Effectiveness of Basic Body Awareness Therapy in Survivors of Covid-19, Health Workers and Women Suffering From Gender-based Violence Regarding Post-traumatic Stress Disorders: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 54
- 主要终点
- Change in Davidson Trauma Scale (DTS)
研究概览
简要总结
The aim of this randomized controlled clinical trial is to assess the effectiveness of Basic Body Awareness Therapy online in patients' survivors of Covid-19, health workers and women suffering from gender based violence regarding post-traumatic stress disorder in comparison with treatment as usual. The study will be multicentric in base Hospital Igualada and University of Lleida. The participants will be survivors of Covid-19 that had been inpatient in intensive care and health workers in first line with pandemia as doctors, nurse, physiotherapist, etc. More else, a new context emerge regarding gender based violence during the lockdown time. Outcomes variables will be measured regarding post-traumatic stress disorder, anxiety, depression, pain, quality of life and sleep. Fifty-four patients will be randomly assigned to a control group that will follow treatment as usual. The intervention group that will be received the same treatment adding Basic Body Awareness Therapy. The intervention will last 3 months twice a week at online format. At first month the intervention consisted of 12 movements and 15 min for sharing reflections about experiences. During the subsequent sessions, the treatment will be in group of 8 participants using the same methodology online. If the conditions of pandemia allow, the group will be presential in the health center at last month. Data analysis will performed using ANOVA of variables intragroup with repeated measurements. The analyses of the effects between groups will be performed throught ANOVA intergroup.
详细描述
This protocol of research is addressed to assess the effectiveness of Basic Body Awareness Therapy (BBAT) as physiotherapist intervention adjunct treatment as usual with the aim to improve the symptoms of post-traumatic stress disorder (PTSD) in survivors of Covid-19, health workers and women suffering from gender-based violence.
Nowadays the world lives a pandemic of unknown diseases with a high mortality and propagation. It results a huge number of patients admitted in intensive care unity. Health workers and patients suffering the fact of unknown the outcome of Covid-19 as such as, the treatment and prevention of it. The level of stress of that situation and the isolation could generate a breeding ground for develop the PTSD.
Post-traumatic stress disorder (PTSD) includes symptoms such as persistent re-experiencing, sleep pattern disorders, nightmares, hyperarousal, avoidance of stimuli associated with trauma or phobia occurring after a traumatic experience. Some situations that could provoke PTSD are sexual abuse, gender-based violence or danger of death situations such as wars, kidnapping.
Otherwise some diseases could trigger PTSD, in the epidermal necrolysis comprising Stevens-Johnson syndrome is usual the life-threatening reaction with a prevalence of 65% of patients presents PTSD and 29% possible clinical of PTSD. Also PTSD has been assessed in other situations such as gender-based violence in american students with a prevalence of 40.4%, moreover in war veterans the prevalence is between 11-20% while in war refugees the prevalence is 68% in Denmark. More else, a new context of gender-based violence emerges during the lockdown time in our society.
The pharmacological treatment for PTSD is based in fluoxetine, paroxetine, sertraline and venlafaxine. There is insufficient evidence to recommend for or against offering risperidone and topiramate. Regarding non-pharmacological treatment the strongly recommendations are cognitive-behavioural therapy, cognitive processing therapy, cognitive therapy and prolonged exposure therapy. Additionally, the clinical practice guideline conditionally recommends the use of brief eclectic psychotherapy, eye movement desensitization and reprocessing (EMDR), and narrative exposure therapy (NET) Basic Body Awareness Therapy (BBAT), a health oriented, multi-perspective and person-centred approach with a focus on the patient's resources, is a movement awareness training approach in physiotherapy, aiming to promote movement quality in daily life through self-exploration and self-experience enabling the learning of new movement habits. Understanding movement quality as the art of consciously being, doing and relating to oneself and others will result in more functional daily life, relationships and actions. The features of movement quality as a phenomenon in the physiotherapeutic context are classified into four perspectives- biomechanical, physiological, bio-psycho-social and existential. BBAT consists of a broad scope of movements in the following positions: lying, sitting, standing and walking. Relational movements are practiced in therapy with components such as rhythm, form, elasticity, flow, intention and voice. To gain more functional movement quality, the physiotherapist focuses the guidance on postural balance, free breathing, and awareness, seeking to integrate them into movement. This method is applied in conditions such as psychosomatic, eating disorders, schizophrenia, depression, chronic pain and PTSD.
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)
盲法说明
The researcher will be blinded to group of participant
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
- •a) survivors of COVID-19, health workers and women suffering from gender-based violence with level of post-traumatic stress disorder scale (DSM-V) moderate or severe,
- •b) age >18 years,
- •c) they could manage to stand in the position of "lying", "sitting", and "standing" without assistance
排除标准
- •a) they could not follow the intervention due to mental or physical health
结局指标
主要结局
Change in Davidson Trauma Scale (DTS)
时间窗: Baseline, 1 month , 3 months and 6 months follow up
The DTS is a 17-item self-report measure that assesses the 17 DSM-IV symptoms of PTSD. Items are rated on 5-point frequency (0 = "not at all" to 4 = "every day") and severity scales (0 = "not at all distressing" to 4 = "extremely distressing"). Respondents are asked to identify the trauma that is most disturbing to them and to rate, in the past week, how much trouble they have had with each symptom. The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). It can be used to make a preliminary determination about whether the symptoms meet DSM criteria for PTSD. Scores can also be calculated for each of the 3 PTSD symptom clusters
次要结局
- Change in State-Trait Anxiety Inventory (STAI)(Baseline, 1 month , 3 months and 6 months follow up)
- Change in Beck Depression Inventory (BDI)(Baseline, 1 month , 3 months and 6 months follow up)
- Change in Pittsburgh Sleep Quality Index (PSQI)(Baseline, 1 month , 3 months and 6 months follow up)
- Change in Short Form 36 (SF36)(Baseline, 1 month , 3 months and 6 months follow up)
- Change in Visual Analogue Scale (VAS)(Baseline, 1 month , 3 months and 6 months follow up)
研究者
Cristina Bravo
PhD
Universitat de Lleida
