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

NCT04396314 | Unknown DMC

• 1 other identifier: UL-002
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

PostTraumatic Stress Disorder

Keywords

Basic Body Awareness Therapy; physiotherapy; anxiety; depression

Outcome Measures

Primary Outcomes (1)

• Change in Davidson Trauma Scale (DTS)

  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

  Baseline, 1 month , 3 months and 6 months follow up

Secondary Outcomes (5)

• Change in Beck Depression Inventory (BDI)

  Baseline, 1 month , 3 months and 6 months follow up

• Change in State-Trait Anxiety Inventory (STAI)

  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

• Change in Pittsburgh Sleep Quality Index (PSQI)

  Baseline, 1 month , 3 months and 6 months follow up

Study Arms (2)

Basic Body Awareness Therapy

EXPERIMENTAL

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. 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

Behavioral: Basic Body Awareness Therapy

Control

ACTIVE COMPARATOR

The control group will be treatment for usual for PTSD. Pharmacological treatment is based in fluoxetine, paroxetine, sertraline and venlafaxine. Regarding non-pharmacological treatment the strongly recommendations are cognitive-behavioural therapy, cognitive processing therapy, cognitive therapy and prolonged exposure therapy

Behavioral: Psychological treatment

Interventions

Basic Body Awareness Therapy BEHAVIORAL

Basic Body Awareness Therapy (BBAT), a health oriented, multi-perspective and person-centred approach with a focus on the patient's resources. It 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

Basic Body Awareness Therapy

Psychological treatment BEHAVIORAL

Cognitive-behavioural therapy, cognitive processing therapy, cognitive therapy and prolonged exposure therapy

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• a) they could not follow the intervention due to mental or physical health

Sponsors & Collaborators

• Universitat de Lleida: lead
• Francesc Rubí Carnacea: collaborator

Related Publications (2)

• Bravo C, Skjaerven LH, Espart A, Guitard Sein-Echaluce L, Catalan-Matamoros D. Basic Body Awareness Therapy in patients suffering from fibromyalgia: A randomized clinical trial. Physiother Theory Pract. 2019 Oct;35(10):919-929. doi: 10.1080/09593985.2018.1467520. Epub 2018 May 3.

  PMID: 29723080 RESULT

• Madsen TS, Carlsson J, Nordbrandt M, Jensen JA. Refugee experiences of individual basic body awareness therapy and the level of transference into daily life. An interview study. J Bodyw Mov Ther. 2016 Apr;20(2):243-51. doi: 10.1016/j.jbmt.2015.10.007. Epub 2015 Oct 26.

  PMID: 27210839 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Cristina Bravo Navarro, PhD

  Department Nursing and Physiotherapy

  STUDY DIRECTOR

Central Study Contacts

Cristina Bravo, PhD

CONTACT

+34 656312125; cristina.bravo@udl.cat

Francesc Rubí-Carnacea, PhD

CONTACT

+34 629817981; frubi@dif.udl.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher will be blinded to group of participant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: randomized controlled clinical trial

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 20, 2020
• Study Start: September 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: April 30, 2022
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share