Effectiveness of Basic Body Awareness Therapy in Post-traumatic Stress Disorders: A Randomized Clinical Trial

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.

Due to it is difficult to determinate the number of patients that will develop PTSD. Due to
special circumstances of Spain without protective equipment, lack of health resources,
changes in organization of health system and clinical guidelines and large etc. is
predictable that health workers as nurses, doctors, physiotherapist and other professionals
could develop PTSD, as well as, women suffering from gender violence. Studies about health
workers shows that they are so susceptible to suffer PTSD in pandemic, crisis and emergency
situations. It is predictable PTSD will appear as a high challenge in order to restore the
health of survivors, health workers and women suffering from gender-based violence.

The aim of this study is to assess whether BBAT online adjunct with treatment as usual
improves symptoms of PTSD in comparison of treatment as usual regarding level of anxiety,
depression, quality of life, quality of sleep and pain.

Methods Hypothesis and general objectives: The project will be developed to answer questions
about the effectiveness of BBAT regarding PTSD in survivors of Covid-19, health workers and
women under gender violence. The hypothesis will be based on " the BBAT in survivors of
Covid-19, health workers and women suffering violence as treatment adjunct of usual in
comparison of treatment as usual alone, generate improvement of level of anxiety, depression,
pain, quality of life and sleep diminishing the level of PTSD".

The general objectives will be assessed the response of survivors of Covid-10, health workers
and women suffering violence to BBAT in comparison with treatment as usual. The specific
objectives will be assessed the improvement of level of PTSD regarding anxiety, depression,
quality of life and sleep and pain.

The study follows the Declaration of Helsinki and the "Guidelines for Good Clinical
Practice". The clinical trial will be registered at ClinicalTrials.gov. According to the
Helsinki Declaration, a specific informed consent will be used, which will be authorized by
the local Ethical committee of Arnau de Vilanova Hospital and Igualada Hospital.
Additionally, Royal Decree 3/2018 of 5th December which related to the data protection for
the participants of the research, the data will be saved in an encrypted file. The ethical
Committee of Clinical Research of Arnau de Vilanova of Lleida will approve the protocol.
Clinical information, including clinical charts, pathology reports and working live will be
available in anonymized data file that will be guarded by the main researcher.

Study participants According to the research protocol, the study will be conducted at a
primary healthcare center. Participants will be eligible if 1) survivors of Covid-19, health
workers and women suffering gender 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. The exclusion criteria
will be 1) they could not follow the intervention due to mental or physical health.

The sample size is determined according Argimon' formula of comparison of proportions. The
psychological effectiveness as cognitive behaviour therapy is 60% of improvement of symptoms.
The hypothesis will be arrived to 80% with a risk of 0.05 and statistical power of 95%. Due
to data, the sample size will be of 23 participants by group. More else, the drop-out
estimate is 15% and then, the group will be of 27 participants each one at least. The study
is design multicentric and more than 27 participants are expected to be, the budget have the
estimation of 81 participants in different settings.

A clinical trial will be conducted with two controlled and randomized parallel groups. The
participants will have to be collected from the data base of mental health center of Igualada
Hospital by a postdoc researcher and they will be invited to attend to an informational
meeting. In this meeting, all patients willing to participate will have to sign a written
informed consent form to participate in the trial and will have to full a socio-demographic
questionnaire. The randomized process will complete using the software Epidat v 4.0. A number
will assign to the participants, and then the program will generate two groups of numbers,
the control and intervention groups. The results of randomizations will communicate by
telephone to the participants. The study will start at September 2020 for 24 weeks, and all
participants will assess at baseline, at 1 month of intervention, at end of the 3 months of
treatment period and at 3 months follow-ups. Participants of both groups will be continued
treatment as usual, which included pharmacological and psychological therapy. Participants in
the control group will have the same exposure in time as the intervention group and will ask
to maintain their lifestyle during the whole study and to refrain from starting any new
regular physical activity. In case they could not maintain the same lifestyle during the
study period, they will be asked to inform the researchers at any of the assessments.

Intervention: BBAT will be developed twice a week for 12 weeks online form. The intervention
consisted in one month of individual treatment consisted on 12 movements. During the
subsequent sessions, the participants joined in BBAT group sessions of 9 members each one. If
the state of pandemic allows, the last 4 weeks the intervention will be on-site. The control
group will follow the treatment as usual that consist in pharmacological treatment and
cognitive based behaviour achieving by psychiatrist and psychologist.

Outcomes: the variables of study were in relation to PTSD, anxiety, and depression. The
validate scales will be Davidson Trauma Scale (DTS) for PTSD, Visual Analogue Scale (VAS),
Beck Depression Inventory (BDI) for depression, State Trait Anxiety Inventory (STAI) for
anxiety, Short Form 36(SF-36) y Pittsburgh Scale (PS) for quality of life and sleep.

4.- Principal Investigator and team: The principal investigator will be Joan Blanco-Blanco,
nurse specialist in geriatric and gerontology of Ministry of Education, Culture and Sports
since 2014 and member of committee consultant of national group for studies and assessment of
wound (GNEAUPP). Researcher of the Group of Studies on Society, Health, Education and Culture
(GESEC) of the University of Lleida and collaborator of the Research Group on Health Cures
(GRECS) of the Institute of Biomedical Research of Lleida (IRBLleida) in some projects with
common interests. He is currently a professor at the Faculty of Nursing and Physiotherapy of
the University of Lleida since 2009, where he received his PhD in 2013 (17/4/13) "cum laude",
having directed 4 doctoral theses, more than 30 final papers and more than 15 final papers
for his Master's degree. In this context, he has participated in several projects basically
related to nursing practices in vulnerable groups, intergenerational learning through web
platforms and problems related to aging, dependency and fragility, highlighting his work as a
researcher in the European project ANIMATE and as a principal Researcher in the national
project OTAGO. Reviewer of the journals: Clinical Nursing, Nutrients, Medicina Paliatiava,
Journal of Advanced Nursing and Disability and Rehabilitation. In relation to team
management, he was Dean of the Faculty of Nursing and Physiotherapy for 6 years, until 2019.

The following members also belong to the research team:

- Cristina Bravo Navarro has a research career in line with and favourable to this call,
taking into account that she has already carried out a clinical trial with similar
characteristics evaluating the effectiveness of BBAT in patients with fibromyalgia
assessing variables related to pain, anxiety and depression. She has a doctorate in
physiotherapy from the University of Lleida and a BBAT therapist from the University of
Bergen (Norway). From her thesis "Effectiveness of Basal Body Awareness Therapy in
patients suffering from fibromyalgia" from which numerous articles have been published
in scientific journals.

- Dr. Joan Enric Torra-Bou is a post-doc researcher at the Faculty of Nursing and
Physiotherapy of the University of Lleida with extensive experience in research who has
directed a national project funded in 1998 file: 98/0483. He carried out his doctoral
thesis on topics related to epidemiology. In 2017 he led a project funded by the
Fundation Nursing and Society of the Barcelona College of Nursing PR-247/17. He also has
numerous publications in the field of nursing and epidemiology.

- Dr. Daniel Catalán-Matamoros participates as an expert in BBAT, co-director of the
International Master of Physiotherapy in BBAT at the University of Almería and has
directed several doctoral theses on the effectiveness of BBAT in mental disorders and
has numerous publications in the field of physiotherapy in mental health. He is also the
president of the Spanish Association of Physiotherapists in Mental Health
(www.fisioterapiasm.es) and has been a PI and researcher in projects funded by the
European Commission and the National R&D Plan.

- Francesc Rubí-Carnacea participates as an expert in physical therapy in the field of
chronic pain and therapeutic exercise. He has also participated in the development of
several competitive projects and degree research works. He is a clinical physiotherapist
with more than 25 years of experience in the psychosocial treatment of patients

5.- Impact of the proposal: Regarding the scientific impact in relation within the
challenge of health in pandemic circumstances it is necessary take care of health
workers to cope the possible next pandemic situations and patients to be productive in
society. The achievement of the objectives of the project will directly affect
positively in the social economy of public health due the cost-effectiveness is
significantly low in the physiotherapy intervention than pharmacology and psychology
ones. Besides, the changes in lifestyle of patient probably will be long-lasting and it
will suppose that patients will be autonomous, and they could manage their symptoms by
oneself.

Also, if the hypothesis confirms there will be a new and safety treatment, even the
researcher could hypothesize that movement awareness could effective to prevent the PTSD in
next possible situations.