the nerve system.
The intervention in this project entails individual courses of body therapy including 24 treatment sessions over 6 months for veterans with PTSD, plus recommended daily meditation at home.
The study goals are to:
- Investigate how the body therapy treatment is implemented, and how the participants experience the treatment, respond to the treatment and which transformations participants experience in the everyday life (a process evaluation by qualitative methods).
- Compare the body therapy treatment with treatment as usual (TAU). Symptoms of PTSD, depression, function level, quality of life, and body awareness will be examined at pre-treatment, midway during the treatment period, post-treatment and, if possible, at follow-up to determine if symptoms change over time (an effect evaluation by quantitative methods).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet criteria for clinical PTSD or subclinical PTSD assessed by The Structured Clinical Interview for DSM-IV (SCID)
- •Demonstrate understanding of informed consent and normal cognitive skills
排除标准
- •Current substance dependence (alcohol or drugs)
- •Severe mental disorders such as schizophrenia, Bipolar I or II disorder, or current psychiatric conditions such as psychosis or mania
结局指标
主要结局
Self-reported PTSD symptoms by the PTSD checklist - military version (PCL-M)
时间窗: Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
The PTSD checklist contains 17 items corresponding to the DSM-IV criteria for PTSD. Past month symptom severity is indicated using a 5 point scale. Higher scores represent greater severity.
次要结局
- Self-reported depression symptoms as measured by the Major Depression Inventory (MDI)(Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months))
- Function level using the Sheehan Disability Scale (SDS)(Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months))
- Self-reported quality of life using the World Health Organization Five Well-Being Index (WHO-5)(Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months))
- Self-reported body awareness using the Multidimensional Assessment of Interceptive Awareness (MAIA) Questionnaire(Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months))
研究者
Susan Andersen
Principal investigator
University of Southern Denmark